86. 肺動脈性肺高血圧症 Pulmonary arterial hypertension Clinical trials / Disease details
臨床試験数 : 1,205 / 薬物数 : 684 - (DrugBank : 124) / 標的遺伝子数 : 100 - 標的パスウェイ数 : 193
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT05649748 (ClinicalTrials.gov) | February 28, 2023 | 6/12/2022 | A Study to Assess the Safety, Tolerability, and Effectiveness of the Long-Term Use of Treprostinil Palmitil Inhalation Powder (TPIP) in Participants With Pulmonary Arterial Hypertension (PAH) | An Open-Label Extension Study to Assess the Safety, Tolerability, and Effectiveness of the Long-Term Use of Treprostinil Palmitil Inhalation Powder in Participants With Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension | Drug: Treprostinil Palmitil;Drug: Placebo | Insmed Incorporated | NULL | Recruiting | 18 Years | N/A | All | 100 | Phase 2/Phase 3 | Japan |
| 2 | NCT05452889 (ClinicalTrials.gov) | January 31, 2023 | 9/6/2022 | PET Image in PAH Patients | Utilizing 18F-fluoroglutamine PET Imaging in Patients With Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension | Diagnostic Test: 18F-FGLN PET Imaging;Drug: (18F)FPGLU | Stephen Y. Chan | Bayer;National Heart, Lung, and Blood Institute (NHLBI) | Recruiting | 18 Years | 75 Years | All | 50 | Early Phase 1 | United States |
| 3 | NCT05587712 (ClinicalTrials.gov) | January 19, 2023 | 17/10/2022 | Study to Evaluate Sotatercept (MK-7962) in Children With Pulmonary Arterial Hypertension (PAH) (MK-7962-008) | A Phase 2 Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Sotatercept (MK-7962) in Children From 1 to Less Than 18 Years of Age With PAH on Standard of Care | Pulmonary Arterial Hypertension | Drug: Sotatercept | Merck Sharp & Dohme LLC | NULL | Recruiting | 1 Year | 17 Years | All | 42 | Phase 2 | United States |
| 4 | EUCTR2022-000478-25-ES (EUCTR) | 23/12/2022 | 13/10/2022 | Sotatercept in Children with Pulmonary Artery Hypertension on Standard of Care | A Phase 2 Open-label Study to Evaluate the Safety, Tolerability,Pharmacokinetics, and Pharmacodynamics of Sotatercept (MK-7962) in Children from 1 to Less Than 18 Years of Age With PAH on Standard of Care - Sotatercept in Children with PAH on SoC | Pulmonary arterial hypertension MedDRA version: 21.1;Level: LLT;Classification code 10037403;Term: Pulmonary hypertension NOS;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Sotatercept Product Code: MK-7962 INN or Proposed INN: Sotatercept | Merck Sharp & Dohme LLC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 42 | Phase 2 | United States;Spain;Turkey;Israel;Colombia;United Kingdom;France;Mexico;Poland;Australia;South Africa;Netherlands;Germany | ||
| 5 | EUCTR2021-001910-13-NL (EUCTR) | 08/12/2022 | 16/02/2022 | Inhaled Imatinib Pulmonary Arterial Hypertension Clinical Trial (IMPAHCT) or A Phase 2b/3, Randomized, Controlled, 24-week Dose Ranging and Confirmatory Study of AV-101 in Patients with PAH. | IMPAHCT: A Phase 2b/3, Randomized, Double-Blind, Placebo-Controlled, 24-Week Dose Ranging and Confirmatory Study to Evaluate the Safety and Efficacy of AV-101 in Patients with Pulmonary Arterial Hypertension (PAH). - IMPAHCT | Pulmonary Arterial Hypertension (PAH) MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 20.0;Level: LLT;Classification code 10077729;Term: Pulmonary arterial hypertension WHO functional class III;Classification code 10077730;Term: Pulmonary arterial hypertension WHO functional class IV;Classification code 10077740;Term: Pulmonary arterial hypertension WHO functional class II;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: AV-101 INN or Proposed INN: IMATINIB Other descriptive name: Not Available Product Name: AV-101 INN or Proposed INN: IMATINIB Other descriptive name: Not Available Product Name: AV-101 INN or Proposed INN: IMATINIB Other descriptive name: Not Available | Aerovate Therapeutics, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 462 | Phase 2;Phase 3 | United States;Portugal;Greece;Spain;Ireland;Chile;Israel;Colombia;Italy;France;Australia;South Africa;Netherlands;China;Czechia;Turkey;Austria;United Kingdom;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Singapore;Germany;Sweden | ||
| 6 | NCT05557942 (ClinicalTrials.gov) | November 2, 2022 | 15/9/2022 | Inhaled iMatinib Pulmonary Arterial Hypertension Clinical Trial - Follow Up Long Term Extension (IMPAHCT-FUL) | A Long-Term Extension, Multi-Center Safety Study of AV-101 in Subjects With Pulmonary Arterial Hypertension (PAH) Who Have Completed Study AV-101-002 (IMPAHCT-FUL) | Pulmonary Arterial Hypertension | Drug: AV-101 | Aerovate Therapeutics | NULL | Recruiting | 18 Years | 75 Years | All | 462 | Phase 3 | United States;Australia |
| 7 | NCT05339087 (ClinicalTrials.gov) | October 24, 2022 | 14/4/2022 | Efficacy and Safety of Riociguat in Incipient Pulmonary Vascular Disease as an Indicator for Early PAH | Efficacy and Safety of Riociguat (MK-4836) in Incipient Pulmonary Vascular Disease as an Indicator for Early Pulmonary Arterial Hypertension Double-blind, Randomized, Multicenter, Multinational, Placebo-controlled Phase IIa Study (ESRA) | Pulmonary Vascular Disorder;Primary Pulmonary Hypertension;Systemic Sclerosis;Other Systemic Involvement of Connective Tissue | Drug: Riociguat Oral Tablet;Other: Placebo | Heidelberg University | Merck Sharp & Dohme LLC | Recruiting | 18 Years | N/A | All | 70 | Phase 2 | Germany |
| 8 | NCT04039464 (ClinicalTrials.gov) | August 1, 2022 | 1/7/2019 | Mono vs. Dual Therapy for Pediatric Pulmonary Arterial Hypertension | Kids MoD PAH Trial: Mono- vs. Duo-Therapy for Pediatric Pulmonary Arterial Hypertension | Pediatric Pulmonary Hypertension | Drug: Mono-Therapy with Sildenafil;Drug: Duo-Therapy with Sildenafil + Bosentan | Johns Hopkins University | NULL | Recruiting | 4 Months | 18 Years | All | 100 | Phase 3 | United States;Canada |
| 9 | JPRN-jRCT2051220042 | 07/06/2022 | 09/06/2022 | Clinical trial of Nitric Oxide inhalation therapy in patients with severe PH | A Single-Center, Randomised, Controlled Trial of the Efficacy and Safety of Inhaled Nitric Oxide therapy in the patients with severe right heart failure due to pulmonary hypertension | Pulmonary arterial hypertension (PAH), and Chronic thromboembolic pulmonary hypertension (CTEPH) PH, Nitric oxide, PAH, CTEPH, Right heart failure;D006976 | Study drug: Nitric Oxide (INOflo for inhalation 800ppm) Start inhalation at a concentration of 20 ppm, and if the blood methemoglobin concentration is below 2%, increase the dose by 10 ppm every 5 minutes to a maximum concentration of 40 ppm. On withdrawal from inhalation, if hemodynamics and oxygenation are stable, reduce inhalation dose by half every 5 minutes, gradually decreasing to 5 ppm. And then, If hemodynamics and oxygenation are stable at 1 ppm, attempt inhalation withdrawal every 5 minutes. | Ogo Takeshi | NULL | Pending | >= 18age old | Not applicable | Both | 30 | Phase 2 | Japan |
| 10 | EUCTR2020-005061-13-AT (EUCTR) | 05/05/2022 | 02/12/2021 | A Long-term Follow-up Study of Sotatercept for PAH Treatment | An Open-Label Long-term Follow-up Study to Evaluate the Effects of Sotatercept When Added to Background Pulmonary Arterial Hypertension (PAH) Therapy for the Treatment of PAH - A Long-term Follow-up Study of Sotatercept for PAH | Pulmonary Arterial Hypertension (PAH) MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Sotatercept - 60 mg/vial Product Code: ACE-011/ MK-7962 INN or Proposed INN: SOTATERCEPT Other descriptive name: ActRIIA-IgG1Fc Product Name: Sotatercept - 45 mg/vial Product Code: ACE-011/ MK-7962 INN or Proposed INN: SOTATERCEPT Other descriptive name: ActRIIA-IgG1Fc | Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ, USA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 700 | Phase 3 | Serbia;Portugal;United States;Taiwan;Greece;Spain;Israel;Colombia;Switzerland;Italy;France;Australia;Denmark;Netherlands;Korea, Republic of;Czechia;Austria;United Kingdom;Mexico;Canada;Argentina;Brazil;Poland;Belgium;Croatia;Germany;New Zealand;Sweden | ||
| 11 | EUCTR2021-001910-13-ES (EUCTR) | 28/04/2022 | 25/01/2022 | Inhaled Imatinib Pulmonary Arterial Hypertension Clinical Trial (IMPAHCT) or A Phase 2b/3, Randomized, Controlled, 24-week Dose Ranging and Confirmatory Study of AV-101 in Patients with PAH. | IMPAHCT: A Phase 2b/3, Randomized, Double-Blind, Placebo-Controlled, 24-Week Dose Ranging and Confirmatory Study to Evaluate the Safety and Efficacy of AV-101 in Patients with Pulmonary Arterial Hypertension (PAH). - IMPAHCT | Pulmonary Arterial Hypertension (PAH) MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 20.0;Level: LLT;Classification code 10077729;Term: Pulmonary arterial hypertension WHO functional class III;Classification code 10077730;Term: Pulmonary arterial hypertension WHO functional class IV;Classification code 10077740;Term: Pulmonary arterial hypertension WHO functional class II;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: AV-101 INN or Proposed INN: IMATINIB Other descriptive name: Not Available Product Name: AV-101 INN or Proposed INN: IMATINIB Other descriptive name: Not Available Product Name: AV-101 INN or Proposed INN: IMATINIB Other descriptive name: Not Available | Aerovate Therapeutics, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 462 | Phase 2;Phase 3 | United States;Portugal;Greece;Spain;Chile;Israel;Colombia;Italy;France;Australia;South Africa;Netherlands;China;Czechia;Turkey;Austria;United Kingdom;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Singapore;Germany;Sweden | ||
| 12 | EUCTR2020-005061-13-HR (EUCTR) | 14/04/2022 | 12/05/2022 | A Long-term Follow-up Study of Sotatercept for PAH Treatment | An Open-Label Long-term Follow-up Study to Evaluate the Effects of Sotatercept When Added to Background Pulmonary Arterial Hypertension (PAH) Therapy for the Treatment of PAH - A Long-term Follow-up Study of Sotatercept for PAH | Pulmonary Arterial Hypertension (PAH) MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Sotatercept - 60 mg/vial Product Code: ACE-011 INN or Proposed INN: SOTATERCEPT Other descriptive name: ActRIIA-IgG1Fc Product Name: Sotatercept - 45 mg/vial Product Code: ACE-011 INN or Proposed INN: SOTATERCEPT Other descriptive name: ActRIIA-IgG1Fc | Acceleron Pharma Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 700 | Phase 3 | Serbia;Portugal;United States;Taiwan;Greece;Spain;Israel;Colombia;Italy;Switzerland;France;Australia;Denmark;Netherlands;Korea, Republic of;Czechia;Austria;United Kingdom;Mexico;Canada;Argentina;Brazil;Poland;Belgium;Croatia;Germany;New Zealand;Sweden | ||
| 13 | NCT04954742 (ClinicalTrials.gov) | April 13, 2022 | 29/6/2021 | Effects of Riociguat on RIght VEntricular Size and Function in PAH and CTEPH | An Open-label, Prospective, Single Centre Study of the Effects of Riociguat on RIght VEntricular Size and Function in Pulmonary Arterial Hypertension and Chronic Thromboembolic Pulmonary Hypertension | Primary Pulmonary Arterial Hypertension;Chronic Thromboembolic Pulmonary Hypertension | Drug: Riociguat | Heidelberg University | Merck Sharp & Dohme Corp. | Recruiting | 18 Years | N/A | All | 30 | Phase 4 | Germany |
| 14 | NCT04791514 (ClinicalTrials.gov) | March 29, 2022 | 8/3/2021 | A Study of Treprostinil Palmitil Inhalation Powder (TPIP) In Pulmonary Arterial Hypertension (PAH) | An Open-Label Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of Treprostinil Palmitil Inhalation Powder in Participants With Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension | Drug: Treprostinil Palmitil | Insmed Incorporated | NULL | Terminated | 18 Years | N/A | All | 1 | Phase 2 | United States |
| 15 | EUCTR2020-005061-13-DK (EUCTR) | 25/03/2022 | 22/12/2021 | A Long-term Follow-up Study of Sotatercept for PAH Treatment | An Open-Label Long-term Follow-up Study to Evaluate the Effects of Sotatercept When Added to Background Pulmonary Arterial Hypertension (PAH) Therapy for the Treatment of PAH - A Long-term Follow-up Study of Sotatercept for PAH | Pulmonary Arterial Hypertension (PAH) MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Sotatercept - 60 mg/vial Product Code: ACE-011 INN or Proposed INN: SOTATERCEPT Other descriptive name: ActRIIA-IgG1Fc Product Name: Sotatercept - 45 mg/vial Product Code: ACE-011 INN or Proposed INN: SOTATERCEPT Other descriptive name: ActRIIA-IgG1Fc | Acceleron Pharma Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 700 | Phase 3 | Serbia;Portugal;United States;Taiwan;Greece;Spain;Israel;Colombia;Switzerland;Italy;France;Australia;Denmark;Netherlands;Korea, Republic of;Czechia;Austria;United Kingdom;Mexico;Canada;Argentina;Brazil;Poland;Belgium;Croatia;Germany;New Zealand;Sweden | ||
| 16 | EUCTR2020-005061-13-PT (EUCTR) | 18/03/2022 | 07/12/2021 | A Long-term Follow-up Study of Sotatercept for PAH Treatment | An Open-Label Long-term Follow-up Study to Evaluate the Effects of Sotatercept When Added to Background Pulmonary Arterial Hypertension (PAH) Therapy for the Treatment of PAH - A Long-term Follow-up Study of Sotatercept for PAH | Pulmonary Arterial Hypertension (PAH) MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Sotatercept - 60 mg/vial Product Code: ACE-011 INN or Proposed INN: SOTATERCEPT Other descriptive name: ActRIIA-IgG1Fc Product Name: Sotatercept - 45 mg/vial Product Code: ACE-011 INN or Proposed INN: SOTATERCEPT Other descriptive name: ActRIIA-IgG1Fc | Acceleron Pharma Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 700 | Phase 3 | Germany;New Zealand;Sweden;United States;Serbia;Portugal;Taiwan;Greece;Spain;Israel;Colombia;Italy;Switzerland;France;Denmark;Australia;Netherlands;Korea, Republic of;Czechia;Austria;United Kingdom;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia | ||
| 17 | NCT04811092 (ClinicalTrials.gov) | March 18, 2022 | 16/3/2021 | Study of Sotatercept in Newly Diagnosed Intermediate- and High-Risk PAH Participants (MK-7962-005/A011-13) | A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate Sotatercept When Added to Background Pulmonary Arterial Hypertension (PAH) Therapy in Newly Diagnosed Intermediate- and High-risk PAH Patients | Pulmonary Arterial Hypertension | Drug: Sotatercept;Other: Placebo | Acceleron Pharma Inc. (a wholly owned subsidiary of Merck Sharp and Dohme, a subsidiary of Merck & Co., Inc.) | NULL | Recruiting | 18 Years | N/A | All | 662 | Phase 3 | United States;Argentina;Australia;Austria;Belgium;Brazil;Canada;Colombia;Croatia;Czechia;Denmark;France;Germany;Greece;Israel;Italy;Korea, Republic of;Netherlands;New Zealand;Poland;Portugal;Serbia;Spain;Sweden;Switzerland;Taiwan;United Kingdom |
| 18 | EUCTR2020-005061-13-BE (EUCTR) | 07/03/2022 | 26/11/2021 | A Long-term Follow-up Study of Sotatercept for PAH Treatment | An Open-Label Long-term Follow-up Study to Evaluate the Effects of Sotatercept When Added to Background Pulmonary Arterial Hypertension (PAH) Therapy for the Treatment of PAH - A Long-term Follow-up Study of Sotatercept for PAH | Pulmonary Arterial Hypertension (PAH) MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Sotatercept - 60 mg/vial Product Code: ACE-011 / MK-7962 INN or Proposed INN: SOTATERCEPT Other descriptive name: ActRIIA-IgG1Fc Product Name: Sotatercept - 45 mg/vial Product Code: ACE-011 / MK-7962 INN or Proposed INN: SOTATERCEPT Other descriptive name: ActRIIA-IgG1Fc | Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ, USA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 700 | Phase 3 | Serbia;Portugal;United States;Taiwan;Greece;Israel;Colombia;Switzerland;Italy;France;Australia;Denmark;Netherlands;Korea, Republic of;Czechia;Austria;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Germany;New Zealand;Sweden;Spain | ||
| 19 | EUCTR2020-005061-13-CZ (EUCTR) | 02/03/2022 | 20/12/2021 | A Long-term Follow-up Study of Sotatercept for PAH Treatment | An Open-Label Long-term Follow-up Study to Evaluate the Effects of Sotatercept When Added to Background Pulmonary Arterial Hypertension (PAH) Therapy for the Treatment of PAH - A Long-term Follow-up Study of Sotatercept for PAH | Pulmonary Arterial Hypertension (PAH) MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Sotatercept - 60 mg/vial Product Code: ACE-011 / MK - 7962 INN or Proposed INN: SOTATERCEPT Other descriptive name: ActRIIA-IgG1Fc Product Name: Sotatercept - 45 mg/vial Product Code: ACE-011 / MK-7962 INN or Proposed INN: SOTATERCEPT Other descriptive name: ActRIIA-IgG1Fc | Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ, USA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 700 | Phase 3 | Serbia;Portugal;United States;Taiwan;Greece;Spain;Israel;Colombia;Switzerland;Italy;France;Denmark;Australia;Netherlands;Korea, Republic of;Czechia;Austria;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Brazil;Poland;Belgium;Croatia;Germany;New Zealand;Sweden | ||
| 20 | EUCTR2021-001910-13-FR (EUCTR) | 21/02/2022 | 23/12/2021 | Inhaled Imatinib Pulmonary Arterial Hypertension Clinical Trial (IMPAHCT) or A Phase 2b/3, Randomized, Controlled, 24-week Dose Ranging and Confirmatory Study of AV-101 in Patients with PAH. | IMPAHCT: A Phase 2b/3, Randomized, Double-Blind, Placebo-Controlled, 24-Week Dose Ranging and Confirmatory Study to Evaluate the Safety and Efficacy of AV-101 in Patients with Pulmonary Arterial Hypertension (PAH). - IMPAHCT | Pulmonary Arterial Hypertension (PAH) MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 20.0;Level: LLT;Classification code 10077729;Term: Pulmonary arterial hypertension WHO functional class III;Classification code 10077730;Term: Pulmonary arterial hypertension WHO functional class IV;Classification code 10077740;Term: Pulmonary arterial hypertension WHO functional class II;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: AV-101 INN or Proposed INN: IMATINIB Other descriptive name: Not Available Product Name: AV-101 INN or Proposed INN: IMATINIB Other descriptive name: Not Available Product Name: AV-101 INN or Proposed INN: IMATINIB Other descriptive name: Not Available | Aerovate Therapeutics, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 462 | Phase 2;Phase 3 | United States;Portugal;Greece;Spain;Chile;Israel;Colombia;Italy;France;Australia;South Africa;Netherlands;China;Czechia;Turkey;Austria;United Kingdom;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Singapore;Germany;Sweden | ||
| 21 | JPRN-jRCT2031210626 | 15/02/2022 | 23/02/2022 | SATISFY-JP Trial | Satralizumab, an Anti-IL-6 receptor antibody, in the treatment of pulmonary arterial hypertension; safety and efficacy evaluation in Japan - Multicenter, Investigator-sponsored Trial- - SATISFY-JP Trial | Pulmonary Arterial Hypertension;D006976 | The trial will consist of three periods: a screening period (within 30 days), an efficacy evaluation period (24 weeks), and a continuous administration period (28 weeks). Screening period Written consent will be obtained from patients with PAH who have immune responsive-phenotype and inadequate response to existing drugs. After obtaining consent, screening tests related to the study will be conducted to determine eligibility for the study. Baseline testing will be conducted between enrollment and the start of study drug administration. Efficacy Evaluation Period The study drug will be administered at a dose of 120 mg subcutaneously at initial, 2-week, 4-week, and 4-week intervals thereafter. Efficacy will be assessed after 24 weeks of study drug administration. Subjects who demonstrate efficacy and wish to continue treatment will receive the study drug for 24 weeks and moving to the continuous treatment period. In all other cases, the study will be terminated after 24 weeks of the efficacy evaluation period without the administration of study drug. Continuation Dosing Period Subjects who demonstrate efficacy during the efficacy evaluation period and wish to continue will receive continued treatment with satralizumab at a dose of 120 mg subcutaneously every 4 weeks. | Tamura Yuichi | NULL | Recruiting | >= 20age old | < 80age old | Both | 24 | Phase 2 | Japan |
| 22 | EUCTR2020-005061-13-NL (EUCTR) | 09/02/2022 | 25/11/2021 | A Long-term Follow-up Study of Sotatercept for PAH Treatment | An Open-Label Long-term Follow-up Study to Evaluate the Effects of Sotatercept When Added to Background Pulmonary Arterial Hypertension (PAH) Therapy for the Treatment of PAH - A Long-term Follow-up Study of Sotatercept for PAH | Pulmonary Arterial Hypertension (PAH) MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Sotatercept - 60 mg/vial Product Code: ACE-011 INN or Proposed INN: SOTATERCEPT Other descriptive name: ActRIIA-IgG1Fc Product Name: Sotatercept - 45 mg/vial Product Code: ACE-011 INN or Proposed INN: SOTATERCEPT Other descriptive name: ActRIIA-IgG1Fc | Acceleron Pharma Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 700 | Phase 3 | United States;Serbia;Portugal;Taiwan;Greece;Spain;Ireland;Israel;Colombia;Switzerland;Italy;France;Australia;Denmark;Netherlands;Korea, Republic of;Czechia;Austria;United Kingdom;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Germany;New Zealand;Sweden | ||
| 23 | EUCTR2021-001498-21-DE (EUCTR) | 01/02/2022 | 24/09/2021 | A study to evaluate Sotatercept in Participants with PAH WHO FC III or FC IV at High Risk of Mortality | A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Sotatercept When Added to Maximum Tolerated Background Therapy in Participants With Pulmonary Arterial Hypertension (PAH) World Health Organization (WHO) Functional Class (FC) III or FC IV at High Risk of Mortality - A Phase3 Study of Sotatercept in Participants with PAH WHO FC III or FC IV at High Risk of Mortality | Pulmonary Arterial Hypertension (PAH) MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Sotatercept Product Code: ACE-011 INN or Proposed INN: SOTATERCEPT Other descriptive name: ActRIIA-IgG1Fc | Acceleron Pharma Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 166 | Phase 3 | France;United States;Mexico;Canada;Spain;Belgium;Australia;Israel;Netherlands;Germany;United Kingdom;Italy | ||
| 24 | EUCTR2021-001498-21-IT (EUCTR) | 26/01/2022 | 10/09/2021 | A study to evaluate Sotatercept in Participants with PAH WHO FC III or FC IV at High Risk of Mortality | A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Sotatercept When Added to Maximum Tolerated Background Therapy in Participants With Pulmonary Arterial Hypertension (PAH) World Health Organization (WHO) Functional Class (FC) III or FC IV at High Risk of Mortality - A Phase3 Study of Sotatercept in Participants with PAH WHO FC III or FC IV at High Risk of Mortality | Pulmonary Arterial Hypertension (PAH) MedDRA version: 20.0;Level: SOC;Classification code 10038738;Term: Respiratory, thoracic and mediastinal disorders;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Sotatercept Product Code: [ACE-011] | ACCELERON PHARMA INC. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 166 | Phase 3 | France;United States;Mexico;Canada;Spain;Belgium;Australia;Israel;Netherlands;Germany;United Kingdom;Italy | ||
| 25 | EUCTR2020-005061-13-PL (EUCTR) | 26/01/2022 | 02/12/2021 | A Long-term Follow-up Study of Sotatercept for PAH Treatment | An Open-Label Long-term Follow-up Study to Evaluate the Effects of Sotatercept When Added to Background Pulmonary Arterial Hypertension (PAH) Therapy for the Treatment of PAH - A Long-term Follow-up Study of Sotatercept for PAH | Pulmonary Arterial Hypertension (PAH) MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Sotatercept - 60 mg/vial Product Code: ACE-011/ MK-7962 INN or Proposed INN: SOTATERCEPT Other descriptive name: ActRIIA-IgG1Fc Product Name: Sotatercept - 45 mg/vial Product Code: ACE-011 / MK-7962 INN or Proposed INN: SOTATERCEPT Other descriptive name: ActRIIA-IgG1Fc | Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ, USA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 700 | Phase 3 | United States;Czechia;Portugal;Greece;Austria;Sweden;Netherlands;Poland;Brazil;Korea, Republic of;France;Serbia;Croatia;Colombia;Argentina;United Kingdom;Switzerland;Spain;New Zealand;Canada;Czech Republic;Belgium;Taiwan;Denmark;Mexico;Italy;Israel;Australia;Germany | ||
| 26 | EUCTR2021-000199-12-IT (EUCTR) | 26/01/2022 | 09/09/2021 | A Phase 3 Study of Sotatercept in Newly Diagnosed Intermediate- andHigh-risk Pulmonary arterial hypertension (PAH) Patients. | A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate Sotatercept When Added to Background Pulmonary Arterial Hypertension (PAH) Therapy in Newly Diagnosed Intermediate- and High-risk PAH Patients. - A Phase 3 Study of Sotatercept in Newly Diagnosed Intermediate- and High-risk PAH Patients | Pulmonary Arterial Hypertension (PAH) MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Sotatercept Product Code: [ACE-011] INN or Proposed INN: SOTATERCEPT Other descriptive name: ActRIIA-IgG1Fc | ACCELERON PHARMA INC. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 662 | Phase 3 | Serbia;United States;Portugal;Taiwan;Greece;Spain;Ireland;Israel;Chile;Colombia;Switzerland;Italy;France;Denmark;Australia;South Africa;Netherlands;Korea, Republic of;Czechia;Korea, Democratic People's Republic of;Austria;United Kingdom;Czech Republic;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Germany;New Zealand;Sweden | ||
| 27 | EUCTR2021-000199-12-HR (EUCTR) | 19/01/2022 | 03/02/2022 | A Phase 3 Study of Sotatercept in Newly Diagnosed Intermediate- and High-risk Pulmonary arterial hypertension (PAH) Patients. | A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate Sotatercept When Added to Background Pulmonary Arterial Hypertension(PAH) Therapy in Newly Diagnosed Intermediate- and High-risk PAH Patients. - A Phase 3 Study of Sotatercept in Newly Diagnosed Intermediate- and High-risk PAH Patients | Pulmonary Arterial Hypertension (PAH) MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Sotatercept Product Code: ACE-011 INN or Proposed INN: SOTATERCEPT Other descriptive name: ActRIIA-IgG1Fc | Acceleron Pharma Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 662 | Phase 3 | United States;Portugal;Serbia;Taiwan;Greece;Spain;Ireland;Israel;Colombia;Italy;Switzerland;France;Denmark;Australia;Netherlands;Korea, Republic of;Czechia;Austria;United Kingdom;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Germany;New Zealand;Sweden | ||
| 28 | EUCTR2020-005061-13-SE (EUCTR) | 10/01/2022 | 12/10/2021 | A Long-term Follow-up Study of Sotatercept for PAH Treatment | An Open-Label Long-term Follow-up Study to Evaluate the Effects of Sotatercept When Added to Background Pulmonary Arterial Hypertension (PAH) Therapy for the Treatment of PAH - A Long-term Follow-up Study of Sotatercept for PAH | Pulmonary Arterial Hypertension (PAH) MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Sotatercept - 60 mg/vial Product Code: ACE-011 INN or Proposed INN: SOTATERCEPT Other descriptive name: ActRIIA-IgG1Fc Product Name: Sotatercept - 45 mg/vial Product Code: ACE-011 INN or Proposed INN: SOTATERCEPT Other descriptive name: ActRIIA-IgG1Fc | Acceleron Pharma Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 700 | Phase 3 | Brazil;Belgium;Poland;Croatia;United States;Portugal;Serbia;Taiwan;Greece;Spain;Israel;Colombia;Italy;Switzerland;France;Denmark;Australia;Netherlands;Korea, Republic of;Czechia;Austria;United Kingdom;Mexico;Canada;Argentina;Germany;New Zealand;Sweden | ||
| 29 | EUCTR2020-004971-42-AT (EUCTR) | 21/12/2021 | 07/09/2021 | A Study of Rodatristat Ethyl in Patients With Pulmonary Arterial Hypertension (ELEVATE 2) | A Phase 2b, Dose-Ranging, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Rodatristat Ethyl in Patients with Pulmonary Arterial Hypertension - ELEVATE 2 | Pulmonary Arterial Hypertension (PAH) MedDRA version: 21.1;Level: PT;Classification code 10037400;Term: Pulmonary hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Rodatristat ethyl Product Code: RVT-1201 INN or Proposed INN: Rodatristat ethyl Other descriptive name: Rodatristat ethyl | Altavant Sciences GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 90 | Phase 2 | Serbia;United States;Czechia;Spain;Ukraine;Austria;United Kingdom;Italy;France;Czech Republic;Canada;Poland;Belgium;Bulgaria;Germany;Latvia;Moldova, Republic of;Bosnia and Herzegovina | ||
| 30 | EUCTR2021-000199-12-DK (EUCTR) | 16/12/2021 | 23/08/2021 | A Phase 3 Study of Sotatercept in Newly Diagnosed Intermediate- and High-risk Pulmonary arterial hypertension (PAH) Patients. | A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate Sotatercept When Added to Background Pulmonary Arterial Hypertension(PAH) Therapy in Newly Diagnosed Intermediate- and High-risk PAH Patients. - A Phase 3 Study of Sotatercept in Newly Diagnosed Intermediate- and High-risk PAH Patients | Pulmonary Arterial Hypertension (PAH) MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Sotatercept Product Code: ACE-011 INN or Proposed INN: SOTATERCEPT Other descriptive name: ActRIIA-IgG1Fc | Acceleron Pharma Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 662 | Phase 3 | Serbia;Portugal;United States;Taiwan;Greece;Spain;Ireland;Israel;Colombia;Switzerland;Italy;France;Australia;Denmark;Netherlands;Korea, Republic of;Czechia;Austria;United Kingdom;Czech Republic;Canada;Argentina;Brazil;Poland;Belgium;Croatia;Germany;New Zealand;Sweden | ||
| 31 | NCT05036135 (ClinicalTrials.gov) | December 2, 2021 | 16/8/2021 | A Study of AV-101 (Dry Powder Inhaled Imatinib) in Patients With Pulmonary Arterial Hypertension (PAH) | IMPAHCT: A Phase 2b/3, Randomized, Double-Blind, Placebo-Controlled, 24-Week Dose Ranging and Confirmatory Study to Evaluate the Safety and Efficacy of AV-101 in Patients With Pulmonary Arterial Hypertension (PAH) | Pulmonary Arterial Hypertension | Drug: AV-101;Drug: Placebo | Aerovate Therapeutics | NULL | Recruiting | 18 Years | 75 Years | All | 462 | Phase 2/Phase 3 | United States;Argentina;Australia;Belgium;Canada;Chile;France;Israel;Italy;Poland;Puerto Rico;Singapore;South Africa;Spain;Sweden;United Kingdom |
| 32 | NCT04896008 (ClinicalTrials.gov) | December 1, 2021 | 13/5/2021 | A Study of Sotatercept in Participants With PAH WHO FC III or FC IV at High Risk of Mortality (MK-7962-006/ZENITH) | A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Sotatercept When Added to Maximum Tolerated Background Therapy in Participants With Pulmonary Arterial Hypertension (PAH) World Health Organization (WHO) Functional Class (FC) III or FC IV at High Risk Mortality | Pulmonary Arterial Hypertension | Drug: Sotatercept;Other: Placebo | Acceleron Pharma Inc. (a wholly owned subsidiary of Merck Sharp and Dohme, a subsidiary of Merck & Co., Inc.) | NULL | Recruiting | 18 Years | 75 Years | All | 200 | Phase 3 | United States;Australia;Belgium;Canada;France;Germany;Israel;Italy;Mexico;Netherlands;Spain;United Kingdom |
| 33 | EUCTR2021-000199-12-CZ (EUCTR) | 29/11/2021 | 10/09/2021 | A Phase 3 Study of Sotatercept in Newly Diagnosed Intermediate- and High-risk Pulmonary arterial hypertension (PAH) Patients. | A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate Sotatercept When Added to Background Pulmonary Arterial Hypertension(PAH) Therapy in Newly Diagnosed Intermediate- and High-risk PAH Patients. - A Phase 3 Study of Sotatercept in Newly Diagnosed Intermediate- and High-risk PAH Patients | Pulmonary Arterial Hypertension (PAH) MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Sotatercept Product Code: ACE-011 INN or Proposed INN: SOTATERCEPT Other descriptive name: ActRIIA-IgG1Fc | Acceleron Pharma Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 662 | Phase 3 | Serbia;Portugal;United States;Taiwan;Greece;Spain;Ireland;Israel;Colombia;Italy;Switzerland;France;Australia;Denmark;Netherlands;Korea, Republic of;Czechia;Austria;United Kingdom;Czech Republic;Canada;Argentina;Brazil;Poland;Belgium;Croatia;Germany;New Zealand;Sweden | ||
| 34 | EUCTR2021-004002-21-AT (EUCTR) | 26/11/2021 | 06/09/2021 | A non-randomized, single-center, open, two-period study with paired design to compare measured steady-state treprostinil concentrations in human plasma under treatment with a 10 mg/ml treprostinil formulation and following a switch to a 20 mg/ml treprostinil formulation in patients with pulmonary arterial hypertension (PAH) | A single center, open-label, two-period, non-randomized, paired-design study to compare steady-state plasma levels following switch from a 10 mg/ml treprostinil formulation to a 20 mg/ml treprostinil formulation in patients with pulmonary arterial hypertension (PAH) | pulmonary arterial hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: 20 mg/ml Treprostinil INN or Proposed INN: treprostinil sodium Other descriptive name: TREPROSTINIL SODIUM Trade Name: Trisuva(r) Product Name: Trisuva(r) INN or Proposed INN: treprostinil sodium Other descriptive name: TREPROSTINIL SODIUM | AOP Orphan Pharmaceuticals GmbH | NULL | Not Recruiting | Female: yes Male: yes | 16 | Phase 2 | Austria | ||
| 35 | EUCTR2021-001498-21-NL (EUCTR) | 15/11/2021 | 14/09/2021 | A study to evaluate Sotatercept in Participants with PAH WHO FC III or FC IV at High Risk of Mortality | A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Sotatercept When Added to Maximum Tolerated Background Therapy in Participants With Pulmonary Arterial Hypertension (PAH) World Health Organization (WHO) Functional Class (FC) III or FC IV at High Risk of Mortality - A Phase3 Study of Sotatercept in Participants with PAH WHO FC III or FC IV at High Risk of Mortality | Pulmonary Arterial Hypertension (PAH) MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Sotatercept Product Code: ACE-011 INN or Proposed INN: SOTATERCEPT Other descriptive name: ActRIIA-IgG1Fc | Acceleron Pharma Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 166 | Phase 3 | France;United States;Mexico;Canada;Spain;Belgium;Australia;Israel;Germany;Netherlands;United Kingdom;Italy | ||
| 36 | EUCTR2021-000199-12-AT (EUCTR) | 12/11/2021 | 26/08/2021 | A Phase 3 Study of Sotatercept in Newly Diagnosed Intermediate- and High-risk Pulmonary arterial hypertension (PAH) Patients. | A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate Sotatercept When Added to Background Pulmonary Arterial Hypertension(PAH) Therapy in Newly Diagnosed Intermediate- and High-risk PAH Patients. - A Phase 3 Study of Sotatercept in Newly Diagnosed Intermediate- and High-risk PAH Patients | Pulmonary Arterial Hypertension (PAH) MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Sotatercept Product Code: ACE-011 INN or Proposed INN: SOTATERCEPT Other descriptive name: ActRIIA-IgG1Fc | Acceleron Pharma Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 662 | Phase 3 | Serbia;Portugal;United States;Taiwan;Greece;Spain;Ireland;Israel;Chile;Colombia;Switzerland;Italy;France;Denmark;Australia;South Africa;Netherlands;Korea, Republic of;Czechia;Austria;United Kingdom;Czech Republic;Canada;Argentina;Brazil;Poland;Belgium;Croatia;Germany;New Zealand;Sweden | ||
| 37 | EUCTR2021-001498-21-ES (EUCTR) | 11/11/2021 | 31/08/2021 | A study to evaluate Sotatercept in Participants with PAH WHO FC III or FC IV at High Risk of Mortality | A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Sotatercept When Added to Maximum Tolerated Background Therapy in Participants With Pulmonary Arterial Hypertension (PAH) World Health Organization (WHO) Functional Class (FC) III or FC IV at High Risk of Mortality - A Phase3 Study of Sotatercept in Participants with PAH WHO FC III or FC IV at High Risk of Mortality | Pulmonary Arterial Hypertension (PAH) MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Sotatercept Product Code: ACE-011 INN or Proposed INN: SOTATERCEPT Other descriptive name: ActRIIA-IgG1Fc | Acceleron Pharma Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 166 | Phase 3 | France;United States;Mexico;Canada;Belgium;Spain;Australia;Israel;Netherlands;Germany;United Kingdom;Italy | ||
| 38 | EUCTR2021-000199-12-ES (EUCTR) | 27/10/2021 | 23/08/2021 | A Phase 3 Study of Sotatercept in Newly Diagnosed Intermediate- and High-risk Pulmonary arterial hypertension (PAH) Patients. | A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate Sotatercept When Added to Background Pulmonary Arterial Hypertension(PAH) Therapy in Newly Diagnosed Intermediate- and High-risk PAH Patients. - A Phase 3 Study of Sotatercept in Newly Diagnosed Intermediate- and High-risk PAH Patients | Pulmonary Arterial Hypertension (PAH) MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Sotatercept Product Code: ACE-011 INN or Proposed INN: SOTATERCEPT Other descriptive name: ActRIIA-IgG1Fc | Acceleron Pharma Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 662 | Phase 3 | United States;Serbia;Portugal;Taiwan;Greece;Spain;Ireland;Israel;Chile;Colombia;Italy;Switzerland;France;Australia;South Africa;Netherlands;Korea, Republic of;Czechia;Austria;United Kingdom;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Germany;New Zealand;Sweden | ||
| 39 | EUCTR2020-004971-42-DE (EUCTR) | 26/10/2021 | 19/04/2021 | A Study of Rodatristat Ethyl in Patients With Pulmonary Arterial Hypertension (ELEVATE 2) | A Phase 2b, Dose-Ranging, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Rodatristat Ethyl in Patients with Pulmonary Arterial Hypertension - ELEVATE 2 | Pulmonary Arterial Hypertension (PAH) MedDRA version: 21.1;Level: PT;Classification code 10037400;Term: Pulmonary hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Rodatristat ethyl Product Code: RVT-1201 INN or Proposed INN: Rodatristat ethyl Other descriptive name: Rodatristat ethyl | Altavant Sciences GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 90 | Phase 2 | United States;Czechia;Ukraine;United Kingdom;Spain;Canada;Austria;Latvia;Czech Republic;Belgium;Moldova, Republic of;Poland;Italy;France;Bulgaria;Serbia;Bosnia and Herzegovina;Germany | ||
| 40 | EUCTR2021-000199-12-NL (EUCTR) | 20/10/2021 | 30/08/2021 | A Phase 3 Study of Sotatercept in Newly Diagnosed Intermediate- and High-risk Pulmonary arterial hypertension (PAH) Patients. | A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate Sotatercept When Added to Background Pulmonary Arterial Hypertension(PAH) Therapy in Newly Diagnosed Intermediate- and High-risk PAH Patients. - A Phase 3 Study of Sotatercept in Newly Diagnosed Intermediate- and High-risk PAH Patients | Pulmonary Arterial Hypertension (PAH) MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Sotatercept Product Code: ACE-011 INN or Proposed INN: SOTATERCEPT Other descriptive name: ActRIIA-IgG1Fc | Acceleron Pharma Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 662 | Phase 3 | United States;Serbia;Portugal;Taiwan;Greece;Spain;Israel;Colombia;Switzerland;Italy;France;Australia;Denmark;Netherlands;Korea, Republic of;Czechia;Austria;United Kingdom;Czech Republic;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Germany;New Zealand;Sweden | ||
| 41 | EUCTR2021-000199-12-DE (EUCTR) | 19/10/2021 | 19/08/2021 | A Phase 3 Study of Sotatercept in Newly Diagnosed Intermediate- and High-risk Pulmonary arterial hypertension (PAH) Patients. | A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate Sotatercept When Added to Background Pulmonary Arterial Hypertension(PAH) Therapy in Newly Diagnosed Intermediate- and High-risk PAH Patients. - A Phase 3 Study of Sotatercept in Newly Diagnosed Intermediate- and High-risk PAH Patients | Pulmonary Arterial Hypertension (PAH) MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Sotatercept Product Code: ACE-011 INN or Proposed INN: SOTATERCEPT Other descriptive name: ActRIIA-IgG1Fc | Acceleron Pharma Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 662 | Phase 3 | Argentina;Brazil;Poland;Belgium;Croatia;Germany;New Zealand;Sweden;Austria;United Kingdom;Czech Republic;Canada;Serbia;United States;Portugal;Taiwan;Greece;Spain;Israel;Colombia;Switzerland;Italy;France;Australia;Denmark;Netherlands;Korea, Republic of;Czechia | ||
| 42 | EUCTR2020-004971-42-BG (EUCTR) | 12/10/2021 | 05/07/2021 | A Study of Rodatristat Ethyl in Patients With Pulmonary Arterial Hypertension (ELEVATE 2) | A Phase 2b, Dose-Ranging, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Rodatristat Ethyl in Patients with Pulmonary Arterial Hypertension - ELEVATE 2 | Pulmonary Arterial Hypertension (PAH) MedDRA version: 21.1;Level: PT;Classification code 10037400;Term: Pulmonary hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Rodatristat ethyl Product Code: RVT-1201 INN or Proposed INN: Rodatristat ethyl Other descriptive name: Rodatristat ethyl | Altavant Sciences GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 90 | Phase 2 | Serbia;United States;Czechia;Spain;Ukraine;Austria;United Kingdom;Italy;France;Czech Republic;Canada;Poland;Belgium;Bulgaria;Latvia;Germany;Moldova, Republic of;Bosnia and Herzegovina | ||
| 43 | EUCTR2021-000199-12-SE (EUCTR) | 04/10/2021 | 05/08/2021 | A Phase 3 Study of Sotatercept in Newly Diagnosed Intermediate- and High-risk Pulmonary arterial hypertension (PAH) Patients. | A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate Sotatercept When Added to Background Pulmonary Arterial Hypertension(PAH) Therapy in Newly Diagnosed Intermediate- and High-risk PAH Patients. - A Phase 3 Study of Sotatercept in Newly Diagnosed Intermediate- and High-risk PAH Patients | Pulmonary Arterial Hypertension (PAH) MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Sotatercept Product Code: ACE-011 INN or Proposed INN: SOTATERCEPT Other descriptive name: ActRIIA-IgG1Fc | Acceleron Pharma Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 662 | Phase 3 | United States;Serbia;Portugal;Taiwan;Greece;Spain;Ireland;Israel;Colombia;Switzerland;Italy;France;Australia;Denmark;Netherlands;Korea, Republic of;Czechia;Austria;United Kingdom;Czech Republic;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Germany;New Zealand;Sweden | ||
| 44 | EUCTR2020-004971-42-PL (EUCTR) | 20/08/2021 | 25/05/2021 | A Study of Rodatristat Ethyl in Patients With Pulmonary Arterial Hypertension (ELEVATE 2) | A Phase 2b, Dose-Ranging, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Rodatristat Ethyl in Patients with Pulmonary Arterial Hypertension - ELEVATE 2 | Pulmonary Arterial Hypertension (PAH) MedDRA version: 21.1;Level: PT;Classification code 10037400;Term: Pulmonary hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Rodatristat ethyl Product Code: RVT-1201 INN or Proposed INN: Rodatristat ethyl Other descriptive name: Rodatristat ethyl | Altavant Sciences GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 90 | Phase 2 | Serbia;United States;Czechia;Spain;Ukraine;Austria;United Kingdom;Italy;France;Czech Republic;Canada;Poland;Belgium;Bulgaria;Latvia;Germany;Moldova, Republic of;Bosnia and Herzegovina | ||
| 45 | EUCTR2020-004971-42-ES (EUCTR) | 22/07/2021 | 22/07/2021 | A Study of Rodatristat Ethyl in Patients With Pulmonary Arterial Hypertension (ELEVATE 2) | A Phase 2b, Dose-Ranging, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Rodatristat Ethyl in Patients with Pulmonary Arterial Hypertension - ELEVATE 2 | Pulmonary Arterial Hypertension (PAH) MedDRA version: 21.1;Level: PT;Classification code 10037400;Term: Pulmonary hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Rodatristat ethyl Product Code: RVT-1201 INN or Proposed INN: Rodatristat ethyl Other descriptive name: Rodatristat ethyl | Altavant Sciences GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 90 | Phase 2 | Serbia;United States;Czechia;Spain;Ukraine;Russian Federation;United Kingdom;Italy;France;Canada;Poland;Belgium;Bulgaria;Germany;Latvia;Bosnia and Herzegovina | ||
| 46 | EUCTR2020-004971-42-CZ (EUCTR) | 22/07/2021 | 06/05/2021 | A Study of Rodatristat Ethyl in Patients With Pulmonary Arterial Hypertension (ELEVATE 2) | A Phase 2b, Dose-Ranging, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Rodatristat Ethyl in Patients with Pulmonary Arterial Hypertension - ELEVATE 2 | Pulmonary Arterial Hypertension (PAH) MedDRA version: 21.1;Level: PT;Classification code 10037400;Term: Pulmonary hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Rodatristat ethyl Product Code: RVT-1201 INN or Proposed INN: Rodatristat ethyl Other descriptive name: Rodatristat ethyl | Altavant Sciences GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 90 | Phase 2 | Serbia;United States;Czechia;Spain;Ukraine;Austria;United Kingdom;Italy;France;Czech Republic;Canada;Poland;Belgium;Bulgaria;Latvia;Germany;Moldova, Republic of;Bosnia and Herzegovina | ||
| 47 | NCT04813926 (ClinicalTrials.gov) | July 16, 2021 | 22/3/2021 | A Study to Learn About How Well Riociguat Works, How Safe it is and How it is Used Under Real World Conditions in Patients in the United States Who Are Receiving Riociguat for High Blood Pressure in the Arteries That Carry Blood From the Heart to the Lungs (Pulmonary Arterial Hypertension, PAH) | RiOciguAt UseRs Registry | Pulmonary Arterial Hypertension | Drug: Riociguat (Adempas, BAY63-2521) | Bayer | Xcenda, LLC | Recruiting | 18 Years | N/A | All | 500 | United States;Puerto Rico | |
| 48 | EUCTR2020-004971-42-BE (EUCTR) | 12/07/2021 | 28/04/2021 | A Study of Rodatristat Ethyl in Patients With Pulmonary Arterial Hypertension (ELEVATE 2) | A Phase 2b, Dose-Ranging, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Rodatristat Ethyl in Patients with Pulmonary Arterial Hypertension - ELEVATE 2 | Pulmonary Arterial Hypertension (PAH) MedDRA version: 21.1;Level: PT;Classification code 10037400;Term: Pulmonary hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Rodatristat ethyl Product Code: RVT-1201 INN or Proposed INN: Rodatristat ethyl Other descriptive name: Rodatristat ethyl | Altavant Sciences GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 90 | Phase 2 | Serbia;United States;Czechia;Spain;Ukraine;Russian Federation;United Kingdom;Italy;France;Canada;Belgium;Poland;Bulgaria;Germany;Latvia;Bosnia and Herzegovina | ||
| 49 | EUCTR2020-004971-42-LV (EUCTR) | 09/07/2021 | 22/04/2021 | A Study of Rodatristat Ethyl in Patients With Pulmonary Arterial Hypertension (ELEVATE 2) | A Phase 2b, Dose-Ranging, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Rodatristat Ethyl in Patients with Pulmonary Arterial Hypertension - ELEVATE 2 | Pulmonary Arterial Hypertension (PAH) MedDRA version: 21.1;Level: PT;Classification code 10037400;Term: Pulmonary hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Rodatristat ethyl Product Code: RVT-1201 INN or Proposed INN: Rodatristat ethyl Other descriptive name: Rodatristat ethyl | Altavant Sciences GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 90 | Phase 2 | United States;Serbia;Czechia;Spain;Ukraine;Russian Federation;United Kingdom;Italy;France;Canada;Belgium;Poland;Bulgaria;Latvia;Germany;Bosnia and Herzegovina | ||
| 50 | EUCTR2020-005061-13-ES (EUCTR) | 06/07/2021 | 08/07/2021 | A Long-term Follow-up Study of Sotatercept for PAH Treatment | An Open-Label Long-term Follow-up Study to Evaluate the Effects of Sotatercept When Added to Background Pulmonary Arterial Hypertension (PAH) Therapy for the Treatment of PAH - A Long-term Follow-up Study of Sotatercept for PAH | Pulmonary Arterial Hypertension (PAH) MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Sotatercept Product Code: ACE-011 INN or Proposed INN: SOTATERCEPT Other descriptive name: ActRIIA-IgG1Fc | Acceleron Pharma Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 700 | Phase 3 | Serbia;United States;Czechia;Spain;Ireland;Austria;Israel;United Kingdom;Switzerland;Italy;France;Mexico;Argentina;Poland;Brazil;Belgium;Australia;Netherlands;Germany;New Zealand;Sweden;Korea, Republic of | ||
| 51 | EUCTR2020-004971-42-IT (EUCTR) | 05/07/2021 | 07/06/2021 | A Study of Rodatristat Ethyl in Patients With Pulmonary Arterial Hypertension (ELEVATE 2) | A Phase 2b, Dose-Ranging, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Rodatristat Ethyl in Patients with Pulmonary Arterial Hypertension - ELEVATE 2 | Pulmonary Arterial Hypertension (PAH) MedDRA version: 21.1;Level: PT;Classification code 10037400;Term: Pulmonary hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Rodatristat ethyl Product Code: [RVT-1201] INN or Proposed INN: Rodatristat ethyl Other descriptive name: Rodatristat ethyl | Altavant Sciences GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 90 | Phase 2 | Serbia;United States;Czechia;Spain;Ukraine;Russian Federation;United Kingdom;Italy;France;Canada;Belgium;Poland;Bulgaria;Germany;Latvia;Bosnia and Herzegovina | ||
| 52 | EUCTR2020-005169-15-ES (EUCTR) | 28/06/2021 | 05/07/2021 | Clinical Study of Inhaled GB002 for the Treatment of WHO Group 1 Pulmonary Arterial Hypertension (PAH) | An Open-label Extension Study Evaluating the Long-term Safety and Efficacy of Oral Inhalation of GB002 for the Treatment of WHO Group 1 Pulmonary Arterial Hypertension (PAH) | Pulmonary Arterial Hypertension (PAH) MedDRA version: 20.0;Level: LLT;Classification code 10077739;Term: Pulmonary arterial hypertension WHO functional class I;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: GB002 Capsules Product Code: GB002 INN or Proposed INN: Seralutinib Other descriptive name: (S)-3-((3-(1-((6-(3,4-DIMETHOXYPHENYL)PRYAZIN-2- YL)AMINO)ETHYL)PHENYL)CARBAMOYL)-5-METHYLPRIDIN-1-IUM | GB002, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 80 | Phase 2 | France;United States;Serbia;Czechia;Canada;Belgium;Spain;Austria;Australia;Israel;Germany;United Kingdom | ||
| 53 | EUCTR2020-004142-11-PL (EUCTR) | 24/06/2021 | 23/03/2021 | A Phase 3 Study of Sotatercept for the Treatment of PAH | A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Compare the Efficacy and Safety of Sotatercept Versus Placebo When Added to Background Pulmonary Arterial Hypertension (PAH) Therapy for the Treatment of PAH - A Phase 3 Study of Sotatercept for the Treatment of PAH | Pulmonary Arterial Hypertension (PAH) MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Sotatercept Product Code: ACE-011 INN or Proposed INN: SOTATERCEPT Other descriptive name: ActRIIA-IgG1Fc | Acceleron Pharma Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 284 | Phase 3 | United States;Serbia;Czechia;Spain;Ireland;Austria;Israel;United Kingdom;Switzerland;Italy;France;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Australia;Netherlands;Germany;New Zealand;Sweden;Korea, Republic of | ||
| 54 | EUCTR2020-004142-11-IT (EUCTR) | 23/06/2021 | 08/06/2021 | A Phase 3 Study of Sotatercept for the Treatment of PAH | A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Compare the Efficacy and Safety of Sotatercept Versus Placebo When Added to Background Pulmonary Arterial Hypertension (PAH) Therapy for the Treatment of PAH - - | Pulmonary Arterial Hypertension (PAH) MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Sotatercept Product Code: [ACE-011] | ACCELERON PHARMA INC. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 284 | Phase 3 | Serbia;United States;Czechia;Spain;Korea, Democratic People's Republic of;Ireland;Austria;Israel;United Kingdom;Switzerland;Italy;France;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Australia;Netherlands;Germany;New Zealand;Sweden;Korea, Republic of | ||
| 55 | EUCTR2017-003934-10-PL (EUCTR) | 23/06/2021 | 26/07/2019 | A clinical study to investigate the long term safety of the drug macitentan in patients with pulmonary hypertension and who were previously treated with macitentan in clinical studies. | mUlticenter, single-arM, open-laBel, long-teRm safety study with macitEntan in patients with puLmonary hypertension previousLy treated with mAcitentan in clinical studies - UMBRELLA | Pulmonary arterial hypertension (PAH)Chronic thromboembolic pulmonary hypertension (CTEPH) MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 21.1;Level: LLT;Classification code 10068739;Term: Chronic thromboembolic pulmonary hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Opsumit Product Name: Macitentan Product Code: ACT-064992 INN or Proposed INN: MACITENTAN | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 176 | Phase 3 | France;Belarus;Belgium;Poland;Ukraine;Turkey;Russian Federation;Germany | ||
| 56 | EUCTR2020-005061-13-DE (EUCTR) | 22/06/2021 | 24/02/2021 | A Long-term Follow-up Study of Sotatercept for PAH Treatment | An Open-Label Long-term Follow-up Study to Evaluate the Effects of Sotatercept When Added to Background Pulmonary Arterial Hypertension (PAH) Therapy for the Treatment of PAH - A Long-term Follow-up Study of Sotatercept for PAH | Pulmonary Arterial Hypertension (PAH) MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Sotatercept - 60 mg/vial Product Code: ACE-011 INN or Proposed INN: SOTATERCEPT Other descriptive name: ActRIIA-IgG1Fc Product Name: Sotatercept - 45 mg/vial Product Code: ACE-011 INN or Proposed INN: SOTATERCEPT Other descriptive name: ActRIIA-IgG1Fc | Acceleron Pharma Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 700 | Phase 3 | United States;Portugal;Serbia;Taiwan;Greece;Spain;Ireland;Israel;Colombia;Switzerland;Italy;France;Denmark;Australia;Netherlands;Korea, Republic of;Czechia;Austria;United Kingdom;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Germany;New Zealand;Sweden | ||
| 57 | EUCTR2020-005169-15-CZ (EUCTR) | 17/06/2021 | 07/04/2021 | Clinical Study of Inhaled GB002 for the Treatment of WHO Group 1 Pulmonary Arterial Hypertension (PAH) | An Open-label Extension Study Evaluating the Long-term Safety and Efficacy of Oral Inhalation of GB002 for the Treatment of WHO Group 1 Pulmonary Arterial Hypertension (PAH) | Pulmonary Arterial Hypertension (PAH) MedDRA version: 20.0;Level: LLT;Classification code 10077739;Term: Pulmonary arterial hypertension WHO functional class I;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: GB002 Capsules Product Code: GB002 INN or Proposed INN: Seralutinib Other descriptive name: (S)-3-((3-(1-((6-(3,4-DIMETHOXYPHENYL)PRYAZIN-2- YL)AMINO)ETHYL)PHENYL)CARBAMOYL)-5-METHYLPRIDIN-1-IUM | GB002, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 80 | Phase 2 | Serbia;United States;Czechia;Spain;Austria;Israel;United Kingdom;France;Czech Republic;Canada;Belgium;Australia;Germany | ||
| 58 | EUCTR2020-005169-15-AT (EUCTR) | 16/06/2021 | 13/04/2021 | Clinical Study of Inhaled GB002 for the Treatment of WHO Group 1 Pulmonary Arterial Hypertension (PAH) | An Open-label Extension Study Evaluating the Long-term Safety and Efficacy of Oral Inhalation of GB002 for the Treatment of WHO Group 1 Pulmonary Arterial Hypertension (PAH) | Pulmonary Arterial Hypertension (PAH) MedDRA version: 20.0;Level: LLT;Classification code 10077739;Term: Pulmonary arterial hypertension WHO functional class I;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: GB002 Capsules Product Code: GB002 INN or Proposed INN: Seralutinib Other descriptive name: (S)-3-((3-(1-((6-(3,4-DIMETHOXYPHENYL)PRYAZIN-2- YL)AMINO)ETHYL)PHENYL)CARBAMOYL)-5-METHYLPRIDIN-1-IUM | GB002, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 80 | Phase 2 | Serbia;United States;Czechia;Spain;Austria;Israel;United Kingdom;France;Czech Republic;Canada;Belgium;Australia;Germany | ||
| 59 | NCT04732221 (ClinicalTrials.gov) | May 19, 2021 | 27/1/2021 | A Study of the Efficacy and Safety of MK-5475 in Participants With Pulmonary Arterial Hypertension (INSIGNIA-PAH: Phase 2/3 Study of an Inhaled sGC Stimulator in PAH) (MK-5475-007) | A Phase 2/3, Multicenter, Randomized, Double-blind, Placebo-Controlled, Adaptive Design Study to Evaluate the Efficacy and Safety of MK-5475 in Adults With Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension;Hypertension, Pulmonary | Drug: MK-5475;Drug: Placebo to MK-5475 | Merck Sharp & Dohme LLC | NULL | Recruiting | 18 Years | 75 Years | All | 450 | Phase 2/Phase 3 | United States;Argentina;Australia;Belgium;Canada;Colombia;France;Germany;Greece;Israel;Italy;Mexico;New Zealand;Poland;Russian Federation;Sweden;Turkey;United Kingdom |
| 60 | EUCTR2020-004142-11-DE (EUCTR) | 12/05/2021 | 19/01/2021 | A Phase 3 Study of Sotatercept for the Treatment of PAH | A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Compare the Efficacy and Safety of Sotatercept Versus Placebo When Added to Background Pulmonary Arterial Hypertension (PAH) Therapy for the Treatment of PAH - A Phase 3 Study of Sotatercept for the Treatment of PAH | Pulmonary Arterial Hypertension (PAH) MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Sotatercept Product Code: ACE-011 INN or Proposed INN: SOTATERCEPT Other descriptive name: ActRIIA-IgG1Fc | Acceleron Pharma Inc. | NULL | Not Recruiting | Female: yes Male: yes | 284 | Phase 3 | Argentina;United States;Czechia;United Kingdom;Switzerland;Spain;New Zealand;Canada;Austria;Sweden;Netherlands;Czech Republic;Belgium;Ireland;Brazil;Korea, Republic of;Poland;Mexico;Italy;Israel;Australia;France;Serbia;Germany | ||
| 61 | NCT04796337 (ClinicalTrials.gov) | May 12, 2021 | 22/2/2021 | A Long-term Follow-up Study of Sotatercept for PAH Treatment (MK-7962-004) | An Open-label Long-term Follow-up Study to Evaluate the Effects of Sotatercept When Added to Background Pulmonary Arterial Hypertension (PAH) Therapy for the Treatment of PAH | Pulmonary Arterial Hypertension;PAH | Biological: Sotatercept | Acceleron Pharma Inc. (a wholly owned subsidiary of Merck Sharp and Dohme, a subsidiary of Merck & Co., Inc.) | NULL | Recruiting | 18 Years | N/A | All | 700 | Phase 3 | United States;Argentina;Australia;Austria;Belgium;Brazil;Canada;Colombia;Croatia;Czechia;Denmark;France;Germany;Greece;Israel;Italy;Korea, Republic of;Mexico;Netherlands;New Zealand;Poland;Portugal;Serbia;Spain;Sweden;Switzerland;Taiwan;United Kingdom |
| 62 | EUCTR2019-002669-37-BE (EUCTR) | 04/05/2021 | 18/01/2021 | Clinical Study of Inhaled GB002 for the Treatment of WHO Group 1 Pulmonary Arterial Hypertension (PAH) | A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Clinical Study to Evaluate the Efficacy and Safety of Oral Inhalation of GB002 for the Treatment of WHO Group 1 Pulmonary Arterial Hypertension (PAH) | Pulmonary Arterial Hypertension (PAH) MedDRA version: 20.0;Level: LLT;Classification code 10077739;Term: Pulmonary arterial hypertension WHO functional class I;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: GB002 Capsules Product Code: GB002 INN or Proposed INN: Seralutinib Other descriptive name: (S)-3-((3-(1-((6-(3,4-DIMETHOXYPHENYL)PRYAZIN-2-YL)AMINO)ETHYL)PHENYL)CARBAMOYL)-5-METHYLPRIDIN-1-IUM | GB002, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 80 | Phase 2 | Serbia;United States;Czechia;Spain;Austria;Israel;United Kingdom;France;Czech Republic;Canada;Belgium;Australia;Germany | ||
| 63 | EUCTR2019-002817-21-FI (EUCTR) | 16/04/2021 | 11/02/2021 | A study to see if it is safe and helpful to add Selexipag to other PAH medication in children and adolescents. | A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Parallel-Group, Event-Driven, Group-Sequential Study with Open-Label Extension Period to Assess the Efficacy and Safety of Selexipag as Add-On Treatment to Standard of Care in Children Aged =2 to <18 years with Pulmonary Arterial Hypertension. - SALTO | Pulmonary Arterial Hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Uptravi Product Name: Selexipag Product Code: JNJ-67896049 (ACT-293987) INN or Proposed INN: SELEXIPAG Product Name: Selexipag Product Code: JNJ-67896049 (ACT-293987) INN or Proposed INN: SELEXIPAG | Actelion Pharmaceuticals Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 237 | Phase 3 | Portugal;Belarus;Serbia;United States;Taiwan;Spain;Thailand;Ukraine;Ireland;Russian Federation;Israel;Colombia;Switzerland;Italy;France;Malaysia;Viet Nam;Australia;Denmark;China;Korea, Republic of;Finland;Lithuania;Turkey;Austria;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;Sweden | ||
| 64 | EUCTR2020-004142-11-BE (EUCTR) | 15/04/2021 | 08/02/2021 | A Phase 3 Study of Sotatercept for the Treatment of PAH | A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Compare the Efficacy and Safety of Sotatercept Versus Placebo When Added to Background Pulmonary Arterial Hypertension (PAH) Therapy for the Treatment of PAH - A Phase 3 Study of Sotatercept for the Treatment of PAH | Pulmonary Arterial Hypertension (PAH) MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Sotatercept Product Code: ACE-011 INN or Proposed INN: SOTATERCEPT Other descriptive name: ActRIIA-IgG1Fc | Acceleron Pharma Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 284 | Phase 3 | United States;Serbia;Czechia;Spain;Ireland;Austria;Israel;United Kingdom;Switzerland;Italy;France;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Australia;Netherlands;Germany;New Zealand;Sweden;Korea, Republic of | ||
| 65 | NCT05569655 (ClinicalTrials.gov) | April 6, 2021 | 1/10/2022 | Efficacy and Safety Evaluation of Tolvaptan in the Treatment of Patients With RHF Caused by PAH | Efficacy and Safety Evaluation of Tolvaptan in the Treatment of Patients With Right Heart Failure Caused by Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension;Randomized Controlled Trial | Drug: Tolvaptan;Drug: Furosemide | Chinese Pulmonary Vascular Disease Research Group | NULL | Recruiting | 18 Years | N/A | All | 100 | N/A | China |
| 66 | NCT04816604 (ClinicalTrials.gov) | April 5, 2021 | 23/3/2021 | Open-label Extension Study of GB002 in Adult Subjects With Pulmonary Arterial Hypertension (PAH) | An Open-label Extension Study Evaluating the Long-term Safety and Efficacy of Oral Inhalation of GB002 for the Treatment of WHO Group 1 Pulmonary Arterial Hypertension (PAH) | Pulmonary Arterial Hypertension | Device: Generic Dry Powder Inhaler;Drug: GB002 (seralutinib) | GB002, Inc., a wholly owned subsidiary of Gossamer Bio, Inc. | NULL | Recruiting | 18 Years | 80 Years | All | 100 | Phase 2 | United States;Australia;Czechia;France;Germany;Spain;United Kingdom |
| 67 | EUCTR2020-004142-11-SE (EUCTR) | 26/03/2021 | 28/01/2021 | A Phase 3 Study of Sotatercept for the Treatment of PAH | A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Compare the Efficacy and Safety of Sotatercept Versus Placebo When Added to Background Pulmonary Arterial Hypertension (PAH) Therapy for the Treatment of PAH - A Phase 3 Study of Sotatercept for the Treatment of PAH | Pulmonary Arterial Hypertension (PAH) MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Sotatercept Product Code: ACE-011 INN or Proposed INN: SOTATERCEPT Other descriptive name: ActRIIA-IgG1Fc | Acceleron Pharma Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 284 | Phase 3 | Serbia;United States;Czechia;Spain;Ireland;Austria;Israel;United Kingdom;Switzerland;Italy;France;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Australia;Netherlands;Germany;New Zealand;Sweden;Korea, Republic of | ||
| 68 | EUCTR2020-004142-11-NL (EUCTR) | 24/03/2021 | 17/02/2021 | A Phase 3 Study of Sotatercept for the Treatment of PAH | A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Compare the Efficacy and Safety of Sotatercept Versus Placebo When Added to Background Pulmonary Arterial Hypertension (PAH) Therapy for the Treatment of PAH - A Phase 3 Study of Sotatercept for the Treatment of PAH | Pulmonary Arterial Hypertension (PAH) MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Sotatercept Product Code: ACE-011 INN or Proposed INN: SOTATERCEPT Other descriptive name: ActRIIA-IgG1Fc | Acceleron Pharma Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 284 | Phase 3 | United States;Serbia;Czechia;Spain;Ireland;Austria;Israel;United Kingdom;Switzerland;Italy;France;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Australia;Netherlands;Germany;New Zealand;Sweden;Korea, Republic of | ||
| 69 | NCT04576988 (ClinicalTrials.gov) | January 25, 2021 | 28/9/2020 | A Study of Sotatercept for the Treatment of Pulmonary Arterial Hypertension (MK-7962-003/A011-11)(STELLAR) | A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Compare the Efficacy and Safety of Sotatercept Versus Placebo When Added to Background Pulmonary Arterial Hypertension (PAH) Therapy for the Treatment of PAH | Pulmonary Arterial Hypertension | Biological: Sotatercept;Drug: Placebo;Drug: Background PAH Therapy | Acceleron Pharma Inc. (a wholly owned subsidiary of Merck Sharp and Dohme, a subsidiary of Merck & Co., Inc.) | NULL | Completed | 18 Years | N/A | All | 324 | Phase 3 | United States;Argentina;Australia;Belgium;Brazil;Canada;Czechia;France;Germany;Israel;Italy;Korea, Republic of;Mexico;Netherlands;New Zealand;Poland;Serbia;Spain;Sweden;Switzerland;United Kingdom |
| 70 | EUCTR2019-002669-37-CZ (EUCTR) | 21/01/2021 | 22/10/2020 | Clinical Study of Inhaled GB002 for the Treatment of WHO Group 1 Pulmonary Arterial Hypertension (PAH) | A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Clinical Study to Evaluate the Efficacy and Safety of Oral Inhalation of GB002 for the Treatment of WHO Group 1 Pulmonary Arterial Hypertension (PAH) | Pulmonary Arterial Hypertension (PAH) MedDRA version: 20.0;Level: LLT;Classification code 10077739;Term: Pulmonary arterial hypertension WHO functional class I;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: GB002 Capsules Product Code: GB002 INN or Proposed INN: Seralutinib Other descriptive name: (S)-3-((3-(1-((6-(3,4-DIMETHOXYPHENYL)PRYAZIN-2-YL)AMINO)ETHYL)PHENYL)CARBAMOYL)-5-METHYLPRIDIN-1-IUM | GB002, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 80 | Phase 2 | Austria;Israel;United Kingdom;France;Czech Republic;Canada;Belgium;Australia;Germany;Serbia;Czechia;Spain;United States | ||
| 71 | EUCTR2019-002669-37-DE (EUCTR) | 07/01/2021 | 28/07/2020 | Clinical Study of Inhaled GB002 for the Treatment of WHO Group 1 Pulmonary Arterial Hypertension (PAH) | A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Clinical Study to Evaluate the Efficacy and Safety of Oral Inhalation of GB002 for the Treatment of WHO Group 1 Pulmonary Arterial Hypertension (PAH) | Pulmonary Arterial Hypertension (PAH) MedDRA version: 20.0;Level: LLT;Classification code 10077739;Term: Pulmonary arterial hypertension WHO functional class I;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: GB002 Capsules Product Code: GB002 INN or Proposed INN: Seralutinib Other descriptive name: (S)-3-((3-(1-((6-(3,4-DIMETHOXYPHENYL)PRYAZIN-2-YL)AMINO)ETHYL)PHENYL)CARBAMOYL)-5-METHYLPRIDIN-1-IUM | GB002, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 80 | Phase 2 | Serbia;United States;Czechia;Spain;Austria;Israel;United Kingdom;France;Czech Republic;Canada;Belgium;Australia;Germany | ||
| 72 | NCT04280523 (ClinicalTrials.gov) | January 5, 2021 | 15/1/2020 | TranspulmonarY Estrogen Gradient and Estrogen Receptors (TYEGER) in PAH | TranspulmonarY Estrogen Gradient and Estrogen Receptors (TYEGER) in PAH | Pulmonary Arterial Hypertension | Drug: ESR-specific PET scan | Vanderbilt University Medical Center | NULL | Recruiting | 13 Years | N/A | All | 40 | Phase 2 | United States |
| 73 | EUCTR2019-002669-37-AT (EUCTR) | 15/12/2020 | 07/08/2020 | Clinical Study of Inhaled GB002 for the Treatment of WHO Group 1 Pulmonary Arterial Hypertension (PAH) | A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Clinical Study to Evaluate the Efficacy and Safety of Oral Inhalation of GB002 for the Treatment of WHO Group 1 Pulmonary Arterial Hypertension (PAH) | Pulmonary Arterial Hypertension (PAH) MedDRA version: 20.0;Level: LLT;Classification code 10077739;Term: Pulmonary arterial hypertension WHO functional class I;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: GB002 Capsules Product Code: GB002 INN or Proposed INN: Seralutinib Other descriptive name: (S)-3-((3-(1-((6-(3,4-DIMETHOXYPHENYL)PRYAZIN-2-YL)AMINO)ETHYL)PHENYL)CARBAMOYL)-5-METHYLPRIDIN-1-IUM | GB002, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 80 | Phase 2 | Serbia;United States;Czechia;Spain;Austria;Israel;United Kingdom;France;Czech Republic;Canada;Belgium;Australia;Germany | ||
| 74 | NCT04456998 (ClinicalTrials.gov) | December 14, 2020 | 30/6/2020 | GB002 in Adult Subjects With Pulmonary Arterial Hypertension (PAH) | A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Clinical Study to Evaluate the Efficacy and Safety of Oral Inhalation of GB002 for the Treatment of WHO Group 1 Pulmonary Arterial Hypertension (PAH) | Pulmonary Artery Hypertension | Drug: GB002 (seralutinib);Drug: Placebo;Device: Generic Dry Powder Inhaler | GB002, Inc., a wholly owned subsidiary of Gossamer Bio, Inc. | NULL | Completed | 18 Years | 75 Years | All | 86 | Phase 2 | United States;Australia;Austria;Belgium;Canada;Czechia;France;Germany;Serbia;Spain;United Kingdom;Israel |
| 75 | NCT04084678 (ClinicalTrials.gov) | October 29, 2020 | 6/9/2019 | A Study of Ralinepag to Evaluate Effects on Exercise Capacity by CPET in Subjects With WHO Group 1 PH | A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Ralinepag to Evaluate Safety and Effects on Exercise Capacity Assessed by CPET in Subjects With WHO Group 1 Pulmonary Hypertension Who Recently Initiated Therapy | PAH;Pulmonary Hypertension;Hypertension;Connective Tissue Disease;Familial Primary Pulmonary Hypertension;Vascular Diseases;Cardiovascular Diseases;Hypertension, Pulmonary;Lung Diseases;Respiratory Tract Disease;Pulmonary Arterial Hypertension | Drug: Ralinepag;Drug: Placebo | United Therapeutics | NULL | Active, not recruiting | 18 Years | N/A | All | 10 | Phase 3 | United States;Argentina;Australia;Austria;Belgium;Brazil;Canada;Germany;Italy;Poland;Spain |
| 76 | JPRN-JapicCTI-194971 | 23/10/2020 | 25/09/2019 | Clinical study to compare the efficacy and safety of macitentan and tadalafil monotherapies with the corresponding fixed-dose combination therapy in subjects with pulmonary arterial hypertension (PAH) | Prospective, Multi-center, Double-blind, Randomized, Active-controlled, Triple-dummy, Parallel-group, Group-sequential, Adaptive Phase 3 Clinical Study to Compare the Efficacy and Safety of Macitentan and Tadalafil Monotherapies with the Corresponding Fixed Dose Combination in Subjects with Pulmonary Arterial Hypertension (PAH), Followed by an Open-label Treatment Period with Macitentan and Tadalafil Fixed Dose Combination Therapy | pulmonary arterial hypertension | Intervention name : ACT-064992D INN of the intervention : - Dosage And administration of the intervention : Subjects to receive FDC macitentan/tadalafil (macitentan 10 mg and tadalafil 40 mg) plus matching placebos for the two other study treatments. Control intervention name : Macitentan INN of the control intervention : - Dosage And administration of the control intervention : Film-coated tablet with 10 mg macitentan, to be administered orally once daily. Control intervention name : Tadalafil INN of the control intervention : - Dosage And administration of the control intervention : Film-coated tablet with 40 mg tadalafil (2 x 20 mg tablets), to be administered orally once daily. Control intervention name : Placebo INN of the control intervention : - Dosage And administration of the control intervention : FDC therapy + Placebo macitentan + Placebo tadalafil , Macitentan mono-therapy + Placebo tadalafil + Placebo FDC, Tadalafil mono-therapy + Placebo macitentan + Placebo FDC | Janssen Pharmaceutical K.K. | NULL | complete | 18 | BOTH | 170 | Phase 3 | Japan, South America, Europe | |
| 77 | EUCTR2019-002669-37-GB (EUCTR) | 08/10/2020 | 11/05/2020 | Clinical Study of Inhaled GB002 for the Treatment of WHO Group 1 Pulmonary Arterial Hypertension (PAH) | A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Clinical Study to Evaluate the Efficacy and Safety of Oral Inhalation of GB002 for the Treatment of WHO Group 1 Pulmonary Arterial Hypertension (PAH) | Pulmonary Arterial Hypertension (PAH) MedDRA version: 20.0;Level: LLT;Classification code 10077739;Term: Pulmonary arterial hypertension WHO functional class I;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: GB002 Capsules Product Code: GB002 INN or Proposed INN: Seralutinib Other descriptive name: (S)-3-((3-(1-((6-(3,4-DIMETHOXYPHENYL)PRYAZIN-2-YL)AMINO)ETHYL)PHENYL)CARBAMOYL)-5-METHYLPRIDIN-1-IUM | GB002, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 80 | Phase 2 | United States;Serbia;France;Austria;Australia;Israel;Germany;United Kingdom;Canada;Belgium;Singapore | ||
| 78 | NCT04567602 (ClinicalTrials.gov) | October 6, 2020 | 23/9/2020 | A Study of Pulmonary Arterial Hypertension Participants Treated With Macitentan or Selexipag | Non-Interventional Study on Pulmonary Arterial Hypertension Patients Treated With Macitentan or Selexipag: Experience From an Italian Cohort (INSPECTIO) | Pulmonary Arterial Hypertension | Drug: PAH medication | Janssen-Cilag S.p.A. | NULL | Active, not recruiting | 18 Years | N/A | All | 186 | Italy | |
| 79 | EUCTR2019-002669-37-FR (EUCTR) | 01/10/2020 | 15/07/2020 | Clinical Study of Inhaled GB002 for the Treatment of WHO Group 1 Pulmonary Arterial Hypertension (PAH) | A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Clinical Study to Evaluate the Efficacy and Safety of Oral Inhalation of GB002 for the Treatment of WHO Group 1 Pulmonary Arterial Hypertension (PAH) | Pulmonary Arterial Hypertension (PAH) MedDRA version: 20.0;Level: LLT;Classification code 10077739;Term: Pulmonary arterial hypertension WHO functional class I;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: GB002 Capsules Product Code: GB002 INN or Proposed INN: Seralutinib Other descriptive name: (S)-3-((3-(1-((6-(3,4-DIMETHOXYPHENYL)PRYAZIN-2-YL)AMINO)ETHYL)PHENYL)CARBAMOYL)-5-METHYLPRIDIN-1-IUM | GB002, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 80 | Phase 2 | United States;Serbia;France;Canada;Belgium;Singapore;Austria;Australia;Israel;Germany;United Kingdom | ||
| 80 | NCT04266197 (ClinicalTrials.gov) | September 25, 2020 | 22/1/2020 | Vardenafil Inhaled for Pulmonary Arterial Hypertension PRN Phase 2B Study | A Phase 2b, Open-label, Single Dose Study to Evaluated the Safety and Efficacy of RT234 on Exercise Parameters Assessed by Cardiopulmonary Exercise Testing (CPET) in Subjects With Pulmonary Arterial Hypertension (PAH) | Pulmonary Arterial Hypertension | Combination Product: Drug: RT234 - vardenafil inhalation powder; Device: Axially Oscillating Sphere dry powder inhaler (AOS DPI) | Respira Therapeutics, Inc. | NULL | Recruiting | 18 Years | 80 Years | All | 86 | Phase 2 | United States;Serbia |
| 81 | EUCTR2020-002788-80-DE (EUCTR) | 09/09/2020 | 08/06/2020 | Study to evaluate the safety, tolerability and efficacy of AZD4831 in thetreatment of patients with pulmonary hypertension | An explorative study to assess the safety, tolerability, and efficacy of AZD4831 in the treatment of pulmonary arterial hypertension (PAH)(MPO-PAH) | Group 1: Pulmonary arterial hypertension (PAH)Group 2: Postcapillary pulmonary hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 21.1;Classification code 10037400;Term: Pulmonary hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: AZD4831 | University of Cologne | NULL | Not Recruiting | Female: yes Male: yes | 15 | Phase 2 | Germany | ||
| 82 | EUCTR2019-002817-21-LT (EUCTR) | 13/08/2020 | 25/05/2020 | A study to see if it is safe and helpful to add Selexipag to other PAH medication in children and adolescents. | A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Parallel-Group, Event-Driven, Group-Sequential Study with Open-Label Extension Period to Assess the Efficacy and Safety of Selexipag as Add-On Treatment to Standard of Care in Children Aged =2 to <18 years with Pulmonary Arterial Hypertension. - SALTO | Pulmonary Arterial Hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Uptravi Product Name: Selexipag Product Code: JNJ-67896049 (ACT-293987) INN or Proposed INN: SELEXIPAG Product Name: Selexipag Product Code: JNJ-67896049 (ACT-293987) INN or Proposed INN: SELEXIPAG Product Name: Selexipag Product Code: JNJ-67896049 (ACT-293987) INN or Proposed INN: SELEXIPAG Product Name: Selexipag Product Code: JNJ-67896049 (ACT-293987) INN or Proposed INN: SELEXIPAG | Actelion Pharmaceuticals Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 237 | Phase 3 | Serbia;Portugal;United States;Belarus;Taiwan;Thailand;Spain;Ukraine;Ireland;Russian Federation;Israel;Colombia;Switzerland;Italy;France;Malaysia;Viet Nam;Australia;China;Korea, Republic of;Finland;Turkey;Lithuania;Hungary;Mexico;Canada;Brazil;Poland;Belgium;Bulgaria;Germany;Sweden | ||
| 83 | EUCTR2019-003309-88-DE (EUCTR) | 30/07/2020 | 21/02/2020 | A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Ralinepag to Evaluate Safety and Effects on Exercise Capacity Assessed by Cardiopulmonary Exercise Testing in Subjects with World Health Organization Group 1 Pulmonary Hypertension Who Recently Initiated Therapy - ADVANCE Capacity | A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Ralinepag to Evaluate Safety and Effects on Exercise Capacity Assessed by Cardiopulmonary Exercise Testing in Subjects with World Health Organization Group 1 Pulmonary Hypertension Who Recently Initiated Therapy - ADVANCE Capacity | pulmonary arterial hypertension (PAH) MedDRA version: 20.0;Level: LLT;Classification code 10077731;Term: Pulmonary hypertension WHO functional class I;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: RALINEPAG Other descriptive name: AR392830 Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: RALINEPAG Other descriptive name: AR392830 Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: RALINEPAG Other descriptive name: AR392830 | United Therapeutics Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 193 | Phase 3 | United States;Argentina;Spain;Poland;Belgium;Brazil;Austria;Australia;Germany;United Kingdom;Italy | ||
| 84 | EUCTR2020-001157-48-GB (EUCTR) | 28/07/2020 | 09/07/2020 | PIPAH study: Using imatinib (drug) in Pulmonary Arterial Hypertension | Identifying a safe and tolerated dose of Imatinib forpatients with Pulmonary Arterial Hypertension (PAH) - Positioning Imatinib for Pulmonary Arterial Hypertension (PIPAH) | Pulmonary Arterial Hypertension (Idiopathic, heritable, or assosicated with anorexigens) MedDRA version: 21.1;Level: LLT;Classification code 10036727;Term: Primary pulmonary hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 21.1;Level: PT;Classification code 10037400;Term: Pulmonary hypertension;Classification code 10068739;Term: Chronic thromboembolic pulmonary hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 20.0;Classification code 10050701;Term: Congenital pulmonary hypertension;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 20.0;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Imatinib mesilate Product Name: Imatinib mesilate INN or Proposed INN: Imatinib mesilate | Imperial College London | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 43 | Phase 2 | United Kingdom | ||
| 85 | EUCTR2019-002817-21-PT (EUCTR) | 27/07/2020 | 06/02/2020 | A study to see if it is safe and helpful to add Selexipag to other PAH medication in children and adolescents. | A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Parallel-Group, Event-Driven, Group-Sequential Study with Open-Label Extension Period to Assess the Efficacy and Safety of Selexipag as Add-On Treatment to Standard of Care in Children Aged greater or equal than 2 to under 18 years with Pulmonary Arterial Hypertension. - SALTO | Pulmonary Arterial Hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Uptravi Product Name: Selexipag Product Code: JNJ-67896049 (ACT-293987) INN or Proposed INN: SELEXIPAG Product Name: Selexipag Product Code: JNJ-67896049 (ACT-293987) INN or Proposed INN: SELEXIPAG | Actelion Pharmaceuticals Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 237 | Phase 3 | Germany;Belarus;Portugal;Serbia;United States;Taiwan;Spain;Thailand;Ukraine;Ireland;Russian Federation;Israel;Colombia;Switzerland;Italy;France;Malaysia;Viet Nam;Australia;Denmark;China;Korea, Republic of;Finland;Lithuania;Turkey;Austria;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Bulgaria;Sweden | ||
| 86 | EUCTR2019-003309-88-AT (EUCTR) | 14/07/2020 | 20/02/2020 | A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Ralinepag to Evaluate Safety and Effects on Exercise Capacity Assessed by Cardiopulmonary Exercise Testing in Subjects with World Health Organization Group 1 Pulmonary Hypertension Who Recently Initiated Therapy | A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Ralinepag to Evaluate Safety and Effects on Exercise Capacity Assessed by Cardiopulmonary Exercise Testing in Subjects with World Health Organization Group 1 Pulmonary Hypertension Who Recently Initiated Therapy - ADVANCE Capacity | pulmonary arterial hypertension (PAH) MedDRA version: 20.0;Level: LLT;Classification code 10077731;Term: Pulmonary hypertension WHO functional class I;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: RALINEPAG Other descriptive name: AR392830 Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: RALINEPAG Other descriptive name: AR392830 Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: RALINEPAG Other descriptive name: AR392830 | United Therapeutics Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 193 | Phase 3 | United States;Canada;Argentina;Spain;Poland;Belgium;Brazil;Australia;Austria;Germany;United Kingdom;Italy | ||
| 87 | EUCTR2018-001189-40-NL (EUCTR) | 07/07/2020 | 19/12/2018 | An open-label extension (OLE) study to evaluate the long-term safety and efficacy of ralinepag in patients with pulmonary arterial hypertension | A Study Evaluating the Long-Term Efficacy and Safety of Ralinepag in Subjects with PAH via an Open-Label Extension (ADVANCE-Extension) - ADVANCE-extension | Pulmonary arterial hypertension (PAH) MedDRA version: 20.0;Level: LLT;Classification code 10077731;Term: Pulmonary hypertension WHO functional class I;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: AR392830 Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: AR392830 Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: AR392830 | United Therapeutics Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1000 | Phase 3 | Portugal;Serbia;United States;Taiwan;Greece;Ukraine;Israel;Chile;Italy;France;Australia;Denmark;Netherlands;China;Korea, Republic of;Turkey;United Kingdom;Hungary;Mexico;European Union;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Croatia;Bulgaria;Sweden | ||
| 88 | EUCTR2019-003309-88-ES (EUCTR) | 03/06/2020 | 21/02/2020 | A randomized double blind, placebo controlled study in pulmonary arterial hypertension using cardiopulmonary exercise testing. | A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Ralinepag to Evaluate Safety and Effects on Exercise Capacity Assessed by Cardiopulmonary Exercise Testing in Subjects with World Health Organization Group 1 Pulmonary Hypertension Who Recently Initiated Therapy (ADVANCE Capacity) - ADVANCE Capacity | pulmonary arterial hypertension (PAH) MedDRA version: 20.0;Level: LLT;Classification code 10077731;Term: Pulmonary hypertension WHO functional class I;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: RALINEPAG Other descriptive name: AR392830 Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: RALINEPAG Other descriptive name: AR392830 Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: RALINEPAG Other descriptive name: AR392830 | United Therapeutics Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 193 | Phase 3 | United States;Czech Republic;Argentina;Poland;Brazil;Belgium;Spain;Austria;Australia;Germany;United Kingdom;Italy | ||
| 89 | EUCTR2019-003309-88-GB (EUCTR) | 02/06/2020 | 11/02/2020 | A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Ralinepag to Evaluate Safety and Effects on Exercise Capacity Assessed by Cardiopulmonary Exercise Testing in Subjects with World Health Organization Group 1 Pulmonary Hypertension Who Recently Initiated Therapy | A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Ralinepag to Evaluate Safety and Effects on Exercise Capacity Assessed by Cardiopulmonary Exercise Testing in Subjects with World Health Organization Group 1 Pulmonary Hypertension Who Recently Initiated Therapy - ADVANCE Capacity | pulmonary arterial hypertension (PAH) MedDRA version: 20.0;Level: LLT;Classification code 10077731;Term: Pulmonary hypertension WHO functional class I;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: RALINEPAG Other descriptive name: AR392830 Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: RALINEPAG Other descriptive name: AR392830 Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: RALINEPAG Other descriptive name: AR392830 | United Therapeutics Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 193 | Phase 3 | United States;Czech Republic;Argentina;Spain;Poland;Brazil;Belgium;Austria;Australia;Germany;Italy;United Kingdom | ||
| 90 | EUCTR2019-003309-88-PL (EUCTR) | 14/05/2020 | 26/02/2020 | A Study of Ralinepag to Evaluate Safety and Effects on Exercise Capacity in Subjects with Pulmonary Hypertension | A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Ralinepag to Evaluate Safety and Effects on Exercise Capacity Assessed by Cardiopulmonary Exercise Testing in Subjects with World Health Organization Group 1 Pulmonary Hypertension Who Recently Initiated Therapy - ADVANCE Capacity | pulmonary arterial hypertension (PAH) MedDRA version: 20.0;Level: LLT;Classification code 10077731;Term: Pulmonary hypertension WHO functional class I;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: RALINEPAG Other descriptive name: AR392830 Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: RALINEPAG Other descriptive name: AR392830 Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: RALINEPAG Other descriptive name: AR392830 | United Therapeutics Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 193 | Phase 3 | United States;Argentina;Belgium;Spain;Brazil;Poland;Austria;Australia;Germany;United Kingdom;Italy | ||
| 91 | EUCTR2019-003309-88-IT (EUCTR) | 06/05/2020 | 24/05/2021 | na | A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Ralinepag to Evaluate Safety and Effects on Exercise Capacity Assessed by Cardiopulmonary Exercise Testing in Subjects with World Health Organization Group 1 Pulmonary Hypertension Who Recently Initiated Therapy - ADVANCE Capacity | pulmonary arterial hypertension (PAH) MedDRA version: 20.0;Level: LLT;Classification code 10077731;Term: Pulmonary hypertension WHO functional class I;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Ralinepag Product Code: [APD811] INN or Proposed INN: RALINEPAG Other descriptive name: AR392830 Product Name: Ralinepag Product Code: [APD811] INN or Proposed INN: RALINEPAG Other descriptive name: AR392830 Product Name: Ralinepag Product Code: [APD811] INN or Proposed INN: RALINEPAG Other descriptive name: AR392830 | UNITED THERAPEUTICS CORPORATION | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 193 | Phase 3 | United States;Czechia;Argentina;Spain;Poland;Belgium;Brazil;Austria;Australia;Germany;United Kingdom;Italy | ||
| 92 | EUCTR2019-002817-21-IT (EUCTR) | 22/04/2020 | 17/06/2021 | A study to see if it is safe and helpful to add Selexipag to other PAH medication in children and adolescents. | A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Parallel- Group, Event-Driven, Group-Sequential Study with Open-Label Extension Period to Assess the Efficacy and Safety of Selexipag as Add-On Treatment to Standard of Care in Children Aged =2 to <18 years with Pulmonary Arterial Hypertension. - SALTO | Pulmonary Arterial Hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Uptravi Product Name: Selexipag Product Code: [JNJ-67896049 (ACT-293987)] Product Name: Selexipag Product Code: [JNJ-67896049 (ACT-293987)] | ACTELION PHARMACEUTICALS LTD | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 237 | Phase 3 | Portugal;Serbia;Belarus;United States;Taiwan;Spain;Thailand;Ukraine;Russian Federation;Israel;Colombia;Switzerland;Italy;Vietnam;France;Malaysia;Australia;Denmark;Netherlands;China;Korea, Republic of;Finland;Lithuania;Turkey;Austria;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Bulgaria;Germany;Sweden | ||
| 93 | EUCTR2019-002817-21-DE (EUCTR) | 16/04/2020 | 30/10/2019 | A study to see if it is safe and helpful to add Selexipag to other PAH medication in children and adolescents. | A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Parallel-Group, Event-Driven, Group-Sequential Study with Open-Label Extension Period to Assess the Efficacy and Safety of Selexipag as Add-On Treatment to Standard of Care in Children Aged =2 to <18 years with Pulmonary Arterial Hypertension. - SALTO | Pulmonary Arterial Hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Uptravi Product Name: Selexipag Product Code: JNJ-67896049 (ACT-293987) INN or Proposed INN: SELEXIPAG Product Name: Selexipag Product Code: JNJ-67896049 (ACT-293987) INN or Proposed INN: SELEXIPAG | Actelion Pharmaceuticals Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 237 | Phase 3 | Portugal;Serbia;Belarus;United States;Taiwan;Spain;Thailand;Ukraine;Russian Federation;Israel;Colombia;Switzerland;Italy;Vietnam;France;Malaysia;Australia;Denmark;China;Korea, Republic of;Finland;Lithuania;Turkey;Austria;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;Sweden | ||
| 94 | EUCTR2018-001189-40-CZ (EUCTR) | 11/03/2020 | 27/11/2018 | An open-label extension (OLE) study to evaluate the long-term safety and efficacy of ralinepag in patients with pulmonary arterial hypertension | A Study Evaluating the Long-term Efficacy and Safety of Ralinepag in Subjects with PAH via an Open-label Extension (ADVANCE-Extension) - ADVANCE-extension | Pulmonary arterial hypertension (PAH) MedDRA version: 20.0;Level: LLT;Classification code 10077731;Term: Pulmonary hypertension WHO functional class I;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: AR392830 Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: AR392830 Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: AR392830 | United Therapeutics Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1000 | Phase 3 | Portugal;Serbia;United States;Taiwan;Greece;Ukraine;Israel;Chile;Italy;France;Australia;Denmark;Netherlands;China;Korea, Republic of;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;European Union;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Croatia;Bulgaria;Sweden | ||
| 95 | EUCTR2019-002817-21-BG (EUCTR) | 11/02/2020 | 06/01/2020 | A study to see if it is safe and helpful to add Selexipag to other PAH medication in children and adolescents. | A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Parallel-Group, Event-Driven, Group-Sequential Study with Open-Label Extension Period to Assess the Efficacy and Safety of Selexipag as Add-On Treatment to Standard of Care in Children Aged =2 to <18 years with Pulmonary Arterial Hypertension. - SALTO | Pulmonary Arterial Hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Uptravi Product Name: Selexipag Product Code: JNJ-67896049 (ACT-293987) INN or Proposed INN: SELEXIPAG Product Name: Selexipag Product Code: JNJ-67896049 (ACT-293987) INN or Proposed INN: SELEXIPAG Product Name: Selexipag Product Code: JNJ-67896049 (ACT-293987) INN or Proposed INN: SELEXIPAG Other descriptive name: Selexipag Product Name: Selexipag Product Code: JNJ-67896049 (ACT-293987) INN or Proposed INN: SELEXIPAG Other descriptive name: Selexipag | Actelion Pharmaceuticals Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 237 | Phase 3 | Serbia;Portugal;Belarus;United States;Taiwan;Thailand;Spain;Ukraine;Ireland;Russian Federation;Israel;Colombia;Switzerland;Italy;France;Malaysia;Viet Nam;Denmark;Australia;China;Korea, Republic of;Finland;Turkey;Lithuania;Austria;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Poland;Bulgaria;Germany;Sweden | ||
| 96 | EUCTR2019-002817-21-HU (EUCTR) | 05/02/2020 | 29/11/2019 | A study to see if it is safe and helpful to add Selexipag to other PAH medication in children and adolescents. | A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Parallel-Group, Event-Driven, Group-Sequential Study with Open-Label Extension Period to Assess the Efficacy and Safety of Selexipag as Add-On Treatment to Standard of Care in Children Aged =2 to <18 years with Pulmonary Arterial Hypertension. - SALTO | Pulmonary Arterial Hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Uptravi Product Name: Selexipag Product Code: JNJ-67896049 (ACT-293987) INN or Proposed INN: SELEXIPAG Product Name: Selexipag Product Code: JNJ-67896049 (ACT-293987) INN or Proposed INN: SELEXIPAG | Actelion Pharmaceuticals Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 237 | Phase 3 | Serbia;Portugal;United States;Belarus;Taiwan;Thailand;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Switzerland;Vietnam;France;Malaysia;Australia;Denmark;Netherlands;China;Korea, Republic of;Finland;Lithuania;Turkey;Austria;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany;Sweden | ||
| 97 | NCT03926793 (ClinicalTrials.gov) | February 4, 2020 | 22/4/2019 | Clinical Study of Inhaled GB002 for Treatment of WHO Group I Pulmonary Arterial Hypertension | A Phase 1b, Randomized, Subject- and Investigator-Blinded, Placebo-Controlled, Multi-Center Clinical Trial to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Biomarkers of Inhaled GB002 in Subjects With WHO Group 1 Pulmonary Arterial Hypertension (PAH) | Pulmonary Arterial Hypertension | Drug: GB002;Drug: Placebo;Device: Generic Dry Powder Inhaler | GB002, Inc., a wholly owned subsidiary of Gossamer Bio, Inc. | NULL | Completed | 18 Years | 75 Years | All | 8 | Phase 1 | United States;United Kingdom |
| 98 | EUCTR2019-002817-21-ES (EUCTR) | 07/01/2020 | 11/11/2019 | A study to see if it is safe and helpful to add Selexipag to other PAH medication in children and adolescents. | A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Parallel-Group, Event-Driven, Group-Sequential Study with Open-Label Extension Period to Assess the Efficacy and Safety of Selexipag as Add-On Treatment to Standard of Care in Children Aged =2 to <18 years with Pulmonary Arterial Hypertension. - SALTO | Pulmonary Arterial Hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Uptravi Product Name: Selexipag Product Code: JNJ-67896049 (ACT-293987) INN or Proposed INN: SELEXIPAG Product Name: Selexipag Product Code: JNJ-67896049 (ACT-293987) INN or Proposed INN: SELEXIPAG | Actelion Pharmaceuticals Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 237 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Portugal;Belarus;United States;Taiwan;Thailand;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Switzerland;Vietnam;France;Malaysia;Australia;Denmark;Netherlands;China;Korea, Republic of;Finland;Lithuania;Turkey;Austria;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany;Sweden | ||
| 99 | ChiCTR1900028152 | 2020-01-01 | 2019-12-13 | Serum interleukins-6: a predictive biomarker for connective tissue disease-associated pulmonary arterial hypertension (CTD-PAH) | Serum interleukins-6: a predictive biomarker for connective tissue disease-associated pulmonary arterial hypertension (CTD-PAH) | pulmonary arterial hypertension | Gold Standard:Clinical outcome;Index test:serum IL-6; | Zhongda Hospital Affiliated to Southeast University | NULL | Pending | 18 | 80 | Both | Target condition:200;Difficult condition:0 | N/A | China |
| 100 | EUCTR2019-002414-40-GB (EUCTR) | 17/12/2019 | 24/10/2019 | An extension study, at multiple study sites, for patients with Pulmonary Arterial Hypertension who took part in study CXA-10-301, to look at the continuing safety of CXA-10 and how well it works long term: all patients will receive CXA-10 treatment. | A Phase 2, Multi-Center, Open-Label Study to Evaluate Long-term Safety and Efficacy of CXA-10 in Subjects with Pulmonary Arterial Hypertension on Stable Background Therapy: Extension to Study CXA-10-301. - Open label extension of CXA-10 in Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension (PAH). MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 21.1;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: CXA-10 Product Code: CXA-10 INN or Proposed INN: 10-nitro-9(E)-octadec-9-enoic acid | Complexa Inc. | NULL | Not Recruiting | Female: yes Male: yes | 115 | Phase 2 | United States;United Kingdom | ||
| 101 | EUCTR2018-002796-18-IT (EUCTR) | 28/11/2019 | 29/01/2021 | To study the safety and effectiveness of the maximum tolerated dose of zamicastat, found in BIA-51058-201, in the treatment of long-term PAH. | An open-label, multicentre study to evaluate the safety and efficacy of zamicastat as adjunctive therapy in long-term treatment of pulmonary arterial hypertension (PAH) disease - Safety and efficacy of BIA 5-1058 in PAH | Pulmonary arterial hypertension MedDRA version: 20.0;Level: SOC;Classification code 10038738;Term: Respiratory, thoracic and mediastinal disorders;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: zamicastat Product Code: [BIA-5-1058] INN or Proposed INN: zamicastat | BIAL-Portela & Ca, S.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 40 | Phase 2 | Portugal;Spain;Ukraine;Austria;Germany;United Kingdom;Italy | ||
| 102 | NCT03782818 (ClinicalTrials.gov) | November 20, 2019 | 17/12/2018 | Olaparib for PAH: a Multicenter Clinical Trial | Olaparib for Pulmonary Arterial Hypertension: a Multicenter Clinical Trial | Pulmonary Arterial Hypertension | Drug: Olaparib | Laval University | Canadian Institutes of Health Research (CIHR);AstraZeneca | Recruiting | 18 Years | 75 Years | All | 20 | Phase 1/Phase 2 | Canada |
| 103 | EUCTR2018-002448-10-DE (EUCTR) | 08/11/2019 | 17/08/2018 | Study to find the most promising therapeutic dosage of zamicastat for the treatment of PAH disease. | An open-label, multicentre study to evaluate pharmacokinetics, safety and efficacy of zamicastat as adjunctive therapy in pulmonary arterial hypertension (PAH) - Pharmacokinetics, safety and efficacy of BIA 5-1058 in PAH | Pulmonary arterial hypertension;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Zamicastat Product Code: BIA 5-1058 INN or Proposed INN: ZAMICASTAT Other descriptive name: BIA 5-1058 | Bial - Portela & Ca, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 40 | Phase 2 | Portugal;France;Spain;Belgium;Ukraine;Austria;Germany;United Kingdom;Italy | ||
| 104 | EUCTR2018-002448-10-IT (EUCTR) | 29/10/2019 | 01/02/2021 | Study to find the most promising therapeutic dosage of zamicastat for the treatment of PAH disease. | An open-label, multicentre study to evaluate pharmacokinetics, safety and efficacy of zamicastat as adjunctive therapy in pulmonary arterial hypertension (PAH) - Pharmacokinetics, safety and efficacy of BIA 5-1058 in PAH | Pulmonary arterial hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: zamicastat Product Code: [BIA 5-1058] INN or Proposed INN: zamicastat | BIAL-Portela & Ca, S.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 40 | Phase 2 | Portugal;Spain;Ukraine;Austria;Germany;United Kingdom;Italy | ||
| 105 | EUCTR2014-004786-25-BG (EUCTR) | 11/10/2019 | 01/07/2019 | A clinical study to compare the efficacy and safety of macitentan and tadalafil monotherapies with the corresponding fixed dose combination in subjects with pulmonary arterial hypertension (PAH). | Prospective, multi-center, double-blind, randomized, active-controlled, triple-dummy, parallel-group, group-sequential, adaptive Phase 3 clinical study to compare the efficacy and safety of macitentan and tadalafil monotherapies with the corresponding fixed dose combination in subjects with pulmonary arterial hypertension (PAH), followed by an open-label treatment period with macitentan and tadalafil fixed dose combination therapy | Pulmonary Arterial Hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Code: CJNJ-68150420-ZZZ-G001 (ACT-064992D) INN or Proposed INN: MACITENTAN Other descriptive name: ACT-064992 INN or Proposed INN: TADALAFIL Other descriptive name: ACT-178418 Trade Name: Adcirca® INN or Proposed INN: TADALAFIL Other descriptive name: ACT-178418 Trade Name: Opsumit® Product Name: macitentan Product Code: ACT-064992 INN or Proposed INN: MACITENTAN Other descriptive name: ACT-064992 | Actelion Pharmaceuticals Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 250 | Phase 3 | United States;Czechia;Taiwan;Spain;Turkey;Russian Federation;Italy;Hungary;Mexico;Canada;Poland;Brazil;Malaysia;Australia;Bulgaria;South Africa;Germany;China;Japan | ||
| 106 | NCT03683186 (ClinicalTrials.gov) | September 23, 2019 | 19/9/2018 | A Study Evaluating the Long-Term Efficacy and Safety of Ralinepag in Subjects With PAH Via an Open-Label Extension | A Phase 3 Open-label Extension (OLE) Study to Evaluate the Long-term Safety and Efficacy of Ralinepag in Subjects With World Health Organization (WHO) Group 1 Pulmonary Arterial Hypertension (PAH) | PAH;Pulmonary Hypertension;Pulmonary Arterial Hypertension;Hypertension;Connective Tissue Diseases;Familial Primary Pulmonary Hypertension;Vascular Diseases;Cardiovascular Diseases;Hypertension, Pulmonary;Lung Diseases;Respiratory Tract Disease | Drug: Ralinepag | United Therapeutics | NULL | Enrolling by invitation | 18 Years | N/A | All | 1000 | Phase 3 | Poland;Portugal;Romania;Serbia;Singapore;Spain;Taiwan;Turkey;Ukraine;United Kingdom;United States;Sweden;Argentina;Australia;Austria;Belgium;Brazil;Bulgaria;Canada;Chile;China;Croatia;Czechia;Denmark;France;Germany;Greece;Hungary;Israel;Italy;Korea, Republic of;Mexico;Netherlands |
| 107 | NCT03950739 (ClinicalTrials.gov) | September 17, 2019 | 9/5/2019 | Open-label, Clinical Study to Evaluate the Safety and Tolerability of TreT in Subjects With PAH Currently Using Tyvaso | An Open-label, Clinical Study to Evaluate the Safety and Tolerability of Treprostinil Inhalation Powder (TreT) in Subjects With Pulmonary Arterial Hypertension Currently Using Tyvaso | Pulmonary Arterial Hypertension | Drug: Treprostinil Inhalation Powder | United Therapeutics | NULL | Active, not recruiting | 18 Years | N/A | All | 51 | Phase 1 | United States |
| 108 | EUCTR2014-004786-25-DE (EUCTR) | 05/09/2019 | 02/05/2019 | A clinical study to compare the efficacy and safety of macitentan and tadalafil monotherapies with the corresponding fixed dose combination in subjects with pulmonary arterial hypertension (PAH). | Prospective, multi-center, double-blind, randomized, active-controlled, triple-dummy, parallel-group, group-sequential, adaptive Phase 3 clinical study to compare the efficacy and safety of macitentan and tadalafil monotherapies with the corresponding fixed dose combination in subjects with pulmonary arterial hypertension (PAH), followed by an open-label treatment period with macitentan and tadalafil fixed dose combination therapy | Pulmonary Arterial Hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Code: CJNJ-68150420-ZZZ-G001 (ACT- 064992D) INN or Proposed INN: MACITENTAN Other descriptive name: ACT-064992 INN or Proposed INN: TADALAFIL Other descriptive name: ACT-178418 Trade Name: Adcirca® INN or Proposed INN: TADALAFIL Other descriptive name: ACT-178418 Trade Name: Opsumit® Product Name: macitentan Product Code: ACT-064992 INN or Proposed INN: MACITENTAN Other descriptive name: ACT-064992 | Actelion Pharmaceuticals Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 250 | Phase 3 | United States;Czechia;Taiwan;Spain;Turkey;Russian Federation;Italy;Hungary;Mexico;Canada;Brazil;Malaysia;Poland;Australia;South Africa;Bulgaria;Germany;China;Japan | ||
| 109 | EUCTR2018-001189-40-PT (EUCTR) | 02/09/2019 | 27/03/2019 | An open-label extension (OLE) study to evaluate the long-term safety and efficacy of ralinepag in patients with pulmonary arterial hypertension | A Study Evaluating the Long-term Efficacy and Safety of Ralinepag in Subjects with PAH via an Open-label Extension (ADVANCE-Extension) - ADVANCE-extension | Pulmonary arterial hypertension (PAH) MedDRA version: 20.0;Level: LLT;Classification code 10077731;Term: Pulmonary hypertension WHO functional class I;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: AR392830 Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: AR392830 Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: AR392830 | United Therapeutic Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1000 | Phase 3 | Serbia;Portugal;United States;Taiwan;Greece;Ukraine;Israel;Chile;Italy;France;Australia;Denmark;Netherlands;China;Korea, Republic of;Turkey;United Kingdom;Hungary;Mexico;European Union;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Croatia;Bulgaria;Sweden | ||
| 110 | EUCTR2018-001187-33-PT (EUCTR) | 02/09/2019 | 22/03/2019 | A study evaluating the efficacy and safety of ralinepag in treatment of patients with pulmonary hypertension. | A Study Evaluating the Efficacy and Safety of Ralinepag to Improve Treatment Outcomes in PAH Patients - ADVANCE-Outcomes | pulmonary arterial hypertension (PAH) MedDRA version: 20.0;Level: LLT;Classification code 10077731;Term: Pulmonary hypertension WHO functional class I;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: NA Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: NA Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: NA | United Therapeutics Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 700 | Phase 3 | Serbia;Portugal;United States;Taiwan;Greece;Ukraine;Israel;Chile;Australia;Denmark;Netherlands;China;Korea, Republic of;Turkey;United Kingdom;Hungary;Mexico;European Union;Canada;Argentina;Brazil;Poland;Belgium;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden | ||
| 111 | EUCTR2018-003093-27-GB (EUCTR) | 16/08/2019 | 12/06/2019 | Clinical Study of Inhaled GB002 for the Treatment of WHO Group I Pulmonary Arterial Hypertension (PAH) | A Phase 1b, Randomized, Subject- and Investigator-Blinded, Placebo-Controlled, Multi-Center Clinical Trial to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Biomarkers of Inhaled GB002 in Subjects with WHO Group 1 Pulmonary Arterial Hypertension (PAH) - GB002 in Adult Subjects with PAH | Pulmonary Arterial Hypertension (PAH) MedDRA version: 20.0;Level: LLT;Classification code 10077739;Term: Pulmonary arterial hypertension WHO functional class I;System Organ Class: 100000004855 ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: GB002 Capsules Product Code: GB002 INN or Proposed INN: GB002 | GB002, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 16 | Human pharmacology (Phase 1): yes Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | France;United States;Denmark;Netherlands;United Kingdom;Sweden | ||
| 112 | EUCTR2014-004786-25-ES (EUCTR) | 13/08/2019 | 11/06/2019 | A clinical study to compare the efficacy and safety of macitentan and tadalafil monotherapies with the corresponding fixed dose combination in subjects with pulmonary arterial hypertension (PAH). | Prospective, multi-center, double-blind, randomized, active-controlled, triple-dummy, parallel-group, group-sequential, adaptive Phase 3 clinical study to compare the efficacy and safety of macitentan and tadalafil monotherapies with the corresponding fixed dose combination in subjects with pulmonary arterial hypertension (PAH), followed by an open-label treatment period with macitentan and tadalafil fixed dose combination therapy | Pulmonary Arterial Hypertension MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Code: ACT-064992D INN or Proposed INN: MACITENTAN INN or Proposed INN: TADALAFIL Trade Name: Adcirca® INN or Proposed INN: TADALAFIL Trade Name: Opsumit® Product Name: macitentan Product Code: ACT-064992 INN or Proposed INN: MACITENTAN | Actelion Pharmaceuticals Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 170 | Phase 3 | United States;Taiwan;Spain;Turkey;Russian Federation;Italy;Czech Republic;Hungary;Mexico;Canada;Poland;Malaysia;Brazil;Australia;Bulgaria;Germany;Japan;China | ||
| 113 | EUCTR2014-004786-25-PL (EUCTR) | 10/08/2019 | 28/05/2019 | A clinical study to compare the efficacy and safety of macitentan and tadalafil monotherapies with the corresponding fixed dose combination in subjects with pulmonary arterial hypertension (PAH). | Prospective, multi-center, double-blind, randomized, active-controlled, triple-dummy, parallel-group, group-sequential, adaptive Phase 3 clinical study to compare the efficacy and safety of macitentan and tadalafil monotherapies with the corresponding fixed dose combination in subjects with pulmonary arterial hypertension (PAH), followed by an open-label treatment period with macitentan and tadalafil fixed dose combination therapy | Pulmonary Arterial Hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Code: CJNJ-68150420-ZZZ-G001(ACT-064992D) INN or Proposed INN: MACITENTAN Other descriptive name: ACT-064992 INN or Proposed INN: TADALAFIL Other descriptive name: ACT-178418 Trade Name: Adcirca® INN or Proposed INN: TADALAFIL Other descriptive name: ACT-178418 Trade Name: Opsumit® Product Name: macitentan Product Code: ACT-064992 INN or Proposed INN: MACITENTAN Other descriptive name: ACT-064992 | Actelion Pharmaceuticals Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 250 | Phase 3 | United States;Czechia;Taiwan;Spain;Turkey;Russian Federation;Italy;Hungary;Mexico;Canada;Poland;Brazil;Malaysia;Australia;Bulgaria;South Africa;Germany;China;Japan | ||
| 114 | NCT04053543 (ClinicalTrials.gov) | August 9, 2019 | 19/7/2019 | CXA-10 Study in Subjects With Pulmonary Arterial Hypertension | A Phase 2, Multi-Center, Open-Label Study to Evaluate Long-term Safety and Efficacy of CXA-10 in Subjects With Pulmonary Arterial Hypertension on Stable Background Therapy: Extension to Study CXA-10-301 | PAH | Drug: CXA-10 | Complexa, Inc. | Medpace, Inc.;Innovative Analytics;Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) | Terminated | 18 Years | N/A | All | 33 | Phase 2 | United States;United Kingdom |
| 115 | EUCTR2014-004786-25-IT (EUCTR) | 06/08/2019 | 17/06/2021 | A clinical study to compare the efficacy and safety of macitentan and tadalafil monotherapies with the corresponding fixed dose combination in subjects with pulmonary arterial hypertension (PAH). | Prospective, multi-center, double-blind, randomized, active-controlled, triple-dummy, parallel-group, group-sequential, adaptive Phase 3 clinical study to compare the efficacy and safety of macitentan and tadalafil monotherapies with the corresponding fixed dose combination in subjects with pulmonary arterial hypertension (PAH), followed by an open-label treatment period with macitentan and tadalafil fixed dose combination therapy - Nap | Pulmonary Arterial Hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: CJNJ-68150420-ZZZ-G001 (ACT- 064992D) Product Code: [CJNJ-68150420-ZZZ-G001 (ACT- 064992D)] INN or Proposed INN: MACITENTAN Other descriptive name: D.3.6.2 - dose massima specificare: giornaliera INN or Proposed INN: TADALAFIL Other descriptive name: D.3.6.2 - dose massima specificare: giornaliera Trade Name: Adcirca® Product Name: G04BE08 Product Code: [G04BE08] INN or Proposed INN: TADALAFIL Other descriptive name: D.3.6.2 - dose massima specificare: giornaliera Trade Name: Opsumit® Product Name: macitentan Product Code: [ACT-064992] INN or Proposed INN: MACITENTAN | ACTELION PHARMACEUTICALS LTD | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 250 | Phase 3 | United States;Czechia;Taiwan;Spain;Turkey;Russian Federation;Italy;Hungary;Mexico;Canada;Poland;Brazil;Malaysia;Australia;Bulgaria;South Africa;Germany;China;Japan | ||
| 116 | EUCTR2018-002796-18-PT (EUCTR) | 30/07/2019 | 30/10/2018 | To study the safety and effectiveness of the maximum tolerated dose of zamicastat, found in BIA-51058-201, in the treatment of long-term PAH. | An open-label, multicentre study to evaluate the safety and efficacy of zamicastat as adjunctive therapy in long-term treatment of pulmonary arterial hypertension (PAH) disease | Pulmonary arterial hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Zamicastat Product Code: BIA-5-1058 INN or Proposed INN: ZAMICASTAT Other descriptive name: BIA 5-1058 | Bial - Portela & Ca, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 40 | Phase 2 | Portugal;Spain;Belgium;Ukraine;Austria;Germany;United Kingdom;Italy | ||
| 117 | NCT03904693 (ClinicalTrials.gov) | July 29, 2019 | 4/4/2019 | Clinical Study to Compare the Efficacy and Safety of Macitentan and Tadalafil Monotherapies With the Corresponding Fixed-dose Combination Therapy in Subjects With Pulmonary Arterial Hypertension (PAH) | Prospective, Multi-center, Double-blind, Randomized, Active-controlled, Triple-dummy, Parallel-group, Group-sequential, Adaptive Phase 3 Clinical Study to Compare the Efficacy and Safety of Macitentan and Tadalafil Monotherapies With the Corresponding Fixed Dose Combination in Subjects With Pulmonary Arterial Hypertension (PAH), Followed by an Open-label Treatment Period With Macitentan and Tadalafil Fixed Dose Combination Therapy | Pulmonary Arterial Hypertension (PAH) (WHO Group 1 PH) | Drug: FDC macitentan/tadalafil;Drug: Macitentan 10 mg;Drug: Tadalafil 40 mg;Drug: Placebo FDC;Drug: Placebo macitentan;Drug: Placebo tadalafil | Actelion | NULL | Active, not recruiting | 18 Years | N/A | All | 187 | Phase 3 | United States;Australia;Brazil;Bulgaria;Canada;China;Czechia;Germany;Hungary;Italy;Japan;Malaysia;Mexico;Poland;Russian Federation;South Africa;Spain;Taiwan;Turkey |
| 118 | NCT03863990 (ClinicalTrials.gov) | July 15, 2019 | 19/2/2019 | Study Performed at Various Medical Centers to Learn More About Survival and Expected Course of Pulmonary Arterial Hypertension, a Type of High Blood Pressure in the Lungs Related to the Narrowing of the Small Blood Vessels in the Lungs | Survival and Prognostic Factors in Pulmonary Arterial Hypertension. A Multicenter Observational Registry (START) | Pulmonary Arterial Hypertension | Drug: PAH medication | Bayer | NULL | Completed | 18 Years | N/A | All | 104 | Argentina | |
| 119 | EUCTR2016-001062-28-FI (EUCTR) | 03/07/2019 | 03/07/2019 | A study to find out whether the medicine macitentan works in children with pulmonary arterial hypertension (PAH) | A multicenter, open-label, randomized, study with single-arm extension period to assess the pharmacokinetics, safety and efficacy of macitentan versus standard of care in children with pulmonary arterial hypertension - TOMORROW: pediaTric use Of Macitentan tO delay disease pRogRessiOn in PAH Worldwide | Pulmonary arterial hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: macitentan Product Code: ACT-064992/ JNJ-67896062 INN or Proposed INN: MACITENTAN Product Name: macitentan Product Code: ACT-064992/ JNJ-67896062 INN or Proposed INN: MACITENTAN Product Name: macitentan Product Code: ACT-064992/ JNJ-67896062 INN or Proposed INN: MACITENTAN Product Name: macitentan Product Code: ACT-064992/ JNJ-67896062 INN or Proposed INN: MACITENTAN Product Name: macitentan Product Code: ACT-064992/ JNJ-67896062 INN or Proposed INN: MACITENTAN | ACTELION Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 3 | Portugal;United States;Philippines;Finland;Spain;Thailand;Ukraine;Austria;Israel;Russian Federation;Colombia;France;Hungary;Mexico;Canada;Poland;Brazil;Malaysia;Viet Nam;Australia;South Africa;China;Korea, Republic of | ||
| 120 | NCT04316143 (ClinicalTrials.gov) | June 6, 2019 | 18/3/2020 | Pharmacokinetics, Safety and Efficacy of BIA 5-1058 in PAH | An Open-label, Multicentre Study to Evaluate Pharmacokinetics, Safety and Efficacy of Zamicastat as Adjunctive Therapy in Pulmonary Arterial Hypertension (PAH) | Pulmonary Arterial Hypertension | Drug: Zamicastat | Bial - Portela C S.A. | NULL | Completed | 18 Years | 65 Years | All | 33 | Phase 2 | Spain |
| 121 | EUCTR2018-001189-40-HR (EUCTR) | 21/05/2019 | 05/06/2019 | An open-label extension (OLE) study to evaluate the long-term safety and efficacy of ralinepag in patients with pulmonary arterial hypertension | A Study Evaluating the Long-term Efficacy and Safety of Ralinepag in Subjects with PAH via an Open-label Extension (ADVANCE-Extension) - ADVANCE-extension | Pulmonary arterial hypertension (PAH) MedDRA version: 20.0;Level: LLT;Classification code 10077731;Term: Pulmonary hypertension WHO functional class I;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: AR392830 Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: AR392830 Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: AR392830 | United Therapeutics Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1000 | Phase 3 | Portugal;Serbia;United States;Taiwan;Greece;Ukraine;Israel;Chile;Italy;France;Australia;Denmark;Netherlands;China;Korea, Republic of;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;European Union;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Croatia;Bulgaria;Sweden | ||
| 122 | EUCTR2018-001187-33-HR (EUCTR) | 20/05/2019 | 05/06/2019 | A study evaluating the efficacy and safety of ralinepag in treatment of patients with pulmonary hypertension. | A StuDy eVAluatiNg the EffiCacy and Safety of RalinEpag To Improve Treatment OUTCOMES in PAH Patients - ADVANCE-outcomes | pulmonary arterial hypertension (PAH) MedDRA version: 20.0;Level: LLT;Classification code 10077731;Term: Pulmonary hypertension WHO functional class I;System Organ Class: 100000004855 ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: NA Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: NA Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: NA | Arena Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 700 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Serbia;Taiwan;Greece;Thailand;Ukraine;Chile;Israel;Switzerland;Australia;Denmark;Netherlands;China;Korea, Republic of;Turkey;United Kingdom;Hungary;European Union;Mexico;Canada;Argentina;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden | ||
| 123 | EUCTR2016-001067-36-PL (EUCTR) | 08/05/2019 | 18/02/2019 | A study to find out whether some PAH patients may benefit by replacing their current phosphodiesterase-5 inhibitors (PDE-5i) with or without endothelin receptor antagonist (ERA), with Riociguat | A prospective, randomized, international, multicenter, double-arm, controlled, open-label study of Riociguat in patients with pulmonary arterial hypertension (PAH) who are on a stable dose of phosphodiesterase-5 inhibitors (PDE-5i) with or without endothelin receptor antagonist (ERA), but not at treatment goal - Riociguat rEplacing PDE-5i therapy evaLuated Against Continued PDE-5i thErapy | Pulmonary Arterial Hypertension (PAH) MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Adempas Product Name: Adempas® 0.5 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas® 1.0 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas® 1.5 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas® 2.0 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas® 2.5 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adcirca Product Name: ADCIRCA 20 mg film-coated tablets INN or Proposed INN: TADALAFIL | Bayer AG | NULL | Not Recruiting | Female: yes Male: yes | 218 | Phase 4 | United States;Portugal;Taiwan;Greece;Spain;Turkey;Austria;United Kingdom;Switzerland;Italy;France;Czech Republic;Mexico;Canada;Poland;Belgium;Brazil;Australia;Denmark;Netherlands;Germany;New Zealand;Japan;Korea, Republic of | ||
| 124 | EUCTR2018-001187-33-NL (EUCTR) | 16/04/2019 | 18/12/2018 | A study evaluating the efficacy and safety of ralinepag in treatment of patients with pulmonary hypertension. | A Study Evaluating the Efficacy and Safety of Ralinepag To Improve Treatment Outcomes in PAH Patients - ADVANCE-Outcomes | pulmonary arterial hypertension (PAH) MedDRA version: 20.0;Level: LLT;Classification code 10077731;Term: Pulmonary hypertension WHO functional class I;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: NA Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: NA Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: NA | United Therapeutics Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 700 | Phase 3 | Portugal;Serbia;United States;Taiwan;Greece;Ukraine;Israel;Chile;Australia;Denmark;Netherlands;China;Korea, Republic of;Turkey;United Kingdom;Hungary;Mexico;European Union;Canada;Argentina;Brazil;Poland;Belgium;Singapore;Croatia;Bulgaria;Germany;Sweden | ||
| 125 | EUCTR2018-001189-40-BG (EUCTR) | 10/04/2019 | 29/01/2019 | An open-label extension (OLE) study to evaluate the long-term safety and efficacy of ralinepag in patients with pulmonary arterial hypertension | A Study Evaluating the Long-term Efficacy and Safety of Ralinepag in Subjects with PAH via an Open-label Extension (ADVANCE-Extension) - ADVANCE-extension | Pulmonary arterial hypertension (PAH) MedDRA version: 20.0;Level: LLT;Classification code 10077731;Term: Pulmonary hypertension WHO functional class I;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: AR392830 Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: AR392830 Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: AR392830 | United Therapeutics Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1000 | Phase 3 | United States;Serbia;Portugal;Taiwan;Greece;Ukraine;Israel;Chile;France;Australia;Denmark;China;Korea, Republic of;Turkey;United Kingdom;Hungary;European Union;Mexico;Canada;Argentina;Brazil;Belgium;Singapore;Croatia;Bulgaria;Sweden | ||
| 126 | EUCTR2018-001187-33-BG (EUCTR) | 10/04/2019 | 13/12/2018 | A study evaluating the efficacy and safety of ralinepag in treatment of patients with pulmonary hypertension. | A StuDy eVAluatiNg the EffiCacy and Safety of RalinEpag To Improve Treatment OUTCOMES in PAH Patients - ADVANCE-outcomes | pulmonary arterial hypertension (PAH) MedDRA version: 20.0;Level: LLT;Classification code 10077731;Term: Pulmonary hypertension WHO functional class I;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: NA Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: NA Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: NA | United Therapeutics Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 700 | Phase 3 | Portugal;Serbia;United States;Taiwan;Greece;Ukraine;Israel;Chile;Australia;Denmark;Netherlands;China;Korea, Republic of;Turkey;United Kingdom;Hungary;Mexico;European Union;Canada;Argentina;Brazil;Poland;Belgium;Singapore;Croatia;Bulgaria;Germany;Sweden | ||
| 127 | NCT03795428 (ClinicalTrials.gov) | April 10, 2019 | 18/12/2018 | Long-Term, Open Label Extension Study of Pemziviptadil (PB1046) in PAH Subjects Following Completion of Study PB1046-PT-CL-0004 | A Long-Term, Open Label Extension Study of Pemziviptadil (PB1046) Subcutaneous Injections in Pulmonary Arterial Hypertension Subjects Following Completion of Study PB1046-PT-CL-0004 | Pulmonary Arterial Hypertension | Drug: Pemziviptadil (PB1046) Injection | PhaseBio Pharmaceuticals Inc. | NULL | Recruiting | 18 Years | 79 Years | All | 63 | Phase 2 | United States |
| 128 | EUCTR2018-001187-33-GB (EUCTR) | 03/04/2019 | 31/10/2018 | A study evaluating the efficacy and safety of ralinepag in treatment of patients with pulmonary hypertension. | A Study Evaluating the Efficacy and Safety of Ralinepag to Improve Treatment Outcomes in PAH Patients - ADVANCE-Outcomes | pulmonary arterial hypertension (PAH) MedDRA version: 20.0;Level: LLT;Classification code 10077731;Term: Pulmonary hypertension WHO functional class I;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: NA Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: NA Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: NA | United Therapeutics Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 700 | Phase 3 | Singapore;United States;Portugal;Greece;Sweden;Netherlands;China;Brazil;Korea, Republic of;Poland;Chile;Serbia;Bulgaria;Croatia;Argentina;Romania;Hungary;Ukraine;United Kingdom;Canada;Turkey;Belgium;European Union;Taiwan;Denmark;Mexico;Israel;Australia;Germany | ||
| 129 | EUCTR2018-001187-33-GR (EUCTR) | 03/04/2019 | 20/03/2019 | A study evaluating the efficacy and safety of ralinepag in treatment of patients with pulmonary hypertension. | A Study Evaluating the Efficacy and Safety of Ralinepag to ImproveTreatment Outcomes in PAH Patients - ADVANCE-Outcomes | pulmonary arterial hypertension (PAH) MedDRA version: 20.0;Level: LLT;Classification code 10077731;Term: Pulmonary hypertension WHO functional class I;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: NA Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: NA Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: NA | United Therapeutics Corporation | NULL | Not Recruiting | Female: yes Male: yes | 700 | Phase 3 | Portugal;Serbia;United States;Taiwan;Greece;Ukraine;Israel;Chile;Australia;Denmark;Netherlands;China;Korea, Republic of;Turkey;United Kingdom;Hungary;Mexico;European Union;Canada;Argentina;Brazil;Poland;Belgium;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden | ||
| 130 | EUCTR2018-001189-40-GR (EUCTR) | 03/04/2019 | 20/03/2019 | An open-label extension (OLE) study to evaluate the long-term safety and efficacy of ralinepag in patients with pulmonary arterial hypertension | A StuDy EVAluatiNg the Long-Term EffiCacy and Safety of RalinEpag in Subjects with PAH via an Open-Label EXTENSION - ADVANCE-extension | Pulmonary arterial hypertension (PAH) MedDRA version: 20.0;Level: LLT;Classification code 10077731;Term: Pulmonary hypertension WHO functional class I;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag | United Therapeutics Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1000 | Phase 3 | United States;Serbia;Portugal;Taiwan;Greece;Ukraine;Israel;Chile;France;Australia;Denmark;China;Korea, Republic of;Turkey;United Kingdom;Hungary;European Union;Mexico;Canada;Argentina;Brazil;Belgium;Singapore;Croatia;Bulgaria;Sweden | ||
| 131 | NCT04062565 (ClinicalTrials.gov) | March 25, 2019 | 29/3/2019 | Trial to Evaluate Parenteral Treprostinil and Riociguat on Right Ventriculo-vascular Coupling and Morphology in Those With Advanced PAH | A Prospective Trial to Evaluate Up-front Parenteral Treprostinil and Riociguat on Right Ventriculo-vascular Coupling and Morphology in Patients With Advanced Pulmonary Arterial Hypertension (IIR-3810) | Pulmonary Arterial Hypertension | Drug: Treprostinil Injectable Product;Drug: Riociguat Pill | University of Arizona | NULL | Recruiting | 18 Years | N/A | All | 20 | Phase 3 | United States |
| 132 | EUCTR2018-001187-33-DE (EUCTR) | 18/03/2019 | 29/10/2018 | A study evaluating the efficacy and safety of ralinepag in treatment of patients with pulmonary hypertension. | A Study Evaluating the Efficacy and Safety of Ralinepag to Improve Treatment Outcomes in PAH Patients - ADVANCE-Outcomes | pulmonary arterial hypertension (PAH) MedDRA version: 20.0;Level: LLT;Classification code 10077731;Term: Pulmonary hypertension WHO functional class I;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: AR392830 Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: AR392830 Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: AR392830 | United Therapeutics Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 700 | Phase 3 | Singapore;United States;Portugal;Greece;Sweden;Netherlands;China;Brazil;Korea, Republic of;Poland;Chile;Serbia;Bulgaria;Croatia;Argentina;Romania;Hungary;Ukraine;United Kingdom;Canada;Turkey;Belgium;European Union;Taiwan;Denmark;Mexico;Israel;Australia;Germany | ||
| 133 | EUCTR2018-001387-39-DE (EUCTR) | 15/03/2019 | 30/01/2019 | The effect of oxygen therapy in patients with pulmonary Hypertension. | A prospective, randomized, controlled trial to assess the effect of long-term oxygen therapy on 6-minute walking distance, clinical parameters and hemodynamics in patients with pulmonary arterial hypertension (PAH) and chronic thromboembolic pulmonary hypertension (CTEPH) - SOPHA | pulmonary arterial hypertension (PAH) and chronic thromboembolicpulmonary hypertension (CTEPH);Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Oxygen, liquid INN or Proposed INN: OXYGEN Other descriptive name: Sauerstoff | Thoraxklinik-Heidelberg gGmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 40 | Phase 2 | Germany | ||
| 134 | EUCTR2018-002796-18-GB (EUCTR) | 12/03/2019 | 19/06/2019 | To study the safety and how effective Long-term Zamicastat treatment is for Pulmonary Arterial Hypertension | An open-label, multicentre study to evaluate the safety and efficacy of zamicastat as adjunctive therapy in long-term treatment of pulmonary arterial hypertension (PAH) disease. - Safety and efficacy of BIA 5-1058 in PAH | Pulmonary Arterial Hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Zamicastat Product Code: BIA 5-1058 INN or Proposed INN: Zamicastat | Bial - Portela & Ca, S.A | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 32 | Phase 2 | Portugal;Belgium;Spain;Ukraine;Austria;Netherlands;Germany;United Kingdom | ||
| 135 | JPRN-JapicCTI-194651 | 12/3/2019 | 05/03/2019 | MD-711 Phase 2/3 Study in PAH | MD-711 Phase 2/3 Study in Pulmonary Arterial Hypertension | Pulmonary arterial hypertension | Intervention name : MD-711 INN of the intervention : treprostinil Dosage And administration of the intervention : Inhaled admistration Control intervention name : - INN of the control intervention : - Dosage And administration of the control intervention : - | Mochida Pharmaceutical Co., Ltd. | NULL | complete | 18 | 75 | BOTH | 15 | Phase 2-3 | Japan |
| 136 | EUCTR2018-001189-40-GB (EUCTR) | 11/03/2019 | 26/11/2018 | An open-label extension (OLE) study to evaluate the long-term safety and efficacy of ralinepag in patients with pulmonary arterial hypertension | A StuDy EVAluatiNg the Long-Term EffiCacy and Safety of RalinEpag in Subjects with PAH via an Open-Label EXTENSION - ADVANCE-extension | Pulmonary arterial hypertension (PAH) MedDRA version: 20.0;Level: LLT;Classification code 10077731;Term: Pulmonary hypertension WHO functional class I;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag | United Therapeutics Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1000 | Phase 3 | Singapore;United States;Portugal;Greece;Sweden;Netherlands;China;Brazil;Korea, Republic of;Poland;Chile;Serbia;France;Bulgaria;Croatia;Argentina;Hungary;Ukraine;United Kingdom;Canada;Czech Republic;Turkey;Belgium;European Union;Taiwan;Denmark;Mexico;Italy;Israel;Australia | ||
| 137 | EUCTR2018-001189-40-BE (EUCTR) | 05/03/2019 | 10/12/2018 | An open-label extension (OLE) study to evaluate the long-term safety and efficacy of ralinepag in patients with pulmonary arterial hypertension | A Study Evaluating the Long-term Efficacy and Safety of Ralinepag inSubjects with PAH via an Open-label Extension (ADVANCE-Extension) - ADVANCE-extension | Pulmonary arterial hypertension (PAH) MedDRA version: 20.0;Level: LLT;Classification code 10077731;Term: Pulmonary hypertension WHO functional class I;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: AR392830 Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: AR392830 Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: AR392830 | United Therapeutics Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1000 | Phase 3 | Singapore;United States;Portugal;Greece;Sweden;Netherlands;China;Brazil;Korea, Republic of;Poland;Chile;Serbia;France;Bulgaria;Croatia;Argentina;Hungary;Ukraine;United Kingdom;Canada;Czech Republic;Turkey;Belgium;European Union;Taiwan;Denmark;Mexico;Italy;Israel;Australia | ||
| 138 | NCT03789643 (ClinicalTrials.gov) | March 2019 | 26/12/2018 | Study to Evaluate Efficacy and Safety of JTT-251 in Participants With Pulmonary Arterial Hypertension | A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of JTT-251 Administered for 24 Weeks to Participants With Pulmonary Arterial Hypertension (RELIEF-PAH) | Pulmonary Arterial Hypertension | Drug: JTT-251;Drug: Placebo | Akros Pharma Inc. | NULL | Withdrawn | 18 Years | 80 Years | All | 0 | Phase 2 | NULL |
| 139 | EUCTR2018-001189-40-IT (EUCTR) | 21/02/2019 | 14/11/2019 | An open-label extension (OLE) study to evaluate the long-term safety and efficacy of ralinepag in patients with pulmonary arterial hypertension | A StuDy EVAluatiNg the Long-Term EffiCacy and Safety of RalinEpag in Subjects with PAH via an Open-Label EXTENSION - ADVANCE-extension | Pulmonary arterial hypertension (PAH) MedDRA version: 20.0;Level: LLT;Classification code 10077731;Term: Pulmonary hypertension WHO functional class I;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag | United Therapeutics Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1000 | Phase 3 | Portugal;Serbia;United States;Taiwan;Greece;Ukraine;Israel;Chile;Italy;France;Australia;Denmark;China;Korea, Republic of;Turkey;United Kingdom;Hungary;Mexico;European Union;Canada;Argentina;Brazil;Belgium;Singapore;Croatia;Bulgaria;Sweden | ||
| 140 | EUCTR2018-001189-40-DK (EUCTR) | 20/02/2019 | 11/12/2018 | An open-label extension (OLE) study to evaluate the long-term safety and efficacy of ralinepag in patients with pulmonary arterial hypertension | A Study Evaluating the Long-term Efficacy and Safety of Ralinepag in Subjects with PAH via an Open-label Extension (ADVANCE-Extension) - ADVANCE-extension | Pulmonary arterial hypertension (PAH) MedDRA version: 20.0;Level: LLT;Classification code 10077731;Term: Pulmonary hypertension WHO functional class I;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: AR392830 Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: AR392830 Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: AR392830 | United Therapeutics Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1000 | Phase 3 | Portugal;Serbia;United States;Taiwan;Greece;Ukraine;Israel;Chile;Italy;France;Australia;Denmark;Netherlands;China;Korea, Republic of;Turkey;United Kingdom;Hungary;Mexico;European Union;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Croatia;Bulgaria;Sweden | ||
| 141 | EUCTR2018-001187-33-BE (EUCTR) | 18/02/2019 | 10/12/2018 | A study evaluating the efficacy and safety of ralinepag in treatment of patients with pulmonary hypertension. | A Study Evaluating the Efficacy and Safety of Ralinepag to Improve Treatment Outcomes in PAH Patients - ADVANCE-Outcomes | pulmonary arterial hypertension (PAH) MedDRA version: 20.0;Level: LLT;Classification code 10077731;Term: Pulmonary hypertension WHO functional class I;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: AR392830 Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: AR392830 Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: AR392830 | United Therapeutics Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 700 | Phase 3 | Portugal;Serbia;United States;Taiwan;Greece;Ukraine;Israel;Chile;Australia;Denmark;Netherlands;China;Korea, Republic of;Turkey;United Kingdom;Hungary;Mexico;European Union;Canada;Argentina;Brazil;Belgium;Poland;Singapore;Croatia;Bulgaria;Germany;Sweden | ||
| 142 | EUCTR2018-001189-40-FR (EUCTR) | 15/02/2019 | 16/11/2018 | An open-label extension (OLE) study to evaluate the long-term safety and efficacy of ralinepag in patients with pulmonary arterial hypertension | A StuDy EVAluatiNg the Long-Term EffiCacy and Safety of RalinEpag in Subjects with PAH via an Open-Label EXTENSION - ADVANCE-extension | Pulmonary arterial hypertension (PAH) MedDRA version: 20.0;Level: LLT;Classification code 10077731;Term: Pulmonary hypertension WHO functional class I;System Organ Class: 100000004855 ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag | Arena Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1000 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Serbia;Taiwan;Greece;Thailand;Ukraine;Chile;Israel;Switzerland;France;Australia;Denmark;China;Korea, Republic of;Turkey;United Kingdom;Hungary;European Union;Mexico;Canada;Argentina;Brazil;Belgium;Singapore;Croatia;Bulgaria;Japan;Sweden | ||
| 143 | EUCTR2018-001189-40-SE (EUCTR) | 11/02/2019 | 19/11/2018 | An open-label extension (OLE) study to evaluate the long-term safety and efficacy of ralinepag in patients with pulmonary arterial hypertension | A StuDy EVAluatiNg the Long-Term EffiCacy and Safety of RalinEpag in Subjects with PAH via an Open-Label EXTENSION - ADVANCE-extension | Pulmonary arterial hypertension (PAH) MedDRA version: 20.0;Level: LLT;Classification code 10077731;Term: Pulmonary hypertension WHO functional class I;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag | United Therapeutics Corporation | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Phase 3 | Portugal;Serbia;United States;Taiwan;Greece;Ukraine;Israel;Chile;Italy;France;Australia;Denmark;Netherlands;China;Korea, Republic of;Turkey;United Kingdom;Hungary;Mexico;European Union;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Croatia;Bulgaria;Sweden | ||
| 144 | EUCTR2018-002448-10-GB (EUCTR) | 11/02/2019 | 19/06/2019 | Multi centre study to assess the safety, effective and movement of Zamicastat within the body when given to a patient with pulmonary arterial hypertension as an additional medication. | An open-label, multicentre study to evaluate pharmacokinetics, safety and efficacy of zamicastat as adjunctive therapy in pulmonary arterial hypertension (PAH) - Pharmcokinetics, safety and efficacy of BIA-5-1058 in PAH | Pulmonary arterial hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Zamicastat Product Code: BIA 5-1058 | Bial - Portela & Ca, S.A | NULL | Not Recruiting | Female: yes Male: yes | 32 | Phase 2 | Portugal;Spain;Ukraine;Austria;Netherlands;Germany;United Kingdom | ||
| 145 | EUCTR2018-001187-33-SE (EUCTR) | 05/02/2019 | 29/10/2018 | A study evaluating the efficacy and safety of ralinepag in treatment of patients with pulmonary hypertension. | A Study Evaluating the Efficacy and Safety of Ralinepag to Improve Treatment Outcomes in PAH Patients - ADVANCE-Outcomes | pulmonary arterial hypertension (PAH) MedDRA version: 20.0;Level: LLT;Classification code 10077731;Term: Pulmonary hypertension WHO functional class I;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: AR392830 Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: AR392830 Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: AR392830 | United Therapeutics Corporation | NULL | Not Recruiting | Female: yes Male: yes | 700 | Phase 3 | Portugal;Serbia;United States;Taiwan;Greece;Ukraine;Israel;Chile;Australia;Denmark;Netherlands;China;Korea, Republic of;Turkey;United Kingdom;Hungary;Mexico;European Union;Canada;Argentina;Brazil;Belgium;Singapore;Croatia;Bulgaria;Germany;Sweden | ||
| 146 | EUCTR2018-001187-33-DK (EUCTR) | 29/01/2019 | 26/11/2018 | A study evaluating the efficacy and safety of ralinepag in treatment of patients with pulmonary hypertension. | A Study Evaluating the Efficacy and Safety of Ralinepag to Improve Treatment Outcomes in PAH Patients - ADVANCE-Outcomes | pulmonary arterial hypertension (PAH) MedDRA version: 20.0;Level: LLT;Classification code 10077731;Term: Pulmonary hypertension WHO functional class I;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: NA Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: NA Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: NA | United Therapeutics Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 700 | Phase 3 | Singapore;United States;Portugal;Greece;Sweden;Netherlands;China;Brazil;Korea, Republic of;Poland;Chile;Serbia;Bulgaria;Croatia;Argentina;Romania;Hungary;Ukraine;United Kingdom;Canada;Turkey;Belgium;European Union;Taiwan;Denmark;Mexico;Israel;Australia;Germany | ||
| 147 | NCT03754660 (ClinicalTrials.gov) | January 21, 2019 | 23/11/2018 | This Study Tests the Safety of Inhaled BAY1237592, How the Drug is Tolerated and How it Effects Patients With High Blood Pressure in the Arteries of the Lungs in the Two Different Disease Groups Pulmonary Arterial Hypertension (PAH) and Chronic Thromboembolic Pulmonary Hypertension (CTEPH) | A Non-randomized Two Part Multi-center, Open-label, Single Dose Trial With an Escalation Part in Untreated Pulmonary Arterial Hypertension (PAH) and Chronic Thromboembolic Pulmonary Hypertension (CTEPH) Patients (Part A), Followed by a Parallel-group Part in Untreated and Pre-treated Patients With PAH and CTEPH (Part B) to Investigate the Safety, Tolerability and Pharmacodynamics of Inhaled BAY1237592 | Hypertension, Pulmonary | Drug: BAY1237592 | Bayer | NULL | Completed | 18 Years | 80 Years | All | 38 | Phase 1 | Austria;Czechia;Germany;Poland |
| 148 | EUCTR2018-002796-18-ES (EUCTR) | 17/01/2019 | 16/11/2018 | To study the safety and effectiveness of the maximum tolerated dose of zamicastat, found in BIA-51058-201, in the treatment of long-term PAH. | An open-label, multicentre study to evaluate the safety and efficacy of zamicastat as adjunctive therapy in long-term treatment of pulmonary arterial hypertension (PAH) disease | Pulmonary arterial hypertension MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Zamicastat Product Code: BIA-5-1058 INN or Proposed INN: ZAMICASTAT Other descriptive name: BIA 5-1058 | Bial - Portela & Ca, S.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 40 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Portugal;Spain;Ukraine;Austria;United Kingdom | ||
| 149 | EUCTR2018-001189-40-PL (EUCTR) | 16/01/2019 | 21/03/2019 | An open-label extension (OLE) study to evaluate the long-term safety and efficacy of ralinepag in patients with pulmonary arterial hypertension | A Study Evaluating the Long-Term Efficacy and Safety of Ralinepag in Subjects with PAH via an Open-Label Extension (ADVANCE-Extension) - ADVANCE-extension | Pulmonary arterial hypertension (PAH) MedDRA version: 20.0;Level: LLT;Classification code 10077731;Term: Pulmonary hypertension WHO functional class I;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: AR392830 Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: AR392830 Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: AR392830 | United Therapeutics Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1000 | Phase 3 | Portugal;Serbia;United States;Taiwan;Greece;Ukraine;Israel;Chile;Italy;France;Australia;Denmark;Netherlands;China;Korea, Republic of;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;European Union;Canada;Argentina;Brazil;Poland;Belgium;Singapore;Croatia;Bulgaria;Sweden | ||
| 150 | EUCTR2018-001187-33-PL (EUCTR) | 16/01/2019 | 06/12/2018 | A study evaluating the efficacy and safety of ralinepag in treatment of patients with pulmonary hypertension. | A Study Evaluating the Efficacy and Safety of Ralinepag to Improve Treatment Outcomes in PAH Patients - ADVANCE-Outcomes | pulmonary arterial hypertension (PAH) MedDRA version: 20.0;Level: LLT;Classification code 10077731;Term: Pulmonary hypertension WHO functional class I;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: AR392830 Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: AR392830 Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: AR392830 | United Therapeutics Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 700 | Phase 3 | Portugal;Serbia;United States;Taiwan;Greece;Ukraine;Israel;Chile;Australia;Denmark;Netherlands;China;Korea, Republic of;Turkey;United Kingdom;Hungary;Mexico;European Union;Canada;Argentina;Brazil;Poland;Belgium;Singapore;Croatia;Bulgaria;Germany;Sweden | ||
| 151 | EUCTR2018-001189-40-HU (EUCTR) | 14/01/2019 | 21/01/2019 | An open-label extension (OLE) study to evaluate the long-term safety and efficacy of ralinepag in patients with pulmonary arterial hypertension | A study evaluating the Long-Term Efficacy and Safety of Ralinepag in Subjects with PAH via an Open-label Extension (ADVANCE-Extension) - ADVANCE-extension | Pulmonary arterial hypertension (PAH) MedDRA version: 20.0;Level: LLT;Classification code 10077731;Term: Pulmonary hypertension WHO functional class I;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: AR392830 Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: AR392830 Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: AR392830 | United Therapeutics Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1000 | Phase 3 | Portugal;United States;Serbia;Taiwan;Greece;Ukraine;Israel;Chile;Italy;France;Australia;Denmark;China;Korea, Republic of;Turkey;United Kingdom;Hungary;European Union;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Singapore;Croatia;Bulgaria;Sweden | ||
| 152 | EUCTR2018-001187-33-HU (EUCTR) | 14/01/2019 | 06/11/2018 | A study evaluating the efficacy and safety of ralinepag in treatment of patients with pulmonary hypertension. | A Study Evaluating the EffiCacy and Safety of Ralinepag To Improve Treatment Outcomes in PAH Patients - ADVANCE-Outcomes | pulmonary arterial hypertension (PAH) MedDRA version: 20.0;Level: LLT;Classification code 10077731;Term: Pulmonary hypertension WHO functional class I;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: NA Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: NA Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: NA | United Therapeutics Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 700 | Phase 3 | Portugal;Serbia;United States;Taiwan;Greece;Ukraine;Israel;Chile;Australia;Denmark;Netherlands;China;Korea, Republic of;Turkey;United Kingdom;Hungary;Mexico;European Union;Canada;Argentina;Brazil;Poland;Belgium;Singapore;Croatia;Bulgaria;Germany;Sweden | ||
| 153 | EUCTR2017-004738-27-BE (EUCTR) | 04/01/2019 | 31/08/2018 | A Phase 2 Study of Sotatercept for the Treatment of PAH | A Phase 2, Double-Blind, Placebo-Controlled, Randomized Study to Compare the Efficacy and Safety of Sotatercept (ACE-011) Versus Placebo When Added to Standard of Care for the Treatment of Pulmonary Arterial Hypertension (PAH) | Pulmonary Arterial Hypertension (PAH) MedDRA version: 20.0;Level: LLT;Classification code 10077739;Term: Pulmonary arterial hypertension WHO functional class I;System Organ Class: 100000004855 ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Sotatercept Product Code: ACE-011 INN or Proposed INN: SOTATERCEPT Other descriptive name: ActRIIA-IgG1Fc | Acceleron Pharma Inc. | NULL | Not Recruiting | Female: yes Male: yes | 100 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | France;United States;Brazil;Spain;Belgium;Australia;Israel;Germany;United Kingdom | ||
| 154 | EUCTR2018-002796-18-AT (EUCTR) | 20/12/2018 | 06/11/2018 | To study the safety and effectiveness of the maximum tolerated dose of zamicastat, found in BIA-51058-201, in the treatment of long-term PAH. | An open-label, multicentre study to evaluate the safety and efficacy of zamicastat as adjunctive therapy in long-term treatment of pulmonary arterial hypertension (PAH) disease | Pulmonary arterial hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Zamicastat Product Code: BIA-5-1058 INN or Proposed INN: ZAMICASTAT Other descriptive name: BIA 5-1058 | Bial - Portela & Ca, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 40 | Phase 2 | Portugal;Spain;Ukraine;Austria;Germany;United Kingdom;Italy | ||
| 155 | NCT03657095 (ClinicalTrials.gov) | December 10, 2018 | 18/5/2018 | A Study With BPS-314d-MR-PAH-303 in Participants With Pulmonary Arterial Hypertension | An Open-label Extension of BPS-314d-MR-PAH-302 in Pulmonary Arterial Hypertension Patients | Pulmonary Arterial Hypertension | Drug: Esuberaprost;Drug: Placebo | Lung Biotechnology PBC | NULL | Terminated | 18 Years | 85 Years | All | 112 | Phase 3 | United States;Israel |
| 156 | EUCTR2018-002448-10-PT (EUCTR) | 26/11/2018 | 04/09/2018 | Study to find the most promising therapeutic dosage of zamicastat for the treatment of PAH disease. | An open-label, multicentre study to evaluate pharmacokinetics, safety and efficacy of zamicastat as adjunctive therapy in pulmonary arterial hypertension (PAH) - Pharmacokinetics, safety and efficacy of BIA 5-1058 in PAH | Pulmonary arterial hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Zamicastat Product Code: BIA 5-1058 INN or Proposed INN: ZAMICASTAT Other descriptive name: BIA 5-1058 | Bial - Portela & Ca, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 40 | Phase 2 | France;Portugal;Spain;Belgium;Ukraine;Austria;Netherlands;Germany;United Kingdom;Italy | ||
| 157 | EUCTR2018-002448-10-ES (EUCTR) | 21/11/2018 | 09/10/2018 | Study to find the most promising therapeutic dosage of zamicastat for the treatment of PAH disease. | An open-label, multicentre study to evaluate pharmacokinetics, safety and efficacy of zamicastat as adjunctive therapy in pulmonary arterial hypertension (PAH) - Pharmacokinetics, safety and efficacy of BIA 5-1058 in PAH | Pulmonary arterial hypertension MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Zamicastat Product Code: BIA 5-1058 INN or Proposed INN: ZAMICASTAT Other descriptive name: BIA 5-1058 | Bial - Portela & Ca, S.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 40 | Phase 2 | Portugal;Spain;Ukraine;Austria | ||
| 158 | EUCTR2018-002448-10-AT (EUCTR) | 31/10/2018 | 08/08/2018 | Study to find the most promising therapeutic dosage of zamicastat for the treatment of PAH disease. | An open-label, multicentre study to evaluate pharmacokinetics, safety and efficacy of zamicastat as adjunctive therapy in pulmonary arterial hypertension (PAH) - Pharmacokinetics, safety and efficacy of BIA 5-1058 in PAH | Pulmonary arterial hypertension;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Zamicastat Product Code: BIA 5-1058 INN or Proposed INN: ZAMICASTAT Other descriptive name: BIA 5-1058 | Bial - Portela & Ca, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 40 | Phase 2 | Portugal;Spain;Ukraine;Austria;Germany;United Kingdom;Italy | ||
| 159 | NCT03251872 (ClinicalTrials.gov) | October 25, 2018 | 13/8/2017 | Olaparib for PAH: a Pilot Study | Olaparib for Pulmonary Arterial Hypertension: a Pilot Clinical Study | Pulmonary Arterial Hypertension | Drug: Olaparib | Laval University | NULL | Terminated | 18 Years | 75 Years | All | 6 | Early Phase 1 | Canada |
| 160 | EUCTR2017-004738-27-GB (EUCTR) | 18/10/2018 | 24/06/2019 | A Phase 2 Study of Sotatercept for the Treatment of PAH | A Phase 2, Double-Blind, Placebo-Controlled, Randomized Study to Compare the Efficacy and Safety of Sotatercept (ACE-011) Versus Placebo When Added to Standard of Care for the Treatment of Pulmonary Arterial Hypertension (PAH) | Pulmonary Arterial Hypertension (PAH) MedDRA version: 20.0;Level: LLT;Classification code 10077739;Term: Pulmonary arterial hypertension WHO functional class I;System Organ Class: 100000004855 ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Sotatercept Product Code: ACE-011 INN or Proposed INN: SOTATERCEPT Other descriptive name: ActRIIA-IgG1Fc | Acceleron Pharma Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 90 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | France;United States;Brazil;Belgium;Spain;Australia;Israel;Germany;United Kingdom | ||
| 161 | EUCTR2013-004362-34-LV (EUCTR) | 03/10/2018 | 02/07/2018 | A MULTINATIONAL, MULTICENTER STUDY TO ASSESS THE EFFECTS OF ORAL SILDENAFIL ON MORTALITY IN ADULTS WITH PULMONARY ARTERIAL HYPERTENSION | A MULTINATIONAL, MULTICENTER STUDY TO ASSESS THE EFFECTS OF ORAL SILDENAFIL ON MORTALITY IN ADULTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH) | Pulmonary Arterial Hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09] | Product Name: Sildenafil Product Code: UK 092480 INN or Proposed INN: Sildenafil Other descriptive name: SILDENAFIL CITRATE Product Name: Sildenafil Product Code: UK 092480 INN or Proposed INN: Sildenafil Other descriptive name: SILDENAFIL CITRATE Product Name: Sildenafil Product Code: UK 092480 INN or Proposed INN: Sildenafil Other descriptive name: SILDENAFIL CITRATE | Pfizer Inc., 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 429 | Phase 3;Phase 4 | United States;Portugal;Serbia;Hong Kong;Greece;Spain;Thailand;Ukraine;Israel;Russian Federation;Malaysia;Australia;South Africa;Latvia;Netherlands;Bosnia and Herzegovina;Turkey;Austria;Czech Republic;Mexico;Belgium;Poland;Singapore;Croatia;Romania;Germany;Sweden | ||
| 162 | EUCTR2017-000216-42-FR (EUCTR) | 27/09/2018 | 23/07/2018 | Daily life physical activity and disease symptoms assessed in patients withpulmonary arterial hypertension (PAH) treated with selexipag | A multi-center, double-blind, placebo-controlled, Phase 4 study in patients with pulmonary arterial hypertension to assess the effect of selexipag on daily life physical activity and patient’s self-reported symptoms and their impacts - TRACE | Pulmonary arterial hypertension MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Uptravi Product Name: Selexipag Product Code: ACT-293987 INN or Proposed INN: Selexipag Other descriptive name: SELEXIPAG | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 4 | United States;Portugal;France;Ireland;Austria;Norway;Germany;United Kingdom;Switzerland;Sweden | ||
| 163 | EUCTR2017-004738-27-ES (EUCTR) | 04/09/2018 | 05/09/2018 | A Phase 2 Study of Sotatercept for the Treatment of PAH | A Phase 2, Double-Blind, Placebo-Controlled, Randomized Study to Compare the Efficacy and Safety of Sotatercept (ACE-011) Versus Placebo When Added to Standard of Care for the Treatment of Pulmonary Arterial Hypertension (PAH) | Pulmonary Arterial Hypertension (PAH) MedDRA version: 20.0;Level: LLT;Classification code 10077739;Term: Pulmonary arterial hypertension WHO functional class I;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Sotatercept Product Code: ACE-011 INN or Proposed INN: SOTATERCEPT Other descriptive name: ActRIIA-IgG1Fc | Acceleron Pharma Inc. | NULL | Not Recruiting | Female: yes Male: yes | 90 | Phase 2 | United States;France;Brazil;Belgium;Spain;Australia;Israel;Germany;United Kingdom | ||
| 164 | NCT03626688 (ClinicalTrials.gov) | August 30, 2018 | 27/7/2018 | A Study Evaluating the Efficacy and Safety of Ralinepag to Improve Treatment Outcomes in PAH Patients | A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Ralinepag When Added to PAH Standard of Care or PAH Specific Background Therapy in Subjects With WHO Group 1 PAH | PAH;Pulmonary Hypertension;Pulmonary Arterial Hypertension;Hypertension;Connective Tissue Diseases;Familial Primary Pulmonary Hypertension;Vascular Diseases;Cardiovascular Diseases;Hypertension, Pulmonary;Lung Diseases;Respiratory Tract Disease | Drug: Ralinepag;Drug: Placebo | United Therapeutics | NULL | Recruiting | 18 Years | N/A | All | 1000 | Phase 3 | United States;Argentina;Australia;Austria;Belgium;Brazil;Bulgaria;Canada;Chile;China;Croatia;Czechia;Denmark;France;Germany;Greece;Hungary;Israel;Italy;Korea, Republic of;Mexico;Netherlands;Poland;Portugal;Romania;Serbia;Singapore;Spain;Sweden;Taiwan;Turkey;Ukraine;United Kingdom |
| 165 | EUCTR2015-005223-90-BE (EUCTR) | 16/08/2018 | 24/05/2016 | This is a multicenter, double-blind, randomized, placebo-controlled, parallel-group study to investigate the efficacy, tolerability and safety of pulsed inhaled nitric oxide 75mcg/kg IBW/hr, 12 hours per day or longer for 18 weeks in symptomatic subjects with pulmonary arterial hypertension. (Part 1), followed by an open-label extension (Part 2) whichprovides active therapy to all subjects completing the first 18 weeks. | A PHASE 3, PLACEBO CONTROLLED, DOUBLE-BLIND, RANDOMIZED, CLINICAL STUDY TO DETERMINE EFFICACY, SAFETY AND TOLERABILITY OF PULSED, INHALED NITRIC OXIDE (iNO) VERSUS PLACEBO IN SYMPTOMATIC SUBJECTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH): INOvation-1 (Part 1 and Part 2) | Pulmonary Arterial Hypertension MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: inhaled nitric oxide & INOpulse delivery Product Code: iNO INN or Proposed INN: NITRIC OXIDE Other descriptive name: inhaled NO with pulsed delivery | Bellerophon Pulse Technologies LLC | NULL | Not Recruiting | Female: yes Male: yes | 188 | Phase 3 | Serbia;Portugal;United States;Spain;Ukraine;Austria;Israel;Colombia;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Croatia;Australia;Netherlands;Germany;Korea, Republic of | ||
| 166 | EUCTR2017-004738-27-DE (EUCTR) | 15/08/2018 | 03/08/2018 | A Phase 2 Study of Sotatercept for the Treatment of PAH | A Phase 2, Double-Blind, Placebo-Controlled, Randomized Study to Compare the Efficacy and Safety of Sotatercept (ACE-011) Versus Placebo When Added to Standard of Care for the Treatment of Pulmonary Arterial Hypertension (PAH) | Pulmonary Arterial Hypertension (PAH) MedDRA version: 20.0;Level: LLT;Classification code 10077739;Term: Pulmonary arterial hypertension WHO functional class I;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Sotatercept Product Code: ACE-011 INN or Proposed INN: SOTATERCEPT Other descriptive name: ActRIIA-IgG1Fc | Acceleron Pharma Inc. | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 2 | United States;France;Spain;Brazil;Belgium;Australia;Israel;Germany;United Kingdom | ||
| 167 | NCT03449524 (ClinicalTrials.gov) | August 1, 2018 | 14/2/2018 | PRIMEx - A Study of 2 Doses of Oral CXA-10 in Pulmonary Arterial Hypertension (PAH) | Phase 2 Multicenter, Double-Blind, Placebo Controlled, Efficacy, Safety, and Pharmacokinetic Study of 2 Doses of CXA-10 on Stable Background Therapy in Subjects With Pulmonary Arterial Hypertension | PAH | Drug: 75mg CXA-10;Drug: 150mg CXA-10;Other: Placebo | Complexa, Inc. | Medpace, Inc.;Philips Healthcare;Cardiovascular Clinical Science Foundation;MicroConstants;Innovative Analytics;Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) | Terminated | 18 Years | 80 Years | All | 69 | Phase 2 | United States;United Kingdom |
| 168 | NCT03602781 (ClinicalTrials.gov) | August 2018 | 6/7/2018 | Study of PAH Subjects With LTOT Use That Have Demonstrated Improved Exercise Tolerance With the Use of Inhaled Nitric | Phase 3, Multicenter, Randomized, Double-blind, Placebo Controlled Withdrawal Study of Pulmonary Arterial Hypertension(PAH) Subjects With LTOT Use That Have Demonstrated Improved Exercise Tolerance With the Use of Inhaled Nitric Oxide (INO) | Pulmonary Arterial Hypertension | Drug: Placebo;Drug: iNO | Bellerophon Pulse Technologies | Worldwide Clinical Trials | Withdrawn | 18 Years | N/A | All | 0 | Phase 3 | United States;Canada |
| 169 | EUCTR2015-003438-28-GB (EUCTR) | 21/06/2018 | 13/11/2017 | The efficacy and safety of initial triple versus initial dual oral combinationtherapy in patients with newly diagnosed pulmonary arterial hypertension | The efficacy and safety of initial triple versus initial dual oral combinationtherapy in patients with newly diagnosed pulmonary arterial hypertension:A multi-center, double-blind, placebo-controlled, Phase 3b study - TRITON - Macitentan, Tadalafil and Selexipag Study in Patients with PAH | Pulmonary arterial hypertension (PAH) MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Uptravi Product Name: Selexipag Product Code: ACT-293987 INN or Proposed INN: Selexipag Other descriptive name: SELEXIPAG Trade Name: Opsumit Product Name: Macitentan Product Code: ACT-064992 INN or Proposed INN: Macitentan Other descriptive name: MACITENTAN Trade Name: Adcirca Product Name: Adcirca INN or Proposed INN: TADALAFIL Other descriptive name: TADALAFIL | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 238 | Phase 3 | United States;Spain;Ireland;Austria;Italy;United Kingdom;Switzerland;France;Canada;Belgium;Brazil;Australia;Denmark;Norway;Netherlands;Germany;Sweden | ||
| 170 | NCT03496207 (ClinicalTrials.gov) | June 13, 2018 | 29/3/2018 | A Study of Sotatercept for the Treatment of Pulmonary Arterial Hypertension (PAH) | A Phase 2, Double-Blind, Placebo-Controlled, Randomized Study to Compare the Efficacy and Safety of Sotatercept (ACE-011) Versus Placebo When Added to Standard of Care for the Treatment of Pulmonary Arterial Hypertension (PAH) | Pulmonary Arterial Hypertension | Drug: Placebo;Drug: Sotatercept | Acceleron Pharma Inc. (a wholly owned subsidiary of Merck Sharp and Dohme, a subsidiary of Merck & Co., Inc.) | NULL | Completed | 18 Years | N/A | All | 106 | Phase 2 | United States;Australia;Brazil;France;Germany;Israel;Spain;United Kingdom |
| 171 | EUCTR2017-000216-42-PT (EUCTR) | 14/05/2018 | 03/11/2017 | Daily life physical activity and disease symptoms assessed in patients withpulmonary arterial hypertension (PAH) treated with selexipag | A multi-center, double-blind, placebo-controlled, Phase 4 study in patients with pulmonary arterial hypertension to assess the effect of selexipag on daily life physical activity and patient’s self-reported symptoms and their impacts - TRACE | Pulmonary arterial hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Uptravi Product Name: Selexipag Product Code: ACT-293987 INN or Proposed INN: Selexipag Other descriptive name: SELEXIPAG | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 4 | United States;France;Portugal;Ireland;Austria;Norway;Netherlands;Germany;United Kingdom;Switzerland;Sweden | ||
| 172 | EUCTR2017-003934-10-FR (EUCTR) | 19/03/2018 | 19/01/2018 | A clinical study to investigate the long term safety of the drug macitentan in patients with pulmonary arterial hypertension and who were previously treated with macitentan in clinical studies. | mUlticenter, single-arM, open-laBel, long-teRm safety study with macitEntan in patients with puLmonary arterial hypertension previousLy treated with mAcitentan in clinical studies - UMBRELLA | Pulmonary arterial hypertension (PAH) MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Opsumit Product Name: Macitentan Product Code: ACT-064992 INN or Proposed INN: MACITENTAN | Actelion Pharmaceuticals Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 94 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France | ||
| 173 | NCT03362047 (ClinicalTrials.gov) | March 1, 2018 | 22/11/2017 | (RIGHT HEART III Study - Right Ventricular Hemodynamic Evaluation and Response to Treatment) | Untersuchung Des Einflusses PAH-spezifischer Medikation Auf Die rechtsventrikuläre Funktion Bei Patienten Mit Pulmonaler Arterieller Hypertonie (PAH) Unter Basalen Bedingungen | Pulmonary Arterial Hypertension (PAH) | Drug: Riciguat Group;Drug: Macitentan Group | University of Giessen | Philipps University Marburg Medical Center | Recruiting | 18 Years | 85 Years | All | 30 | Phase 2 | Germany |
| 174 | NCT03177603 (ClinicalTrials.gov) | February 21, 2018 | 23/5/2017 | A Dose-escalation Study in Subjects With Pulmonary Arterial Hypertension (PAH) | An Open-label, Dose-escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Doses of GSK2586881 in Participants With Pulmonary Arterial Hypertension | Hypertension, Pulmonary | Drug: GSK2586881 | GlaxoSmithKline | NULL | Completed | 18 Years | 75 Years | All | 23 | Phase 2 | United States;Germany;Spain |
| 175 | NCT02939599 (ClinicalTrials.gov) | February 1, 2018 | 12/10/2016 | Long-term Extension Study of the Safety and Pharmacokinetics of QCC374 in PAH Patients | Long-term, Open Label, Multicenter, Extension Study to Evaluate the Safety and Tolerability of QCC374 in Patients With Pulmonary Arterial Hypertension (PAH) | Pulmonary Arterial Hypertension | Drug: QCC374 | Novartis Pharmaceuticals | NULL | Terminated | 18 Years | N/A | All | 5 | Phase 2 | United States;Germany;United Kingdom |
| 176 | EUCTR2015-003438-28-ES (EUCTR) | 19/01/2018 | 01/12/2017 | The efficacy and safety of initial triple versus initial dual oral combinationtherapy in patients with newly diagnosed pulmonary arterial hypertension | The efficacy and safety of initial triple versus initial dual oral combinationtherapy in patients with newly diagnosed pulmonary arterial hypertension:A multi-center, double-blind, placebo-controlled, Phase 3b study - TRITON | Pulmonary arterial hypertension (PAH) MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Selexipag Product Code: ACT-293987 INN or Proposed INN: Selexipag Other descriptive name: SELEXIPAG Trade Name: Opsumit Product Name: Macitentan Product Code: ACT-064992 INN or Proposed INN: Macitentan Other descriptive name: MACITENTAN Trade Name: Adcirca Product Name: Adcirca INN or Proposed INN: TADALAFIL Other descriptive name: TADALAFIL | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 238 | Phase 3 | United States;Spain;Ireland;Austria;United Kingdom;Switzerland;Italy;France;Canada;Belgium;Brazil;Australia;Denmark;Germany;Netherlands;Norway;Sweden | ||
| 177 | EUCTR2016-001411-20-GB (EUCTR) | 12/01/2018 | 09/01/2017 | Long-term extension study of the safety and pharmacokinetics of QCC374 in PAH patients | Long-term, open label, multicenter, extension study to evaluate the safety and tolerability of QCC374 in patients with PAH | Pulmonary arterial hypertension MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Code: QCC374 0.015 mg INN or Proposed INN: TBD Product Code: QCC374 0.06 mg INN or Proposed INN: TBD | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 38 | Phase 2 | United States;Taiwan;Germany;United Kingdom;Korea, Republic of | ||
| 178 | EUCTR2017-000216-42-DE (EUCTR) | 30/11/2017 | 26/05/2017 | Daily life physical activity and disease symptoms assessed in patients withpulmonary arterial hypertension (PAH) treated with selexipag | A multi-center, double-blind, placebo-controlled, Phase 4 study in patients with pulmonary arterial hypertension to assess the effect of selexipag on daily life physical activity and patient’s self-reported symptoms and their impacts - TRACE | Pulmonary arterial hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Uptravi Product Name: Selexipag Product Code: ACT-293987 INN or Proposed INN: Selexipag Other descriptive name: SELEXIPAG | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 4 | United States;Portugal;France;Ireland;Austria;Norway;Netherlands;Germany;United Kingdom;Switzerland;Sweden | ||
| 179 | EUCTR2017-000216-42-SE (EUCTR) | 24/10/2017 | 16/05/2017 | Daily life physical activity and disease symptoms assessed in patients withpulmonary arterial hypertension (PAH) treated with selexipag | A multi-center, double-blind, placebo-controlled, Phase 4 study in patients with pulmonary arterial hypertension to assess the effect of selexipag on daily life physical activity and patient’s self-reported symptoms and their impacts - TRACE | Pulmonary arterial hypertension MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Uptravi Product Name: Selexipag Product Code: ACT-293987 INN or Proposed INN: Selexipag Other descriptive name: SELEXIPAG | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 4 | United States;Portugal;France;Ireland;Austria;Norway;Netherlands;Germany;United Kingdom;Switzerland;Sweden | ||
| 180 | NCT02932410 (ClinicalTrials.gov) | October 24, 2017 | 12/10/2016 | A Study to Assess Whether Macitentan Delays Disease Progression in Children With Pulmonary Arterial Hypertension (PAH) | A Multicenter, Open-label, Randomized, Study With Single-arm Extension Period to Assess the Pharmacokinetics, Safety and Efficacy of Macitentan Versus Standard of Care in Children With Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension | Drug: Macitentan;Other: Standard-of-care | Actelion | NULL | Recruiting | 1 Month | 17 Years | All | 300 | Phase 3 | United States;Australia;Austria;Brazil;Canada;China;Colombia;Finland;France;Hungary;Israel;Korea, Republic of;Malaysia;Mexico;Philippines;Poland;Portugal;Russian Federation;South Africa;Spain;Thailand;Ukraine;Vietnam;Argentina;Bulgaria |
| 181 | NCT03315507 (ClinicalTrials.gov) | October 20, 2017 | 2/10/2017 | A Study to Assess the Safety, Tolerability, and Hemodynamic Response of PB1046 in Subjects With PAH | An Open-Label, Dose Titration Study to Assess the Safety, Tolerability, and Hemodynamic Response of PB1046, A Sustained-Release Analogue of Vasoactive Intestinal Peptide, In Adult Subjects With Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension | Drug: PB1046 Subcutaneous Injection | PhaseBio Pharmaceuticals Inc. | NULL | Completed | 18 Years | N/A | All | 3 | Phase 1 | United States |
| 182 | EUCTR2016-001411-20-DE (EUCTR) | 17/10/2017 | 07/08/2017 | Long-term extension study of the safety and pharmacokinetics of QCC374 in PAH patients | Long-term, open label, multicenter, extension study to evaluate the safety and tolerability of QCC374 in patients with PAH | Pulmonary arterial hypertension MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Code: QCC374 0.015 mg INN or Proposed INN: TBD Product Code: QCC374 0.06 mg INN or Proposed INN: TBD | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 38 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Taiwan;Germany;United Kingdom;Korea, Republic of | ||
| 183 | NCT03145298 (ClinicalTrials.gov) | October 1, 2017 | 2/5/2017 | ALlogeneic Cardiosphere-derived Stem Cells (CDCs) for Pulmonary Hypertension therApy | A Phase I Study of the Safety and Feasibility of Central Intravenous Delivery of Allogeneic Human Cardiosphere-Derived Stem Cells in Patients With Pulmonary Arterial Hypertension ALPHA Trial | Pulmonary Arterial Hypertension (PAH) | Biological: Allogeneic Human Cardiosphere-Derived Stem Cells;Biological: Placebo | Cedars-Sinai Medical Center | California Institute for Regenerative Medicine (CIRM) | Active, not recruiting | 18 Years | 75 Years | All | 26 | Phase 1 | United States |
| 184 | NCT03001414 (ClinicalTrials.gov) | September 28, 2017 | 15/12/2016 | Study of Angiogenic Cell Therapy for Progressive Pulmonary Hypertension: Intervention With Repeat Dosing of eNOS-enhanced EPCs | A Multicentre, Late Phase Clinical Trial to Establish the Efficacy and Safety of Repeat Dosing of Autologous Endothelial Progenitor Cells (EPCs) Transfected With Human Endothelial NO-synthase (eNOS) in Patients With Pulmonary Arterial Hypertension (PAH) on Top of Conventional Treatments | Hypertension,Pulmonary | Biological: Placebo followed by Autologous EPCs transfected with human eNOS;Biological: Autologous EPCs transfected with human eNOS followed by Placebo;Biological: Autologous EPCs transfected with human eNOS | Northern Therapeutics | Ottawa Hospital Research Institute | Active, not recruiting | 18 Years | 80 Years | All | 12 | Phase 2/Phase 3 | Canada |
| 185 | NCT02927366 (ClinicalTrials.gov) | September 19, 2017 | 5/10/2016 | Safety, Pharmacokinetics and Efficacy Study of QCC374 in PAH Patients | A Randomized, Parallel-group, Placebo-controlled Subject and Investigator Blinded Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of QCC374 in the Treatment of Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension | Drug: QCC374;Drug: Placebo Matching | Novartis Pharmaceuticals | NULL | Terminated | 18 Years | N/A | All | 8 | Phase 2 | United States;Germany;Korea, Republic of;United Kingdom;Taiwan |
| 186 | EUCTR2017-000216-42-IE (EUCTR) | 12/09/2017 | 05/05/2017 | Daily life physical activity and disease symptoms assessed in patients withpulmonary arterial hypertension (PAH) treated with selexipag | A multi-center, double-blind, placebo-controlled, Phase 3b study in patients with pulmonary arterial hypertension to assess the effect of selexipag on daily life physical activity and patient’s self-reported symptoms and their impacts - TRACE | Pulmonary arterial hypertension MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Uptravi Product Name: Selexipag Product Code: ACT-293987 INN or Proposed INN: Selexipag Other descriptive name: SELEXIPAG | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 4 | Portugal;France;United States;Ireland;Austria;Norway;Netherlands;Germany;United Kingdom;Switzerland;Sweden | ||
| 187 | EUCTR2017-000212-41-DE (EUCTR) | 01/09/2017 | 27/06/2017 | Study to test a new drug to treat patients with Pulmonary Arterial Hypertension (PAH) | An Open-label, Dose-escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Doses of GSK2586881 in Participants with Pulmonary Arterial Hypertension - PH 2a, SD, DE, safety, PK/PD study of GSK2586881 in Pulmonary Arterial Hypertension pts | Pulmonary arterial hypertension MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 20.0;Level: LLT;Classification code 10077739;Term: Pulmonary arterial hypertension WHO functional class I;Classification code 10077729;Term: Pulmonary arterial hypertension WHO functional class III;Classification code 10077740;Term: Pulmonary arterial hypertension WHO functional class II;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: GSK2586881 Product Code: GSK2586881 INN or Proposed INN: GSK2586881 Other descriptive name: Recombinant Human Angiotensin-converting enzyme 2 (ACE2), APN01 | GlaxoSmithKline Research & Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 24 | Phase 2 | United States;Germany;Spain | ||
| 188 | EUCTR2017-000216-42-AT (EUCTR) | 29/08/2017 | 09/06/2017 | Daily life physical activity and disease symptoms assessed in patients withpulmonary arterial hypertension (PAH) treated with selexipag | A multi-center, double-blind, placebo-controlled, Phase 4 study in patients with pulmonary arterial hypertension to assess the effect of selexipag on daily life physical activity and patient’s self-reported symptoms and their impacts - TRACE | Pulmonary arterial hypertension MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Uptravi Product Name: Selexipag Product Code: ACT-293987 INN or Proposed INN: Selexipag Other descriptive name: SELEXIPAG | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 4 | United States;Portugal;France;Ireland;Austria;Norway;Netherlands;Germany;United Kingdom;Switzerland;Sweden | ||
| 189 | EUCTR2015-005223-90-HR (EUCTR) | 23/08/2017 | 12/09/2017 | This is a multicenter, double-blind, randomized, placebo-controlled,parallel-group study to investigate the efficacy, tolerability and safety ofpulsed inhaled nitric oxide 75mcg/kg IBW/hr, 12 hours per day or longerfor 18 weeks in symptomatic subjects with pulmonary arterialhypertension. (Part 1), followed by an open-label extension (Part 2) whichprovides active therapy to all subjects completing the first 18 weeks. | A PHASE 3, PLACEBO CONTROLLED, DOUBLE-BLIND, RANDOMIZED,CLINICAL STUDY TO DETERMINE EFFICACY, SAFETY AND TOLERABILITY OF PULSED, INHALED NITRIC OXIDE (iNO) VERSUS PLACEBO IN SYMPTOMATIC SUBJECTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH): INOvation-1 (Part 1 and Part 2) | Pulmonary Arterial Hypertension MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: inhaled nitric oxide & INOpulse delivery Product Code: iNO INN or Proposed INN: NITRIC OXIDE Other descriptive name: inhaled NO with pulsed delivery | Bellerophon Pulse Technologies LLC | NULL | Not Recruiting | Female: yes Male: yes | 188 | Phase 3 | Serbia;Portugal;United States;Spain;Ukraine;Austria;Israel;Colombia;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Croatia;Australia;Netherlands;Germany;Korea, Republic of | ||
| 190 | EUCTR2017-000212-41-ES (EUCTR) | 10/08/2017 | 22/06/2017 | Study to test a new drug to treat patients with Pulmonary Arterial Hypertension (PAH). | An Open-label, Dose-escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Doses of GSK2586881 in Participants with Pulmonary Arterial Hypertension. - PH 2a, SD, DE, safety, PK/PD study of GSK2586881 in Pulmonary Arterial Hypertension pts | Pulmonary arterial hypertension MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 20.0;Level: LLT;Classification code 10077739;Term: Pulmonary arterial hypertension WHO functional class I;Classification code 10077729;Term: Pulmonary arterial hypertension WHO functional class III;Classification code 10077740;Term: Pulmonary arterial hypertension WHO functional class II;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: GSK2586881 Product Code: GSK2586881 INN or Proposed INN: GSK2586881 Other descriptive name: Recombinant Human Angiotensin-converting enzyme 2 (ACE2), APN01 | GlaxoSmithKline, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 24 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Spain;Germany | ||
| 191 | EUCTR2016-001412-38-DE (EUCTR) | 27/07/2017 | 03/04/2017 | Safety, pharmacokinetics and efficacy study of QCC374 in PAH patients | A randomized, parallel-group, placebo-controlled subject and investigator blinded study to assess the safety, tolerability, pharmacokinetics and efficacy of QCC374 in the treatment of pulmonary arterial hypertension | Pulmonary arterial hypertension MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Code: QCC374 0.015 mg INN or Proposed INN: TBD Product Code: QCC374 0.06 mg INN or Proposed INN: TBD | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 38 | Phase 2 | United States;Taiwan;Germany;United Kingdom;Korea, Republic of | ||
| 192 | EUCTR2016-001062-28-ES (EUCTR) | 13/07/2017 | 13/01/2017 | A study to find out whether the medicine macitentan works in children with pulmonary arterial hypertension (PAH) | A multicenter, open-label, randomized, event-driven study to assess efficacy, safety and pharmacokinetics of macitentan versus standard of care in children with pulmonary arterial hypertension - TOMORROW: pediaTric use Of Macitentan tO delay disease pRogRessiOn in PAH Worldwide | Pulmonary arterial hypertension MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: macitentan Product Code: ACT-064992 INN or Proposed INN: MACITENTAN Product Name: macitentan Product Code: ACT-064992 INN or Proposed INN: MACITENTAN Product Name: macitentan Product Code: ACT-064992 INN or Proposed INN: MACITENTAN | ACTELION Pharmaceuticals Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 3 | Portugal;United States;Philippines;Spain;Thailand;Ukraine;Austria;Russian Federation;Israel;Vietnam;France;Hungary;Mexico;Canada;Argentina;Poland;Australia;South Africa;Bulgaria;Germany;China;Korea, Republic of | ||
| 193 | EUCTR2017-000216-42-GB (EUCTR) | 11/07/2017 | 05/05/2017 | Daily life physical activity and disease symptoms assessed in patients withpulmonary arterial hypertension (PAH) treated with selexipag | A multi-center, double-blind, placebo-controlled, Phase 4 study in patients with pulmonary arterial hypertension to assess the effect of selexipag on daily life physical activity and patient’s self-reported symptoms and their impacts - TRACE | Pulmonary arterial hypertension MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Uptravi Product Name: Selexipag Product Code: ACT-293987 INN or Proposed INN: Selexipag Other descriptive name: SELEXIPAG | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 4 | Portugal;France;United States;Ireland;Austria;Norway;Netherlands;Germany;Switzerland;United Kingdom;Sweden | ||
| 194 | EUCTR2014-003952-29-BE (EUCTR) | 07/06/2017 | 03/01/2017 | Riociguat for treatment of PAH in children from 6 to less than 18 years old | Open-label, individual dose titration study to evaluate safety, tolerability and pharmacokinetics of riociguat in children from 6 to less than 18 years of age with pulmonary arterial hypertension (PAH) - PATENT-CHILD | Pulmonary arterial hypertension (PAH) MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Adempas Product Name: Adempas 0.5 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas 1.0 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas 1.5 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas 2.0 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat | Bayer AG | NULL | Not Recruiting | Female: yes Male: yes | 20 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Spain;Turkey;Colombia;United Kingdom;Italy;France;Hungary;Mexico;Belgium;Poland;Romania;Germany;Netherlands;Japan | ||
| 195 | EUCTR2016-001062-28-PT (EUCTR) | 15/05/2017 | 23/12/2016 | A study to find out whether the medicine macitentan works in children with pulmonary arterial hypertension (PAH) | A multicenter, open-label, randomized, event-driven study to assess efficacy, safety and pharmacokinetics of macitentan versus standard of care in children with pulmonary arterial hypertension - TOMORROW: pediaTric use Of Macitentan tO delay disease pRogRessiOn in PAH Worldwide | Pulmonary arterial hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: macitentan Product Code: ACT-064992 INN or Proposed INN: MACITENTAN Product Name: macitentan Product Code: ACT-064992 INN or Proposed INN: MACITENTAN Product Name: macitentan Product Code: ACT-064992 INN or Proposed INN: MACITENTAN | ACTELION Pharmaceuticals Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 3 | United States;Portugal;Philippines;Finland;Thailand;Spain;Ukraine;Austria;Russian Federation;Israel;Colombia;France;Hungary;Mexico;Canada;Poland;Brazil;Malaysia;Viet Nam;Australia;South Africa;China;Korea, Republic of | ||
| 196 | NCT03016468 (ClinicalTrials.gov) | May 2017 | 6/1/2017 | Safety of Transition From Selexipag to Remodulin® Then Oral Treprostinil in Symptomatic Adult PAH | A Multicenter, 16-Week, Open-label Study Evaluating the Safety of Transition From Selexipag to Remodulin® Then Oral Treprostinil in Symptomatic Subjects With Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension | Drug: Parenteral Remodulin (treprostinil) injection;Drug: Oral Treprostinil | United Therapeutics | NULL | Withdrawn | 18 Years | 75 Years | All | 0 | Phase 2 | NULL |
| 197 | NCT02587325 (ClinicalTrials.gov) | April 1, 2017 | 23/10/2015 | Phase 1/1b Study With Nab-sirolimus for Patients With Severe Pulmonary Arterial Hypertension | A Phase 1/1b Clinical Trial of ABI-009, an mTOR Inhibitor, for Patients With Severe Pulmonary Arterial Hypertension (PAH) | Pulmonary Hypertension | Drug: nab-sirolimus (also known as ABI-009, nab-rapamycin, albumin-bound rapamycin) | Aadi Bioscience, Inc. | NULL | Completed | 18 Years | N/A | All | 15 | Phase 1 | United States |
| 198 | EUCTR2016-001067-36-DE (EUCTR) | 22/03/2017 | 10/11/2016 | A study to find out whether some PAH patients may benefit by replacing their current phosphodiesterase-5 inhibitors (PDE-5i) with or without endothelin receptor antagonist (ERA), with Riociguat | A prospective, randomized, international, multicenter, double-arm, controlled, open-label study of Riociguat in patients with pulmonary arterial hypertension (PAH) who are on a stable dose of phosphodiesterase-5 inhibitors (PDE-5i) with or without endothelin receptor antagonist (ERA), but not at treatment goal - Riociguat rEplacing PDE-5i therapy evaLuated Against Continued PDE-5i thErapy | Pulmonary Arterial Hypertension (PAH) MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Adempas Product Name: Adempas® 0.5 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas® 1.0 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas® 1.5 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas® 2.0 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas® 2.5 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adcirca Product Name: ADCIRCA 20 mg film-coated tablets INN or Proposed INN: TADALAFIL | Bayer AG | NULL | Not Recruiting | Female: yes Male: yes | 218 | Phase 4 | United States;Portugal;Taiwan;Greece;Spain;Turkey;Austria;United Kingdom;Switzerland;Italy;France;Czech Republic;Mexico;Canada;Poland;Belgium;Brazil;Australia;Denmark;Netherlands;Germany;New Zealand;Japan;Korea, Republic of | ||
| 199 | EUCTR2016-001067-36-DK (EUCTR) | 15/03/2017 | 23/12/2016 | A study to find out whether some PAH patients may benefit by replacing their current phosphodiesterase-5 inhibitors (PDE-5i) with or without endothelin receptor antagonist (ERA), with Riociguat | A prospective, randomized, international, multicenter, double-arm, controlled, open-label study of Riociguat in patients with pulmonary arterial hypertension (PAH) who are on a stable dose of phosphodiesterase-5 inhibitors (PDE-5i) with or without endothelin receptor antagonist (ERA), but not at treatment goal - Riociguat rEplacing PDE-5i therapy evaLuated Against Continued PDE-5i thErapy | Pulmonary Arterial Hypertension (PAH) MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Adempas Product Name: Adempas® 0.5 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas® 1.0 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas® 1.5 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas® 2.0 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas® 2.5 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adcirca Product Name: ADCIRCA 20 mg film-coated tablets INN or Proposed INN: TADALAFIL | Bayer AG | NULL | Not Recruiting | Female: yes Male: yes | 218 | Phase 4 | United States;Portugal;Taiwan;Greece;Spain;Turkey;Austria;United Kingdom;Switzerland;Italy;France;Czech Republic;Mexico;Canada;Poland;Belgium;Brazil;Denmark;Australia;Netherlands;Germany;New Zealand;Japan;Korea, Republic of | ||
| 200 | EUCTR2016-001067-36-GR (EUCTR) | 02/03/2017 | 17/01/2017 | A study to find out whether some PAH patients may benefit by replacing their current phosphodiesterase-5 inhibitors (PDE-5i) with or without endothelin receptor antagonist (ERA), with Riociguat | A prospective, randomized, international, multicenter, double-arm, controlled, open-label study of Riociguat in patients with pulmonary arterial hypertension (PAH) who are on a stable dose of phosphodiesterase-5 inhibitors (PDE-5i) with or without endothelin receptor antagonist (ERA), but not at treatment goal - Riociguat rEplacing PDE-5i therapy evaLuated Against Continued PDE-5i thErapy | Pulmonary Arterial Hypertension (PAH) MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Adempas Product Name: Adempas® 0.5 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas® 1.0 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas® 1.5 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas® 2.0 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas® 2.5 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adcirca Product Name: ADCIRCA 20 mg film-coated tablets INN or Proposed INN: TADALAFIL | Bayer AG | NULL | Not Recruiting | Female: yes Male: yes | 218 | Phase 4 | Switzerland;Portugal;United States;Taiwan;Greece;Spain;Turkey;Austria;Italy;United Kingdom;France;Czech Republic;Mexico;Canada;Poland;Belgium;Brazil;Denmark;Australia;Netherlands;Germany;New Zealand;Japan;Korea, Republic of | ||
| 201 | EUCTR2015-005223-90-AT (EUCTR) | 28/02/2017 | 16/01/2017 | This is a multicenter, double-blind, randomized, placebo-controlled, parallel-group study to investigate the efficacy, tolerability and safety of pulsed inhaled nitric oxide 75mcg/kg IBW/hr, 12 hours per day or longer for 18 weeks in symptomatic subjects with pulmonary arterial hypertension. (Part 1), followed by an open-label extension (Part 2) whichprovides active therapy to all subjects completing the first 18 weeks. | A PHASE 3, PLACEBO CONTROLLED, DOUBLE-BLIND, RANDOMIZED, CLINICAL STUDY TO DETERMINE EFFICACY, SAFETY AND TOLERABILITY OF PULSED, INHALED NITRIC OXIDE (iNO) VERSUS PLACEBO IN SYMPTOMATIC SUBJECTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH): INOvation-1 (Part 1 and Part 2) | Pulmonary Arterial Hypertension MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: inhaled nitric oxide & INOpulse delivery Product Code: iNO INN or Proposed INN: NITRIC OXIDE Other descriptive name: inhaled NO with pulsed delivery | Bellerophon Pulse Technologies LLC | NULL | Not Recruiting | Female: yes Male: yes | 188 | Phase 3 | Serbia;Portugal;United States;Spain;Ukraine;Austria;Israel;Colombia;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Croatia;Australia;Netherlands;Germany;Korea, Republic of | ||
| 202 | EUCTR2016-001067-36-NL (EUCTR) | 23/02/2017 | 07/12/2016 | A study to find out whether some PAH patients may benefit by replacing their current phosphodiesterase-5 inhibitors (PDE-5i) with or without endothelin receptor antagonist (ERA), with Riociguat | A prospective, randomized, international, multicenter, double-arm, controlled, open-label study of Riociguat in patients with pulmonary arterial hypertension (PAH) who are on a stable dose of phosphodiesterase-5 inhibitors (PDE-5i) with or without endothelin receptor antagonist (ERA), but not at treatment goal - Riociguat rEplacing PDE-5i therapy evaLuated Against Continued PDE-5i thErapy | Pulmonary Arterial Hypertension (PAH) MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Adempas Product Name: Adempas® 0.5 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas® 1.0 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas® 1.5 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas® 2.0 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas® 2.5 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adcirca Product Name: ADCIRCA 20 mg film-coated tablets INN or Proposed INN: TADALAFIL | Bayer AG | NULL | Not Recruiting | Female: yes Male: yes | 218 | Phase 4 | United States;Portugal;Taiwan;Greece;Spain;Turkey;Austria;United Kingdom;Switzerland;Italy;France;Czech Republic;Mexico;Canada;Poland;Belgium;Brazil;Australia;Denmark;Netherlands;Germany;New Zealand;Japan;Korea, Republic of | ||
| 203 | EUCTR2016-001067-36-BE (EUCTR) | 20/02/2017 | 14/11/2016 | A study to find out whether some PAH patients may benefit by replacing their current phosphodiesterase-5 inhibitors (PDE-5i) with or without endothelin receptor antagonist (ERA), with Riociguat | A prospective, randomized, international, multicenter, double-arm, controlled, open-label study of Riociguat in patients with pulmonary arterial hypertension (PAH) who are on a stable dose of phosphodiesterase-5 inhibitors (PDE-5i) with or without endothelin receptor antagonist (ERA), but not at treatment goal - Riociguat rEplacing PDE-5i therapy evaLuated Against Continued PDE-5i thErapy | Pulmonary Arterial Hypertension (PAH) MedDRA version: 19.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Adempas Product Name: Adempas® 0.5 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas® 1.0 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas® 1.5 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas® 2.0 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas® 2.5 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adcirca Product Name: ADCIRCA 20 mg film-coated tablets INN or Proposed INN: TADALAFIL | Bayer AG | NULL | Not Recruiting | Female: yes Male: yes | 218 | Phase 4 | United States;Portugal;Taiwan;Greece;Spain;Turkey;Austria;United Kingdom;Switzerland;Italy;France;Czech Republic;Mexico;Canada;Poland;Belgium;Brazil;Australia;Denmark;Netherlands;Germany;New Zealand;Japan;Korea, Republic of | ||
| 204 | EUCTR2016-001062-28-AT (EUCTR) | 07/02/2017 | 21/12/2016 | A study to find out whether the medicine macitentan works in children with pulmonary arterial hypertension (PAH) | A multicenter, open-label, randomized, study with single-arm extension period to assess the pharmacokinetics, safety and efficacy of macitentan versus standard of care in children with pulmonary arterial hypertension - TOMORROW: pediaTric use Of Macitentan tO delay disease pRogRessiOn in PAH Worldwide | Pulmonary arterial hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: macitentan Product Code: ACT-064992 / JNJ-67896062 INN or Proposed INN: MACITENTAN Product Name: macitentan Product Code: ACT-064992 / JNJ-67896062 INN or Proposed INN: MACITENTAN Product Name: macitentan Product Code: ACT-064992 / JNJ-67896062 INN or Proposed INN: MACITENTAN Product Name: macitentan Product Code: ACT-064992 / JNJ-67896062 INN or Proposed INN: MACITENTAN Product Name: macitentan Product Code: ACT-064992 / JNJ-67896062 INN or Proposed INN: MACITENTAN | ACTELION Pharmaceuticals Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 3 | Portugal;United States;Philippines;Finland;Spain;Thailand;Ukraine;Austria;Russian Federation;Israel;Colombia;France;Hungary;Mexico;Canada;Poland;Brazil;Malaysia;Viet Nam;Australia;South Africa;China;Korea, Republic of | ||
| 205 | EUCTR2016-001062-28-HU (EUCTR) | 25/01/2017 | 15/12/2016 | A study to find out whether the medicine macitentan works in children with pulmonary arterial hypertension (PAH) | A multicenter, open-label, randomized, event-driven study to assess efficacy, safety and pharmacokinetics of macitentan versus standard of care in children with pulmonary arterial hypertension - TOMORROW: pediaTric use Of Macitentan tO delay disease pRogRessiOn in PAH Worldwide | Pulmonary arterial hypertension MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: macitentan Product Code: ACT-064992 INN or Proposed INN: MACITENTAN Product Name: macitentan Product Code: ACT-064992 INN or Proposed INN: MACITENTAN Product Name: macitentan Product Code: ACT-064992 INN or Proposed INN: MACITENTAN | ACTELION Pharmaceuticals Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 3 | Portugal;United States;Philippines;Spain;Thailand;Ukraine;Austria;Russian Federation;Israel;Vietnam;France;Hungary;Mexico;Canada;Argentina;Poland;Australia;South Africa;Bulgaria;Germany;China;Korea, Republic of | ||
| 206 | EUCTR2016-001067-36-CZ (EUCTR) | 19/01/2017 | 13/10/2016 | A study to find out whether some PAH patients may benefit by replacing their current phosphodiesterase-5 inhibitors (PDE-5i) with or without endothelin receptor antagonist (ERA), with Riociguat | A prospective, randomized, international, multicenter, double-arm, controlled, open-label study of Riociguat in patients with pulmonary arterial hypertension (PAH) who are on a stable dose of phosphodiesterase-5 inhibitors (PDE-5i) with or without endothelin receptor antagonist (ERA), but not at treatment goal - Riociguat rEplacing PDE-5i therapy evaLuated Against Continued PDE-5i thErapy | Pulmonary Arterial Hypertension (PAH) MedDRA version: 19.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Adempas Product Name: Adempas® 0.5 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas® 1.0 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas® 1.5 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas® 2.0 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas® 2.5 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adcirca Product Name: ADCIRCA 20 mg film-coated tablets INN or Proposed INN: TADALAFIL Trade Name: Revatio Product Name: Revatio 20 mg film-coated tablets INN or Proposed INN: SILDENAF | Bayer AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 218 | Phase 4 | Portugal;United States;Taiwan;Greece;Spain;Turkey;Austria;Italy;Switzerland;United Kingdom;France;Czech Republic;Mexico;Canada;Belgium;Brazil;Australia;Denmark;Netherlands;Germany;New Zealand;Japan;Korea, Republic of | ||
| 207 | EUCTR2015-005223-90-NL (EUCTR) | 17/01/2017 | 05/09/2016 | This is a multicenter, double-blind, randomized, placebo-controlled, parallel-group study to investigate the efficacy, tolerability and safety of pulsed inhaled nitric oxide 75mcg/kg IBW/hr, 12 hours per day or longer for 18 weeks in symptomatic subjects with pulmonary arterial hypertension. (Part 1), followed by an open-label extension (Part 2) which provides active therapy to all subjects completing the first 18 weeks. | A PHASE 3, PLACEBO CONTROLLED, DOUBLE-BLIND, RANDOMIZED, CLINICAL STUDY TO DETERMINE EFFICACY, SAFETY AND TOLERABILITY OF PULSED, INHALED NITRIC OXIDE (iNO) VERSUS PLACEBO IN SYMPTOMATIC SUBJECTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH): INOvation-1 (Part 1 and Part 2) | Pulmonary Arterial Hypertension MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: inhaled nitric oxide & INOpulse delivery Product Code: iNO INN or Proposed INN: NITRIC OXIDE Other descriptive name: inhaled NO with pulsed delivery | Bellerophon Pulse Technologies LLC | NULL | Not Recruiting | Female: yes Male: yes | 188 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Portugal;United States;Spain;Ukraine;Austria;Israel;Colombia;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Croatia;Australia;Netherlands;Germany;Korea, Republic of | ||
| 208 | NCT02891850 (ClinicalTrials.gov) | January 11, 2017 | 26/8/2016 | Riociguat rEplacing PDE-5i Therapy evaLuated Against Continued PDE-5i thErapy | A Prospective, Randomized, International, Multicenter, Double-arm, Controlled, Open-label Study of Riociguat in Patients With Pulmonary Arterial Hypertension (PAH) Who Are on a Stable Dose of Phosphodiesterase-5 Inhibitors (PDE-5i) With or Without Endothelin Receptor Antagonist (ERA), But Not at Treatment Goal | Pulmonary Arterial Hypertension | Drug: Adempas (Riociguat, BAY63-2521);Drug: Sildenafil;Drug: Tadalafil | Bayer | NULL | Completed | 18 Years | 75 Years | All | 225 | Phase 4 | United States;Austria;Belgium;Brazil;Canada;Czechia;Denmark;France;Germany;Greece;Italy;Japan;Korea, Republic of;Mexico;Netherlands;Poland;Portugal;Spain;Taiwan;Turkey;United Kingdom;Australia;Switzerland |
| 209 | EUCTR2016-001067-36-PT (EUCTR) | 29/12/2016 | 13/09/2016 | A study to find out whether some PAH patients may benefit by replacing their current phosphodiesterase-5 inhibitors (PDE-5i) with or without endothelin receptor antagonist (ERA), with Riociguat | A prospective, randomized, international, multicenter, double-arm, controlled, open-label study of Riociguat in patients with pulmonary arterial hypertension (PAH) who are on a stable dose of phosphodiesterase-5 inhibitors (PDE-5i) with or without endothelin receptor antagonist (ERA), but not at treatment goal - Riociguat rEplacing PDE-5i therapy evaLuated Against Continued PDE-5i thErapy | Pulmonary Arterial Hypertension (PAH) MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Adempas Product Name: Adempas® 0.5 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas® 1.0 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas® 1.5 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas® 2.0 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas® 2.5 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Product Name: Tadalafil INN or Proposed INN: TADALAFIL | Bayer AG | NULL | Not Recruiting | Female: yes Male: yes | 218 | Phase 4 | United States;Portugal;Taiwan;Greece;Spain;Turkey;Austria;United Kingdom;Switzerland;Italy;France;Czech Republic;Mexico;Canada;Poland;Belgium;Brazil;Australia;Denmark;Netherlands;Germany;New Zealand;Japan;Korea, Republic of | ||
| 210 | EUCTR2016-001067-36-GB (EUCTR) | 21/12/2016 | 24/10/2016 | A study to find out whether some PAH patients may benefit by replacing their current phosphodiesterase-5 inhibitors (PDE-5i) with or without endothelin receptor antagonist (ERA), with Riociguat | A prospective, randomized, international, multicenter, double-arm, controlled, open-label study of Riociguat in patients with pulmonary arterial hypertension (PAH) who are on a stable dose of phosphodiesterase-5 inhibitors (PDE-5i) with or without endothelin receptor antagonist (ERA), but not at treatment goal - Riociguat rEplacing PDE-5i therapy evaLuated Against Continued PDE-5i thErapy | Pulmonary Arterial Hypertension (PAH) MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Adempas Product Name: Adempas® 0.5 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas® 1.0 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas® 1.5 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas® 2.0 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas® 2.5 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Product Name: Tadalafil INN or Proposed INN: TADALAFIL | Bayer AG | NULL | Not Recruiting | Female: yes Male: yes | 218 | Phase 4 | Portugal;United States;Taiwan;Greece;Spain;Turkey;Austria;Italy;United Kingdom;Switzerland;France;Czech Republic;Mexico;Canada;Poland;Belgium;Brazil;Australia;Denmark;Netherlands;Germany;New Zealand;Japan;Korea, Republic of | ||
| 211 | EUCTR2015-005223-90-DE (EUCTR) | 16/12/2016 | 09/05/2016 | This is a multicenter, double-blind, randomized, placebo-controlled, parallel-group study to investigate the efficacy, tolerability and safety of pulsed inhaled nitric oxide 75mcg/kg IBW/hr, 12 hours per day or longer for 18 weeks in symptomatic subjects with pulmonary arterial hypertension. (Part 1), followed by an open-label extension (Part2) which provides active therapy to all subjects completing the first 18 weeks. | A PHASE 3, PLACEBO CONTROLLED, DOUBLE-BLIND, RANDOMIZED, CLINICAL STUDY TO DETERMINE EFFICACY, SAFETY AND TOLERABILITY OF PULSED, INHALED NITRIC OXIDE (iNO) VERSUS PLACEBO IN SYMPTOMATIC SUBJECTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH): INOvation-1 (Part 1 and Part 2) | Pulmonary Arterial Hypertension MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: inhaled nitric oxide & INOpulse delivery Product Code: iNO INN or Proposed INN: NITRIC OXIDE Other descriptive name: inhaled NO with pulsed delivery | Bellerophon Pulse Technologies LLC | NULL | Not Recruiting | Female: yes Male: yes | 188 | Phase 3 | Colombia;Hungary;United States;Ukraine;United Kingdom;Portugal;Spain;Canada;Czech Republic;Netherlands;Austria;Belgium;Korea, Republic of;Italy;Israel;Australia;France;Serbia;Germany;Croatia | ||
| 212 | EUCTR2016-001067-36-IT (EUCTR) | 12/12/2016 | 05/11/2020 | A study to find out whether some PAH patients may benefit by replacing their current hosphodiesterase-5 inhibitors (PDE-5i) with or without endothelin receptor antagonist (ERA), with Riociguat | A prospective, randomized, international, multicenter, double-arm, controlled, open-label study of Riociguat in patients with pulmonary arterial hypertension (PAH) who are on a stable dose of phosphodiesterase-5 inhibitors (PDE-5i) with or without endothelin receptor antagonist (ERA), but not at treatment goal - Riociguat rEplacing PDE-5i therapy evaLuated Against Continued PDE-5i thErapy | Pulmonary Arterial Hypertension (PAH) MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: ADEMPAS - 1 MG - COMPRESSA RIVESTITA CON FILM - USO ORALE - BLISTER (PP/ALU) - 42 COMPRESSE Product Name: Adempas¿ 1.0 INN or Proposed INN: Riociguat Other descriptive name: Riociguat Trade Name: ADEMPAS - 1,5 MG - COMPRESSA RIVESTITA CON FILM - USO ORALE - BLISTER (PP/ALU) - 42 COMPRESSE Product Name: Adempas¿ 1.5 mg INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: ADEMPAS - 0,5 MG - COMPRESSA RIVESTITA CON FILM - USO ORALE - BLISTER (PP/ALU) - 42 COMPRESSE Product Name: Adempas¿ 0.5 mg compressa rivestita con film INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: ADEMPAS - 2 MG - COMPRESSA RIVESTITA CON FILM - USO ORALE - BLISTER (PP/ALU) - 42 COMPRESSE Product Name: Adempas¿ 2.0 mg INN or Proposed INN: Riociguat Other descriptive name: Riociguat Trade Name: ADEMPAS - 2,5 MG - COMPRESSA RIVESTITA CON FILM - USO ORALE - BLISTER (PP/ALU) - 42 COMPRESSE Product Name: Adempas¿ 2.5 mg INN or Proposed INN: Riociguat | BAYER AG | NULL | Not Recruiting | Female: yes Male: yes | 218 | Phase 4 | France;Denmark;Australia;Netherlands;Korea, Republic of;Czechia;Turkey;Austria;United Kingdom;Czech Republic;Mexico;Canada;Brazil;Belgium;Poland;Germany;Japan;New Zealand;Portugal;United States;Taiwan;Greece;Spain;Italy;Switzerland | ||
| 213 | NCT02981082 (ClinicalTrials.gov) | December 2016 | 30/11/2016 | Dimethyl Fumarate (DMF) in Systemic Sclerosis-Associated Pulmonary Arterial Hypertension | A Double-blinded, Placebo-controlled Pilot Study of Dimethyl Fumarate (DMF) in Pulmonary Arterial Hypertension (PAH) Associated With Systemic Sclerosis (SSc-PAH): The Effect of DMF on Clinical Disease and Biomarkers of Oxidative Stress. | Systemic Sclerosis;Pulmonary; Hypertension | Drug: Dimethyl Fumarate (DMF);Drug: Placebo Oral Tablet | Robert Lafyatis | Biogen | Terminated | 18 Years | 80 Years | All | 6 | Phase 1 | United States |
| 214 | EUCTR2015-005223-90-PT (EUCTR) | 30/11/2016 | 09/05/2016 | This is a multicenter, double-blind, randomized, placebo-controlled, parallel-group study to investigate the efficacy, tolerability and safety of pulsed inhaled nitric oxide 75mcg/kg IBW/hr, 16 hours per day or longer for 18 weeks in symptomatic subjects with pulmonary arterial hypertension. | A PHASE 3, PLACEBO CONTROLLED, DOUBLE-BLIND, RANDOMIZED, CLINICAL STUDY TO DETERMINE EFFICACY, SAFETY AND TOLERABILITY OF PULSED, INHALED NITRIC OXIDE (iNO) VERSUS PLACEBO IN SYMPTOMATIC SUBJECTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH): INOvation-1 | Pulmonary Arterial Hypertension MedDRA version: 19.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: inhaled nitric oxide & INOpulse delivery Product Code: iNO INN or Proposed INN: NITRIC OXIDE Other descriptive name: inhaled NO with pulsed delivery | Bellerophon Pulse Technologies LLC | NULL | Not Recruiting | Female: yes Male: yes | 188 | Phase 3 | Serbia;Portugal;United States;Spain;Ukraine;Austria;Israel;Italy;United Kingdom;France;Czech Republic;Canada;Belgium;Croatia;Australia;Netherlands;Germany;Korea, Republic of | ||
| 215 | EUCTR2016-001067-36-ES (EUCTR) | 21/11/2016 | 09/09/2016 | A study to find out whether some PAH patients may benefit by replacing their current phosphodiesterase-5 inhibitors (PDE-5i) with or without endothelin receptor antagonist (ERA), with Riociguat | A prospective, randomized, international, multicenter, double-arm, controlled, open-label study of Riociguat in patients with pulmonary arterial hypertension (PAH) who are on a stable dose of phosphodiesterase-5 inhibitors (PDE-5i) with or without endothelin receptor antagonist (ERA), but not at treatment goal - Riociguat rEplacing PDE-5i therapy evaLuated Against Continued PDE-5i thErapy | Pulmonary Arterial Hypertension (PAH) MedDRA version: 19.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Adempas Product Name: Adempas® 0.5 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas® 1.0 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas® 1.5 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas® 2.0 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas® 2.5 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adcirca Product Name: ADCIRCA 20 mg film-coated tablets INN or Proposed INN: TADALAFIL | Bayer AG | NULL | Not Recruiting | Female: yes Male: yes | 218 | Phase 4 | United States;Portugal;Taiwan;Greece;Spain;Turkey;Austria;United Kingdom;Switzerland;Italy;France;Czech Republic;Mexico;Canada;Poland;Belgium;Brazil;Australia;Denmark;Netherlands;Germany;New Zealand;Japan;Korea, Republic of | ||
| 216 | EUCTR2016-001067-36-AT (EUCTR) | 10/11/2016 | 20/09/2016 | A study to find out whether some PAH patients may benefit by replacing their current phosphodiesterase-5 inhibitors (PDE-5i) with or without endothelin receptor antagonist (ERA), with Riociguat | A prospective, randomized, international, multicenter, double-arm, controlled, open-label study of Riociguat in patients with pulmonary arterial hypertension (PAH) who are on a stable dose of phosphodiesterase-5 inhibitors (PDE-5i) with or without endothelin receptor antagonist (ERA), but not at treatment goal - Riociguat rEplacing PDE-5i therapy evaLuated Against Continued PDE-5i thErapy | Pulmonary Arterial Hypertension (PAH) MedDRA version: 19.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Adempas Product Name: Adempas® 0.5 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas® 1.0 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas® 1.5 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas® 2.0 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas® 2.5 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adcirca Product Name: ADCIRCA 20 mg film-coated tablets INN or Proposed INN: TADALAFIL Trade Name: Revatio Product Name: Revatio 20 mg film-coated tablets INN or Proposed INN: SILDENAF | Bayer AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 218 | Phase 4 | Portugal;United States;Taiwan;Greece;Spain;Turkey;Austria;Italy;Switzerland;United Kingdom;France;Czech Republic;Mexico;Canada;Belgium;Brazil;Australia;Denmark;Netherlands;Germany;New Zealand;Japan;Korea, Republic of | ||
| 217 | EUCTR2016-000196-24-GB (EUCTR) | 18/10/2016 | 28/11/2016 | A STUDY OF THE EFFICACY AND SAFETY OF BARDOXOLONE METHYL IN PATIENTS WITH CONNECTIVE TISSUE DISEASE-ASSOCIATED PULMONARY ARTERIAL HYPERTENSION | A STUDY OF THE EFFICACY AND SAFETY OF BARDOXOLONE METHYL IN PATIENTS WITH CONNECTIVE TISSUE DISEASE-ASSOCIATED PULMONARY ARTERIAL HYPERTENSION - CATALYST | Connective Tissue Disease-Associated Pulmonary Arterial Hypertension (WHO Group I CTD-PAH);Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Bardoxolone Methyl Product Code: RTA 402 INN or Proposed INN: bardoxolone methyl Other descriptive name: BARDOXOLONE METHYL, CDDO-Me, CDDO-Methyl Ester, NSC 713200, Chemical Name: Oleana-1,9(11)-dien-28-oic acid, 2-cyano-3,12-dioxo-, methyl ester Product Name: Bardoxolone Methyl Product Code: RTA 402 INN or Proposed INN: bardoxolone methyl Other descriptive name: BARDOXOLONE METHYL, CDDO-Me, CDDO-Methyl Ester, NSC 713200, Chemical Name: Oleana-1,9(11)-dien-28-oic acid, 2-cyano-3,12-dioxo-, methyl ester | Reata Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 3 | United States;Philippines;Spain;Ireland;Chile;Israel;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Australia;Netherlands;Germany;Japan | ||
| 218 | EUCTR2016-000196-24-BE (EUCTR) | 17/10/2016 | 11/07/2016 | A STUDY OF THE EFFICACY AND SAFETY OF BARDOXOLONE METHYL IN PATIENTS WITH CONNECTIVE TISSUE DISEASE-ASSOCIATED PULMONARY ARTERIAL HYPERTENSION | A STUDY OF THE EFFICACY AND SAFETY OF BARDOXOLONE METHYL IN PATIENTS WITH CONNECTIVE TISSUE DISEASE-ASSOCIATED PULMONARY ARTERIAL HYPERTENSION - CATALYST | Connective Tissue Disease-Associated Pulmonary Arterial Hypertension (WHO Group I CTD-PAH);Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Bardoxolone Methyl Product Code: RTA 402 INN or Proposed INN: bardoxolone methyl Other descriptive name: BARDOXOLONE METHYL, CDDO-Me, CDDO-Methyl Ester, NSC 713200, Chemical Name: Oleana-1,9(11)-dien-28-oic acid, 2-cyano-3,12-dioxo-, methyl ester Product Name: Bardoxolone Methyl Product Code: RTA 402 INN or Proposed INN: bardoxolone methyl Other descriptive name: BARDOXOLONE METHYL, CDDO-Me, CDDO-Methyl Ester, NSC 713200, Chemical Name: Oleana-1,9(11)-dien-28-oic acid, 2-cyano-3,12-dioxo-, methyl ester | Reata Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 130 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Spain;Ireland;Chile;Israel;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Australia;Netherlands;Germany;Japan | ||
| 219 | EUCTR2016-000196-24-NL (EUCTR) | 10/10/2016 | 13/07/2016 | BADOXOLONE METHYL IN PATIENTS WITH CONNECTIVE TISSUE DISEASE-ASSOCIATED PULMONARY ARTERIAL HYPERTENSION | A STUDY OF THE EFFICACY AND SAFETY OF BARDOXOLONE METHYL IN PATIENTS WITH CONNECTIVE TISSUE DISEASE-ASSOCIATED PULMONARY ARTERIAL HYPERTENSION - CATALYST | Connective Tissue Disease-Associated Pulmonary Arterial Hypertension (WHO Group I CTD-PAH);Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Bardoxolone Methyl Product Code: RTA 402 INN or Proposed INN: bardoxolone methyl Other descriptive name: BARDOXOLONE METHYL, CDDO-Me, CDDO-Methyl Ester, NSC 713200, Chemical Name: Oleana-1,9(11)-dien-28-oic acid, 2-cyano-3,12-dioxo-, methyl ester Product Name: Bardoxolone Methyl Product Code: RTA 402 INN or Proposed INN: bardoxolone methyl Other descriptive name: BARDOXOLONE METHYL, CDDO-Me, CDDO-Methyl Ester, NSC 713200, Chemical Name: Oleana-1,9(11)-dien-28-oic acid, 2-cyano-3,12-dioxo-, methyl ester | Reata Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 3 | United States;Philippines;Spain;Ireland;Chile;Israel;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Australia;Netherlands;Germany;Japan | ||
| 220 | EUCTR2015-005223-90-CZ (EUCTR) | 27/09/2016 | 22/06/2016 | This is a multicenter, double-blind, randomized, placebo-controlled, parallel-group study to investigate the efficacy, tolerability and safety of pulsed inhaled nitric oxide 75mcg/kg IBW/hr, 12 hours per day or longer for 18 weeks in symptomatic subjects with pulmonary arterial hypertension. (Part 1), followed by an open-label extension (Part 2) whichprovides active therapy to all subjects completing the first 18 weeks. | A PHASE 3, PLACEBO CONTROLLED, DOUBLE-BLIND, RANDOMIZED, CLINICAL STUDY TO DETERMINE EFFICACY, SAFETY AND TOLERABILITY OF PULSED, INHALED NITRIC OXIDE (iNO) VERSUS PLACEBO IN SYMPTOMATIC SUBJECTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH): INOvation-1 (Part 1 and Part 2) | Pulmonary Arterial Hypertension MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: inhaled nitric oxide & INOpulse delivery Product Code: iNO INN or Proposed INN: NITRIC OXIDE Other descriptive name: inhaled NO with pulsed delivery | Bellerophon Pulse Technologies LLC | NULL | Not Recruiting | Female: yes Male: yes | 188 | Phase 3 | Serbia;Portugal;United States;Spain;Ukraine;Austria;Israel;Colombia;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Croatia;Australia;Netherlands;Germany;Korea, Republic of | ||
| 221 | EUCTR2015-005223-90-IT (EUCTR) | 15/09/2016 | 22/06/2021 | This is a multicenter, double-blind, randomized, placebo-controlled, parallel-group study to investigate the efficacy, tolerability and safety of pulsed inhaled nitric oxide 75mcg/kg IBW/hr, 12 hours per day or longer for 18 weeks in symptomatic subjects with pulmonary arterial hypertension. (Part 1), followed by an open-label extension (Part 2) which provides active therapy to all subjects completing the first 18 weeks. | A phase 3, placebo controlled, double-blind, randomized, clinical study to determine efficacy, safety and tolerability of pulsed, inhaled nitric oxide (iNO) versus placebo in symptomatic subjects with pulmonary arterial hypertension (PAH): INOvation-1 (Part 1 and Part 2) - Efficacy and safety of iNO in Pulmonary Arterial Hypertension, v1.0 | Pulmonary Arterial Hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Inhaled nitric oxide & INOpulse delivery Product Code: iNO INN or Proposed INN: Ossido Nitrico Other descriptive name: inhaled NO with pulsed delivery | BELLEROPHON PULSE TECHNOLOGIES LLC | NULL | Not Recruiting | Female: yes Male: yes | 188 | Phase 3 | Portugal;Serbia;United States;Czechia;Spain;Ukraine;Austria;Israel;Colombia;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Croatia;Australia;Netherlands;Germany;Korea, Republic of | ||
| 222 | EUCTR2016-000196-24-CZ (EUCTR) | 30/08/2016 | 18/07/2016 | A STUDY OF THE EFFICACY AND SAFETY OF BARDOXOLONE METHYL IN PATIENTS WITH CONNECTIVE TISSUE DISEASE-ASSOCIATED PULMONARY ARTERIAL HYPERTENSION | A STUDY OF THE EFFICACY AND SAFETY OF BARDOXOLONE METHYL IN PATIENTS WITH CONNECTIVE TISSUE DISEASE-ASSOCIATED PULMONARY ARTERIAL HYPERTENSION - CATALYST | Connective Tissue Disease-Associated Pulmonary Arterial Hypertension (WHO Group I CTD-PAH);Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Bardoxolone Methyl Product Code: RTA 402 INN or Proposed INN: bardoxolone methyl Other descriptive name: BARDOXOLONE METHYL, CDDO-Me, CDDO-Methyl Ester, NSC 713200, Chemical Name: Oleana-1,9(11)-dien-28-oic acid, 2-cyano-3,12-dioxo-, methyl ester Product Name: Bardoxolone Methyl Product Code: RTA 402 INN or Proposed INN: bardoxolone methyl Other descriptive name: BARDOXOLONE METHYL, CDDO-Me, CDDO-Methyl Ester, NSC 713200, Chemical Name: Oleana-1,9(11)-dien-28-oic acid, 2-cyano-3,12-dioxo-, methyl ester | Reata Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 3 | United States;Philippines;Spain;Ireland;Chile;Israel;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Australia;Netherlands;Germany;Japan | ||
| 223 | EUCTR2015-003438-28-DK (EUCTR) | 17/08/2016 | 30/05/2016 | The efficacy and safety of initial triple versus initial dual oral combination therapy in patients with newly diagnosed pulmonary arterial hypertension | The efficacy and safety of initial triple versus initial dual oral combination therapy in patients with newly diagnosed pulmonary arterial hypertension: A multi-center, double-blind, placebo-controlled, Phase 3b study - TRITON - Macitentan, Tadalafil and Selexipag Study in Patients with PAH | Pulmonary arterial hypertension (PAH) MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Uptravi Product Name: Selexipag Product Code: ACT-293987 INN or Proposed INN: Selexipag Other descriptive name: SELEXIPAG Trade Name: Opsumit Product Name: Macitentan Product Code: ACT-064992 INN or Proposed INN: Macitentan Other descriptive name: MACITENTAN Trade Name: Adcirca Product Name: Adcirca INN or Proposed INN: TADALAFIL Other descriptive name: TADALAFIL | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 238 | Phase 3 | United States;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Canada;Belgium;Brazil;Denmark;Australia;Norway;Netherlands;Germany;Sweden | ||
| 224 | EUCTR2016-000196-24-DE (EUCTR) | 11/08/2016 | 27/06/2016 | BARDOXOLONE METHYL IN PATIENTS WITH CONNECTIVE TISSUE DISEASE-ASSOCIATED PULMONARY ARTERIAL HYPERTENSION | A STUDY OF THE EFFICACY AND SAFETY OF BARDOXOLONE METHYL IN PATIENTS WITH CONNECTIVE TISSUE DISEASE-ASSOCIATED PULMONARY ARTERIAL HYPERTENSION - CATALYST | Connective Tissue Disease-Associated Pulmonary Arterial Hypertension (WHO Group I CTD-PAH);Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Bardoxolone Methyl Product Code: RTA 402 INN or Proposed INN: bardoxolone methyl Other descriptive name: BARDOXOLONE METHYL, CDDO-Me, CDDO-Methyl Ester, NSC 713200, Chemical Name: Oleana-1,9(11)-dien-28-oic acid, 2-cyano-3,12-dioxo-, methyl ester Product Name: Bardoxolone Methyl Product Code: RTA 402 INN or Proposed INN: bardoxolone methyl Other descriptive name: BARDOXOLONE METHYL, CDDO-Me, CDDO-Methyl Ester, NSC 713200, Chemical Name: Oleana-1,9(11)-dien-28-oic acid, 2-cyano-3,12-dioxo-, methyl ester | Reata Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 3 | United States;Philippines;Spain;Ireland;Chile;Israel;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Australia;Germany;Netherlands;Japan | ||
| 225 | NCT02825160 (ClinicalTrials.gov) | August 1, 2016 | 15/6/2016 | Non-interventional, Postauthorization Safety Study of Ventavis for Pulmonary Arterial Hypertension (PAH) | Drug Use Investigation of Ventavis for Pulmonary Arterial Hypertension (PAH) | Hypertension, Pulmonary | Drug: Ventavis (Iloprost, BAYQ6256) | Bayer | NULL | Recruiting | N/A | N/A | All | 270 | Japan | |
| 226 | EUCTR2014-003952-29-PL (EUCTR) | 28/07/2016 | 13/04/2016 | Riociguat for treatment of PAH in children from 6 to less than 18 years old | Open-label, individual dose titration study to evaluate safety, tolerability and pharmacokinetics of riociguat in children from 6 to less than 18 years of age with pulmonary arterial hypertension (PAH) - PATENT-CHILD | Pulmonary arterial hypertension (PAH) MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Adempas Product Name: Adempas 0.5 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas 1.0 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas 1.5 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas 2.0 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat | Bayer AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 20 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Taiwan;Spain;Turkey;Colombia;United Kingdom;Italy;France;Hungary;Mexico;Poland;Belgium;Romania;Netherlands;Germany;Japan | ||
| 227 | EUCTR2015-005223-90-GB (EUCTR) | 12/07/2016 | 11/04/2016 | This is a multicenter, double-blind, randomized, placebo-controlled, parallel-group study to investigate the efficacy, tolerability and safety of pulsed inhaled nitric oxide 75mcg/kg IBW/hr, 12 hours per day or longer for 18 weeks in symptomatic subjects with pulmonary arterial hypertension. (Part 1), followed by an open-label extension (Part 2) which provides active therapy to all subjects completing the first 18 weeks. | A PHASE 3, PLACEBO CONTROLLED, DOUBLE-BLIND, RANDOMIZED, CLINICAL STUDY TO DETERMINE EFFICACY, SAFETY AND TOLERABILITY OF PULSED, INHALED NITRIC OXIDE (iNO) VERSUS PLACEBO IN SYMPTOMATIC SUBJECTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH): INOvation-1 (Part 1 and Part 2) | Pulmonary Arterial Hypertension MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: inhaled nitric oxide & INOpulse delivery Product Code: iNO INN or Proposed INN: NITRIC OXIDE Other descriptive name: inhaled NO with pulsed delivery | Bellerophon Pulse Technologies LLC | NULL | Not Recruiting | Female: yes Male: yes | 188 | Phase 3 | United States;Serbia;Portugal;Spain;Ukraine;Austria;Israel;Colombia;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Croatia;Australia;Netherlands;Germany;Korea, Republic of | ||
| 228 | EUCTR2016-000196-24-ES (EUCTR) | 04/07/2016 | 01/06/2016 | A STUDY OF THE EFFICACY AND SAFETY OF BARDOXOLONE METHYL IN PATIENTS WITH CONNECTIVE TISSUE DISEASE-ASSOCIATED PULMONARY ARTERIAL HYPERTENSION | A STUDY OF THE EFFICACY AND SAFETY OF BARDOXOLONE METHYL IN PATIENTS WITH CONNECTIVE TISSUE DISEASE-ASSOCIATED PULMONARY ARTERIAL HYPERTENSION - CATALYST | Connective Tissue Disease-Associated Pulmonary Arterial Hypertension (WHO Group I CTD-PAH);Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Bardoxolone Methyl Product Code: RTA 402 INN or Proposed INN: bardoxolone methyl Other descriptive name: BARDOXOLONE METHYL, CDDO-Me, CDDO-Methyl Ester, NSC 713200, Chemical Name: Oleana-1,9(11)-dien-28-oic acid, 2-cyano-3,12-dioxo-, methyl ester Product Name: Bardoxolone Methyl Product Code: RTA 402 INN or Proposed INN: bardoxolone methyl Other descriptive name: BARDOXOLONE METHYL, CDDO-Me, CDDO-Methyl Ester, NSC 713200, Chemical Name: Oleana-1,9(11)-dien-28-oic acid, 2-cyano-3,12-dioxo-, methyl ester | Reata Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 130 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Spain;Ireland;Chile;Israel;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Australia;Netherlands;Germany;Japan | ||
| 229 | NCT02899533 (ClinicalTrials.gov) | July 2016 | 2/8/2016 | [18F]FES PET/CT in PAH | [18F]Fluoroestradiol (FES) PET/CT Imaging To Evaluate In Vivo ER In Patients With Pulmonary Arterial Hypertension (PAH) | Pulmonary Arterial Hypertension | Drug: [18F] FES | University of Pennsylvania | NULL | Terminated | 18 Years | N/A | Female | 5 | United States | |
| 230 | EUCTR2015-003438-28-FR (EUCTR) | 20/06/2016 | 21/04/2016 | The efficacy and safety of initial triple versus initial dual oral combination therapy in patients with newly diagnosed pulmonary arterial hypertension | The efficacy and safety of initial triple versus initial dual oral combination therapy in patients with newly diagnosed pulmonary arterial hypertension: A multi-center, double-blind, placebo-controlled, Phase 3b study - TRITON | Pulmonary arterial hypertension (PAH) MedDRA version: 19.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Selexipag Product Code: ACT-293987 INN or Proposed INN: Selexipag Other descriptive name: SELEXIPAG Trade Name: Opsumit Product Name: Macitentan Product Code: ACT-064992 INN or Proposed INN: Macitentan Other descriptive name: MACITENTAN Trade Name: Adcirca Product Name: Adcirca INN or Proposed INN: Tadalafil Other descriptive name: TADALAFIL | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 144 | Phase 3 | United States;Spain;Austria;United Kingdom;Italy;Switzerland;France;Canada;Belgium;Australia;Denmark;Germany;Netherlands;Norway;Sweden | ||
| 231 | NCT02759419 (ClinicalTrials.gov) | June 16, 2016 | 29/4/2016 | A Long-term Extension Study of Riociguat in Patients With Symptomatic Pulmonary Arterial Hypertension. | An Open-label, Multi-national, Multi-center, Single-arm, Uncontrolled, Long-term Extension Study of Orally Administered Riociguat in Patients With Symptomatic Pulmonary Arterial Hypertension (PAH) Who Received Riociguat in a Bayer Clinical Trial | Hypertension, Pulmonary | Drug: Adempas (Riociguat, BAY63-2521) | Bayer | NULL | Recruiting | 18 Years | N/A | All | 25 | Phase 4 | France;Italy;Korea, Republic of;Poland;Thailand |
| 232 | NCT02885012 (ClinicalTrials.gov) | June 2016 | 3/5/2016 | Crossover Study From Macitentan or Bosentan Over to Ambrisentan | A Safety and Clinical Efficacy Study Measuring Echocardiographic Composite Comparing Ambrisentan (Letairis®) After a Switch From Bosentan (Tracleer®) or Macintentan (Opsumit®) in Treatment of Pulmonary Arterial Hypertension (PAH) | Pulmonary Arterial Hypertension | Drug: Ambrisentan | Medical University of South Carolina | Ochsner Health System | Terminated | 18 Years | 80 Years | All | 3 | Phase 4 | United States |
| 233 | NCT02705807 (ClinicalTrials.gov) | May 2016 | 25/2/2016 | Evaluation of a New Thermostable Formulation of FLOLAN in Japanese Subjects | An Open Label, Single-arm Study Evaluating a New Thermostable Formulation of FLOLAN™ in Japanese Subjects With Pulmonary Arterial Hypertension (PAH) | Cardiovascular Disease | Drug: FLOLAN injection with currently marketed diluent;Drug: FLOLAN injection with reformulated diluent | GlaxoSmithKline | NULL | Completed | 18 Years | 75 Years | All | 10 | Phase 4 | Japan |
| 234 | EUCTR2014-003952-29-DE (EUCTR) | 21/04/2016 | 10/08/2015 | Riociguat for treatment of PAH in children from 6 to less than 18 years old | Open-label, individual dose titration study to evaluate safety, tolerability and pharmacokinetics of riociguat in children from 6 to less than 18 years of age with pulmonary arterial hypertension (PAH) - PATENT-CHILD | Pulmonary arterial hypertension (PAH) MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Adempas Product Name: Adempas 0.5 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas 1.0 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas 1.5 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas 2.0 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas 2.5 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Product Name: Riociguat granules 0.3% for oral application Product Code: BAY63-2521 INN or Proposed INN: Riociguat | Bayer AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 20 | Phase 3 | United States;Taiwan;Spain;Turkey;Colombia;United Kingdom;Italy;France;Hungary;Mexico;Poland;Belgium;Romania;Germany;Japan | ||
| 235 | EUCTR2015-003438-28-NO (EUCTR) | 11/04/2016 | 09/03/2016 | The efficacy and safety of initial triple versus initial dual oral combinationtherapy in patients with newly diagnosed pulmonary arterial hypertension | The efficacy and safety of initial triple versus initial dual oral combinationtherapy in patients with newly diagnosed pulmonary arterial hypertension:A multi-center, double-blind, placebo-controlled, Phase 3b study - TRITON | Pulmonary arterial hypertension (PAH) MedDRA version: 18.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Selexipag Product Code: ACT-293987 INN or Proposed INN: Selexipag Other descriptive name: SELEXIPAG Trade Name: Opsumit Product Name: Macitentan Product Code: ACT-064992 INN or Proposed INN: Macitentan Other descriptive name: MACITENTAN Trade Name: Adcirca Product Name: Adcirca INN or Proposed INN: Tadalafil Other descriptive name: TADALAFIL | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 144 | Phase 3 | United States;Spain;Austria;United Kingdom;Italy;Switzerland;France;Canada;Belgium;Australia;Denmark;Norway;Germany;Netherlands;Sweden | ||
| 236 | EUCTR2014-003952-29-ES (EUCTR) | 01/04/2016 | 17/02/2016 | Riociguat for treatment of PAH in children from 6 to less than 18 years old | Open-label, individual dose titration study to evaluate safety, tolerability and pharmacokinetics of riociguat in children from 6 to less than 18 years of age with pulmonary arterial hypertension (PAH) - PATENT-CHILD | Pulmonary arterial hypertension (PAH) MedDRA version: 18.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Adempas Product Name: Adempas 0.5 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas 1.0 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas 1.5 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas 2.0 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas 2.5 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Product Name: Riociguat granules 0.3% for oral application Product Code: BAY63-2521 INN or Proposed INN: Riociguat | Bayer Healthcare AG | NULL | Not Recruiting | Female: yes Male: yes | 20 | Phase 3 | United Kingdom;France;Hungary;Belgium;Poland;Spain;Turkey;Netherlands;Germany;Japan;Italy | ||
| 237 | NCT02725372 (ClinicalTrials.gov) | April 2016 | 19/1/2016 | Clinical Study of Pulsed, Inhaled Nitric Oxide Versus Placebo in Symptomatic Subjects With PAH | A Phase 3, Placebo Controlled, Double-Blind, Randomized, Clinical Study to Determine Efficacy, Safety, and Tolerability of Pulsed, Inhaled Nitric Oxide (iNO) Versus Placebo in Symptomatic Subjects With PAH (Part 1 and Part 2) | Pulmonary Arterial Hypertension | Drug: Inhaled Nitric Oxide 75 mcg/kg IBW/hr;Drug: Placebo | Bellerophon Pulse Technologies | Worldwide Clinical Trials | Terminated | 18 Years | 85 Years | All | 207 | Phase 3 | United States;Australia;Austria;Belgium;Canada;Colombia;Croatia;Czechia;France;Germany;Israel;Italy;Netherlands;Portugal;Serbia;Spain;Ukraine;United Kingdom |
| 238 | NCT02734953 (ClinicalTrials.gov) | April 2016 | 26/3/2016 | Effect of iNO on Invasively Derived Pulmonary Pressures in Patients With PAH | Effects of iNO on Invasively Derived Pulmonary Vascular Parameters in Patients With Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension | Drug: Nitric Oxide | Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) | NULL | Completed | 18 Years | 80 Years | All | 10 | Phase 2 | United States |
| 239 | EUCTR2015-003438-28-DE (EUCTR) | 04/03/2016 | 19/01/2016 | The efficacy and safety of initial triple versus initial dual oral combinationtherapy in patients with newly diagnosed pulmonary arterial hypertension | The efficacy and safety of initial triple versus initial dual oral combinationtherapy in patients with newly diagnosed pulmonary arterial hypertension:A multi-center, double-blind, placebo-controlled, Phase 3b study - TRITON - Macitentan, Tadalafil and Selexipag Study in Patients with PAH | Pulmonary arterial hypertension (PAH) MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Uptravi Product Name: Selexipag Product Code: ACT-293987 INN or Proposed INN: Selexipag Other descriptive name: SELEXIPAG Trade Name: Opsumit Product Name: Macitentan Product Code: ACT-064992 INN or Proposed INN: Macitentan Other descriptive name: MACITENTAN Trade Name: Adcirca Product Name: Adcirca INN or Proposed INN: TADALAFIL Other descriptive name: TADALAFIL | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 238 | Phase 3 | United States;Spain;Ireland;Austria;United Kingdom;Switzerland;Italy;France;Canada;Belgium;Brazil;Australia;Denmark;Germany;Netherlands;Norway;Sweden | ||
| 240 | EUCTR2015-003438-28-BE (EUCTR) | 03/03/2016 | 09/06/2020 | The efficacy and safety of initial triple versus initial dual oral combinationtherapy in patients with newly diagnosed pulmonary arterial hypertension | The efficacy and safety of initial triple versus initial dual oral combinationtherapy in patients with newly diagnosed pulmonary arterial hypertension:A multi-center, double-blind, placebo-controlled, Phase 3b study - TRITON - Macitentan, Tadalafil and Selexipag Study in Patients with PAH | Pulmonary arterial hypertension (PAH) MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Uptravi Product Name: Selexipag Product Code: ACT-293987 INN or Proposed INN: Selexipag Other descriptive name: SELEXIPAG Trade Name: Opsumit Product Name: Macitentan Product Code: ACT-064992 INN or Proposed INN: Macitentan Other descriptive name: MACITENTAN Trade Name: Adcirca Product Name: Adcirca INN or Proposed INN: TADALAFIL Other descriptive name: TADALAFIL | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 238 | Phase 3 | United States;Spain;Ireland;Austria;United Kingdom;Switzerland;Italy;France;Canada;Belgium;Brazil;Australia;Denmark;Germany;Netherlands;Norway;Sweden | ||
| 241 | NCT02652429 (ClinicalTrials.gov) | March 2016 | 17/12/2015 | Long-Term Extension Study of Inhaled Nitric Oxide (iNO) for PAH | An Open-Label Long-Term Safety Study of Inhaled Nitric Oxide (iNO) for PAH for Subjects in the PULSE-PAH-006 and PULSE-PAH-004 Studies Who Continue to Need iNO Therapy | Pulmonary Arterial Hypertension | Drug: Inhaled Nitric Oxide | Bellerophon Pulse Technologies | NULL | Active, not recruiting | N/A | N/A | All | 22 | Phase 3 | United States;Canada |
| 242 | EUCTR2012-000097-26-PL (EUCTR) | 27/02/2016 | 20/01/2016 | International, multicenter, randomized (1:1 oral treprostinil (UT-15C): placebo), double-blind, placebo-controlled study in subjects with Pulmonary Arterial Hypertension (PAH) who are receiving background oral monotherapy | A Phase III, International, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Clinical Worsening Study of UT-15C in Subjects with Pulmonary Arterial Hypertension Receiving Background Oral Monotherapy. | Pulmonary Arterial Hypertension MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine | United Therapeutics Corporation | NULL | Not Recruiting | Female: yes Male: yes | 850 | Phase 3 | Israel;Chile;Italy;United Kingdom;India;United States;Taiwan;Greece;Austria;France;Mexico;Canada;Argentina;Belgium;Poland;Brazil;Singapore;Australia;Denmark;Netherlands;Germany;China;Korea, Republic of;Sweden | ||
| 243 | EUCTR2014-002590-10-FR (EUCTR) | 11/02/2016 | 02/03/2016 | Effect of bronchodilators on effort induced dyspnoea in lung hypertension patients | Effect of bronchodilators on effort induced dyspnoea in patients suffering lung hypertension - BD-HTAP | Idiopathic or heritable patients with pulmonary arterial hypertension (PAH). MedDRA version: 18.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Bromure d'Ipratropium Product Name: Bromure d'Ipratropium INN or Proposed INN: Bromure d'Ipratropium Trade Name: Salbutamol Product Name: Salbutamol INN or Proposed INN: Salbutamol | ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP) | NULL | Not Recruiting | Female: yes Male: yes | 18 | Phase 3 | France | ||
| 244 | EUCTR2015-002835-17-DE (EUCTR) | 18/01/2016 | 26/11/2015 | RIGHT HEART III Study – Right ventricular hemodynamic evaluation and response to treatment | Investigation of the influence of PAH-specific medication on right ventricular function in patients with pulmonary arterial hypertension (PAH) under basal conditions - RIGHT HEART III | Pulmonary arterial Hypertension (PAH) MedDRA version: 21.1;Level: LLT;Classification code 10037403;Term: Pulmonary hypertension NOS;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 20.0;Classification code 10077729;Term: Pulmonary arterial hypertension WHO functional class III;Classification code 10077740;Term: Pulmonary arterial hypertension WHO functional class II;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Adempas® INN or Proposed INN: RIOCIGUAT Trade Name: Opsumit® INN or Proposed INN: MACITENTAN | Justus Liebig Universität Gießen | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 30 | Phase 2 | Germany | ||
| 245 | EUCTR2015-003438-28-AT (EUCTR) | 12/01/2016 | 25/07/2017 | The efficacy and safety of initial triple versus initial dual oral combination therapy in patients with newly diagnosed pulmonary arterial hypertension | The efficacy and safety of initial triple versus initial dual oral combination therapy in patients with newly diagnosed pulmonary arterial hypertension: A multi-center, double-blind, placebo-controlled, Phase 3b study - TRITON | Pulmonary arterial hypertension (PAH) MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Uptravi Product Name: Selexipag Product Code: ACT-293987 INN or Proposed INN: Selexipag Other descriptive name: SELEXIPAG Trade Name: Opsumit Product Name: Macitentan Product Code: ACT-064992 INN or Proposed INN: Macitentan Other descriptive name: MACITENTAN Trade Name: Adcirca Product Name: Adcirca INN or Proposed INN: Tadalafil Other descriptive name: TADALAFIL | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 238 | Phase 3 | United States;Spain;Ireland;Austria;United Kingdom;Switzerland;Italy;France;Canada;Belgium;Brazil;Australia;Denmark;Germany;Netherlands;Norway;Sweden | ||
| 246 | EUCTR2014-003952-29-GB (EUCTR) | 25/11/2015 | 27/07/2015 | Riociguat for treatment of PAH in children from 6 to less than 18 years old | Open-label, individual dose titration study to evaluate safety, tolerability and pharmacokinetics of riociguat in children from 6 to less than 18 years of age with pulmonary arterial hypertension (PAH) - PATENT-CHILD | Pulmonary arterial hypertension (PAH) MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Adempas Product Name: Adempas 0.5 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas 1.0 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas 1.5 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas 2.0 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas 2.5 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Product Name: Riociguat granules 0.3% for oral application Product Code: BAY63-2521 INN or Proposed INN: Riociguat | Bayer AG | NULL | Not Recruiting | Female: yes Male: yes | 20 | Phase 3 | United States;Spain;Turkey;Colombia;United Kingdom;Italy;France;Hungary;Mexico;Belgium;Poland;Romania;Germany;Netherlands;Japan | ||
| 247 | NCT02551653 (ClinicalTrials.gov) | November 17, 2015 | 14/9/2015 | Positron Emission Tomography (PET) Study to Evaluate Biodistribution of [11C]-GSK2256098 in Healthy Subjects and Idiopathic Pulmonary Arterial Hypertension (PAH) Patients | A Microdose Study to Evaluate the Biodistribution of [11C]-GSK2256098 in the Lungs and Heart of Healthy Subjects and Idiopathic Pulmonary Arterial Hypertension (PAH) Patients Using Positron Emission Tomography (PET) | Hypertension, Pulmonary | Drug: [11C]-GSK2256098 500 MBq | GlaxoSmithKline | NULL | Completed | 40 Years | 70 Years | All | 10 | Phase 1 | United Kingdom |
| 248 | NCT02562235 (ClinicalTrials.gov) | October 29, 2015 | 28/9/2015 | Riociguat in Children With Pulmonary Arterial Hypertension (PAH) | Open-label, Individual Dose Titration Study to Evaluate Safety, Tolerability and Pharmacokinetics of Riociguat in Children From 6 to Less Than 18 Years of Age With Pulmonary Arterial Hypertension (PAH) | Hypertension, Pulmonary | Drug: Riociguat (Adempas, BAY63-2521) | Bayer | Merck Sharp & Dohme LLC | Active, not recruiting | 6 Years | 17 Years | All | 24 | Phase 3 | Colombia;Germany;Hungary;Italy;Japan;Mexico;Poland;Taiwan;Turkey;Belgium;Brazil;France;Netherlands;Romania;Spain;United Kingdom;United States |
| 249 | EUCTR2015-002799-26-GB (EUCTR) | 27/10/2015 | 21/09/2015 | A therapeutic trial of blockade of interleukin-6 using the drug Tocilizumab in pulmonary arterial hypertension | TRANSFORM-UK: A Therapeutic Open Label Study of Tocilizumab in the Treatment of Pulmonary Arterial Hypertension - An open label study of Tocilizumab in PAH | Pulmonary arterial hypertension;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: RoActemra INN or Proposed INN: Tocilizumab Other descriptive name: n/a | Papworth Hospital NHS Foundation Trust | NULL | Not Recruiting | Female: yes Male: yes | 26 | Phase 2 | United Kingdom | ||
| 250 | EUCTR2013-004362-34-HR (EUCTR) | 21/10/2015 | 26/05/2015 | A MULTINATIONAL, MULTICENTER STUDY TO ASSESS THE EFFECTS OF ORAL SILDENAFIL ON MORTALITY IN ADULTS WITH PULMONARY ARTERIAL HYPERTENSION | A MULTINATIONAL, MULTICENTER STUDY TO ASSESS THE EFFECTS OF ORAL SILDENAFIL ON MORTALITY IN ADULTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH) | Pulmonary Arterial Hypertension MedDRA version: 18.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09] | Product Name: Sildenafil Product Code: UK 092480 INN or Proposed INN: Sildenafil Other descriptive name: SILDENAFIL CITRATE Product Name: Sildenafil Product Code: UK 092480 INN or Proposed INN: Sildenafil Other descriptive name: SILDENAFIL CITRATE Product Name: Sildenafil Product Code: UK 092480 INN or Proposed INN: Sildenafil Other descriptive name: SILDENAFIL CITRATE | Pfizer Inc., 235 East 42nd Street, New York, NY 10017 | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 429 | United States;Portugal;Serbia;Taiwan;Hong Kong;Greece;Thailand;Spain;Ukraine;Israel;Russian Federation;Italy;Malaysia;Denmark;Australia;South Africa;Netherlands;Lithuania;Austria;Hungary;Czech Republic;Mexico;Canada;Brazil;Belgium;Poland;Singapore;Croatia;Romania;Bulgaria;Germany;Sweden | |||
| 251 | NCT02576002 (ClinicalTrials.gov) | October 2015 | 13/10/2015 | Epidemiology and Treatment Patterns of Paediatric PAH (Pulmonary Arterial Hypertension) | Study to Estimate the Incidence and Prevalence and Treatment Patterns of Pediatric Pulmonary Hypertension in the US | Hypertension, Pulmonary | Drug: Assigned pulmonary hypertension medication | Bayer | NULL | Completed | N/A | 18 Years | Both | 2691 | N/A | United States |
| 252 | NCT02545465 (ClinicalTrials.gov) | September 15, 2015 | 8/9/2015 | A Study to Understand the Treatment Patterns in Patients With Pulmonary Arterial Hypertension or Chronic Thromboembolic Pulmonary Hypertension During a Switch of Treatment to Adempas in Real-life Clinical Practice | Retrospective Chart Review of Patients With PAH or Inoperable/Persistent/Recurrent CTEPH Who Transition Their PH Treatment to Adempas | Hypertension, Pulmonary | Drug: Riociguat (Adempas, BAY63-2521) | Bayer | NULL | Completed | N/A | N/A | All | 125 | N/A | Belgium;Canada;Colombia;Germany;Japan;Sweden;Turkey;Denmark;United Kingdom |
| 253 | EUCTR2014-003952-29-IT (EUCTR) | 09/09/2015 | 15/07/2015 | Riociguat for treatment of PAH in children from 6 to less than 18 years old | Open-label, individual dose titration study to evaluate safety, tolerability and pharmacokinetics of riociguat in children from 6 to less than 18 years of age with pulmonary arterial hypertension (PAH) - PATENT-CHILD | Hypertension, Pulmonary;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Adempas Product Name: Adempas 0.5 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas 1.0 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas 1.5 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas 2.0 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas 2.5 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Product Name: Riociguat granules 0.3% for oral application Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT | Bayer Healthcare AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 20 | Spain;Turkey;Austria;Italy;United Kingdom;France;Hungary;Canada;Poland;Australia;Germany;Netherlands;Japan | |||
| 254 | NCT02253394 (ClinicalTrials.gov) | September 2015 | 17/9/2014 | The Combination Ambrisentan Plus Spironolactone in Pulmonary Arterial Hypertension Study | The Combination Ambrisentan Plus Spironolactone in Pulmonary Arterial Hypertension Study (The CAPS-PAH Study) | Pulmonary Arterial Hypertension | Drug: Ambrisentan plus Spironolactone;Drug: Ambrisentan plus Placebo | Brigham and Women's Hospital | Gilead Sciences | Terminated | 18 Years | N/A | All | 2 | Phase 4 | United States |
| 255 | EUCTR2013-004362-34-SE (EUCTR) | 26/08/2015 | 13/03/2014 | A MULTINATIONAL, MULTICENTER STUDY TO ASSESS THE EFFECTS OF ORAL SILDENAFIL ON MORTALITY IN ADULTS WITH PULMONARY ARTERIAL HYPERTENSION | A MULTINATIONAL, MULTICENTER STUDY TO ASSESS THE EFFECTS OF ORAL SILDENAFIL ON MORTALITY IN ADULTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH) | Pulmonary Arterial Hypertension MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09] | Product Name: Sildenafil Product Code: UK 092480 INN or Proposed INN: Sildenafil Other descriptive name: SILDENAFIL CITRATE Product Name: Sildenafil Product Code: UK 092480 INN or Proposed INN: Sildenafil Other descriptive name: SILDENAFIL CITRATE Product Name: Sildenafil Product Code: UK 092480 INN or Proposed INN: Sildenafil Other descriptive name: SILDENAFIL CITRATE | Pfizer Inc., 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 429 | Phase 3;Phase 4 | United States;Portugal;Serbia;Taiwan;Hong Kong;Greece;Thailand;Spain;Ukraine;Israel;Russian Federation;Italy;Malaysia;Denmark;Australia;South Africa;Latvia;Netherlands;Lithuania;Austria;Czech Republic;Hungary;Mexico;Canada;Brazil;Belgium;Poland;Singapore;Croatia;Romania;Bulgaria;Germany;Sweden | ||
| 256 | EUCTR2014-003952-29-HU (EUCTR) | 25/08/2015 | 06/07/2015 | Riociguat for treatment of PAH in children from 6 to less than 18 years old | Open-label, individual dose titration study to evaluate safety, tolerability and pharmacokinetics of riociguat in children from 6 to less than 18 years of age with pulmonary arterial hypertension (PAH) - PATENT-CHILD | Hypertension, Pulmonary;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Adempas Product Name: Adempas 0.5 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas 1.0 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas 1.5 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas 2.0 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas 2.5 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Product Name: Riociguat granules 0.3% for oral application Product Code: BAY63-2521 INN or Proposed INN: Riociguat | Bayer AG | NULL | Not Recruiting | Female: yes Male: yes | 20 | Phase 3 | United States;Taiwan;Spain;Turkey;Colombia;United Kingdom;Italy;France;Hungary;Mexico;Belgium;Poland;Romania;Germany;Netherlands;Japan | ||
| 257 | EUCTR2014-002131-34-NL (EUCTR) | 29/07/2015 | 05/03/2015 | A clinical trial with GS-4997 in Subjects with Pulmonary Arterial Hypertension | A Phase 2, Dose-Ranging, Randomized, Double-Blind, Placebo-Controlled Study of GS-4997 in Subjects with Pulmonary Arterial Hypertension | Men and women, ages 18 through 75 years, with a diagnosis of idiopathic PAH, heritable PAH or PAH associated with connective tissue disease (PAH-CTD), congenital heart defects (repaired), drug and toxin use, or human immunodeficiency virus (HIV) infection. MedDRA version: 18.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Code: GS-4997 2 mg INN or Proposed INN: Not available Product Code: GS-4997 6 mg INN or Proposed INN: Not available Product Code: GS-4997 18 mg INN or Proposed INN: Not available | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | France;United States;Canada;Spain;Germany;Netherlands;Italy;United Kingdom | ||
| 258 | NCT02428985 (ClinicalTrials.gov) | June 29, 2015 | 21/4/2015 | Prospective, Non-interventional, Multi-center, Post-authorization Safety Study of Riociguat for Pulmonary Arterial Hypertension (PAH) | Drug Use Investigation of Riociguat for Pulmonary Arterial Hypertension (PAH) | Hypertension, Pulmonary | Drug: Riociguat (ADEMPAS, BAY63-2521) | Bayer | NULL | Recruiting | N/A | N/A | All | 600 | Japan | |
| 259 | EUCTR2014-002131-34-ES (EUCTR) | 18/05/2015 | 11/03/2015 | A clinical trial with GS-4997 in Subjects with Pulmonary Arterial Hypertension | A Phase 2, Dose-Ranging, Randomized, Double-Blind, Placebo-Controlled Study of GS-4997 in Subjects with Pulmonary Arterial Hypertension | Men and women, ages 18 through 75 years, with a diagnosis of idiopathic PAH, heritable PAH or PAH associated with connective tissue disease (PAH-CTD), congenital heart defects (repaired), drug and toxin use, or human immunodeficiency virus (HIV) infection. MedDRA version: 17.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Code: GS-4997 2 mg INN or Proposed INN: Not available Product Code: GS-4997 6 mg INN or Proposed INN: Not available Product Code: GS-4997 18 mg INN or Proposed INN: Not available | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | France;United States;Canada;Spain;Netherlands;Germany;Italy;United Kingdom | ||
| 260 | EUCTR2014-002131-34-GB (EUCTR) | 15/05/2015 | 15/07/2015 | A clinical trial with GS-4997 in Subjects with Pulmonary Arterial Hypertension | A Phase 2, Dose-Ranging, Randomized, Double-Blind, Placebo-Controlled Study of GS-4997 in Subjects with Pulmonary Arterial Hypertension | Men and women, ages 18 through 75 years, with a diagnosis of idiopathic PAH, heritable PAH or PAH associated with connective tissue disease (PAH-CTD), congenital heart defects (repaired), drug and toxin use, or human immunodeficiency virus (HIV) infection. MedDRA version: 18.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Code: GS-4997 2 mg INN or Proposed INN: Not available Product Code: GS-4997 6 mg INN or Proposed INN: Not available Product Code: GS-4997 18 mg INN or Proposed INN: Not available | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | France;United States;Canada;Spain;Netherlands;Germany;Italy;United Kingdom | ||
| 261 | EUCTR2013-004362-34-PT (EUCTR) | 08/05/2015 | 18/02/2015 | A MULTINATIONAL, MULTICENTER STUDY TO ASSESS THE EFFECTS OF ORAL SILDENAFIL ON MORTALITY IN ADULTS WITH PULMONARY ARTERIAL HYPERTENSION | A MULTINATIONAL, MULTICENTER STUDY TO ASSESS THE EFFECTS OF ORAL SILDENAFIL ON MORTALITY IN ADULTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH) | Pulmonary Arterial Hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09] | Product Name: Sildenafil Product Code: UK 092480 INN or Proposed INN: Sildenafil Other descriptive name: SILDENAFIL CITRATE Product Name: Sildenafil Product Code: UK 092480 INN or Proposed INN: Sildenafil Other descriptive name: SILDENAFIL CITRATE Product Name: Sildenafil Product Code: UK 092480 INN or Proposed INN: Sildenafil Other descriptive name: SILDENAFIL CITRATE | Pfizer Inc., 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 429 | Phase 3;Phase 4 | Serbia;Portugal;United States;Taiwan;Hong Kong;Greece;Spain;Thailand;Ukraine;Russian Federation;Israel;Italy;Malaysia;Australia;Denmark;South Africa;Latvia;Netherlands;Czechia;Lithuania;Austria;Czech Republic;Hungary;Mexico;Canada;Poland;Brazil;Belgium;Singapore;Romania;Croatia;Bulgaria;Germany;Sweden | ||
| 262 | EUCTR2014-002131-34-DE (EUCTR) | 07/05/2015 | 27/02/2015 | A clinical trial with GS-4997 in Subjects with Pulmonary Arterial Hypertension | A Phase 2, Dose-Ranging, Randomized, Double-Blind, Placebo-Controlled Study of GS-4997 in Subjects with Pulmonary Arterial Hypertension | Men and women, ages 18 through 75 years, with a diagnosis of idiopathic PAH, heritable PAH or PAH associated with connective tissue disease (PAH-CTD), congenital heart defects (repaired), drug and toxin use, or human immunodeficiency virus (HIV) infection. MedDRA version: 18.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Code: GS-4997 2 mg INN or Proposed INN: Not available Product Code: GS-4997 6 mg INN or Proposed INN: Not available Product Code: GS-4997 18 mg INN or Proposed INN: Not available | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | France;United States;Canada;Spain;Netherlands;Germany;Italy;United Kingdom | ||
| 263 | EUCTR2013-004362-34-NL (EUCTR) | 23/04/2015 | 29/01/2015 | A MULTINATIONAL, MULTICENTER STUDY TO ASSESS THE EFFECTS OF ORAL SILDENAFIL ON MORTALITY IN ADULTS WITH PULMONARY ARTERIAL HYPERTENSION | A MULTINATIONAL, MULTICENTER STUDY TO ASSESS THE EFFECTS OF ORAL SILDENAFIL ON MORTALITY IN ADULTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH) | Pulmonary Arterial Hypertension MedDRA version: 17.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09] | Product Name: Sildenafil Product Code: UK 092480 INN or Proposed INN: Sildenafil Other descriptive name: SILDENAFIL CITRATE Product Name: Sildenafil Product Code: UK 092480 INN or Proposed INN: Sildenafil Other descriptive name: SILDENAFIL CITRATE Product Name: Sildenafil Product Code: UK 092480 INN or Proposed INN: Sildenafil Other descriptive name: SILDENAFIL CITRATE | Pfizer Inc., 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 429 | Phase 3;Phase 4 | Serbia;Portugal;United States;Taiwan;Hong Kong;Greece;Thailand;Spain;Ukraine;Russian Federation;Israel;Italy;Malaysia;Australia;Denmark;South Africa;Netherlands;Lithuania;Austria;Czech Republic;Hungary;Mexico;Canada;Poland;Brazil;Belgium;Singapore;Romania;Croatia;Bulgaria;Germany;Sweden | ||
| 264 | EUCTR2014-002131-34-IT (EUCTR) | 09/04/2015 | 15/01/2016 | A clinical trial with GS-4997 in Subjects with Pulmonary Arterial Hypertension | A Phase 2, Dose-Ranging, Randomized, Double-Blind, Placebo-Controlled Study of GS-4997 in Subjects with Pulmonary Arterial Hypertension | Men and women, ages 18 through 75 years, with a diagnosis of idiopathic PAH, heritable PAH or PAH associated with connective tissue disease (PAH-CTD), congenital heart defects (repaired), drug and toxin use, or human immunodeficiency virus (HIV) infection. MedDRA version: 18.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Code: GS-4997 2 mg INN or Proposed INN: Not available Product Code: GS-4997 6 mg INN or Proposed INN: Not available Product Code: GS-4997 18 mg INN or Proposed INN: Not available | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | France;United States;Canada;Spain;Netherlands;Germany;United Kingdom;Italy | ||
| 265 | JPRN-JapicCTI-142722 | 01/1/2015 | 27/11/2014 | ACT-385781A extension study for PAH pediatric patients | Open-label, long-term, efficacy, safety, and tolerability extension study using ACT-385781A in the treatment of Japanese children with pulmonary arterial hypertension who completed the AC-066A308 study. | Pulmonary arterial hypertension (PAH) | Intervention name : ACT-385781A INN of the intervention : epoprostenol Dosage And administration of the intervention : continuous intravenous infusion | Actelion Pharmaceuticals Japan Ltd. | NULL | 14 | BOTH | 3 | Phase 3 | NULL | ||
| 266 | NCT02276872 (ClinicalTrials.gov) | December 18, 2014 | 21/10/2014 | Safety, Tolerability, and Pharmacokinetics of Oral Treprostinil in Pediatric PAH Patients Aged 7 to 17 Years | A Multicenter, Open-Label, 24-Week, Uncontrolled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Oral Treprostinil Extended Release Tablets Following Transition From Remodulin or Inhaled Prostacyclin Therapy or as Add-on to Current PAH Therapy in De Novo Prostacyclin Pediatric Subjects Aged 7 to 17 Years With Pulmonary Arterial Hypertension | PAH | Drug: oral treprostinil | United Therapeutics | NULL | Completed | 7 Years | 17 Years | All | 32 | Phase 2 | United States |
| 267 | EUCTR2013-004362-34-GR (EUCTR) | 21/11/2014 | 24/11/2014 | A MULTINATIONAL, MULTICENTER STUDY TO ASSESS THE EFFECTS OF ORAL SILDENAFIL ON MORTALITY IN ADULTS WITH PULMONARY ARTERIAL HYPERTENSION | A MULTINATIONAL, MULTICENTER STUDY TO ASSESS THE EFFECTS OF ORAL SILDENAFIL ON MORTALITY IN ADULTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH) | Pulmonary Arterial Hypertension MedDRA version: 17.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09] | Trade Name: Revatio INN or Proposed INN: Sildenafil Other descriptive name: SILDENAFIL CITRATE Product Name: Sildenafil Product Code: UK 092480 INN or Proposed INN: Sildenafil Other descriptive name: SILDENAFIL CITRATE Product Name: Sildenafil Product Code: UK 092480 INN or Proposed INN: Sildenafil Other descriptive name: SILDENAFIL CITRATE | Pfizer Inc., 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 429 | Phase 4 | United States;Portugal;Serbia;Taiwan;Hong Kong;Greece;Thailand;Spain;Ukraine;Israel;Russian Federation;Italy;Malaysia;Denmark;Australia;South Africa;Latvia;Netherlands;Lithuania;Austria;Hungary;Czech Republic;Mexico;Canada;Brazil;Belgium;Poland;Singapore;Croatia;Romania;Bulgaria;Germany;Sweden | ||
| 268 | EUCTR2013-004362-34-PL (EUCTR) | 22/10/2014 | 17/07/2014 | A MULTINATIONAL, MULTICENTER STUDY TO ASSESS THE EFFECTS OF ORAL SILDENAFIL ON MORTALITY IN ADULTS WITH PULMONARY ARTERIAL HYPERTENSION | A MULTINATIONAL, MULTICENTER STUDY TO ASSESS THE EFFECTS OF ORAL SILDENAFIL ON MORTALITY IN ADULTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH) | Pulmonary Arterial Hypertension MedDRA version: 17.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09] | Trade Name: Revatio INN or Proposed INN: Sildenafil Other descriptive name: SILDENAFIL CITRATE Product Name: Sildenafil Product Code: UK 092480 INN or Proposed INN: Sildenafil Other descriptive name: SILDENAFIL CITRATE Product Name: Sildenafil Product Code: UK 092480 INN or Proposed INN: Sildenafil Other descriptive name: SILDENAFIL CITRATE | Pfizer Inc., 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 429 | Phase 3;Phase 4 | United States;Portugal;Serbia;Taiwan;Hong Kong;Greece;Thailand;Spain;Ukraine;Israel;Russian Federation;Italy;Malaysia;Denmark;Australia;South Africa;Latvia;Netherlands;Lithuania;Austria;Czech Republic;Hungary;Mexico;Canada;Brazil;Belgium;Poland;Singapore;Croatia;Romania;Bulgaria;Germany;Sweden | ||
| 269 | EUCTR2013-001759-10-GB (EUCTR) | 29/09/2014 | 27/08/2014 | Open-label, international, multicenter, non-placebo controlled (uncontrolled), phase IIIb study of riociguat in patients with Pulmonary Arterial Hypertension (PAH) who demonstrate an insufficient response to treatment with phosphodiesterase-5 inhibitors (PDE-5i) | Open-label, international, multicenter, single-arm, uncontrolled, phase IIIb study of riociguat in patients with pulmonary arterial hypertension (PAH) who demonstrate an insufficient response to treatment with phosphodiesterase-5 inhibitors (PDE-5i) - RESPITE | Hypertension, Pulmonary;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Adempas Product Name: Adempas 0.5 mg Film Coated Tablet Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas 1 mg Film Coated Tablet Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas 1.5 mg Film Coated Tablet Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas 2 mg Film Coated Tablet Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas 2.5 mg Film Coated Tablet Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT | Bayer AG | NULL | Not Recruiting | Female: yes Male: yes | 70 | Phase 2;Phase 3 | United States;Czech Republic;Canada;Belgium;Germany;Switzerland;United Kingdom | ||
| 270 | EUCTR2013-004362-34-RO (EUCTR) | 25/09/2014 | 30/05/2014 | A MULTINATIONAL, MULTICENTER STUDY TO ASSESS THE EFFECTS OF ORAL SILDENAFIL ON MORTALITY IN ADULTS WITH PULMONARY ARTERIAL HYPERTENSION | A MULTINATIONAL, MULTICENTER STUDY TO ASSESS THE EFFECTS OF ORAL SILDENAFIL ON MORTALITY IN ADULTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH) | Pulmonary Arterial Hypertension MedDRA version: 17.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09] | Trade Name: Revatio INN or Proposed INN: Sildenafil Other descriptive name: SILDENAFIL CITRATE Product Name: Sildenafil Product Code: UK 092480 INN or Proposed INN: Sildenafil Other descriptive name: SILDENAFIL CITRATE Product Name: Sildenafil Product Code: UK 092480 INN or Proposed INN: Sildenafil Other descriptive name: SILDENAFIL CITRATE | Pfizer Inc., 235 East 42nd Street, New York, NY 10017 | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 429 | Serbia;Portugal;United States;Taiwan;Hong Kong;Greece;Thailand;Spain;Ukraine;Russian Federation;Israel;Italy;Malaysia;Australia;Denmark;South Africa;Netherlands;Lithuania;Austria;Czech Republic;Hungary;Mexico;Canada;Poland;Brazil;Belgium;Singapore;Romania;Croatia;Bulgaria;Germany;Sweden | |||
| 271 | NCT02060487 (ClinicalTrials.gov) | September 22, 2014 | 29/1/2014 | Effects of Oral Sildenafil on Mortality in Adults With PAH | A MULTINATIONAL, MULTICENTER STUDY TO ASSESS THE EFFECTS OF ORAL SILDENAFIL ON MORTALITY IN ADULTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH) | Pulmonary Arterial Hypertension | Drug: sildenafil citrate | Pfizer's Upjohn has merged with Mylan to form Viatris Inc. | NULL | Terminated | 18 Years | 74 Years | All | 385 | Phase 4 | United States;Australia;Belgium;Bosnia and Herzegovina;Croatia;Czechia;Germany;Greece;Hong Kong;Israel;Latvia;Malaysia;Mexico;Poland;Romania;Russian Federation;Serbia;Singapore;South Africa;Spain;Thailand;Turkey;Ukraine;Austria;Czech Republic;Netherlands;Portugal |
| 272 | EUCTR2013-004362-34-CZ (EUCTR) | 08/09/2014 | 13/05/2014 | A MULTINATIONAL, MULTICENTER STUDY TO ASSESS THE EFFECTS OF ORAL SILDENAFIL ON MORTALITY IN ADULTS WITH PULMONARY ARTERIAL HYPERTENSION | A MULTINATIONAL, MULTICENTER STUDY TO ASSESS THE EFFECTS OF ORAL SILDENAFIL ON MORTALITY IN ADULTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH) | Pulmonary Arterial Hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09] | Product Name: Sildenafil Product Code: UK 092480 INN or Proposed INN: Sildenafil Other descriptive name: SILDENAFIL CITRATE Product Name: Sildenafil Product Code: UK 092480 INN or Proposed INN: Sildenafil Other descriptive name: SILDENAFIL CITRATE | Pfizer Inc., 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 429 | Phase 3;Phase 4 | United States;Portugal;Serbia;Hong Kong;Greece;Spain;Thailand;Ukraine;Israel;Russian Federation;Malaysia;Australia;South Africa;Latvia;Netherlands;Bosnia and Herzegovina;Turkey;Austria;Czech Republic;Mexico;Belgium;Poland;Singapore;Croatia;Romania;Germany;Sweden | ||
| 273 | JPRN-JapicCTI-142721 | 01/9/2014 | 27/11/2014 | ACT-385781A for PAH pediatric patients | Prospectiove, single-arm, Open-label, multi-center study to assess the efficacy, safety, and tolerability of ACT-385781A in Japanese children with pulmonary arterial hypertension. | Pulmonary arterial hypertension (PAH) | Intervention name : ACT-385781A INN of the intervention : epoprostenol Dosage And administration of the intervention : continuous intravenous infusion Control intervention name : null | Actelion Pharmaceuticals Japan Ltd. | NULL | 14 | BOTH | 3 | Phase 3 | NULL | ||
| 274 | EUCTR2012-000097-26-GR (EUCTR) | 05/08/2014 | 11/06/2014 | International, multicenter, randomized (1:1 oral treprostinil (UT-15C): placebo), double-blind, placebo-controlled study in subjects with Pulmonary Arterial Hypertension (PAH) who are receiving background oral monotherapy | A Phase III, International, Multi-Center, Randomized, Double- Blind, Placebo-Controlled, Clinical Worsening Study of UT-15C in Subjects with Pulmonary Arterial Hypertension Receiving Background Oral Monotherapy | Pulmonary Arterial Hypertension MedDRA version: 17.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine | United Therapeutics Corporation | NULL | Not Recruiting | Female: yes Male: yes | 858 | Phase 3 | France;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Denmark;Peru;Australia;Netherlands;Germany;China;Korea, Republic of;Sweden;United States;Taiwan;Greece;Austria;Israel;Italy;United Kingdom;India | ||
| 275 | EUCTR2012-000097-26-DK (EUCTR) | 31/07/2014 | 22/05/2014 | International, multicenter, randomized (1:1 oral treprostinil (UT-15C): placebo), double-blind, placebo-controlled study in subjects with Pulmonary Arterial Hypertension (PAH) who are receiving background oral monotherapy | A Phase III, International, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Clinical Worsening Study of UT-15C in Subjects with Pulmonary Arterial Hypertension Receiving Background Oral Monotherapy. | Pulmonary Arterial Hypertension MedDRA version: 19.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine | United Therapeutics Corporation | NULL | Not Recruiting | Female: yes Male: yes | 850 | Phase 3 | United States;Taiwan;Greece;Austria;Chile;Israel;United Kingdom;Italy;India;France;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Denmark;Australia;Netherlands;Germany;China;Sweden;Korea, Republic of | ||
| 276 | EUCTR2013-004362-34-DE (EUCTR) | 30/07/2014 | 25/03/2014 | A MULTINATIONAL, MULTICENTER STUDY TO ASSESS THE EFFECTS OF ORAL SILDENAFIL ON MORTALITY IN ADULTS WITH PULMONARY ARTERIAL HYPERTENSION | A MULTINATIONAL, MULTICENTER STUDY TO ASSESS THE EFFECTS OF ORAL SILDENAFIL ON MORTALITY IN ADULTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH) | Pulmonary Arterial Hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09] | Product Name: Sildenafil Product Code: UK 092480 INN or Proposed INN: Sildenafil Other descriptive name: SILDENAFIL CITRATE Product Name: Sildenafil Product Code: UK 092480 INN or Proposed INN: Sildenafil Other descriptive name: SILDENAFIL CITRATE Product Name: Sildenafil Product Code: UK 092480 INN or Proposed INN: Sildenafil Other descriptive name: SILDENAFIL CITRATE | Pfizer Inc., 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 429 | Phase 3;Phase 4 | United States;Portugal;Serbia;Hong Kong;Greece;Spain;Thailand;Ukraine;Israel;Russian Federation;Malaysia;Australia;South Africa;Latvia;Netherlands;Bosnia and Herzegovina;Turkey;Austria;Czech Republic;Mexico;Belgium;Poland;Singapore;Croatia;Romania;Germany;Sweden | ||
| 277 | EUCTR2013-004362-34-ES (EUCTR) | 30/06/2014 | 08/05/2014 | A MULTINATIONAL, MULTICENTER STUDY TO ASSESS THE EFFECTS OF ORAL SILDENAFIL ON MORTALITY IN ADULTS WITH PULMONARY ARTERIAL HYPERTENSION | A MULTINATIONAL, MULTICENTER STUDY TO ASSESS THE EFFECTS OF ORAL SILDENAFIL ON MORTALITY IN ADULTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH) | Pulmonary Arterial Hypertension MedDRA version: 17.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09] | Trade Name: Revatio INN or Proposed INN: Sildenafil Other descriptive name: SILDENAFIL CITRATE Product Name: Sildenafil Product Code: UK 092480 INN or Proposed INN: Sildenafil Other descriptive name: SILDENAFIL CITRATE Product Name: Sildenafil Product Code: UK 092480 INN or Proposed INN: Sildenafil Other descriptive name: SILDENAFIL CITRATE | Pfizer Inc., 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 429 | Phase 4 | Australia;South Africa;Latvia;Netherlands;Lithuania;Austria;Czech Republic;Hungary;Mexico;Canada;Brazil;Belgium;Poland;Singapore;Croatia;Romania;Bulgaria;Germany;Sweden;United States;Portugal;Serbia;Taiwan;Hong Kong;Greece;Thailand;Spain;Ukraine;Israel;Russian Federation;Italy;Malaysia;Denmark | ||
| 278 | NCT02112487 (ClinicalTrials.gov) | June 23, 2014 | 8/4/2014 | Extension of the Psychometric Validation Study ORCHESTRA in Patients With PAH | An Extension of AC-055-310, a Multi-center, Open-label, Single-arm, Phase 3b Study of Macitentan in Patients With Pulmonary Arterial Hypertension to Psychometrically Validate the French, Italian and Spanish Versions of the PAH-SYMPACT™ | Pulmonary Arterial Hypertension | Drug: Macitentan | Actelion | NULL | Completed | 18 Years | 80 Years | All | 88 | Phase 3 | France;Italy;Spain |
| 279 | EUCTR2012-000097-26-BE (EUCTR) | 18/06/2014 | 14/04/2014 | International, multicenter, randomized (1:1 oral treprostinil (UT-15C): placebo), double-blind, placebo-controlled study in subjects with Pulmonary Arterial Hypertension (PAH) who are receiving background oral monotherapy | A Phase III, International, Multi-Center, Randomized, Double- Blind, Placebo-Controlled, Clinical Worsening Study of UT-15C in Subjects with Pulmonary Arterial Hypertension Receiving Background Oral Monotherapy | Pulmonary Arterial Hypertension MedDRA version: 16.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostin | United Therapeutics Corporation | NULL | Not Recruiting | Female: yes Male: yes | 858 | Phase 3 | United States;Taiwan;Greece;Austria;Israel;United Kingdom;Italy;India;France;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Denmark;Peru;Australia;Netherlands;Germany;China;Korea, Republic of;Sweden | ||
| 280 | EUCTR2013-004362-34-BE (EUCTR) | 12/06/2014 | 17/03/2014 | A MULTINATIONAL, MULTICENTER STUDY TO ASSESS THE EFFECTS OF ORAL SILDENAFIL ON MORTALITY IN ADULTS WITH PULMONARY ARTERIAL HYPERTENSION | A MULTINATIONAL, MULTICENTER STUDY TO ASSESS THE EFFECTS OF ORAL SILDENAFIL ON MORTALITY IN ADULTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH) | Pulmonary Arterial Hypertension MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09] | Product Name: Sildenafil Product Code: UK 092480 INN or Proposed INN: Sildenafil Other descriptive name: SILDENAFIL CITRATE Product Name: Sildenafil Product Code: UK 092480 INN or Proposed INN: Sildenafil Other descriptive name: SILDENAFIL CITRATE Product Name: Sildenafil Product Code: UK 092480 INN or Proposed INN: Sildenafil Other descriptive name: SILDENAFIL CITRATE | Pfizer Inc., 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 429 | Phase 3 | United States;Portugal;Serbia;Taiwan;Hong Kong;Greece;Thailand;Spain;Ukraine;Israel;Russian Federation;Italy;Malaysia;Denmark;Australia;South Africa;Latvia;Netherlands;Lithuania;Austria;Hungary;Czech Republic;Mexico;Canada;Brazil;Belgium;Poland;Singapore;Croatia;Romania;Bulgaria;Germany;Sweden | ||
| 281 | EUCTR2012-000097-26-SE (EUCTR) | 09/06/2014 | 10/04/2014 | International, multicenter, randomized (1:1 oral treprostinil (UT-15C): placebo), double-blind, placebo-controlled study in subjects with Pulmonary Arterial Hypertension (PAH) who are receiving background oral monotherapy | A Phase III, International, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Clinical Worsening Study of UT-15C in Subjects with Pulmonary Arterial Hypertension Receiving Background Oral Monotherapy. | Pulmonary Arterial Hypertension MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine | United Therapeutics Corporation | NULL | Not Recruiting | Female: yes Male: yes | 850 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Taiwan;Greece;Austria;Israel;Chile;Italy;United Kingdom;India;France;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Australia;Denmark;Netherlands;Germany;China;Korea, Republic of;Sweden | ||
| 282 | EUCTR2013-004362-34-AT (EUCTR) | 12/05/2014 | 13/03/2014 | A MULTINATIONAL, MULTICENTER STUDY TO ASSESS THE EFFECTS OF ORAL SILDENAFIL ON MORTALITY IN ADULTS WITH PULMONARY ARTERIAL HYPERTENSION | A MULTINATIONAL, MULTICENTER STUDY TO ASSESS THE EFFECTS OF ORAL SILDENAFIL ON MORTALITY IN ADULTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH) | Pulmonary Arterial Hypertension MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09] | Product Name: Sildenafil Product Code: UK 092480 INN or Proposed INN: Sildenafil Other descriptive name: SILDENAFIL CITRATE Product Name: Sildenafil Product Code: UK 092480 INN or Proposed INN: Sildenafil Other descriptive name: SILDENAFIL CITRATE Product Name: Sildenafil Product Code: UK 092480 INN or Proposed INN: Sildenafil Other descriptive name: SILDENAFIL CITRATE | Pfizer Inc., 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 429 | Phase 3;Phase 4 | United States;Portugal;Serbia;Taiwan;Hong Kong;Greece;Thailand;Spain;Ukraine;Israel;Russian Federation;Italy;Malaysia;Denmark;Australia;South Africa;Latvia;Netherlands;Lithuania;Austria;Hungary;Czech Republic;Mexico;Canada;Brazil;Belgium;Poland;Singapore;Croatia;Romania;Bulgaria;Germany;Sweden | ||
| 283 | NCT02120339 (ClinicalTrials.gov) | May 2014 | 17/4/2014 | Carvedilol PAH A Pilot Study of Efficacy and Safety | Beta Blockers in Pulmonary Arterial Hypertension (PAH) A Pilot Study of Efficacy and Safety | Pulmonary Hypertension;Cardiac MRI <40 | Drug: Carvedilol | University of Minnesota | NULL | Terminated | 18 Years | 99 Years | All | 5 | Phase 1 | United States |
| 284 | NCT02304198 (ClinicalTrials.gov) | April 2014 | 26/11/2014 | Clinical Trial to Evaluate the Long-term Safety of Udenafil in Patient With PAH | A Single-arm, Open-label, Extension Study to Evaluate the Long-term Safety of Udenafil in Patient With Pulmonary Arterial Hypertension(PAH) | Pulmonary Arterial Hypertension | Drug: Udenafil | Dong-A ST Co., Ltd. | NULL | Completed | 18 Years | N/A | Both | 59 | Phase 2/Phase 3 | Korea, Republic of |
| 285 | NCT02032836 (ClinicalTrials.gov) | March 10, 2014 | 9/1/2014 | Comparative PK PD Study in PAH Patients (Fox vs. I-Neb) | A Multi-center, Open-label, Randomized Cross-over Study to Compare the Acute Tolerability and Pharmacokinetics of BAYQ6256 (Iloprost; Ventavis) Inhalation Using the I-Neb Nebulizer and the FOX Nebulizer in Patients With Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension | Drug: lloprost(Ventavis,BAYQ6252, 20 µg/mL);Drug: lloprost(Ventavis,BAYQ6252, 10 µg/mL) | Bayer | NULL | Completed | 18 Years | N/A | All | 27 | Phase 1/Phase 2 | Austria;Germany |
| 286 | NCT02081690 (ClinicalTrials.gov) | March 1, 2014 | 5/3/2014 | A Pulmonary Arterial Hypertension Study With Macitentan to Validate the PAH-SYMPACT™ in France, Italy and Spain | A Multi-center, Open-label, Single-arm, Phase 3b Study of Macitentan in Patients With Pulmonary Arterial Hypertension to Psychometrically Validate the French, Italian and Spanish Versions of the PAH-SYMPACT™ | Pulmonary Arterial Hypertension | Drug: Macitentan | Actelion | NULL | Terminated | 18 Years | 80 Years | All | 160 | Phase 3 | France;Italy;Spain |
| 287 | EUCTR2013-003462-14-ES (EUCTR) | 20/02/2014 | 05/12/2013 | Study of the drug macitentan in patients with pulmonary arterial hypertension in order to test the French, Italian, and Spanish translations of a patient questionnaire called PAH-SYMPACT. | A multi-center, open-label, single-arm, Phase 3b study of macitentan in patients with pulmonary arterial hypertension to psychometrically validate the French, Italian and Spanish versions of the PAH-SYMPACT? - ORCHESTRA | Pulmonary arterial hypertensionHipertensión arterial pulmonar MedDRA version: 14.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: macitentan Product Code: ACT-064992 INN or Proposed INN: MACITENTAN | ACTELION Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 160 | Phase 3 | Spain | ||
| 288 | EUCTR2013-003489-15-ES (EUCTR) | 20/02/2014 | 27/12/2013 | An extension of the ORCHESTRA (AC-055-310) studyExtension del estudio ORCHESTRA (AC-055-310) | An extension of AC-055-310, a multi-center, open-label, single-arm, Phase 3b study of macitentan in patients with pulmonary arterial hypertension to psychometrically validate the French, Italian and Spanish versions of the PAH-SYMPACT™ - ORCHESTRA Ext. | Pulmonary arterial hypertension MedDRA version: 16.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: macitentan Product Code: ACT-064992 INN or Proposed INN: MACITENTAN | ACTELION Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 160 | Phase 3 | Spain;Italy | ||
| 289 | NCT02007629 (ClinicalTrials.gov) | February 18, 2014 | 6/12/2013 | Riociguat Clinical Effects Studied in Patients With Insufficient Treatment Response to Phosphodiesterase-5 Inhibitor | An Open-label, International, Multicenter, Single-arm, Uncontrolled, Phase IIIb Study of Riociguat in Patients With Pulmonary Arterial Hypertension (PAH) Who Demonstrate an Insufficient Response to Treatment With Phosphodiesterase-5 Inhibitors (PDE-5i) | Hypertension, Pulmonary | Drug: Riociguat (Adempas, BAY63-2521) | Bayer | NULL | Completed | 18 Years | 75 Years | All | 61 | Phase 3 | United States;Belgium;Canada;Czechia;France;Germany;Italy;Switzerland;United Kingdom;Czech Republic |
| 290 | NCT01824290 (ClinicalTrials.gov) | February 5, 2014 | 1/4/2013 | A Study of Tadalafil in Pediatric Participants With Pulmonary Arterial Hypertension (PAH) | A Double-Blind Efficacy and Safety Study of the Phosphodiesterase Type 5 Inhibitor Tadalafil in Pediatric Patients With Pulmonary Arterial Hypertension | Hypertension, Pulmonary | Drug: Tadalafil;Drug: Placebo;Drug: ERA as specific PAH treatment | Eli Lilly and Company | NULL | Completed | 6 Months | 17 Years | All | 35 | Phase 3 | United States;Austria;Belgium;Brazil;France;Germany;Israel;Italy;Japan;Mexico;Netherlands;Poland;Spain;Turkey;Canada;Romania;Switzerland |
| 291 | EUCTR2013-001759-10-CZ (EUCTR) | 23/01/2014 | 24/10/2013 | Open-label, international, multicenter, non-placebo controlled (uncontrolled), phase IIIb study of riociguat in patients with Pulmonary Arterial Hypertension (PAH) who demonstrate an insufficient response to treatment with phosphodiesterase-5 inhibitors (PDE-5i) | Open-label, international, multicenter, single-arm, uncontrolled, phase IIIb study of riociguat in patients with pulmonary arterial hypertension (PAH) who demonstrate an insufficient response to treatment with phosphodiesterase-5 inhibitors (PDE-5i) - RESPITE | Hypertension, Pulmonary;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Adempas Product Name: BAY 63-2521 Tablet Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: BAY 63-2521 Tablet Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: BAY 63-2521 Tablet Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: BAY 63-2521 Tablet Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: BAY 63-2521 Tablet Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT | Bayer AG | NULL | Not Recruiting | Female: yes Male: yes | 70 | Phase 2;Phase 3 | United States;Czech Republic;Canada;Belgium;Germany;United Kingdom;Switzerland | ||
| 292 | NCT02042014 (ClinicalTrials.gov) | January 22, 2014 | 17/1/2014 | Open-label, Multi-center Protocol to Provide QTI571 to PAH Patients Who Participated in the Extension Study (A2301E1) in Japan | An Open-label, Multi-center Protocol to Provide QTI571 to PAH Patients Who Participated in the Extension Study (A2301E1) in Japan and Are Judged by the Investigator to Benefit From Continued QTI571 Treatment | Severe Pulmonary Arterial Hypertension | Drug: QTI571 | Novartis Pharmaceuticals | NULL | Completed | 18 Years | N/A | All | 8 | Phase 3 | Japan |
| 293 | EUCTR2013-001759-10-IT (EUCTR) | 14/01/2014 | 28/10/2013 | Open-label, international, multicenter, non-placebo controlled (uncontrolled), phase IIIb study of riociguat in patients with Pulmonary Arterial Hypertension (PAH) who demonstrate an insufficient response to treatment with approved dosages of phosphodiesterase-5 inhibitors (PDE-5i) | Open-label, international, multicenter, single-arm, uncontrolled, phase IIIb study of riociguat in patients with pulmonary arterial hypertension (PAH) who demonstrate an insufficient response to treatment with approved dosages of phosphodiesterase-5 inhibitors (PDE-5i) - RESPITE | Hypertension, Pulmonary;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: BAY 63-2521 Tablet Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Product Name: BAY 63-2521 Tablet Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Product Name: BAY 63-2521 Tablet Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Product Name: BAY 63-2521 Tablet Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Product Name: BAY 63-2521 Tablet Product Code: BAY 63-2521 | Bayer HealthCare AG | NULL | Not Recruiting | Female: yes Male: yes | 70 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Czech Republic;Canada;Belgium;Germany;United Kingdom;Switzerland;Italy | ||
| 294 | EUCTR2013-001759-10-FR (EUCTR) | 06/01/2014 | 28/09/2015 | Open-label, international, multicenter, non-placebo controlled (uncontrolled), phase IIIb study of riociguat in patients with Pulmonary Arterial Hypertension (PAH) who demonstrate an insufficient response to treatment with approved dosages of phosphodiesterase-5 inhibitors (PDE-5i) | Open-label, international, multicenter, single-arm, uncontrolled, phase IIIb study of riociguat in patients with pulmonary arterial hypertension (PAH) who demonstrate an insufficient response to treatment with approved dosages of phosphodiesterase-5 inhibitors (PDE-5i) - RESPITE | Hypertension, Pulmonary;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: BAY 63-2521 Tablet Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Product Name: BAY 63-2521 Tablet Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Product Name: BAY 63-2521 Tablet Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Product Name: BAY 63-2521 Tablet Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Product Name: BAY 63-2521 Tablet Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT | Bayer HealthCare AG | NULL | Not Recruiting | Female: yes Male: yes | 70 | Phase 2;Phase 3 | United States;France;Czech Republic;Canada;Belgium;Germany;United Kingdom;Italy;Switzerland | ||
| 295 | EUCTR2013-001759-10-DE (EUCTR) | 03/01/2014 | 15/10/2013 | Open-label, international, multicenter, non-placebo controlled (uncontrolled), phase IIIb study of riociguat in patients with Pulmonary Arterial Hypertension (PAH) who demonstrate an insufficient response to treatment with phosphodiesterase-5 inhibitors (PDE-5i) | Open-label, international, multicenter, single-arm, uncontrolled, phase IIIb study of riociguat in patients with pulmonary arterial hypertension (PAH) who demonstrate an insufficient response to treatment with phosphodiesterase-5 inhibitors (PDE-5i) - RESPITE | Hypertension, Pulmonary;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Adempas Product Name: BAY 63-2521 Tablet Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: BAY 63-2521 Tablet Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: BAY 63-2521 Tablet Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: BAY 63-2521 Tablet Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: BAY 63-2521 Tablet Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT | Bayer AG | NULL | Not Recruiting | Female: yes Male: yes | 70 | Phase 2;Phase 3 | United States;Czech Republic;Canada;Belgium;Germany;United Kingdom;Switzerland | ||
| 296 | JPRN-JapicCTI-142462 | 01/1/2014 | 03/03/2014 | An open-label, multi-center protocol to provide QTI571 to PAH patients who participated in the extension study (A2301E1) in Japan and are judged by the investigator to benefit from continued QTI571 treatment | An open-label, multi-center protocol to provide QTI571 to PAH patients who participated in the extension study (A2301E1) in Japan and are judged by the investigator to benefit from continued QTI571 treatment | pulmonary arterial hypertension | Intervention name : QTI571 INN of the intervention : imatinib Dosage And administration of the intervention : QTI571 200mg up to 400mg (depending on tolerability) taken orally, once a day | Novartis Pharma K.K. | NULL | BOTH | Phase 3 | NULL | ||||
| 297 | EUCTR2013-001759-10-BE (EUCTR) | 20/12/2013 | 20/11/2013 | Open-label, international, multicenter, non-placebo controlled (uncontrolled), phase IIIb study of riociguat in patients with Pulmonary Arterial Hypertension (PAH) who demonstrate an insufficient response to treatment with phosphodiesterase-5 inhibitors (PDE-5i) | An open-label, international, multicenter, single-arm, uncontrolled, phase IIIb study of riociguat in patients with pulmonary arterial hypertension (PAH) who demonstrate an insufficient response to treatment with phosphodiesterase-5 inhibitors (PDE-5i) - RESPITE | Hypertension, Pulmonary;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Adempas Product Name: BAY 63-2521 Tablet Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: BAY 63-2521 Tablet Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: BAY 63-2521 Tablet Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: BAY 63-2521 Tablet Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: BAY 63-2521 Tablet Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT | Bayer HealthCare AG | NULL | Not Recruiting | Female: yes Male: yes | 70 | Phase 2;Phase 3 | United States;Czech Republic;Canada;Belgium;Germany;United Kingdom;Switzerland | ||
| 298 | EUCTR2013-003489-15-IT (EUCTR) | 10/12/2013 | 20/11/2013 | An extension of AC-055-310, a multi-center, open-label, single-arm, Phase 3b study of macitentan in patients with pulmonary arterial hypertension to psychometrically validate the French, Italian and Spanish versions of the PAH-SYMPACT™ - ORCHESTRA Ext. | An extension of AC-055-310, a multi-center, open-label, single-arm, Phase 3b study of macitentan in patients with pulmonary arterial hypertension to psychometrically validate the French, Italian and Spanish versions of the PAH-SYMPACT™ - ORCHESTRA Ext. | Pulmonary arterial hypertension MedDRA version: 16.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: macitentan Product Code: ACT-064992 INN or Proposed INN: MACITENTAN | ACTELION Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 160 | Phase 3 | Spain;Italy | ||
| 299 | EUCTR2013-003462-14-IT (EUCTR) | 10/12/2013 | 20/11/2013 | Study of the drug macitentan in patients with pulmonary arterial hypertension in order to test the French, Italian, and Spanish translations of a patient questionnaire called PAH-SYMPACT. | A multi-center, open-label, single-arm, Phase 3b study of macitentan in patients with pulmonary arterial hypertension to psychometrically validate the French, Italian and Spanish versions of the PAH-SYMPACT™ - ORCHESTRA | Pulmonary arterial hypertension MedDRA version: 16.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: macitentan Product Code: ACT-064992 INN or Proposed INN: MACITENTAN | ACTELION Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 160 | Phase 3 | Spain;Italy | ||
| 300 | NCT01934647 (ClinicalTrials.gov) | November 22, 2013 | 30/8/2013 | Acute Dosing of MK-8892 in Participants With Pulmonary Arterial Hypertension (PAH) (MK-8892-003) | A Non-randomized, Single-Panel, Open-Label Trial to Study the Safety, Tolerability and Pharmacodynamics of MK-8892 Acute Dosing in Subjects With Moderate to Severe Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension | Drug: MK-8892 | Merck Sharp & Dohme Corp. | NULL | Terminated | 18 Years | 70 Years | All | 7 | Phase 1 | Germany |
| 301 | NCT01926509 (ClinicalTrials.gov) | November 14, 2013 | 19/8/2013 | Study to Assess the Safety, Tolerability and Pharmacokinetics (PK) of MK-8892 in Participants With Pulmonary Arterial Hypertension (PAH) (MK-8892-005) | A 28-Day Multiple-Dose Titration Study to Assess the Effects of MK-8892 on Safety, Tolerability and Pharmacokinetics in Subjects With Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension | Drug: MK-8892;Drug: Placebo for MK-8892 | Merck Sharp & Dohme Corp. | NULL | Completed | 18 Years | 70 Years | All | 23 | Phase 1 | Bulgaria;Germany;Moldova, Republic of |
| 302 | EUCTR2013-001100-10-ES (EUCTR) | 12/11/2013 | 12/11/2013 | This study is to allow continued access to QTI571 for patients whoreceived QTI571 for pulmonary arterial hypertension in one of thelong-term extension studies (A2301E1, A2102E1 and E2203) andhave been judged by the investigator to benefit from continuedQTI571 treatment. | An open-label, multi-center protocol to provide QTI571 to PAH patients who participated in one of the extension studies and are judged by the investigator to benefit from continued QTI571 treatment | Pulmonary Arterial Hypertension MedDRA version: 16.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: GLIVEC 100 mg comprimidos recubiertos con película Product Name: Imatinib mesilate Product Code: QTI571 INN or Proposed INN: IMATINIB MESILATE | Novartis Farmacéutica, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 81 | United States;Spain;Australia;Switzerland | |||
| 303 | NCT03638908 (ClinicalTrials.gov) | November 2013 | 12/7/2018 | Fluoxetine in Pulmonary Arterial Hypertension (PAH) Trial | A Phase 2, Open-label, Clinical Trial of Fluoxetine, a Selective Serotonin Reuptake Inhibitor, in the Treatment of Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension | Drug: Fluoxetine | University of Texas Southwestern Medical Center | NULL | Completed | 16 Years | 80 Years | All | 8 | Phase 2 | United States |
| 304 | NCT02000856 (ClinicalTrials.gov) | November 2013 | 19/11/2013 | BEET PAH: a Study to Assess the Effects of Beetroot Juice in Patients With Pulmonary Arterial Hypertension | BEET PAH: a Study to Assess the Effects of Beetroot Juice in Patients With Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension | Dietary Supplement: Beetroot juice | Uppsala University | Karolinska Institutet | Completed | 18 Years | N/A | All | 15 | N/A | Sweden |
| 305 | NCT01966302 (ClinicalTrials.gov) | November 2013 | 15/10/2013 | Compassionate Use of Beraprost Sodium 314d Modified Release for Patients With Pulmonary Arterial Hypertension (PAH) | Compassionate Use of Beraprost Sodium 314d Modified Release (BPS-314d-MR) for Three Patients With Pulmonary Arterial Hypertension (PAH). | Pulmonary Arterial Hypertension | Drug: BPS-314d-MR | Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center | Lung Biotechnology PBC | Completed | 18 Years | 75 Years | All | 1 | Phase 2 | United States |
| 306 | NCT01894035 (ClinicalTrials.gov) | September 23, 2013 | 3/7/2013 | Non-interventional Multi-center Study on Patients Under Routine Treatment of Pulmonary Arterial Hypertension (PAH) With Inhaled Iloprost Using I-Neb as a Device for Inhalation | Study to Assess the Compliance of Patients With Pulmonary Arterial Hypertension Treated With Inhaled Iloprost. | Pulmonary Hypertension | Drug: Iloprost (Ventavis, BAYQ 6256) | Bayer | NULL | Completed | 18 Years | N/A | All | 13 | Portugal | |
| 307 | NCT01847014 (ClinicalTrials.gov) | September 1, 2013 | 2/5/2013 | Clinical Study of Macitentan in Patients With PAH to Psychometrically Validate PAH-SYMPACT Instrument | AC-055-402: An Extension of AC-055-401, a Multi-center, Open-label, Single-arm, Phase 3b Study of Macitentan in Patients With Pulmonary Arterial Hypertension to Psychometrically Validate the PAH-SYMPACT Instrument | Pulmonary Arterial Hypertension | Drug: Macitentan | Actelion | NULL | Terminated | 18 Years | 80 Years | All | 4 | Phase 3 | United States |
| 308 | JPRN-JapicCTI-132155 | 01/8/2013 | 11/06/2013 | Bosentan extension study for PAH pediatric patients | Open-label, long-term, efficacy, safety, and tolerability extension study using the pediatric formulation of bosentan in the treatment of Japanese children with pulmonary arterial hypertension who completed the previous study. | Pulmonary arterial hypertension (PAH) | Intervention name : Ro 47-0203 / ACT-050088 INN of the intervention : bosentan Dosage And administration of the intervention : Oral administration, 2 mg/kg b.i.d, Patients are not to receive a dose exceeding 120 mg b.i.d. | Actelion Pharmaceuticals Japan Ltd. | NULL | 14 | BOTH | 5 | Phase 3 | NULL | ||
| 309 | EUCTR2012-000097-26-IT (EUCTR) | 22/05/2013 | 19/12/2012 | International, multicenter, randomized (1:1 oral treprostinil (UT-15C): placebo), double-blind, placebo-controlled study in subjects with Pulmonary Arterial Hypertension (PAH) who are receiving background oral monotherapy | A Phase III, International, Multi-Center, Randomized, Double- Blind, Placebo-Controlled, Clinical Worsening Study of UT-15C in Subjects with Pulmonary Arterial Hypertension Receiving Background Oral Monotherapy | Pulmonary Arterial Hypertension MedDRA version: 17.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostin | United Therapeutics Corporation | NULL | Not Recruiting | Female: yes Male: yes | 610 | Phase 3 | United States;Taiwan;Greece;Austria;Israel;Chile;United Kingdom;Italy;India;France;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Australia;Denmark;Netherlands;Germany;China;Sweden;Korea, Republic of | ||
| 310 | JPRN-JapicCTI-132154 | 01/5/2013 | Bosentan for PAH pediatric patients | Open-label, multicenter study to assess the efficacy, safety, tolerability, and pharmacokinetics of bosentan in Japanese children with pulmonary arterial hypertension | Pulmonary arterial hypertension (PAH) | Intervention name : Ro47-0203 / ACT-050088 INN of the intervention : bosentan Dosage And administration of the intervention : Oral administration, 2 mg/kg b.i.d, Patients are not to receive a dose exceeding 120 mg b.i.d. Control intervention name : null | Actelion Pharmaceuticals Japan Ltd. | NULL | 14 | BOTH | 5 | Phase 3 | NULL | |||
| 311 | JPRN-JapicCTI-132142 | 01/4/2013 | 03/06/2013 | ACT-385781A PAH Post-marketing study | A Post-marketing, Open-label-study ACT-385781A in patients with pulmonary arterial hypertension | Pulmonary arterial hypertension (PAH) | Intervention name : ACT-385781A INN of the intervention : Epoprostenol Dosage And administration of the intervention : A commercially available epoprostenol sodium preparation will be switched to the study drug at the same dose | Actelion Pharmaceuticals Japan Ltd. | NULL | 20 | BOTH | 5 | Phase 4 | NULL | ||
| 312 | NCT01841762 (ClinicalTrials.gov) | April 1, 2013 | 27/3/2013 | Clinical Study of Macitentan in Patients With Pulmonary Arterial Hypertension to Psychometrically Validate the PAH-SYMPACT Instrument | A Multi-center, Open-label, Single-arm, Phase 3b Study of Macitentan in Patients With Pulmonary Arterial Hypertension to Psychometrically Validate the PAH-SYMPACT Instrument | Pulmonary Arterial Hypertension | Drug: Macitentan | Actelion | NULL | Completed | 18 Years | N/A | All | 284 | Phase 3 | United States |
| 313 | NCT01795950 (ClinicalTrials.gov) | April 2013 | 12/2/2013 | Safety Study of PLX-PAD Cells to Treat Pulmonary Arterial Hypertension (PAH) | A Phase I Safety and Pharmacodynamic Study of Intravenous Infusion of PLX-PAD Cells in Patients With PAH | Pulmonary Arterial Hypertension | Drug: PLX-PAD | United Therapeutics | NULL | Terminated | 18 Years | 75 Years | Both | 6 | Phase 1 | Australia |
| 314 | EUCTR2012-000097-26-NL (EUCTR) | 18/02/2013 | 29/08/2012 | International, multicenter, randomized (1:1 oral treprostinil (UT-15C): placebo), double-blind, placebo-controlled study in subjects with Pulmonary Arterial Hypertension (PAH) who are receiving background oral monotherapy | A Phase III, International, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Clinical Worsening Study of UT-15C in Subjects with Pulmonary Arterial Hypertension Receiving Background Oral Monotherapy. | Pulmonary Arterial Hypertension MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine | United Therapeutics Corporation | NULL | Not Recruiting | Female: yes Male: yes | 850 | Phase 3 | United States;Taiwan;Greece;Austria;Israel;Chile;Italy;United Kingdom;India;France;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Australia;Denmark;Germany;Netherlands;China;Korea, Republic of;Sweden | ||
| 315 | EUCTR2010-021825-11-BG (EUCTR) | 02/01/2013 | 20/11/2012 | A 7-month research project for children aged from 3 months to 11 years with pulmonary arterial hypertension to find out whether bosentan is best tolerated, and most safe and effective when taken two or three times a day | An open label, prospective multicenter study to assess the pharmacokinetics, tolerability, safety and efficacy of the pediatric formulation of bosentan two versus three times a day in children with pulmonary arterial hypertension - FUTURE 3 | Pulmonary arterial hypertension (PAH) in children MedDRA version: 14.1;Level: LLT;Classification code 10064910;Term: Familial (FPAH);System Organ Class: 100000004855 MedDRA version: 14.1;Classification code 10064909;Term: Idiopathic (IPAH);Classification code 10064908;Term: Associated with (APAH);System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Tracleer Product Name: bosentan INN or Proposed INN: BOSENTAN MONOHYDRATE Other descriptive name: Ro-47-0203/029 | Actelion Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 64 | Phase 3 | Serbia;United States;Belarus;Spain;Ukraine;Israel;Russian Federation;Italy;India;France;Hungary;Czech Republic;Mexico;Poland;Australia;Bulgaria;South Africa;Netherlands;Germany;China | ||
| 316 | NCT04955990 (ClinicalTrials.gov) | December 9, 2012 | 29/6/2021 | A Study of Real-world Cohort of Pulmonary Arterial Hypertension (PAH) Participants | An International, Non-Drug Interventional, Real-world Cohort of PAH Patients Newly Initiating PAH Therapy With Guideline-directed Assessments of Disease Severity | Pulmonary Arterial Hypertension | Drug: PAH Therapies | Actelion | NULL | Recruiting | 18 Years | N/A | All | 3000 | Phase 4 | United States;Argentina;Australia;Austria;Belgium;Brazil;Canada;China;Colombia;France;Germany;Italy;Japan;Korea, Republic of;Malaysia;Mexico;Netherlands;Poland;Puerto Rico;Singapore;Spain;Sweden;Turkey;United Kingdom;Russian Federation |
| 317 | NCT01808313 (ClinicalTrials.gov) | December 1, 2012 | 28/2/2013 | Efficacy Study of Ambrisentan in Chinese Patients With Pulmonary Arterial Hypertension (PAH) | An Open Label Phase IIIb Study to Evaluate Efficacy and Safety of Ambrisentan in Chinese Patients With Pulmonary Arterial Hypertension (PAH) | Vascular Disease | Drug: ambrisentan | GlaxoSmithKline | NULL | Completed | 18 Years | 75 Years | All | 134 | Phase 3 | China |
| 318 | NCT01586156 (ClinicalTrials.gov) | December 2012 | 23/4/2012 | PAHTCH Pulmonary Arterial Hypertension Treatment With Carvedilol for Heart Failure (Carvedilol) | Pulmonary Arterial Hypertension Treatment With Carvedilol for Heart Failure | Pulmonary Hypertension | Drug: Carvedilol;Drug: placebo | The Cleveland Clinic | National Institutes of Health (NIH);National Heart, Lung, and Blood Institute (NHLBI) | Completed | 18 Years | 65 Years | All | 30 | N/A | United States |
| 319 | EUCTR2012-000097-26-GB (EUCTR) | 06/11/2012 | 01/08/2012 | International, multicenter, randomized (1:1 oral treprostinil (UT-15C): placebo), double-blind, placebo-controlled study in subjects with Pulmonary Arterial Hypertension (PAH) who are receiving background oral monotherapy | A Phase III, International, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Clinical Worsening Study of UT-15C in Subjects with Pulmonary Arterial Hypertension Receiving Background Oral Monotherapy. | Pulmonary Arterial Hypertension MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine | United Therapeutics Corporation | NULL | Not Recruiting | Female: yes Male: yes | 850 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Taiwan;Greece;Austria;Israel;Chile;Italy;United Kingdom;India;France;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Australia;Denmark;Netherlands;Germany;China;Korea, Republic of;Sweden | ||
| 320 | NCT01725256 (ClinicalTrials.gov) | November 2012 | 8/11/2012 | A Phase 2 Study to Determine the Safety and Efficacy of AIR001 in Subjects With Pulmonary Arterial Hypertension (PAH) | A Phase 2, Multi-Center, Open-label, Randomized, Parallel-Dose Study to Determine the Safety and Efficacy of AIR001 in Subjects With WHO Group 1 Pulmonary Arterial Hypertension (PAH) | Pulmonary Arterial Hypertension | Drug: AIR001 (sodium nitrite inhalation solution) | Aires Pharmaceuticals, Inc. | NULL | Terminated | 18 Years | 75 Years | Both | 29 | Phase 2 | United States;Australia;Hungary |
| 321 | EUCTR2012-000097-26-AT (EUCTR) | 21/09/2012 | 07/08/2012 | International, multicenter, randomized (1:1 oral treprostinil (UT-15C): placebo), double-blind, placebo-controlled study in subjects with Pulmonary Arterial Hypertension (PAH) who are receiving background oral monotherapy | A Phase III, International, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Clinical Worsening Study of UT-15C in Subjects with Pulmonary Arterial Hypertension receiving background oral monotherapy | Pulmonary Arterial Hypertension MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine | United Therapeutics Corporation | NULL | Not Recruiting | Female: yes Male: yes | 850 | Phase 3 | United States;Taiwan;Greece;Austria;Israel;Chile;Italy;United Kingdom;India;France;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Australia;Denmark;Netherlands;Germany;China;Korea, Republic of;Sweden | ||
| 322 | EUCTR2012-000097-26-DE (EUCTR) | 17/09/2012 | 02/08/2012 | International, multicenter, randomized (1:1 oral treprostinil (UT-15C): placebo), double-blind, placebo-controlled study in subjects with Pulmonary Arterial Hypertension (PAH) who are receivingbackground oral monotherapy | A Phase III, International, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Clinical Worsening Study of UT-15C in Subjects with Pulmonary Arterial Hypertension Receiving Background Oral Monotherapy. | Pulmonary Arterial Hypertension MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine | United Therapeutics Corporation | NULL | Not Recruiting | Female: yes Male: yes | 850 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Taiwan;Greece;Austria;Israel;Chile;Italy;United Kingdom;India;France;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Australia;Denmark;Netherlands;Germany;China;Korea, Republic of;Sweden | ||
| 323 | JPRN-JapicCTI-121986 | 01/9/2012 | 17/10/2012 | Macitentan PAH | A multicenter, open-label, phase II/III study to asseses the efficacy, safety and Pharmacokinetics(PK) of macitentan (ACT-064992) in patients with pulmonary arterial hypertension | Pulmonary arterial hypertension (PAH) | Intervention name : ACT-064992 INN of the intervention : macitentan Dosage And administration of the intervention : macitentan tablet 10 mg once daily | Nippon Shinyaku co.,LTD./Actelion Pharmaceuticals Japan Ltd. | NULL | 16 | BOTH | 22 | Phase 2-3 | NULL | ||
| 324 | EUCTR2011-004106-16-BG (EUCTR) | 10/08/2012 | 11/06/2012 | A 5-month research project for children aged from 1 year to 17 years who have high blood pressure in the lung, to see how well bosentan decreases this high blood pressure and improves children's physical capabilities compared to an inactive compound | A randomized, prospective, double-blind, placebo-controlled, group sequential multicenter study to assess efficacy, safety, and tolerability of the pediatric formulation of bosentan in children with pulmonary arterial hypertension - FUTURE 5 | Pulmonary arterial hypertension (PAH) in children MedDRA version: 14.1;Level: LLT;Classification code 10064908;Term: Associated with (APAH);System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 14.1;Classification code 10064909;Term: Idiopathic (IPAH);Classification code 10064910;Term: Familial (FPAH);System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Tracleer Product Name: bosentan INN or Proposed INN: bosentan Other descriptive name: BOSENTAN MONOHYDRATE | Actelion pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 105 | Phase 3 | United States;Serbia;Portugal;Philippines;Taiwan;Ukraine;Guatemala;Russian Federation;Chile;Colombia;Vietnam;India;France;Mexico;Argentina;Malaysia;Singapore;Croatia;Peru;South Africa;Bulgaria;Netherlands;China | ||
| 325 | EUCTR2011-004612-31-PT (EUCTR) | 06/07/2012 | 02/05/2012 | A 12-month research project for children who have gone through the FUTURE 5 research project and who want to continue treatment to see how well bosentan is tolerated when administered over a long period of time. | A prospective, multicenter, non-comparative, open label extension of the FUTURE 5 study to assess safety and tolerability of the pediatric formulation of bosentan in children with pulmonary arterial hypertension - FUTURE 6 | Pulmonary arterial hypertension (PAH) in children MedDRA version: 14.1;Level: LLT;Classification code 10064908;Term: Associated with (APAH);System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 14.1;Classification code 10064909;Term: Idiopathic (IPAH);Classification code 10064910;Term: Familial (FPAH);System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Tracleer Product Name: bosentan INN or Proposed INN: bosentan Other descriptive name: BOSENTAN MONOHYDRATE | Actelion pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 105 | Portugal;Serbia;United States;Philippines;Taiwan;Guatemala;Ukraine;Chile;Russian Federation;Colombia;India;Vietnam;France;Mexico;Argentina;Malaysia;Singapore;Croatia;Peru;South Africa;Bulgaria;Netherlands;China | |||
| 326 | NCT01560624 (ClinicalTrials.gov) | June 26, 2012 | 9/3/2012 | Phase III Clinical Worsening Study of UT-15C in Subjects With PAH Receiving Background Oral Monotherapy | A Phase III, International, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Clinical Worsening Study of UT-15C in Subjects With Pulmonary Arterial Hypertension Receiving Background Oral Monotherapy | Pulmonary Arterial Hypertension | Drug: Treprostinil Diolamine;Drug: Placebo | United Therapeutics | NULL | Completed | 18 Years | 75 Years | All | 690 | Phase 3 | United States;Argentina;Australia;Austria;Brazil;Canada;Chile;China;Denmark;France;Germany;Greece;India;Israel;Italy;Korea, Republic of;Mexico;Netherlands;Poland;Singapore;Sweden;Taiwan;United Kingdom |
| 327 | NCT01469169 (ClinicalTrials.gov) | June 19, 2012 | 8/11/2011 | Inhaled Iloprost (Ventavis): Efficacy, Safety, and Pharmacokinetics (PK) Confirmation Study | A Multi-center, Non-randomized, Open Label, Single-arm Study to Evaluate the Efficacy, Safety, and Pharmacokinetics (PK) of BAY q 6256 (Iloprost) Inhalation in Patients With Pulmonary Arterial Hypertension (PAH) | Hypertension, Pulmonary | Drug: Iloprost (Ventavis inhaled, BAYQ6256) | Bayer | NULL | Completed | 18 Years | 75 Years | All | 27 | Phase 3 | Japan |
| 328 | EUCTR2011-004106-16-PT (EUCTR) | 01/06/2012 | 28/02/2012 | A 5-month research project for children aged from 1 year to 17 years who have high blood pressure in the lung, to see how well bosentan decreases this high blood pressure and improves children's physical capabilities compared to an inactive compound | A randomized, prospective, double-blind, placebo-controlled, group sequential multicenter study to assess efficacy, safety, and tolerability of the pediatric formulation of bosentan in children with pulmonary arterial hypertension - FUTURE 5 | Pulmonary arterial hypertension (PAH) in children MedDRA version: 14.1;Level: LLT;Classification code 10064910;Term: Familial (FPAH);System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 14.1;Classification code 10064909;Term: Idiopathic (IPAH);Classification code 10064908;Term: Associated with (APAH);System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Tracleer Product Name: bosentan INN or Proposed INN: bosentan Other descriptive name: BOSENTAN MONOHYDRATE | Actelion pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 105 | Portugal;Serbia;United States;Philippines;Taiwan;Guatemala;Ukraine;Chile;Russian Federation;Colombia;India;Vietnam;France;Mexico;Argentina;Malaysia;Singapore;Croatia;Peru;South Africa;Bulgaria;Netherlands;China | |||
| 329 | NCT01557647 (ClinicalTrials.gov) | June 2012 | 14/3/2012 | Safety and Efficacy of Inhaled Treprostinil in Patients With PAH | Inhaled Treprostinil for the Treatment of Pulmonary Arterial Hypertension: A Phase III, International, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Event-Driven Study to Evaluate the Safety and Efficacy of Inhaled Treprostinil. | Pulmonary Arterial Hypertension | Drug: Inhaled treprostinil;Drug: Placebo | United Therapeutics | NULL | Withdrawn | 18 Years | 75 Years | Both | 0 | Phase 3 | NULL |
| 330 | NCT01557660 (ClinicalTrials.gov) | June 2012 | 14/3/2012 | Inhaled Treprostinil for PAH: Open-label Extension | Inhaled Treprostinil in Subjects With Pulmonary Arterial Hypertension: An Open-Label, Phase III, International, Multi-Center Study | Pulmonary Arterial Hypertension | Drug: inhaled treprostinil | United Therapeutics | NULL | Withdrawn | 18 Years | N/A | Both | 0 | Phase 3 | NULL |
| 331 | NCT02847260 (ClinicalTrials.gov) | April 2012 | 25/7/2016 | Safety and Tolerability of Rapid Dose Titration of Subcutaneous Remodulin® Therapy in PAH Subjects (RAPID) | A 16 Week, Open Label, Multi-centre, Study to Evaluate the Safety, Tolerability and Pharmacodynamic Effects of a Rapid Dose Titration Regimen of Subcutaneous Remodulin® Therapy in Subjects With Pulmonary Arterial Hypertension (PAH) | Pulmonary Arterial Hypertension | Drug: Remodulin | United Therapeutics | NULL | Completed | 18 Years | N/A | All | 39 | Phase 4 | NULL |
| 332 | EUCTR2011-004631-31-DE (EUCTR) | 13/03/2012 | 10/02/2012 | 16 week study is to assess the safety, tolerability and the effects on the body of a rapid dosing regimen using subcutaneous Remodulin® | A 16 Week, Open Label, Multi-Centre, Study to Evaluate the Safety, Tolerability and Pharmacodynamic Effects of a Rapid Dose Titration Regimen of Subcutaneous Remodulin® Therapy in Subjects with Pulmonary Arterial Hypertension - RAPID study | Pulmonary Arterial Hypertension (PAH) MedDRA version: 14.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 14.1;Level: LLT;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension;Classification code 10065152;Term: Familial pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Remodulin® (treprostinil) 1 mg/ml solution for infusion INN or Proposed INN: Treprostinil Other descriptive name: TREPROSTINIL SODIUM, UT-15 Trade Name: Remodulin® (treprostinil) 2.5 mg/ml solution for infusion INN or Proposed INN: Treprostinil Other descriptive name: TREPROSTINIL SODIUM, UT-15 Trade Name: Remodulin® (treprostinil) 5 mg/ml solution for infusion INN or Proposed INN: Treprostinil Other descriptive name: TREPROSTINIL SODIUM, UT-15 Trade Name: Remodulin® (treprostinil) 10 mg/ml solution for infusion INN or Proposed INN: Treprostinil Other descriptive name: TREPROSTINIL SODIUM, UT-15 | United Therapeutics Corp. | NULL | Not Recruiting | Female: yes Male: yes | 50 | Germany | |||
| 333 | EUCTR2010-018320-10-ES (EUCTR) | 26/12/2011 | 21/11/2011 | An extension of study AC-066A301 to investigate safety and tolerability of the study medication (epoprostenol for injection) | An open-label extension of study AC-066A301 investigating the safety and tolerability of ACT-385781A in patients with pulmonary arterial hypertension (PAH)Extension del estudio AC-066A301, abierta, para investigar la seguridad y la tolerabilidad de ACT-385781A en pacientes con Hipertension Arterial Pulmonar (HAP) - EPITOME-2 Extension | Hipertension Arterial Pulmonar MedDRA version: 14.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Epoprostenol for injection Product Name: Epoprostenol for injection Product Code: ACT-385781A INN or Proposed INN: EPOPROSTENOL SODIUM Trade Name: Epoprostenol for injection Product Name: Epoprostenol for injection Product Code: ACT-385781A INN or Proposed INN: EPOPROSTENOL SODIUM | ACTELION Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 40 | France;Canada;Belgium;Spain;Netherlands;Italy | |||
| 334 | EUCTR2010-021793-12-NL (EUCTR) | 09/11/2011 | 14/02/2011 | A prospective, multicenter, open-label extension of FUTURE 3 to assess thesafety, tolerability and efficacy of the pediatric formulation of bosentan twoversus three times a day in children with pulmonary arterial hypertension - FUTURE 3 study extension | A prospective, multicenter, open-label extension of FUTURE 3 to assess thesafety, tolerability and efficacy of the pediatric formulation of bosentan twoversus three times a day in children with pulmonary arterial hypertension - FUTURE 3 study extension | Pulmonary arterial hypertension (PAH) in children MedDRA version: 12.1;Level: LLT;Classification code 10064908;Term: Associated with (APAH) MedDRA version: 12.1;Classification code 10064909;Term: Idiopathic (IPAH) MedDRA version: 12.1;Classification code 10064910;Term: Familial (FPAH) | Trade Name: Tracleer Product Name: bosentan INN or Proposed INN: BOSENTAN MONOHYDRATE Other descriptive name: Ro-47-0203/029 | Actelion Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 64 | Czech Republic;Hungary;Spain;Germany;Netherlands;Italy | |||
| 335 | EUCTR2011-002943-92-NL (EUCTR) | 07/11/2011 | 22/08/2011 | Study of a new thermostable formulation of Flolan™ to treat Pulmonary Arterial Hypertension (PAH) | A Single-arm, Open Label Study Evaluating the Impact on Lifestyle of a New Thermo Stable Formulation of FLOLAN™ in Subjects with Pulmonary Arterial Hypertension (PAH) | pulmonary arterial hypertension (PAH) MedDRA version: 14.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 14.1;Level: LLT;Classification code 10065150;Term: Associated with pulmonary arterial hypertension;Classification code 10065152;Term: Familial pulmonary arterial hypertension;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: FLOLAN™ and Glycine Diluent Product Name: FLOLAN™ and Glycine Diluent Product Code: 4AU76 INN or Proposed INN: EPOPROSTENOL Trade Name: FLOLAN TM and Glycine Diluent Product Name: FLOLAN™ and Glycine Diluent Product Code: 4AU76 INN or Proposed INN: EPOPROSTENOL | GlaxoSmithKline Research and Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 20 | United States;Canada;Netherlands | |||
| 336 | NCT01462565 (ClinicalTrials.gov) | November 1, 2011 | 13/10/2011 | Study of a New Thermo Stable Formulation of Epoprostenol Sodium to Treat Pulmonary Arterial Hypertension (PAH) | A Single-arm, Open Label Study Evaluating the Impact on Lifestyle of a New Thermo Stable Formulation of FLOLAN® in Subjects With Pulmonary Arterial Hypertension (PAH). (FLOLAN® is a Registered Trademark of the GlaxoSmithKline Group of Companies.) | Hypertension, Pulmonary | Drug: current marketed FLOLAN (epoprostenol sodium);Drug: new thermo stable formulation of epoprostenol sodium | GlaxoSmithKline | NULL | Completed | 18 Years | 75 Years | All | 16 | Phase 4 | United States;Canada;Netherlands |
| 337 | EUCTR2011-001893-24-DE (EUCTR) | 13/10/2011 | 21/09/2011 | To determine oral bioavailability of the oral liquid formulation and potential food effects. | Relative bioavailability and food effect study of two oral liquid formulations in comparison to a 1mg tablet of riociguat to characterize its pharmacokinetic properties in healthy male and female adult subjects in a randomized, open label, 5 fold crossover design | Children with PH due to • Pulmonary arterial hypertension (PAH) • persistent pulmonary hypertension of the newborn (PPHN) MedDRA version: 14.0;Level: LLT;Classification code 10037405;Term: Pulmonary hypertension primary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 14.0;Classification code 10036727;Term: Primary pulmonary hypertension;Classification code 10053592;Term: Newborn persistent pulmonary hypertension;System Organ Class: 10010331 - Congenital, familial and genetic disorders | Product Name: BAY 63-2521 0.3 % Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Product Name: BAY 63-2521 0.06 % Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Product Name: BAY 63-2521 IR tablets 1 mg Product Code: BAY 63-2521 INN or Proposed INN: Riociguat | Bayer HealthCare AG | NULL | Not Recruiting | Female: yes Male: yes | 30 | Germany | |||
| 338 | EUCTR2010-019883-36-DE (EUCTR) | 13/10/2011 | 13/05/2011 | A 24 week, randomized, double blind, multicenter, placebo-controlled efficacy, safety, tolerability and PK trial of Nilotinib (AMN107) in Pulmonary Arterial Hypertension (PAH) | A 24 week, randomized, double blind, multicenter, placebo-controlled efficacy, safety, tolerability and PK trial of Nilotinib (AMN107) in Pulmonary Arterial Hypertension (PAH) | Pulmonary Arterial Hypertension (PAH) Class II or III patients remaining symptomatic despite at least one PAH-specific therapy. MedDRA version: 14.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders | Trade Name: Tasigna® 150 mg Product Name: Tasigna Product Code: AMN107 INN or Proposed INN: nilotinib Product Name: Nilotinib 50 mg Product Code: AMN107 INN or Proposed INN: nilotinib | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 55 | United States;Hungary;Canada;Singapore;Germany;Switzerland;Italy;Korea, Republic of | |||
| 339 | NCT01548950 (ClinicalTrials.gov) | September 2011 | 5/3/2012 | Drug Therapy and Surgery in Congenital Heart Disease With Pulmonary Hypertension | Combined Clinical and Surgical Approaches to Congenital Heart Disease Associated With Pulmonary Arterial Hypertension (PAH-CHD) | Congenital Heart Disease;Pulmonary Arterial Hypertension | Drug: Sildenafil singly or in association with Bosentan | University of Sao Paulo General Hospital | Instituto do Coracao;Fundação de Amparo à Pesquisa do Estado de São Paulo | Completed | 2 Months | N/A | All | 50 | N/A | Brazil |
| 340 | JPRN-UMIN000005973 | 2011/08/01 | 01/08/2011 | Tadalafil study for pediatric PAH on efficacy, safety and pharmacodynamics | Tadalafil study for pediatric PAH on efficacy, safety and pharmacodynamics - Tadalafil study for pediatric PAH | pediatric pulmonary arterial hypertension | single oral administration of tadalafil 1mg/kg | National Cerebral and Cardiovascular Center | NULL | Complete: follow-up complete | Not applicable | 18years-old | Male and Female | 10 | Not applicable | Japan |
| 341 | JPRN-JapicCTI-122017 | 01/8/2011 | 03/12/2012 | ACT-385781A PAH | Open-label study ACT-385781A in patients with pulmonary arterial hypertension | Pulmonary arterial hypertension (PAH) | Intervention name : ACT-385781A INN of the intervention : epoprostenol Dosage And administration of the intervention : Continuous intravenous infusion | Actelion Pharmaceuticals Japan Ltd. | NULL | 20 | BOTH | 10 | Phase 3 | NULL | ||
| 342 | NCT01553721 (ClinicalTrials.gov) | August 2011 | 1/1/2012 | Efficacy and Safety Study of Udenafil in Patient With Pulmonary Arterial Hypertension(PAH) | A Placebo-controlled, Double-blind, Phase II Clinical Study to Evaluate the Efficacy and Safety of Udenafil in Patient With Pulmonary Arterial Hypertension(PAH) | Pulmonary Arterial Hypertension | Drug: udenafil;Drug: placebo | Dong-A ST Co., Ltd. | NULL | Completed | 18 Years | N/A | Both | 63 | Phase 2 | Korea, Republic of |
| 343 | EUCTR2010-018320-10-NL (EUCTR) | 11/07/2011 | 12/05/2011 | An extension of study AC-066A301 to investigate safety and tolerability of the study medication (epoprostenol for injection) | An open-label extension of study AC-066A301 investigating the safety and tolerability of ACT-385781A in patients with pulmonary arterial hypertension (PAH) - EPITOME-2 Extension | Pulmonary Arterial Hypertension MedDRA version: 14.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Epoprostenol for injection Product Name: Epoprostenol for injection Product Code: ACT-385781A INN or Proposed INN: EPOPROSTENOL SODIUM Trade Name: Epoprostenol for injection Product Name: Epoprostenol for injection Product Code: ACT-385781A INN or Proposed INN: EPOPROSTENOL SODIUM | ACTELION Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 40 | France;Canada;Belgium;Spain;Netherlands;Italy | |||
| 344 | EUCTR2011-001312-59-GB (EUCTR) | 24/06/2011 | 15/04/2011 | A double-blinded, randomized, crossover clinical study to assess the efficacy of Qutenza (capsaicin 8% patches) for the reduction of site pain caused by continuous subcutaneous infusion of Remodulin (treprostinil sodium), in Pulmonary Arterial Hypertension Patients - Efficacy of capsaicin 8% patches in Pulmonary Arterial Hypertension | A double-blinded, randomized, crossover clinical study to assess the efficacy of Qutenza (capsaicin 8% patches) for the reduction of site pain caused by continuous subcutaneous infusion of Remodulin (treprostinil sodium), in Pulmonary Arterial Hypertension Patients - Efficacy of capsaicin 8% patches in Pulmonary Arterial Hypertension | Pulmonary arterial hypertension (PAH) is a rare life-threatening disease characterised by high blood pressure in the arteries to the lungs, rapidly evolving in a clinical syndrome of dyspnoea and fatigue and eventually leading to right ventricular failure and death. MedDRA version: 13.1;Level: PT;Classification code 10037400;Term: Pulmonary hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders | Trade Name: Qutenza Product Name: Qutenza INN or Proposed INN: Capsaicin | Imperial College London | NULL | Not Recruiting | Female: yes Male: yes | 0 | United Kingdom | |||
| 345 | NCT01086540 (ClinicalTrials.gov) | June 24, 2011 | 11/3/2010 | Rituximab for Treatment of Systemic Sclerosis-Associated Pulmonary Arterial Hypertension (SSc-PAH) | A Randomized, Double-Blind, Placebo-Controlled, Phase II Multicenter Trial of a Monoclonal Antibody to CD20 (Rituximab) for the Treatment of Systemic Sclerosis-Associated Pulmonary Arterial Hypertension (SSc-PAH) | Systemic Sclerosis-Associated PAH | Biological: Rituximab;Other: Placebo;Diagnostic Test: CMRI;Drug: prednisone;Drug: methylprednisolone;Drug: diphenhydramine;Drug: acetaminophen | National Institute of Allergy and Infectious Diseases (NIAID) | Autoimmunity Centers of Excellence;Rho Federal Systems Division, Inc. | Completed | 18 Years | 75 Years | All | 57 | Phase 2 | United States |
| 346 | NCT01470144 (ClinicalTrials.gov) | June 1, 2011 | 28/10/2011 | Epoprostenol for Injection in Patients With Pulmonary Arterial Hypertension | An Open-label Extension of Study AC-066A301 Investigating the Safety and Tolerability of ACT-385781A in Patients With Pulmonary Arterial Hypertension (PAH) | Pulmonary Arterial Hypertension | Drug: Epoprostenol | Actelion | Chiltern International Ltd.;Effi-stat | Completed | N/A | N/A | All | 41 | Phase 3 | Belgium;Canada;France;Italy;Netherlands;Spain |
| 347 | NCT01392495 (ClinicalTrials.gov) | June 2011 | 11/7/2011 | Extension to CQTI571A2102 to Evaluate Long-term Safety, Tolerability and Efficacy of Imatinib in Severe Pulmonary Arterial Hypertension (PAH) | An Open-label Extension Study to CQTI571A2102 to Evaluate the Long-term Safety, Tolerability and Efficacy of QTI571 (Imatinib) in the Treatment of Severe Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension | Drug: Imatinib | Novartis Pharmaceuticals | NULL | Terminated | N/A | N/A | All | 17 | Phase 3 | United States;Australia;Belgium;Germany;Italy;Lithuania;United Kingdom;Turkey |
| 348 | NCT01352026 (ClinicalTrials.gov) | May 2011 | 10/5/2011 | Evaluation of Metformin Activity in Addition to Conventional Treatment of Grade II or III Pulmonary Arterial Hypertension (PAH) | Pulmonary Arterial Hypertension | Drug: Metformin | Nantes University Hospital | NULL | Withdrawn | 18 Years | 80 Years | Both | 0 | Phase 2 | France | |
| 349 | EUCTR2010-021825-11-NL (EUCTR) | 28/04/2011 | 03/11/2010 | A 7-month research project for children aged from 3 months to 11 years with pulmonary arterial hypertension to find out whether bosentan is best tolerated, and most safe and effective when taken two or three times a day | An open label, prospective multicenter study to assess the pharmacokinetics, tolerability, safety and efficacy of the pediatric formulation of bosentan two versus three times a day in children with pulmonary arterial hypertension - FUTURE 3 | Pulmonary arterial hypertension (PAH) in children MedDRA version: 14.1;Level: LLT;Classification code 10064908;Term: Associated with (APAH);System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 14.1;Classification code 10064909;Term: Idiopathic (IPAH);Classification code 10064910;Term: Familial (FPAH);System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Tracleer Product Name: bosentan INN or Proposed INN: BOSENTAN MONOHYDRATE Other descriptive name: Ro-47-0203/029 | Actelion Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 64 | Serbia;United States;Belarus;Spain;Ukraine;Israel;Russian Federation;Italy;India;France;Hungary;Czech Republic;Mexico;Poland;Australia;Bulgaria;South Africa;Germany;Netherlands;China | |||
| 350 | EUCTR2010-021793-12-ES (EUCTR) | 28/04/2011 | 03/03/2011 | Estudio de extensión, prospectivo, multicéntrico y abierto del estudio FUTURE 3 para evaluar la seguridad, tolerabilidad y eficacia utilizando la formulación pediátrica de bosentan dos veces frente a tres veces al día en niños con hipertensión arterial pulmonar | Estudio de extensión, prospectivo, multicéntrico y abierto del estudio FUTURE 3 para evaluar la seguridad, tolerabilidad y eficacia utilizando la formulación pediátrica de bosentan dos veces frente a tres veces al día en niños con hipertensión arterial pulmonar | Hipertensión arterial pulmonar (PAH) en niños. MedDRA version: 12.1;Level: LLT;Classification code 10064908;Term: Associated with (APAH) MedDRA version: 12.1;Classification code 10064909;Term: Idiopathic (IPAH) MedDRA version: 12.1;Classification code 10064910;Term: Familial (FPAH) | Trade Name: TRACLEER 62,5 mg comprimidos recubiertos con película INN or Proposed INN: BOSENTAN MONOHIDRATO Other descriptive name: BOSENTAN MONOHIDRATO | Actelion Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 64 | Czech Republic;Hungary;Spain;Netherlands;Germany;Italy | |||
| 351 | NCT01392469 (ClinicalTrials.gov) | April 20, 2011 | 10/5/2011 | Pharmacokinetic Effects of QTI571 on Sildenafil and Bosentan in Pulmonary Arterial Hypertension Participants | A Non-Randomized, Multiple Dose, Three Treatment Period, Open-Label, Single Sequence, Single Group Study to Evaluate the Pharmacokinetic Effect of Two Doses of QTI571 (Imatinib) on the Co-administered Drugs Sildenafil and Bosentan in Pulmonary Arterial Hypertension (PAH) Patients | Pulmonary Arterial Hypertension | Drug: Imatinib;Drug: Sildenafil;Drug: Bosentan | Novartis Pharmaceuticals | NULL | Completed | 18 Years | N/A | All | 21 | Phase 3 | United States;Australia;Belgium;Germany;Italy;Lithuania;United Kingdom;Romania;Turkey |
| 352 | EUCTR2010-021960-14-DE (EUCTR) | 08/04/2011 | 03/03/2011 | An open-label extension study to CQTI571A2102 to evaluate the long-term safety, tolerability and efficacy of QTI571 (imatinib) in the treatment of severe pulmonary arterial hypertension | An open-label extension study to CQTI571A2102 to evaluate the long-term safety, tolerability and efficacy of QTI571 (imatinib) in the treatment of severe pulmonary arterial hypertension | Pulmonary arterial hypertension (PAH) MedDRA version: 14.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders | Trade Name: Glivec® Product Code: QTI571 INN or Proposed INN: IMATINIB MESILATE Trade Name: Glivec® Product Code: QTI571 INN or Proposed INN: IMATINIB MESILATE | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 20 | Germany;Italy | |||
| 353 | EUCTR2010-021793-12-DE (EUCTR) | 04/04/2011 | 01/02/2011 | A 1 year follow-up research project for children with pulmonary arterialhypertension (PAH) that participated in the FUTURE 3 core study. This isto find out how well bosentan is tolerated and safe when taken eithertwo or three times a day | A prospective, multicenter, open-label extension of FUTURE 3 to assess the safety, tolerability and efficacy of the pediatric formulation of bosentan two versus three times a day in children with pulmonary arterial hypertension - FUTURE 3 study extension | Pulmonary arterial hypertension (PAH) in children MedDRA version: 16.1;Level: LLT;Classification code 10064910;Term: Familial (FPAH);System Organ Class: 100000004855 MedDRA version: 16.1;Classification code 10064909;Term: Idiopathic (IPAH);Classification code 10064908;Term: Associated with (APAH);System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Tracleer Product Name: bosentan INN or Proposed INN: BOSENTAN MONOHYDRATE Other descriptive name: Ro-47-0203/029 | Actelion Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 64 | United States;Belarus;Serbia;Spain;Ukraine;Israel;Russian Federation;Italy;India;France;Hungary;Czech Republic;Mexico;Poland;Australia;South Africa;Germany;Netherlands;China | |||
| 354 | JPRN-UMIN000005464 | 2011/04/01 | 19/04/2011 | Drug interactions and effects of combination therapy for pulmonary arterial hypertension | Drug interactions and effects of combination therapy for pulmonary arterial hypertension - Drug interactions and effects of PAH combination therapy | pulmonary arterial hypertension | phase 1: sildenafil (60mg/day) and bosentan (250mg/day) for 4 or 5 weeks phase 2: sildenafil(60mg/day) and ambrisentan (5mg/day) for 4 or 5 weeks phase 3: tadalafil (40mg/day) and ambrisentan (5mg/day) for 4 or 5 weeks | Hamamatsu University School of Medicine | University of Shizuoka | Recruiting | 20years-old | Not applicable | Male and Female | 15 | Not applicable | Japan |
| 355 | EUCTR2010-021960-14-IT (EUCTR) | 11/03/2011 | 26/05/2011 | An open-label extension study to CQTI571A2102 to evaluate the long-term safety, tolerability and efficacy ofQTI571 (imatinib) in the treatment of severe pulmonary arterial hypertension. - ND | An open-label extension study to CQTI571A2102 to evaluate the long-term safety, tolerability and efficacy ofQTI571 (imatinib) in the treatment of severe pulmonary arterial hypertension. - ND | Pulmonary arterial hypertension (PAH) MedDRA version: 13.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders | Trade Name: GLIVEC INN or Proposed INN: IMATINIB MESYLATE | NOVARTIS FARMA | NULL | Not Recruiting | Female: yes Male: yes | 20 | Germany;Italy | |||
| 356 | EUCTR2010-021793-12-CZ (EUCTR) | 09/03/2011 | 04/02/2011 | A 1 year follow-up research project for children with pulmonary arterialhypertension (PAH) that participated in the FUTURE 3 core study. This isto find out how well bosentan is tolerated and safe when taken eithertwo or three times a day | A prospective, multicenter, open-label extension of FUTURE 3 to assess the safety, tolerability and efficacy of the pediatric formulation of bosentan two versus three times a day in children with pulmonary arterial hypertension - FUTURE 3 study extension | Pulmonary arterial hypertension (PAH) in children MedDRA version: 14.0;Level: LLT;Classification code 10064908;Term: Associated with (APAH);System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 14.0;Classification code 10064909;Term: Idiopathic (IPAH);Classification code 10064910;Term: Familial (FPAH);System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Tracleer Product Name: bosentan INN or Proposed INN: BOSENTAN MONOHYDRATE Other descriptive name: Ro-47-0203/029 | Actelion Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 64 | Serbia;United States;Belarus;Spain;Ukraine;Israel;Russian Federation;Italy;India;France;Czech Republic;Hungary;Mexico;Poland;South Africa;Netherlands;Germany;China | |||
| 357 | JPRN-JapicCTI-111532 | 01/3/2011 | 27/06/2011 | NS-304 PAH | The clinical study to assess the efficacy, safety and pharmacokinetics of NS-304 in patients with pulmonary arterial hypertension (PAH) | Pulmonary arterial hypertension (PAH) | Intervention name : NS-304 INN of the intervention : Selexipag Dosage And administration of the intervention : Oral administration | NIPPON SHINYAKU CO., LTD. / Actelion Pharmaceuticals Japan Ltd. | NULL | 18 | BOTH | 30 | Phase 2 | NULL | ||
| 358 | NCT01265888 (ClinicalTrials.gov) | March 2011 | 20/12/2010 | Study in Subjects With PAH and PH Secondary to IPF Using Inhaled GeNOsyl. | A Phase 2, Open-Label, Dose-Escalation Study in Subjects With Pulmonary Arterial Hypertension, (PAH, WHO Group 1) and Pulmonary Hypertension Secondary to Idiopathic Pulmonary Fibrosis, (PH-IPF WHO Group 3) Using Inhaled GeNOsyl. | Pulmonary Arterial Hypertension;Idiopathic Pulmonary Fibrosis | Drug: Inhaled Nitric Oxide | Geno LLC | NULL | Completed | 18 Years | 80 Years | Both | 31 | Phase 2 | United States |
| 359 | EUCTR2010-021793-12-HU (EUCTR) | 28/02/2011 | 02/02/2011 | A 1 year follow-up research project for children with pulmonary arterialhypertension (PAH) that participated in the FUTURE 3 core study. This isto find out how well bosentan is tolerated and safe when taken eithertwo or three times a day | A prospective, multicenter, open-label extension of FUTURE 3 to assess the safety, tolerability and efficacy of the pediatric formulation of bosentan two versus three times a day in children with pulmonary arterial hypertension - FUTURE 3 study extension | Pulmonary arterial hypertension (PAH) in children MedDRA version: 16.1;Level: LLT;Classification code 10064910;Term: Familial (FPAH);System Organ Class: 100000004855 MedDRA version: 16.1;Classification code 10064909;Term: Idiopathic (IPAH);Classification code 10064908;Term: Associated with (APAH);System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Tracleer Product Name: bosentan INN or Proposed INN: BOSENTAN MONOHYDRATE Other descriptive name: Ro-47-0203/029 | Actelion Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 64 | South Africa;Netherlands;Germany;China;United States;Belarus;Serbia;Spain;Ukraine;Israel;Russian Federation;Italy;India;France;Hungary;Czech Republic;Mexico;Poland;Australia | |||
| 360 | NCT01246037 (ClinicalTrials.gov) | February 2011 | 18/11/2010 | Beta-blockers in i-PAH | Beta-blocker Therapy in Idiopathic Pulmonary Arterial Hypertension | Idiopathic Pulmonary Arterial Hypertension | Drug: Bisoprolol | VU University Medical Center | ZonMw: The Netherlands Organisation for Health Research and Development | Active, not recruiting | 18 Years | N/A | Both | 30 | Phase 1/Phase 2 | Netherlands |
| 361 | EUCTR2010-021344-17-IT (EUCTR) | 28/01/2011 | 07/02/2011 | A non-randomized, multiple dose, three treatment period, open-label, single sequence, single group study to evaluate the pharmacokinetic effect of two doses of QTI571 (imatinib) on the co-administered drugs sildenafil and bosentan in pulmonary arterial hypertension (PAH) patients. - ND | A non-randomized, multiple dose, three treatment period, open-label, single sequence, single group study to evaluate the pharmacokinetic effect of two doses of QTI571 (imatinib) on the co-administered drugs sildenafil and bosentan in pulmonary arterial hypertension (PAH) patients. - ND | Pulmonary arterial hypertension (PAH) MedDRA version: 9.1;Level: LLT;Classification code 10064911 | Trade Name: GLIVEC INN or Proposed INN: IMATINIB MESYLATE Trade Name: REVATIO INN or Proposed INN: Sildenafil Trade Name: TRACLEER INN or Proposed INN: Bosentan | NOVARTIS FARMA | NULL | Not Recruiting | Female: yes Male: yes | 24 | Italy | |||
| 362 | EUCTR2010-021825-11-ES (EUCTR) | 22/12/2010 | 12/11/2010 | Estudio multicéntrico, prospectivo, abierto para evaluar la farmacocinética, tolerabilidad, seguridad y eficacia de la formulación pediátrica de bosentan, dos veces frente a tres veces al día en niños con hipertensión arterial pulmonar - FUTURE 3 | Estudio multicéntrico, prospectivo, abierto para evaluar la farmacocinética, tolerabilidad, seguridad y eficacia de la formulación pediátrica de bosentan, dos veces frente a tres veces al día en niños con hipertensión arterial pulmonar - FUTURE 3 | Hpertensión arterial pulmonar (PAH) en niños MedDRA version: 12.1;Level: LLT;Classification code 10064908;Term: Associated with (APAH) MedDRA version: 12.1;Classification code 10064909;Term: Idiopathic (IPAH) MedDRA version: 12.1;Classification code 10064910;Term: Familial (FPAH) | Trade Name: TRACLEER 62,5 mg comprimidos recubiertos con película INN or Proposed INN: BOSENTAN MONOHIDRATO Other descriptive name: BOSENTAN MONOHIDRATO | Actelion Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 64 | Phase 3 | Czech Republic;Hungary;Spain;Bulgaria;Germany;Netherlands;Italy | ||
| 363 | EUCTR2010-023233-30-NL (EUCTR) | 13/12/2010 | 06/10/2010 | ‘Intravenous iron treatment in iron deficient patients with pulmonary arterialhypertension' - Treating iron deficiency in PAH | ‘Intravenous iron treatment in iron deficient patients with pulmonary arterialhypertension' - Treating iron deficiency in PAH | Objective: To evaluate the effects of intravenous iron suppletion in iron deficient IPAH patients.Study design: Intervention studyStudy population: Patients with idiopathic pulmonary arterial hypertension (IPAH) and iron deficiencyIntervention:Patients receive a weekly iron bolus infusion until iron levels are restored (correction phase). Then a maintenance dose is given once per month (maintenance phase) until the endpoint after 20 weeks. MedDRA version: 12.1;Level: LLT;Classification code 10064909;Term: Idiopathic (IPAH) | Trade Name: Ferinject Product Name: Ferric carboxymaltose Product Code: RVG 33865 | VU university medical center | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 30 | Netherlands | |||
| 364 | EUCTR2010-021825-11-HU (EUCTR) | 08/12/2010 | 04/11/2010 | An open label, prospective multicenter study to assess the pharmacokinetics, tolerability, safety and efficacy of the pediatric formulation of bosentan two versus three times a day in children with pulmonary arterial hypertension - FUTURE 3 | An open label, prospective multicenter study to assess the pharmacokinetics, tolerability, safety and efficacy of the pediatric formulation of bosentan two versus three times a day in children with pulmonary arterial hypertension - FUTURE 3 | Pulmonary arterial hypertension (PAH) in children MedDRA version: 12.1;Level: LLT;Classification code 10064908;Term: Associated with (APAH) MedDRA version: 12.1;Classification code 10064909;Term: Idiopathic (IPAH) MedDRA version: 12.1;Classification code 10064910;Term: Familial (FPAH) | Trade Name: Tracleer Product Name: bosentan INN or Proposed INN: BOSENTAN MONOHYDRATE Other descriptive name: Ro-47-0203/029 | Actelion Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 64 | Czech Republic;Hungary;Spain;Bulgaria;Germany;Netherlands;Italy | |||
| 365 | EUCTR2010-021825-11-CZ (EUCTR) | 03/12/2010 | 03/12/2010 | A 7-month research project for children aged from 3 months to 11 years with pulmonary arterial hypertension to find out whether bosentan is best tolerated, and most safe and effective when taken two or three times a day | An open label, prospective multicenter study to assess the pharmacokinetics, tolerability, safety and efficacy of the pediatric formulation of bosentan two versus three times a day in children with pulmonary arterial hypertension - FUTURE 3 | Pulmonary arterial hypertension (PAH) in children MedDRA version: 14.0;Level: LLT;Classification code 10064908;Term: Associated with (APAH);System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 14.0;Classification code 10064909;Term: Idiopathic (IPAH);Classification code 10064910;Term: Familial (FPAH);System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Tracleer Product Name: bosentan INN or Proposed INN: BOSENTAN MONOHYDRATE Other descriptive name: Ro-47-0203/029 | Actelion Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 64 | Serbia;United States;Belarus;Spain;Ukraine;Israel;Russian Federation;Italy;India;France;Hungary;Czech Republic;Mexico;Poland;Australia;Bulgaria;South Africa;Netherlands;Germany;China | |||
| 366 | NCT01266265 (ClinicalTrials.gov) | December 2010 | 22/12/2010 | Study of Incidence of Respiratory Tract AEs in Patients Treated With Tyvaso® Compared to Other FDA Approved PAH Therapies | A Postmarketing Observational Study to Assess Respiratory Tract Adverse Events in Pulmonary Arterial Hypertension Patients Treated With Tyvaso® (Treprostinil) Inhalation Solution | Pulmonary Arterial Hypertension | Drug: inhaled prostacyclin;Drug: prostacyclin;Drug: subcutaneous and intravenous prostacyclin;Drug: oral ERA;Drug: oral PDE5 inhibitors | United Therapeutics | NULL | Completed | N/A | N/A | All | 1333 | N/A | United States |
| 367 | EUCTR2010-019547-19-IT (EUCTR) | 30/11/2010 | 14/12/2010 | A randomized, open label study comparing safety and efficacy parameters for a high and a low dose of ambrisentan (adjusted for body weight) for the treatment of pulmonary arterial hypertension in paediatric patients aged 8 years up to 18 years - AMB112529 | A randomized, open label study comparing safety and efficacy parameters for a high and a low dose of ambrisentan (adjusted for body weight) for the treatment of pulmonary arterial hypertension in paediatric patients aged 8 years up to 18 years - AMB112529 | pulmonary arterial hypertension (PAH) MedDRA version: 9.1;Level: LLT;Classification code 10064911 MedDRA version: 9.1;Classification code 10065150 MedDRA version: 9.1;Classification code 10065151 MedDRA version: 9.1;Classification code 10065152 | Trade Name: VOLIBRIS INN or Proposed INN: AMBRISENTAN Trade Name: VOLIBRIS INN or Proposed INN: AMBRISENTAN Product Name: AMBRISENTAN Product Code: GSK1325760 INN or Proposed INN: AMBRISENTAN | GlaxoSmithKline Research & Development, Ltd | NULL | Not Recruiting | Female: yes Male: yes | 66 | France;Hungary;Greece;Spain;Germany;Netherlands;Italy | |||
| 368 | EUCTR2010-021825-11-DE (EUCTR) | 26/11/2010 | 08/11/2010 | A 7-month research project for children aged from 3 months to 11 years with pulmonary arterial hypertension to find out whether bosentan is best tolerated, and most safe and effective when taken two or three times a day | An open label, prospective multicenter study to assess the pharmacokinetics, tolerability, safety and efficacy of the pediatric formulation of bosentan two versus three times a day in children with pulmonary arterial hypertension - FUTURE 3 | Pulmonary arterial hypertension (PAH) in children MedDRA version: 14.1;Level: LLT;Classification code 10064908;Term: Associated with (APAH);System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 14.1;Classification code 10064909;Term: Idiopathic (IPAH);Classification code 10064910;Term: Familial (FPAH);System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Tracleer Product Name: bosentan INN or Proposed INN: BOSENTAN MONOHYDRATE Other descriptive name: Ro-47-0203/029 | Actelion Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 64 | Serbia;United States;Belarus;Spain;Ukraine;Israel;Russian Federation;Italy;India;France;Hungary;Czech Republic;Mexico;Poland;Australia;Bulgaria;South Africa;Netherlands;Germany;China | |||
| 369 | EUCTR2009-011150-17-BE (EUCTR) | 15/11/2010 | 14/06/2010 | Study of two drugs used to treat pulmonary arterial hypertension (PAH) | AMBITION: A Randomised, Multicenter Study of First-Line Ambrisentan and Tadalafil Combination Therapy in Subjects with Pulmonary Arterial Hypertension - AMBITION | Pulmonary arterial hypotension MedDRA version: 16.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Volibris Product Name: ambrisentan 5 mg film-coated tablets INN or Proposed INN: AMBRISENTAN Trade Name: Cialis Product Name: tadalafil 20 mg film-coated tablets INN or Proposed INN: TADALAFIL | GlaxoSmithKline R&D Ltd | NULL | Not Recruiting | Female: yes Male: yes | 614 | United States;Greece;Spain;Austria;United Kingdom;Italy;France;Canada;Belgium;Australia;Netherlands;Germany;Japan;Sweden | |||
| 370 | EUCTR2009-018167-26-FR (EUCTR) | 04/11/2010 | 13/09/2010 | An extension study to QTI571A2301 to evaluate the longterm safety, tolerability and efficacy of oral QTI571 (imatinib) in the treatment of severe pulmonary arterial hypertension. - IMPRES Extension | An extension study to QTI571A2301 to evaluate the longterm safety, tolerability and efficacy of oral QTI571 (imatinib) in the treatment of severe pulmonary arterial hypertension. - IMPRES Extension | Pulmonary arterial hypertension (PAH) patients who have a PVR>1000 dynes.sec.cm-5 despite treatment with two or more specific PAH therapies MedDRA version: 12.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension | Trade Name: Glivec® Product Code: QTI571 INN or Proposed INN: IMATINIB MESYLATE | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 140 | France;Belgium;Spain;Austria;Germany;Italy;United Kingdom | |||
| 371 | NCT01178073 (ClinicalTrials.gov) | October 1, 2010 | 15/7/2010 | A Study of First-Line Ambrisentan and Tadalafil Combination Therapy in Subjects With Pulmonary Arterial Hypertension (PAH) | AMBITION: A Randomised, Multicenter Study of First-Line Ambrisentan and Tadalafil Combination Therapy in Subjects With Pulmonary Arterial Hypertension (PAH) | Hypertension, Pulmonary | Drug: ambrisentan;Drug: tadalafil | GlaxoSmithKline | Gilead Sciences | Completed | 18 Years | 75 Years | All | 610 | Phase 3 | United States;Australia;Austria;Belgium;Canada;France;Germany;Greece;Italy;Japan;Netherlands;Spain;Sweden;United Kingdom |
| 372 | JPRN-UMIN000012669 | 2010/10/01 | 01/10/2015 | Efficacy and safety of sildenafil in the treatment of pulmonary arterial hypertension (PAH) after cardiac surgery in Japanese pediatric population - a PAH management- | Efficacy and safety of sildenafil in the treatment of pulmonary arterial hypertension (PAH) after cardiac surgery in Japanese pediatric population - a PAH management- - Sildenafil for pulmonary arterial hypertension after pediatric cardiac surgery | pulmonary hypertension | Sildenafil will be administered via a nasogastric tube or orally at a dose of 0.5 mg/kg. If the investigator note there is no effect of sildenafil on any parameters and clinical conditions, a repeat dose of sildenafil (0.5 or 1.0 mg/kg) can be given 4 hours after the initial administration by the investigators judgment. Sildenafil will be gradually weaned off for 5 to 7 days. | Osaka Medical College | NULL | Complete: follow-up complete | Not applicable | 24months-old | Male and Female | 20 | Not applicable | Japan |
| 373 | NCT01054105 (ClinicalTrials.gov) | October 2010 | 21/1/2010 | Effect of BMPR-2 Gene Mutations on Hemodynamic Response by Iloprost Inhalation in Pulmonary Arterial Hypertension | The Prevalence of BMPR-2 Gene Mutations in Korean Patients With Pulmonary Arterial Hypertension (PAH) and the Effects of Gene Mutations on Hemodynamic Response by Drug Therapy | Pulmonary Arterial Hypertension | Drug: Iloprost | Gachon University Gil Medical Center | Seoul National University Hospital;Seoul National University Bundang Hospital;The Catholic University of Korea;Bayer | Completed | 20 Years | 80 Years | All | 73 | Korea, Republic of | |
| 374 | EUCTR2010-019883-36-IT (EUCTR) | 20/09/2010 | 24/09/2010 | ND | A 24 week, randomized, double blind, multicenter, placebocontrolled efficacy, safety, tolerability and PK trial of Nilotinib (AMN107) in Pulmonary Arterial Hypertension (PAH) | Pulmonary Arterial Hypertension (PAH) MedDRA version: 14.1;Level: PT;Classification code 10037400;Term: Pulmonary hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: TASIGNA INN or Proposed INN: nilotinib Trade Name: TASIGNA INN or Proposed INN: nilotinib Trade Name: TASIGNA INN or Proposed INN: nilotinib | NOVARTIS FARMA | NULL | Not Recruiting | Female: yes Male: yes | 55 | United States;Hungary;Canada;Singapore;Germany;Italy;Korea, Republic of | |||
| 375 | EUCTR2009-018167-26-GB (EUCTR) | 07/09/2010 | 21/06/2010 | An extension study to QTI571A2301 to evaluate the longterm safety, tolerability and efficacy of oral QTI571 (imatinib) in the treatment of severe pulmonary arterial hypertension. - IMPRES Extension | An extension study to QTI571A2301 to evaluate the longterm safety, tolerability and efficacy of oral QTI571 (imatinib) in the treatment of severe pulmonary arterial hypertension. - IMPRES Extension | Pulmonary arterial hypertension (PAH) patients who have a PVR=800 dynes.sec.cm-5 despite treatment with two or more specific PAH therapies MedDRA version: 14.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders | Trade Name: Glivec® Product Code: QTI571 INN or Proposed INN: IMATINIB MESYLATE Trade Name: Glivec® Product Code: QTI571 INN or Proposed INN: IMATINIB MESYLATE | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 140 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;Belgium;Spain;Austria;Germany;Italy;United Kingdom | ||
| 376 | EUCTR2009-018167-26-BE (EUCTR) | 31/08/2010 | 18/05/2010 | An extension study to QTI571A2301 to evaluate the longterm safety, tolerability and efficacy of oral QTI571 (imatinib) in the treatment of severe pulmonary arterial hypertension. - IMPRES Extension | An extension study to QTI571A2301 to evaluate the longterm safety, tolerability and efficacy of oral QTI571 (imatinib) in the treatment of severe pulmonary arterial hypertension. - IMPRES Extension | Pulmonary arterial hypertension (PAH) patients who have a PVR=800 dynes.sec.cm-5 despite treatment with two or more specific PAH therapies MedDRA version: 12.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension | Trade Name: Glivec® Product Code: QTI571 INN or Proposed INN: IMATINIB MESYLATE | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 160 | Phase 3 | France;Spain;Belgium;Austria;Germany;Italy;United Kingdom | ||
| 377 | EUCTR2010-019883-36-HU (EUCTR) | 31/08/2010 | 08/07/2010 | A 24 week, randomized, double blind, multicenter, placebo-controlled efficacy, safety, tolerability and PK trial of Nilotinib (Tasigna®, AMN107) in Pulmonary Arterial Hypertension (PAH) | A 24 week, randomized, double blind, multicenter, placebo-controlled efficacy, safety, tolerability and PK trial of Nilotinib (Tasigna®, AMN107) in Pulmonary Arterial Hypertension (PAH) | Pulmonary Arterial Hypertension (PAH) Class II or III patients remaining symptomatic despite at least one PAH-specific therapy. MedDRA version: 12.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension | Trade Name: Tasigna® Product Name: Tasigna Product Code: AMN107 INN or Proposed INN: nilotinib Product Name: nilotinib Product Code: AMN107 INN or Proposed INN: nilotinib Product Name: Nilotinib Product Code: AMN107 INN or Proposed INN: nilotinib | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 66 | Hungary;Germany | |||
| 378 | EUCTR2009-011150-17-DE (EUCTR) | 16/08/2010 | 03/08/2010 | Study of two drugs used to treat pulmonary arterial hypertension (PAH) | AMBITION: A Randomised, Multicenter Study of First-Line Ambrisentan and Tadalafil Combination Therapy in Subjects with Pulmonary Arterial Hypertension - AMBITION | Pulmonary arterial hypotension MedDRA version: 14.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Volibris Product Name: ambrisentan 5 mg film-coated tablets INN or Proposed INN: AMBRISENTAN Trade Name: Cialis Product Name: tadalafil 20 mg film-coated tablets INN or Proposed INN: TADALAFIL | GlaxoSmithKline R&D Ltd | NULL | Not Recruiting | Female: yes Male: yes | 614 | United States;Greece;Spain;Austria;United Kingdom;Italy;France;Canada;Belgium;Australia;Germany;Netherlands;Japan;Sweden | |||
| 379 | EUCTR2009-011150-17-GB (EUCTR) | 11/08/2010 | 22/06/2010 | Study of two drugs used to treat pulmonary arterial hypertension (PAH) | AMBITION: A Randomised, Multicenter Study of First-Line Ambrisentan and Tadalafil Combination Therapy in Subjects with Pulmonary Arterial Hypertension - AMBITION | Pulmonary arterial hypotension MedDRA version: 14.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders | Trade Name: Volibris Product Name: ambrisentan 5 mg film-coated tablets INN or Proposed INN: AMBRISENTAN Trade Name: Cialis Product Name: tadalafil 20 mg film-coated tablets INN or Proposed INN: TADALAFIL | GlaxoSmithKline R&D Ltd | NULL | Not Recruiting | Female: yes Male: yes | 545 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | France;Greece;Belgium;Spain;Austria;Germany;Netherlands;Italy;United Kingdom;Sweden | ||
| 380 | EUCTR2009-011150-17-AT (EUCTR) | 03/08/2010 | 22/06/2010 | Study of two drugs used to treat pulmonary arterial hypertension (PAH) | AMBITION: A Randomised, Multicenter Study of First-Line Ambrisentan and Tadalafil Combination Therapy in Subjects with Pulmonary Arterial Hypertension - AMBITION | Pulmonary arterial hypotension MedDRA version: 14.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Volibris Product Name: ambrisentan 5 mg film-coated tablets INN or Proposed INN: AMBRISENTAN Trade Name: Cialis Product Name: tadalafil 20 mg film-coated tablets INN or Proposed INN: TADALAFIL | GlaxoSmithKline R&D Ltd | NULL | Not Recruiting | Female: yes Male: yes | 545 | United States;Greece;Spain;Austria;United Kingdom;Italy;France;Canada;Belgium;Australia;Netherlands;Germany;Japan;Sweden | |||
| 381 | EUCTR2009-014453-32-CZ (EUCTR) | 15/07/2010 | 11/02/2010 | NA | An open-label extension of BPS-MR-PAH-203 in pulmonary arterial hypertension (PAH) patients | Pulmonary Arterial Hypertension MedDRA version: 14.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Beraprost Sodium Modified Release Product Code: BPS-MR INN or Proposed INN: Beraprost Sodium Other descriptive name: TRK-100STP | Lung LLC | NULL | Not Recruiting | Female: yes Male: yes | 36 | Czech Republic;Belgium;Ireland;Germany | |||
| 382 | EUCTR2009-011150-17-SE (EUCTR) | 14/07/2010 | 18/06/2010 | Study of two drugs used to treat pulmonary arterial hypertension (PAH) | AMBITION: A Randomised, Multicenter Study of First-Line Ambrisentan and Tadalafil Combination Therapy in Subjects with Pulmonary Arterial Hypertension - AMBITION | Pulmonary arterial hypotension MedDRA version: 14.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Volibris Product Name: ambrisentan 5 mg film-coated tablets INN or Proposed INN: AMBRISENTAN Trade Name: Cialis Product Name: tadalafil 20 mg film-coated tablets INN or Proposed INN: TADALAFIL | GlaxoSmithKline R&D Ltd | NULL | Not Recruiting | Female: yes Male: yes | 545 | United States;Greece;Spain;Austria;United Kingdom;Italy;France;Canada;Belgium;Australia;Netherlands;Germany;Japan;Sweden | |||
| 383 | EUCTR2010-018320-10-BE (EUCTR) | 02/07/2010 | 13/04/2010 | An extension of study AC-066A301 to investigate safety and tolerability of the study medication (epoprostenol for injection) | An open-label extension of study AC-066A301 investigating the safety and tolerability of ACT-385781A in patients with pulmonary arterial hypertension (PAH) - EPITOME-2 Extension | Pulmonary Arterial Hypertension MedDRA version: 14.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Epoprostenol for injection Product Name: Epoprostenol for injection Product Code: ACT-385781A INN or Proposed INN: EPOPROSTENOL SODIUM Trade Name: Epoprostenol for injection Product Name: Epoprostenol for injection Product Code: ACT-385781A INN or Proposed INN: EPOPROSTENOL SODIUM | ACTELION Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 40 | France;Canada;Spain;Belgium;Netherlands;Italy | |||
| 384 | EUCTR2006-000804-18-PT (EUCTR) | 02/07/2010 | 25/01/2010 | An Open-Label Extension Trial of UT-15C SR in Subjects with Pulmonary Arterial Hypertension - FREEDOM-EXT | An Open-Label Extension Trial of UT-15C SR in Subjects with Pulmonary Arterial Hypertension - FREEDOM-EXT | Idiopathic or familial pulmonary arterial hypertension (PAH), including PAH associated with :1) Appetite suppressant use or 2) Repaired congenital systemic-to-pulmonary shunts (repaired = 5 years) or 3) Collagen Vascular Disease (CVD) or 4) Human Immunodeficiency Virus (HIV) MedDRA version: 8.1;Level: PT;Classification code 10037400;Term: Pulmonary hypertension | Product Name: Treprostinil diethanolamine Product Code: UT-15C SR INN or Proposed INN: Treprostinil diethanolamine Product Name: Treprostinil diethanolamine Product Code: UT-15C SR INN or Proposed INN: Treprostinil diethanolamine Product Name: Treprostinil diethanolamine Product Code: UT-15C SR INN or Proposed INN: Treprostinil diethanolamine Product Name: Treprostinil diethanolamine Product Code: UT-15C SR INN or Proposed INN: Treprostinil diethanolamine Product Name: Treprostinil diethanolamine Product Code: UT-15C SR INN or Proposed INN: treprostinil diethanolamine | United Therapeutics Corporation | NULL | Not Recruiting | Female: yes Male: yes | 900 | Phase 3 | France;Portugal;Spain;Belgium;Ireland;Austria;Germany;Netherlands;Italy;United Kingdom;Sweden | ||
| 385 | NCT01179737 (ClinicalTrials.gov) | July 2010 | 3/8/2010 | Efficacy, Safety, Tolerability and Pharmacokinetics (PK) of Nilotinib (AMN107) in Pulmonary Arterial Hypertension (PAH) | A 24 Week, Randomized, Double Blind, Multicenter, Placebocontrolled Efficacy, Safety, Tolerability and PK Trial of Nilotinib (Tasigna®, AMN107) in Pulmonary Arterial Hypertension (PAH) | Pulmonary Arterial Hypertension | Drug: Nilotinib;Drug: Placebo to nilotinib | Novartis Pharmaceuticals | NULL | Terminated | 18 Years | N/A | All | 23 | Phase 2 | United States;Canada;Germany;Korea, Republic of;Singapore;Switzerland;Hungary;Italy |
| 386 | NCT00796510 (ClinicalTrials.gov) | July 2010 | 20/11/2008 | Study Providing Monotherapy (Sitaxsentan) And Combination Therapy (Sitaxsentan+Sildenafil) To Subjects With Pulmonary Arterial Hypertension (PAH) To Assess Long-Term Safety | A Phase 3, Multi-Center, Open Label Study To Evaluate The Long-Term Safety Of Monotherapy Sitaxsentan Sodium And Combination Therapy With Sitaxsentan Sodium And Sildenafil Citrate In Subjects With Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension;Pulmonary Hypertension | Drug: Sitaxsentan;Drug: Sitaxsentan and Sildenafil | Pfizer | NULL | Terminated | 16 Years | 80 Years | All | 3 | Phase 3 | United States;Romania;Ukraine;Argentina;Bulgaria;Chile;China;Colombia;Costa Rica;Czech Republic;Dominican Republic;India;Mexico;Peru;Philippines;Russian Federation;Saudi Arabia;Serbia;Slovakia;South Africa;Thailand |
| 387 | NCT01305252 (ClinicalTrials.gov) | July 2010 | 2/11/2010 | A 48-week Study of the Effect of Dual Therapy (Inhaled Treprostinil and Tadafafil) Versus Monotherapy (Tadalafil). | CombinatiON Up-FRON t Therapy for PAH - A Phase 4, Randomized, Multicenter Study of Inhaled Treprostinil in Treatment naïve Pulmonary Arterial Hypertension Patients Starting on Tadalafil | Hypertension, Pulmonary | Drug: treprostinil inhalations;Drug: tadalafil | Stanford University | Northwestern University | Completed | 18 Years | 69 Years | All | 21 | Phase 4 | United States |
| 388 | EUCTR2008-003482-68-GR (EUCTR) | 15/06/2010 | 09/11/2009 | Randomized, double-blind, placebo-controlled, multi-centre, multi-national study to evaluate the efficacy and safety of oral BAY 63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with symptomatic Pulmonary Arterial Hypertension (PAH). - PATENT-1 Study, amend 4 | Randomized, double-blind, placebo-controlled, multi-centre, multi-national study to evaluate the efficacy and safety of oral BAY 63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with symptomatic Pulmonary Arterial Hypertension (PAH). - PATENT-1 Study, amend 4 | Pulmonary Arterial Hypertension (PAH) MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension | Product Name: BAY 63-2521 tablets 0.5 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Product Name: BAY 63-2521 tablets 1 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Product Name: BAY 63-2521 tablets 1.5 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Product Name: BAY 63-2521 tablets 2 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb | Bayer HealthCare AG | NULL | Not Recruiting | Female: yes Male: yes | 462 | Portugal;Germany;Netherlands;France;Ireland;Italy;Austria;Sweden;United Kingdom;Czech Republic;Denmark;Belgium;Spain;Greece | |||
| 389 | EUCTR2008-003610-94-GR (EUCTR) | 15/06/2010 | 11/01/2010 | Long-term extension, multi-centre, multi-national study to evaluate the safety and tolerability of oral BAY 63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with symptomatic Pulmonary Arterial Hypertension (PAH). - PATENT-2 | Long-term extension, multi-centre, multi-national study to evaluate the safety and tolerability of oral BAY 63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with symptomatic Pulmonary Arterial Hypertension (PAH). - PATENT-2 | Pulmonary Arterial Hypertension (PAH) MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension | Product Name: BAY 63-2521 tablets 0.5 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Product Name: BAY 63-2521 tablets 1 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Product Name: BAY 63-2521 tablets 1.5 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Product Name: BAY 63-2521 tablets 2 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat | Bayer HealthCare AG | NULL | Not Recruiting | Female: yes Male: yes | 462 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Belgium;Denmark;Germany;Netherlands;Sweden | ||
| 390 | EUCTR2009-018167-26-DE (EUCTR) | 04/05/2010 | 11/03/2010 | An extension study to QTI571A2301 to evaluate the longterm safety, tolerability and efficacy of oral QTI571 (imatinib) in the treatment of severe pulmonary arterial hypertension. - IMPRES Extension | An extension study to QTI571A2301 to evaluate the longterm safety, tolerability and efficacy of oral QTI571 (imatinib) in the treatment of severe pulmonary arterial hypertension. - IMPRES Extension | Pulmonary arterial hypertension (PAH) patients who have a PVR=800 dynes.sec.cm-5 despite treatment with two or more specific PAH therapies MedDRA version: 14.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders | Trade Name: Glivec® Product Code: QTI571 INN or Proposed INN: IMATINIB MESYLATE Trade Name: Glivec® Product Code: QTI571 INN or Proposed INN: IMATINIB MESYLATE | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 140 | France;Belgium;Spain;Austria;Germany;Italy;United Kingdom | |||
| 391 | NCT01105117 (ClinicalTrials.gov) | May 2010 | 15/4/2010 | Epoprostenol for Injection in Pulmonary Arterial Hypertension - Extension of AC-066A401 | An Open-label Extension of Study AC-066A401 Investigating the Safety and Tolerability of ACT-385781A Compared to Flolan® in Injectable Prostanoid Treatment-naïve Patients With Pulmonary Arterial Hypertension (PAH) | Pulmonary Arterial Hypertension | Drug: ACT-385781A (Actelion Epoprostenol);Drug: Flolan® | Actelion | NULL | Completed | 18 Years | 65 Years | All | 2 | Phase 4 | United States |
| 392 | EUCTR2009-018167-26-AT (EUCTR) | 15/04/2010 | 16/02/2010 | An extension study to QTI571A2301 to evaluate the longterm safety, tolerability and efficacy of oral QTI571 (imatinib) in the treatment of severe pulmonary arterial hypertension. - IMPRES Extension | An extension study to QTI571A2301 to evaluate the longterm safety, tolerability and efficacy of oral QTI571 (imatinib) in the treatment of severe pulmonary arterial hypertension. - IMPRES Extension | Pulmonary arterial hypertension (PAH) patients who have a PVR=800 dynes.sec.cm-5 despite treatment with two or more specific PAH therapies MedDRA version: 12.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension | Trade Name: Glivec® Product Code: QTI571 INN or Proposed INN: IMATINIB MESYLATE | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 140 | France;Belgium;Spain;Austria;Germany;Italy;United Kingdom | |||
| 393 | EUCTR2009-014246-29-DE (EUCTR) | 08/04/2010 | 16/11/2009 | A 12-week, double-blind, international, multicenter, dose-response study of the safety and efficacy of Beraprost Sodium Modified Release (BPS-MR) in patients with pulmonary arterial hypertension (PAH) | A 12-week, double-blind, international, multicenter, dose-response study of the safety and efficacy of Beraprost Sodium Modified Release (BPS-MR) in patients with pulmonary arterial hypertension (PAH) | Pulmonary Arterial Hypertension MedDRA version: 12.0;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension | Product Name: Beraprost Sodium Modified Release Product Code: BPS-MR INN or Proposed INN: Beraprost Sodium | Lung Rx | NULL | Not Recruiting | Female: yes Male: yes | 36 | Phase 2 | Czech Republic;Belgium;Ireland;Germany | ||
| 394 | NCT01117987 (ClinicalTrials.gov) | April 2010 | 3/5/2010 | Extension to QTI571A2301 to Evaluate the Long-term Safety, Tolerability and Efficacy of Imatinib in Severe Pulmonary Arterial Hypertension (PAH) | An Extension to QTI571A2301 to Evaluate the Long-term Safety, Tolerability and Efficacy of Oral QTI571 (Imatinib) in the Treatment of Severe Pulmonary Arterial Hypertension: IMPRES Extension | Pulmonary Arterial Hypertension | Drug: Imatinib;Drug: Placebo | Novartis Pharmaceuticals | NULL | Terminated | 18 Years | N/A | All | 144 | Phase 3 | United States;Austria;Belgium;Canada;France;Germany;Italy;Japan;Korea, Republic of;Netherlands;Spain;Switzerland;United Kingdom;Sweden |
| 395 | NCT01105091 (ClinicalTrials.gov) | March 2010 | 15/4/2010 | Epoprostenol for Injection in Pulmonary Arterial Hypertension | A Phase IV, Open-label, Randomized, Multicenter Study of the Safety, Tolerability,and Pharmacokinetics of ACT- 385781A Compared to Flolan® in Injectable Prostanoid Treatment-naïve Patients With Pulmonary Arterial Hypertension (PAH) | Pulmonary Arterial Hypertension | Drug: ACT-385781A (Actelion Epoprostenol);Drug: Flolan® | Actelion | NULL | Completed | 18 Years | 65 Years | All | 30 | Phase 4 | United States |
| 396 | EUCTR2009-014246-29-CZ (EUCTR) | 18/02/2010 | 07/12/2009 | A 12-week, double-blind, international, multicenter, dose-response study of the safety and efficacy of Beraprost Sodium Modified Release (BPS-MR) in patients with pulmonary arterial hypertension (PAH) | A 12-week, double-blind, international, multicenter, dose-response study of the safety and efficacy of Beraprost Sodium Modified Release (BPS-MR) in patients with pulmonary arterial hypertension (PAH) | Pulmonary Arterial Hypertension MedDRA version: 13.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders | Product Name: Beraprost Sodium Modified Release Product Code: BPS-MR INN or Proposed INN: Beraprost Sodium Other descriptive name: TRK-100STP | Lung Rx Inc | NULL | Not Recruiting | Female: yes Male: yes | 36 | Germany;Czech Republic;Belgium;Ireland | |||
| 397 | EUCTR2009-014246-29-IE (EUCTR) | 01/02/2010 | 06/11/2009 | A 12-week, double-blind, international, multicenter, dose-response study of the safety and efficacy of Beraprost Sodium Modified Release (BPS-MR) in patients with pulmonary arterial hypertension (PAH) | A 12-week, double-blind, international, multicenter, dose-response study of the safety and efficacy of Beraprost Sodium Modified Release (BPS-MR) in patients with pulmonary arterial hypertension (PAH) | Pulmonary Arterial Hypertension MedDRA version: 12.0;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension | Product Name: Beraprost Sodium Modified Release Product Code: BPS-MR INN or Proposed INN: Beraprost Sodium | Lung Rx | NULL | Not Recruiting | Female: yes Male: yes | 36 | Czech Republic;Germany;Belgium;Ireland | |||
| 398 | EUCTR2009-014453-32-IE (EUCTR) | 01/02/2010 | 09/11/2009 | An open-label extension of BPS-MR-PAH-203 in pulmonary arterial hypertension (PAH) patients | An open-label extension of BPS-MR-PAH-203 in pulmonary arterial hypertension (PAH) patients | Pulmonary Arterial Hypertension MedDRA version: 14.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders | Product Name: Beraprost Sodium Modified Release Product Code: BPS-MR INN or Proposed INN: Beraprost Sodium Other descriptive name: TRK-100STP | Lung LLC Inc | NULL | Not Recruiting | Female: yes Male: yes | 36 | Czech Republic;Belgium;Ireland;Germany | |||
| 399 | NCT00989963 (ClinicalTrials.gov) | February 1, 2010 | 5/10/2009 | Dose-response Study of the Safety and Efficacy of Beraprost Sodium Modified Release (BPS-MR) in Patients With Pulmonary Arterial Hypertension (PAH) | A 12-week, Double-blind, International, Multicenter, Dose-response Study of the Safety and Efficacy of Beraprost Sodium Modified Release (BPS-MR) in Patients With Pulmonary Arterial Hypertension (PAH) | Pulmonary Arterial Hypertension | Drug: Beraprost Sodium Modified Release | Lung Biotechnology PBC | NULL | Completed | 18 Years | 75 Years | All | 36 | Phase 2 | United States;Belgium;Czechia;Germany;Ireland;Romania;Czech Republic |
| 400 | EUCTR2006-000804-18-SE (EUCTR) | 28/01/2010 | 03/12/2009 | An extension studyof UT-15C tablet in subjects with high blood pressure in the artery that carries blood to the lungs | An Open-Label Extension Trial of UT-15C SR in Subjects with Pulmonary Arterial Hypertension - FREEDOM-EXT | Idiopathic or familial pulmonary arterial hypertension (PAH), including PAH associated with :1) Appetite suppressant use or 2) Repaired congenital systemic-to-pulmonary shunts (repaired = 5 years) or 3) Collagen Vascular Disease (CVD) or 4) Human Immunodeficiency Virus (HIV) MedDRA version: 13.1;Level: PT;Classification code 10037400;Term: Pulmonary hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Treprostinil diethanolamine Product Code: UT-15C SR INN or Proposed INN: Treprostinil diethanolamine Product Name: Treprostinil diethanolamine Product Code: UT-15C SR INN or Proposed INN: Treprostinil diethanolamine Product Name: Treprostinil diethanolamine Product Code: UT-15C SR INN or Proposed INN: Treprostinil diethanolamine Product Name: Treprostinil diethanolamine Product Code: UT-15C SR INN or Proposed INN: Treprostinil diethanolamine Product Name: Treprostinil diethanolamine Product Code: UT-15C SR INN or Proposed INN: treprostinil diethanolamine | United Therapeutics Corporation | NULL | Not Recruiting | Female: yes Male: yes | 900 | Phase 3 | Portugal;Spain;Ireland;Austria;Israel;United Kingdom;Italy;France;Mexico;Puerto Rico;Belgium;Netherlands;Germany;Sweden | ||
| 401 | EUCTR2009-014490-41-ES (EUCTR) | 22/01/2010 | 02/12/2009 | Estudio en fase III, multicéntrico, a doble ciego y controlado con placebo, para demostrar la eficacia y seguridad de ACT-293987 en pacientes con hipertensión arterial pulmonar (PAH) - GRIPHON 2 | Estudio en fase III, multicéntrico, a doble ciego y controlado con placebo, para demostrar la eficacia y seguridad de ACT-293987 en pacientes con hipertensión arterial pulmonar (PAH) - GRIPHON 2 | Hipertensión Arterial Pulmonar MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension | Product Name: ACT-293987 Product Code: ACT-293987 | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 272 | Slovakia;Greece;Spain;Ireland;Austria;Italy;United Kingdom;France;Czech Republic;Hungary;Belgium;Denmark;Netherlands;Germany;Sweden | |||
| 402 | EUCTR2009-014453-32-BE (EUCTR) | 11/01/2010 | 09/11/2009 | An open-label extension of BPS-MR-PAH-203 in pulmonary arterial hypertension (PAH) patients | An open-label extension of BPS-MR-PAH-203 in pulmonary arterial hypertension (PAH) patients | Pulmonary Arterial Hypertension MedDRA version: 14.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Beraprost Sodium Modified Release Product Code: BPS-MR INN or Proposed INN: Beraprost Sodium Other descriptive name: TRK-100STP | Lung LLC | NULL | Not Recruiting | Female: yes Male: yes | 36 | Phase 2 | United States;Czech Republic;Belgium;Ireland;Romania;Germany | ||
| 403 | EUCTR2009-012057-38-NL (EUCTR) | 05/01/2010 | 23/11/2009 | A 24-week randomized placebo-controlled, double-blind multi-center clinical trial evaluating the efficacy and safety of oral QTI571 as an add-on therapy in the treatment of severe pulmonary arterial hypertension: Imatinib in Pulmonary arterial hypertension, a Randomized, Efficacy Study - IMPRES | A 24-week randomized placebo-controlled, double-blind multi-center clinical trial evaluating the efficacy and safety of oral QTI571 as an add-on therapy in the treatment of severe pulmonary arterial hypertension: Imatinib in Pulmonary arterial hypertension, a Randomized, Efficacy Study - IMPRES | Pulmonary arterial hypertension (PAH) patients who have a PVR>1000 dynes.sec.cm-5 despite treatment with two or more specific PAH therapies MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension | Trade Name: Glivec® Product Code: QTI571 INN or Proposed INN: IMATINIB MESYLATE | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 200 | United Kingdom;Germany;Netherlands;Belgium;France;Spain;Italy;Austria;Sweden | |||
| 404 | EUCTR2009-014246-29-BE (EUCTR) | 09/12/2009 | 09/11/2009 | A 12-week, double-blind, international, multicenter, dose-response study of the safety and efficacy of Beraprost Sodium Modified Release (BPS-MR) in patients with pulmonary arterial hypertension (PAH) | A 12-week, double-blind, international, multicenter, dose-response study of the safety and efficacy of Beraprost Sodium Modified Release (BPS-MR) in patients with pulmonary arterial hypertension (PAH) | Pulmonary Arterial Hypertension MedDRA version: 13.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders | Product Name: Beraprost Sodium Modified Release Product Code: BPS-MR INN or Proposed INN: Beraprost Sodium Other descriptive name: TRK-100STP | Lung Rx Inc | NULL | Not Recruiting | Female: yes Male: yes | 36 | Phase 2 | Czech Republic;Belgium;Ireland;Germany | ||
| 405 | NCT01445873 (ClinicalTrials.gov) | December 1, 2009 | 30/9/2011 | Pilot Chart Review Study Of Sitaxentan Sodium (Thelin) In Patients With Pulmonary Arterial Hypertension (PAH) | NON-INTERVENTIONAL (NI) DRUG STUDY PROTOCOL: THREE-COUNTRY PILOT STUDY FOR RETROSPECTIVE CHART REVIEW OF EFFECTIVENESS OF THELIN® (SITAXSENTAN) IN PATIENTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH) | Pulmonary Arterial Hypertension | Drug: Sitaxentan sodium | Pfizer | NULL | Completed | 18 Years | N/A | All | 36 | NULL | |
| 406 | NCT00990314 (ClinicalTrials.gov) | November 30, 2009 | 5/10/2009 | Extension of BPS-MR-PAH-203 in Pulmonary Arterial Hypertension (PAH) Patients | An Open-label Extension of BPS-MR-PAH-203 in Pulmonary Arterial Hypertension (PAH) Patients | Pulmonary Arterial Hypertension | Drug: Beraprost Sodium Modified Release | Lung Biotechnology PBC | NULL | Completed | 18 Years | 75 Years | All | 31 | Phase 2 | United States;Belgium;Czechia;Germany;Ireland;Romania;Czech Republic |
| 407 | EUCTR2008-003610-94-PT (EUCTR) | 04/11/2009 | 22/09/2009 | Long-term study to collect additional information to evaluate the safety and tolerability of BAY 63-2521 in different doses | Long-term extension, multi-centre, multi-national study to evaluate the safety and tolerability of oral BAY 63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with symptomatic Pulmonary Arterial Hypertension (PAH). - PATENT-2 | Pulmonary Arterial Hypertension (PAH) MedDRA version: 19.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Adempas Product Name: BAY 63-2521 coated tablets 0.5 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: BAY 63-2521 Trade Name: Adempas Product Name: BAY 63-2521 coated tablets 1 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: BAY 63-2521 Trade Name: Adempas Product Name: BAY 63-2521 coated tablets 1.5 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: BAY 63-2521 Trade Name: Adempas Product Name: BAY 63-2521 coated tablets 2 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: BAY 63-2521 Trade Name: Adempas Product Name: BAY 63-2521 coated tablets 2.5 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: BAY 63-2521 | Bayer AG | NULL | Not Recruiting | Female: yes Male: yes | 462 | Phase 3 | United States;Portugal;Taiwan;Greece;Thailand;Spain;Ireland;Russian Federation;Israel;Switzerland;Italy;France;Australia;Denmark;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Singapore;Poland;Belgium;Brazil;Germany;New Zealand;Japan;Sweden | ||
| 408 | EUCTR2008-003482-68-PT (EUCTR) | 04/11/2009 | 22/09/2009 | Randomized, double-blind, placebo-controlled, multi-centre, multi-national study to evaluate the efficacy and safety of oral BAY 63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with symptomatic Pulmonary Arterial Hypertension (PAH). - PATENT-1 Study | Randomized, double-blind, placebo-controlled, multi-centre, multi-national study to evaluate the efficacy and safety of oral BAY 63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with symptomatic Pulmonary Arterial Hypertension (PAH). - PATENT-1 Study | Pulmonary Arterial Hypertension (PAH) MedDRA version: 14.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders | Product Name: BAY 63-2521 tablets 0.5 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Product Name: BAY 63-2521 tablets 1 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Product Name: BAY 63-2521 tablets 1.5 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Product Name: BAY 63-2521 tablets 2 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb | Bayer HealthCare AG | NULL | Not Recruiting | Female: yes Male: yes | 462 | United States;Portugal;Taiwan;Greece;Thailand;Spain;Ireland;Israel;Russian Federation;Italy;Switzerland;France;Australia;Denmark;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Germany;Japan;New Zealand;Sweden | |||
| 409 | EUCTR2005-005068-97-BE (EUCTR) | 29/10/2009 | 10/06/2009 | Effects of combination of bosentan and sildenafil versus sildenafil monotherapy on morbidity and mortality in symptomatic patients with pulmonary arterial hypertension – A multicenter, double - blind, randomized, placebo - controlled, parallel group, prospective, event driven Phase IV study - COMPASS 2 | Effects of combination of bosentan and sildenafil versus sildenafil monotherapy on morbidity and mortality in symptomatic patients with pulmonary arterial hypertension – A multicenter, double - blind, randomized, placebo - controlled, parallel group, prospective, event driven Phase IV study - COMPASS 2 | Patients to be included must have PAH belonging to WHO Group I, in agreement with the approved indications for sildenafil in PAH by the US FDA:a.Idiopathic (IPAH)b.Familial (FPAH)c.Associated with (APAH):i.Collagen vascular disease with normal left ventricular function (ejection fraction (EF) > 50%) ii.Congenital systemic-to-pulmonary shunts at least 2 years post surgical repairiii.Drugs and toxins MedDRA version: 9.1;Level: LLT;Classification code 10064908;Term: Associated with (APAH) MedDRA version: 9.1;Classification code 10064910;Term: Familial (FPAH) MedDRA version: 9.1;Classification code 10064909;Term: Idiopathic (IPAH) | Trade Name: Tracleer Product Name: bosentan Product Code: Ro-47-0203 INN or Proposed INN: BOSENTAN MONOHYDRATE Other descriptive name: Ro-47-0203/029 Trade Name: Tracleer Product Name: Bosentan Product Code: Ro-47-0203 INN or Proposed INN: BOSENTAN MONOHYDRATE Other descriptive name: Ro-47-0203/029 | Actelion Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 4 | Portugal;Czech Republic;Greece;Spain;Belgium;Denmark;Germany;United Kingdom;Sweden | ||
| 410 | EUCTR2009-012057-38-FR (EUCTR) | 21/09/2009 | 07/07/2009 | A 24-week randomized placebo-controlled, double-blind multi-center clinical trial evaluating the efficacy and safety of oral QTI571 as an add-on therapy in the treatment of severe pulmonary arterial hypertension: Imatinib in Pulmonary arterial hypertension, a Randomized, Efficacy Study - IMPRES | A 24-week randomized placebo-controlled, double-blind multi-center clinical trial evaluating the efficacy and safety of oral QTI571 as an add-on therapy in the treatment of severe pulmonary arterial hypertension: Imatinib in Pulmonary arterial hypertension, a Randomized, Efficacy Study - IMPRES | Pulmonary arterial hypertension (PAH) patients who have a PVR>1000 dynes.sec.cm-5 despite treatment with two or more specific PAH therapies MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension | Trade Name: Glivec® Product Code: QTI571 INN or Proposed INN: IMATINIB MESYLATE | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 200 | France;Belgium;Spain;Austria;Netherlands;Germany;United Kingdom;Italy;Sweden | |||
| 411 | EUCTR2009-012057-38-BE (EUCTR) | 18/09/2009 | 22/07/2009 | A 24-week randomized placebo-controlled, double-blind multi-center clinical trial evaluating the efficacy and safety of oral QTI571 as an add-on therapy in the treatment of severe pulmonary arterial hypertension: Imatinib in Pulmonary arterial hypertension, a Randomized, Efficacy Study - IMPRES | A 24-week randomized placebo-controlled, double-blind multi-center clinical trial evaluating the efficacy and safety of oral QTI571 as an add-on therapy in the treatment of severe pulmonary arterial hypertension: Imatinib in Pulmonary arterial hypertension, a Randomized, Efficacy Study - IMPRES | Pulmonary arterial hypertension (PAH) patients who have a PVR=800 dynes.sec.cm-5 despite treatment with two or more specific PAH therapies MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension | Trade Name: Glivec® Product Code: QTI571 INN or Proposed INN: IMATINIB MESYLATE | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 200 | United Kingdom;Germany;Netherlands;Belgium;France;Spain;Italy;Austria;Sweden | |||
| 412 | JPRN-JapicCTI-121998 | 01/9/2009 | 26/10/2012 | Bosentan PAH (WHO-FC II) | Open label multicenter study to assess the efficacy, safety, and tolerability of bosentan in Japanese patients with pulmonary arterial hypertension (PAH) in WHO functional class II. | Pulmonary arterial hypertension (PAH) | Intervention name : Ro47-0203 INN of the intervention : Bosentan Dosage And administration of the intervention : Oral administration, Initial dose: 62.5 mg b.i.d. for 4 weeks for all patients, Target dose: 125 mg b.i.d. (62.5 mg b.i.d. if weight < 40 kg) | Actelion Pharmaceuticals Japan Ltd. | NULL | 18 | 74 | BOTH | 16 | Phase 3 | NULL | |
| 413 | EUCTR2009-012057-38-GB (EUCTR) | 18/08/2009 | 15/07/2010 | A 24-week randomized placebo-controlled, double-blind multi-center clinical trial evaluating the efficacy and safety of oral QTI571 as an add-on therapy in the treatment of severe pulmonary arterial hypertension: Imatinib in Pulmonary arterial hypertension, a Randomized, Efficacy Study - IMPRES | A 24-week randomized placebo-controlled, double-blind multi-center clinical trial evaluating the efficacy and safety of oral QTI571 as an add-on therapy in the treatment of severe pulmonary arterial hypertension: Imatinib in Pulmonary arterial hypertension, a Randomized, Efficacy Study - IMPRES | Pulmonary arterial hypertension (PAH) patients who have a PVR=800 dynes.sec.cm-5 despite treatment with two or more specific PAH therapies MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension | Trade Name: Glivec® Product Code: QTI571 INN or Proposed INN: IMATINIB MESYLATE Trade Name: Glivec® Product Code: QTI571 INN or Proposed INN: IMATINIB MESYLATE | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 200 | Germany;United Kingdom;Netherlands;Belgium;France;Spain;Italy;Austria;Sweden | |||
| 414 | EUCTR2009-012057-38-DE (EUCTR) | 13/08/2009 | 10/06/2009 | A 24-week randomized placebo-controlled, double-blind multi-center clinical trial evaluating the efficacy and safety of oral QTI571 as an add-on therapy in the treatment of severe pulmonary arterial hypertension: Imatinib in Pulmonary arterial hypertension, a Randomized, Efficacy Study - IMPRES | A 24-week randomized placebo-controlled, double-blind multi-center clinical trial evaluating the efficacy and safety of oral QTI571 as an add-on therapy in the treatment of severe pulmonary arterial hypertension: Imatinib in Pulmonary arterial hypertension, a Randomized, Efficacy Study - IMPRES | Pulmonary arterial hypertension (PAH) patients who have a PVR =800 dynes.sec.cm-5 despite treatment with two or more specific PAH therapies MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension | Trade Name: Glivec® 100 mg Filmtabletten Product Code: QTI571 INN or Proposed INN: Imatinib mesilate | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 200 | United Kingdom;Germany;Netherlands;Belgium;France;Spain;Italy;Austria;Sweden | |||
| 415 | EUCTR2009-012057-38-SE (EUCTR) | 12/08/2009 | 08/07/2009 | A 24-week randomized placebo-controlled, double-blind multi-center clinical trial evaluating the efficacy and safety of oral QTI571 as an add-on therapy in the treatment of severe pulmonary arterial hypertension: Imatinib in Pulmonary arterial hypertension, a Randomized, Efficacy Study - IMPRES | A 24-week randomized placebo-controlled, double-blind multi-center clinical trial evaluating the efficacy and safety of oral QTI571 as an add-on therapy in the treatment of severe pulmonary arterial hypertension: Imatinib in Pulmonary arterial hypertension, a Randomized, Efficacy Study - IMPRES | Pulmonary arterial hypertension (PAH) patients who have a PVR>1000 dynes.sec.cm-5 despite treatment with two or more specific PAH therapies MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension | Trade Name: Glivec® Product Code: QTI571 INN or Proposed INN: IMATINIB MESYLATE | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 200 | United Kingdom;Germany;Netherlands;Belgium;France;Spain;Italy;Austria;Sweden | |||
| 416 | EUCTR2009-012057-38-AT (EUCTR) | 17/07/2009 | 15/06/2009 | A 24-week randomized placebo-controlled, double-blind multi-center clinical trial evaluating the efficacy and safety of oral QTI571 as an add-on therapy in the treatment of severe pulmonary arterial hypertension: Imatinib in Pulmonary arterial hypertension, a Randomized, Efficacy Study - IMPRES | A 24-week randomized placebo-controlled, double-blind multi-center clinical trial evaluating the efficacy and safety of oral QTI571 as an add-on therapy in the treatment of severe pulmonary arterial hypertension: Imatinib in Pulmonary arterial hypertension, a Randomized, Efficacy Study - IMPRES | Pulmonary arterial hypertension (PAH) patients who have a PVR=800 dynes.sec.cm-5 despite treatment with two or more specific PAH therapies MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension | Trade Name: Glivec® Product Code: QTI571 INN or Proposed INN: IMATINIB MESYLATE | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 200 | United Kingdom;Germany;Netherlands;Belgium;France;Spain;Italy;Austria;Sweden | |||
| 417 | EUCTR2008-006833-29-IE (EUCTR) | 29/06/2009 | 11/12/2008 | An Open-Label Extension of BPS-MR-PAH-201 in Pulmonary Arterial Hypertension (PAH) Patients | An Open-Label Extension of BPS-MR-PAH-201 in Pulmonary Arterial Hypertension (PAH) Patients | Pulmonary Arterial Hypertension MedDRA version: 14.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Beraprost Sodium Modified Release Product Code: BPS-MR INN or Proposed INN: Beraprost Sodium Other descriptive name: TRK-100STP | Lung LLC | NULL | Not Recruiting | Female: yes Male: yes | 19 | Belgium;Ireland | |||
| 418 | EUCTR2008-003290-41-IE (EUCTR) | 29/06/2009 | 11/12/2008 | A Multi-center, open-label, multiple dose, dose finding study exploring the safety and tolerability of Beraprost Sodium Modified Release in PAH patients | A Multi-center, open-label, multiple dose, dose finding study exploring the safety and tolerability of Beraprost Sodium Modified Release in PAH patients | Pulmonary Arterial Hypertension MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension | Product Name: Beraprost Sodium Modified Release Product Code: BPS-MR INN or Proposed INN: Beraprost Sodium Other descriptive name: TRK-100STP | LungRx | NULL | Not Recruiting | Female: yes Male: yes | 10 | Belgium;Ireland | |||
| 419 | EUCTR2005-005068-97-CZ (EUCTR) | 16/06/2009 | 11/06/2009 | Effects of combination of bosentan and sildenafil versus sildenafil monotherapy on morbidity and mortality in symptomatic patients with pulmonary arterial hypertension – A multicenter, double - blind, randomized, placebo - controlled, parallel group, prospective, event driven Phase IV study - COMPASS 2 | Effects of combination of bosentan and sildenafil versus sildenafil monotherapy on morbidity and mortality in symptomatic patients with pulmonary arterial hypertension – A multicenter, double - blind, randomized, placebo - controlled, parallel group, prospective, event driven Phase IV study - COMPASS 2 | Patients to be included must have PAH belonging to WHO Group I, in agreement with the approved indications for sildenafil in PAH by the US FDA:a.Idiopathic (IPAH)b.Familial (FPAH)c.Associated with (APAH):i.Collagen vascular disease with normal left ventricular function (ejection fraction (EF) > 50%) ii.Congenital systemic-to-pulmonary shunts at least 2 years post surgical repairiii.Drugs and toxins MedDRA version: 9.1;Level: LLT;Classification code 10064908;Term: Associated with (APAH) MedDRA version: 9.1;Classification code 10064910;Term: Familial (FPAH) MedDRA version: 9.1;Classification code 10064909;Term: Idiopathic (IPAH) | Trade Name: Tracleer Product Name: bosentan Product Code: Ro-47-0203 INN or Proposed INN: BOSENTAN MONOHYDRATE Other descriptive name: Ro-47-0203/029 Trade Name: Tracleer Product Name: Bosentan Product Code: Ro-47-0203 INN or Proposed INN: BOSENTAN MONOHYDRATE Other descriptive name: Ro-47-0203/029 | Actelion Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 4 | Portugal;Czech Republic;Greece;Belgium;Spain;Denmark;Germany;United Kingdom;Sweden | ||
| 420 | EUCTR2008-003482-68-ES (EUCTR) | 08/06/2009 | 24/10/2008 | Ensayo clínico, multinacional, multicéntrico, aleatorizado ,doble ciego, controlado con placebo, para evaluar la eficacia y la seguridad de BAY 63-2521 (1 mg, 1.5 mg, 2mg, o 2.5 mg ,tid )administrado por vía oral, en pacientes con Hipertensión Arterial Pulmonar (HAP) sintomática-Estudio PATENT -1 Randomized, double-blind, placebo-controlled, multi-centre, multi-national study to evaluate the efficacy and safety of oral BAY 63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with symptomatic Pulmonary Arterial Hypertension (PAH). - PATENT-1 Study | Ensayo clínico, multinacional, multicéntrico, aleatorizado ,doble ciego, controlado con placebo, para evaluar la eficacia y la seguridad de BAY 63-2521 (1 mg, 1.5 mg, 2mg, o 2.5 mg ,tid )administrado por vía oral, en pacientes con Hipertensión Arterial Pulmonar (HAP) sintomática-Estudio PATENT -1 Randomized, double-blind, placebo-controlled, multi-centre, multi-national study to evaluate the efficacy and safety of oral BAY 63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with symptomatic Pulmonary Arterial Hypertension (PAH). - PATENT-1 Study | Hipertensión Arterial Pulmonar (HAP) Pulmonary Arterial Hypertension (PAH) MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension | Product Name: BAY 63-2521 tablets 0.5 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Product Name: BAY 63-2521 tablets 1 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Product Name: BAY 63-2521 tablets 1.5 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb | Bayer HealthCare AG | NULL | Not Recruiting | Female: yes Male: yes | 462 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Belgium;Denmark;Germany;Netherlands;Sweden | ||
| 421 | EUCTR2008-003610-94-GB (EUCTR) | 20/05/2009 | 27/11/2008 | Long-term study to collect additional information to evaluate the safety and tolerability of BAY 63-2521 at different doses | Long-term extension, multi-centre, multi-national study to evaluate the safety and tolerability of oral BAY 63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with symptomatic Pulmonary Arterial Hypertension (PAH). - PATENT-2 | Pulmonary Arterial Hypertension (PAH) MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Adempas Product Name: BAY 63-2521 coated tablets 0.5 mg Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: BAY 63-2521 coated tablets 1 mg Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: ADEMPAS Product Name: BAY 63-2521 coated tablets 1.5 mg Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: BAY 63-2521 coated tablets 2 mg Product Code: BAY 63-2521 INN or Proposed INN: R | Bayer AG | NULL | Not Recruiting | Female: yes Male: yes | 462 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;United States;Taiwan;Greece;Thailand;Spain;Ireland;Russian Federation;Israel;Switzerland;Italy;France;Australia;Denmark;Netherlands;China;Korea, Democratic People's Republic of;Turkey;Austria;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Germany;New Zealand;Japan;Sweden | ||
| 422 | EUCTR2008-003610-94-DK (EUCTR) | 24/04/2009 | 12/03/2009 | Long-term study to collect additional information to evaluate the safetyand tolerability of BAY 63-2521 in different doses | Long-term extension, multi-centre, multi-national study to evaluate the safety and tolerability of oral BAY 63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with symptomatic Pulmonary Arterial Hypertension (PAH). - PATENT-2 study | Pulmonary Arterial Hypertension (PAH) MedDRA version: 17.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Adempas Product Name: BAY 63-2521 coated tablets 0.5 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: BAY 63-2521 Trade Name: Adempas Product Name: BAY 63-2521 coated tablets 1 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: BAY 63-2521 Trade Name: Adempas Product Name: BAY 63-2521 coated tablets 1.5 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: BAY 63-2521 Trade Name: Adempas Product Name: BAY 63-2521 coated tablets 2 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: BAY 63-2521 Trade Name: Adempas Product Name: BAY 63-2521 coated tablets 2.5 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: BAY 63-2521 | Bayer HealthCare AG | NULL | Not Recruiting | Female: yes Male: yes | 462 | Phase 3 | Portugal;United States;Taiwan;Greece;Thailand;Spain;Ireland;Russian Federation;Israel;Switzerland;Italy;France;Australia;Denmark;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Germany;New Zealand;Japan;Sweden | ||
| 423 | EUCTR2008-003610-94-IE (EUCTR) | 06/04/2009 | 09/01/2009 | Long-term extension, multi-centre, multi-national study to evaluate the safety and tolerability of oral BAY 63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with symptomatic Pulmonary Arterial Hypertension (PAH). - PATENT-2 | Long-term extension, multi-centre, multi-national study to evaluate the safety and tolerability of oral BAY 63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with symptomatic Pulmonary Arterial Hypertension (PAH). - PATENT-2 | Pulmonary Arterial Hypertension (PAH) MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension | Product Name: BAY 63-2521 tablets 0.5 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Product Name: BAY 63-2521 tablets 1 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Product Name: BAY 63-2521 tablets 1 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Product Name: BAY 63-2521 tablets 2 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Product Name: BAY 63-2521 tablets 2.5 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb | Bayer HealthCare AG | NULL | Not Recruiting | Female: yes Male: yes | 462 | Portugal;Germany;Netherlands;France;Ireland;Italy;Austria;Sweden;United Kingdom;Czech Republic;Belgium;Denmark;Spain;Greece | |||
| 424 | EUCTR2007-003328-39-AT (EUCTR) | 02/04/2009 | 18/01/2008 | A multi-centre, multinational, open-label single-dose acute hemodynamic study followed by a multi-centre, multinational, randomized, double-blind, parallel-group, placebo controlled study to assess the safety, tolerability, pharmacokinetics and preliminary efficacy (proof-of-concept) of NS-304 in the treatment of pulmonary arterial hypertension in subjects aged 18 years and over | A multi-centre, multinational, open-label single-dose acute hemodynamic study followed by a multi-centre, multinational, randomized, double-blind, parallel-group, placebo controlled study to assess the safety, tolerability, pharmacokinetics and preliminary efficacy (proof-of-concept) of NS-304 in the treatment of pulmonary arterial hypertension in subjects aged 18 years and over | pulmonary arterial hypertension (PAH) (idiopathic PAH, familial PAH, and PAH associated with collagen disease, corrected congenital vitium or anorexigen use) MedDRA version: 9.1;Level: LLT;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065152;Term: Familial pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065150;Term: Associated with pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10064911;Term: Pulmonary arterial hypertension | Product Code: NS-304 INN or Proposed INN: 2-(4-[5,6-diphenylpyrazin-2-yl)(isopropyl)amino]butoxy)-N-(methylsulfonyl)actamide | Nippon Shinyaku Co., LTD | NULL | Not Recruiting | Female: yes Male: yes | 44 | Hungary;United Kingdom;Germany;Belgium;France;Italy;Austria | |||
| 425 | EUCTR2007-003621-24-AT (EUCTR) | 30/03/2009 | 23/04/2008 | Double-blind, randomized, placebo-controlled, dose-finding, parallel-group study to assess the hemodynamic effects, clinical efficacy, tolerability and safety of Aviptadil (Vasoactive Intestinal Peptide) after single and repeated inhalation in patients with pulmonary arterial hypertension. | Double-blind, randomized, placebo-controlled, dose-finding, parallel-group study to assess the hemodynamic effects, clinical efficacy, tolerability and safety of Aviptadil (Vasoactive Intestinal Peptide) after single and repeated inhalation in patients with pulmonary arterial hypertension. | Pulmonary arterial hypertension (PAH) due to idiopathic pulmonary arterial hypertension (IPAH), familial PAH or PAH associated with connective tissue diseases (CTD) (e.g. systemic sclerosis, systemic lupus erythematosus) or to repaired congenital heart defects (RCHD). MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065152;Term: Familial pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065150;Term: Associated with pulmonary arterial hypertension | Product Name: Aviptadil Product Code: VIP INN or Proposed INN: Aviptadil Other descriptive name: VIP | MondoGEN AG | NULL | Not Recruiting | Female: yes Male: yes | 48 | Germany;United Kingdom;Netherlands;Belgium;France;Spain;Italy;Austria | |||
| 426 | EUCTR2007-006453-12-AT (EUCTR) | 19/03/2009 | 23/06/2008 | Study to evaluate if selexipag is safe and efficacious for the treatment of pulmonary arterial hypertension | A multi-centre, multinational, open-label study to evaluate the long-term safety, tolerability and efficacy of selexipag / ACT-293987 (NS-304) in the treatment of pulmonary arterial hypertension in subjects aged 18 years and over (open-extension study to NS 304/-02) | Pulmonary arterial hypertension (PAH) (idiopathic PAH, familial PAH, and PAH associated with collagen disease, corrected congenital vitium or anorexigen use MedDRA version: 19.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Code: Selexipag, ACT-293987 (NS-304) INN or Proposed INN: Selexipag | Actelion Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 40 | Phase 2 | France;Hungary;Belgium;Austria;Germany;Italy;United Kingdom | ||
| 427 | EUCTR2008-003482-68-DK (EUCTR) | 16/03/2009 | 02/02/2009 | Randomized, double-blind, placebo-controlled, multi-centre, multi-national study to evaluate the efficacy and safety of oral BAY 63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with symptomatic Pulmonary Arterial Hypertension (PAH). - PATENT-1 Study | Randomized, double-blind, placebo-controlled, multi-centre, multi-national study to evaluate the efficacy and safety of oral BAY 63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with symptomatic Pulmonary Arterial Hypertension (PAH). - PATENT-1 Study | Pulmonary Arterial Hypertension (PAH) MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension | Product Name: BAY 63-2521 tablets 0.5 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Product Name: BAY 63-2521 tablets 1 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Product Name: BAY 63-2521 tablets 1.5 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Product Name: BAY 63-2521 tablets 2 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb | Bayer HealthCare AG, D-51368 Leverkusen | NULL | Not Recruiting | Female: yes Male: yes | 462 | Portugal;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Belgium;Denmark;Germany;Netherlands;Sweden | |||
| 428 | EUCTR2008-003482-68-AT (EUCTR) | 13/03/2009 | 21/10/2008 | Randomized, double-blind, placebo-controlled, multi-centre, multi-national study to evaluate the efficacy and safety of oral BAY 63 2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with symptomatic Pulmonary Arterial Hypertension (PAH). - PATENT-1 Study | Randomized, double-blind, placebo-controlled, multi-centre, multi-national study to evaluate the efficacy and safety of oral BAY 63 2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with symptomatic Pulmonary Arterial Hypertension (PAH). - PATENT-1 Study | Pulmonary Arterial Hypertension (PAH) MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension | Product Name: BAY 63-2521 tablets 0.5 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Product Name: BAY 63-2521 tablets 1 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Product Name: BAY 63-2521 tablets 1.5 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Product Name: BAY 63-2521 tablets 2 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb | Bayer HealthCare AG | NULL | Not Recruiting | Female: yes Male: yes | 462 | Phase 3 | Portugal;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Belgium;Denmark;Germany;Netherlands;Sweden | ||
| 429 | EUCTR2008-003610-94-AT (EUCTR) | 13/03/2009 | 18/11/2008 | Long-term study to collect additional information to evaluate the safetyand tolerability of BAY 63-2521 in different doses | Long-term extension, multi-centre, multi-national study to evaluate the safety and tolerability of oral BAY 63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with symptomatic Pulmonary Arterial Hypertension (PAH). - PATENT-2 study | Pulmonary Arterial Hypertension (PAH) MedDRA version: 17.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Adempas Product Name: BAY 63-2521 coated tablets 0.5 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: BAY 63-2521 Trade Name: Adempas Product Name: BAY 63-2521 coated tablets 1 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: BAY 63-2521 Trade Name: Adempas Product Name: BAY 63-2521 coated tablets 1.5 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: BAY 63-2521 Trade Name: Adempas Product Name: BAY 63-2521 coated tablets 2 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: BAY 63-2521 Trade Name: Adempas Product Name: BAY 63-2521 coated tablets 2.5 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: BAY 63-2521 | Bayer HealthCare AG | NULL | Not Recruiting | Female: yes Male: yes | 462 | Phase 3 | Portugal;United States;Taiwan;Greece;Thailand;Spain;Ireland;Russian Federation;Israel;Switzerland;Italy;France;Australia;Denmark;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Germany;New Zealand;Japan;Sweden | ||
| 430 | NCT00863681 (ClinicalTrials.gov) | March 12, 2009 | 13/3/2009 | BAY63-2521:Long-term Extension Study in Patients With Pulmonary Arterial Hypertension | Long-term Extension, Multicentre, Multi-national Study to Evaluate the Safety and Tolerability of Oral BAY63-2521 (1mg,1.5 mg, 2.0 mg, 2.5 mg Tid) in Patients With Symptomatic Pulmonary Arterial Hypertension (PAH) | Hypertension, Pulmonary | Drug: Riociguat (BAY63-2521) | Bayer | NULL | Completed | 18 Years | 80 Years | All | 396 | Phase 3 | United States;Argentina;Australia;Austria;Belgium;Brazil;Canada;China;Czechia;Denmark;France;Germany;Greece;Italy;Japan;Korea, Republic of;Mexico;Poland;Portugal;Russian Federation;Singapore;Sweden;Switzerland;Taiwan;Thailand;Turkey;United Kingdom;Czech Republic;Ireland;Israel;Netherlands;New Zealand;Slovakia;Spain |
| 431 | EUCTR2008-003482-68-GB (EUCTR) | 09/03/2009 | 07/01/2009 | Study to evaluate the efficacy and safety of different doses of Bay 63-2521 in patients with pulmonary arterial hypertension. | Randomized, double-blind, placebo-controlled, multi-centre, multi-national study to evaluate the efficacy and safety of oral BAY 63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with symptomatic Pulmonary Arterial Hypertension (PAH). - PATENT-1 Study | Pulmonary Arterial Hypertension (PAH) MedDRA version: 14.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: BAY 63-2521 tablets 0.5 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Product Name: BAY 63-2521 tablets 1 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Product Name: BAY 63-2521 tablets 1.5 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Product Name: BAY 63-2521 tablets 2 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb | Bayer HealthCare AG, D-51368 Leverkusen | NULL | Not Recruiting | Female: yes Male: yes | 462 | Phase 3 | Portugal;United States;Taiwan;Greece;Thailand;Spain;Ireland;Russian Federation;Israel;Italy;Switzerland;France;Denmark;Australia;Netherlands;China;Korea, Republic of;Austria;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Singapore;Germany;New Zealand;Japan;Sweden | ||
| 432 | EUCTR2008-003610-94-BE (EUCTR) | 05/03/2009 | 23/01/2009 | Long-term study to collect additional information to evaluate the safety and tolerability of BAY 63-2521 in different doses | Long-term extension, multi-centre, multi-national study to evaluate the safety and tolerability of oral BAY 63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with symptomatic Pulmonary Arterial Hypertension (PAH). - PATENT-2 study | Pulmonary Arterial Hypertension (PAH) MedDRA version: 18.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Adempas Product Name: BAY 63-2521 coated tablets 0.5 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: BAY 63-2521 Trade Name: Adempas Product Name: BAY 63-2521 coated tablets 1 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: BAY 63-2521 Trade Name: Adempas Product Name: BAY 63-2521 coated tablets 1.5 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: BAY 63-2521 Trade Name: Adempas Product Name: BAY 63-2521 coated tablets 2 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: BAY 63-2521 | Bayer HealthCare AG | NULL | Not Recruiting | Female: yes Male: yes | 462 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;United States;Taiwan;Greece;Thailand;Spain;Ireland;Russian Federation;Israel;Switzerland;Italy;France;Australia;Denmark;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Germany;New Zealand;Japan;Sweden | ||
| 433 | EUCTR2008-003610-94-IT (EUCTR) | 05/03/2009 | 17/03/2009 | Long-term extension, multi-centre, multi-national study to evaluate the safety and tolerability of oral BAY 63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with symptomatic Pulmonary Arterial Hypertension (PAH - PATENT 2 | Long-term extension, multi-centre, multi-national study to evaluate the safety and tolerability of oral BAY 63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with symptomatic Pulmonary Arterial Hypertension (PAH - PATENT 2 | Pulmonary Arterial Hypertension (PAH) MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension | Product Name: BAY 63-2521 INN or Proposed INN: riociguat Product Name: BAY 63-2521 INN or Proposed INN: riociguat Product Name: BAY 63-2521 INN or Proposed INN: riociguat Product Name: BAY 63-2521 INN or Proposed INN: riociguat Product Name: BAY 63-2521 INN or Proposed INN: riociguat | Bayer HealthCare AG | NULL | Not Recruiting | Female: yes Male: yes | 462 | United Kingdom;France;Czech Republic;Belgium;Denmark;Germany;Netherlands;Sweden;Portugal;Greece;Spain;Ireland;Austria;Italy | |||
| 434 | NCT00792571 (ClinicalTrials.gov) | February 28, 2009 | 14/11/2008 | An Open-Label Extension of BPS-MR-PAH-201 in Pulmonary Arterial Hypertension (PAH) Patients | An Open-Label Extension of BPS-MR-PAH-201 in Pulmonary Arterial Hypertension (PAH) Patients. | Pulmonary Arterial Hypertension | Drug: Beraprost Sodium Modified Release | Lung Biotechnology PBC | NULL | Completed | 18 Years | 75 Years | All | 18 | Phase 2 | United States;Belgium;Ireland |
| 435 | EUCTR2008-003482-68-IT (EUCTR) | 17/02/2009 | 17/03/2009 | Randomized, double-blind, placebo-controlled, multi-centre, multi-national study to evaluate the efficacy and safety of oral BAY 63 2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with symptomatic Pulmonary Arterial Hypertension (PAH) - PATENT 1 | Randomized, double-blind, placebo-controlled, multi-centre, multi-national study to evaluate the efficacy and safety of oral BAY 63 2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with symptomatic Pulmonary Arterial Hypertension (PAH) - PATENT 1 | Pulmonary Arterial Hypertension (PAH) MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension | Product Name: BAY 63-2521 INN or Proposed INN: riociguat Product Name: BAY 63-2521 INN or Proposed INN: riociguat Product Name: BAY 63-2521 INN or Proposed INN: riociguat Product Name: BAY 63-2521 INN or Proposed INN: riociguat Product Name: BAY 63-2521 INN or Proposed INN: riociguat | Bayer Healthcare AG | NULL | Not Recruiting | Female: yes Male: yes | 462 | Portugal;Germany;Netherlands;France;Ireland;Italy;Austria;Sweden;United Kingdom;Czech Republic;Denmark;Belgium;Spain;Greece | |||
| 436 | EUCTR2008-003482-68-NL (EUCTR) | 13/02/2009 | 30/10/2008 | Randomized, double-blind, placebo-controlled, multi-centre, multi-national study to evaluate the efficacy and safety of oral BAY 63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with symptomatic Pulmonary Arterial Hypertension (PAH). - PATENT-1 Study | Randomized, double-blind, placebo-controlled, multi-centre, multi-national study to evaluate the efficacy and safety of oral BAY 63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with symptomatic Pulmonary Arterial Hypertension (PAH). - PATENT-1 Study | Pulmonary Arterial Hypertension (PAH) MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension | Product Name: BAY 63-2521 tablets 0.5 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Product Name: BAY 63-2521 tablets 1 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Product Name: BAY 63-2521 tablets 1.5 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Product Name: BAY 63-2521 tablets 2 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb | Bayer HealthCare AG | NULL | Not Recruiting | Female: yes Male: yes | 462 | Portugal;Germany;Netherlands;France;Ireland;Italy;Austria;Sweden;United Kingdom;Czech Republic;Denmark;Belgium;Spain;Greece | |||
| 437 | EUCTR2008-003610-94-NL (EUCTR) | 13/02/2009 | 28/04/2009 | Long-term extension, multi-centre, multi-national study to evaluate the safety and tolerability of oral BAY 63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with symptomatic Pulmonary Arterial Hypertension (PAH). - PATENT-2 | Long-term extension, multi-centre, multi-national study to evaluate the safety and tolerability of oral BAY 63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with symptomatic Pulmonary Arterial Hypertension (PAH). - PATENT-2 | Pulmonary Arterial Hypertension (PAH) MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension | Product Name: BAY 63-2521 tablets 0.5 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Product Name: BAY 63-2521 tablets 1 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Product Name: BAY 63-2521 tablets 1 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Product Name: BAY 63-2521 tablets 2 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat | Bayer HealthCare AG | NULL | Not Recruiting | Female: yes Male: yes | 462 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Belgium;Denmark;Netherlands;Germany;Sweden | ||
| 438 | EUCTR2008-003610-94-CZ (EUCTR) | 12/02/2009 | 02/02/2009 | Long-term study to collect additional information to evaluate the safety and tolerability of BAY 63-2521 in different doses | Long-term extension, multi-centre, multi-national study to evaluate the safety and tolerability of oral BAY 63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with symptomatic Pulmonary Arterial Hypertension (PAH). - PATENT-2 study | Pulmonary Arterial Hypertension (PAH) MedDRA version: 17.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Adempas Product Name: BAY 63-2521 coated tablets 0.5 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: BAY 63-2521 Trade Name: Adempas Product Name: BAY 63-2521 coated tablets 1 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: BAY 63-2521 Trade Name: Adempas Product Name: BAY 63-2521 coated tablets 1.5 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: BAY 63-2521 Trade Name: Adempas Product Name: BAY 63-2521 coated tablets 2 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: BAY 63-2521 | Bayer HealthCare AG | NULL | Not Recruiting | Female: yes Male: yes | 462 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;United States;Taiwan;Greece;Thailand;Spain;Ireland;Russian Federation;Israel;Switzerland;Italy;France;Australia;Denmark;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Germany;New Zealand;Japan;Sweden | ||
| 439 | EUCTR2008-006833-29-BE (EUCTR) | 04/02/2009 | 16/12/2008 | An Open-Label Extension of BPS-MR-PAH-201 in Pulmonary Arterial Hypertension (PAH) Patients | An Open-Label Extension of BPS-MR-PAH-201 in Pulmonary Arterial Hypertension (PAH) Patients | Pulmonary Arterial Hypertension MedDRA version: 14.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Beraprost Sodium Modified Release Product Code: BPS-MR INN or Proposed INN: Beraprost Sodium Other descriptive name: TRK-100STP | Lung LLC | NULL | Not Recruiting | Female: yes Male: yes | 19 | Phase 2 | United States;Belgium;Ireland | ||
| 440 | EUCTR2008-003290-41-BE (EUCTR) | 04/02/2009 | 09/12/2008 | A Multi-center, open-label, multiple dose, dose finding study exploring the safety and tolerability of Beraprost Sodium Modified Release in PAH patients | A Multi-center, open-label, multiple dose, dose finding study exploring the safety and tolerability of Beraprost Sodium Modified Release in PAH patients | Pulmonary Arterial Hypertension MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension | Product Name: Beraprost Sodium Modified Release Product Code: BPS-MR INN or Proposed INN: Beraprost Sodium Other descriptive name: TRK-100STP | Lung Rx | NULL | Not Recruiting | Female: yes Male: yes | 20 | Belgium;Ireland | |||
| 441 | NCT00781885 (ClinicalTrials.gov) | January 31, 2009 | 27/10/2008 | A Multi-Center, Open-Label, Multiple Dose, Dose Finding Study Exploring the Safety and Tolerability of Beraprost Sodium Modified Release in PAH Patients | A Multi-Center, Open-Label, Multiple Dose, Dose Finding Study Exploring the Safety and Tolerability of Beraprost Sodium Modified Release in PAH Patients | Pulmonary Arterial Hypertension | Drug: Beraprost sodium modified release | Lung Biotechnology PBC | NULL | Completed | 18 Years | 75 Years | All | 19 | Phase 2 | United States;Belgium;Ireland |
| 442 | EUCTR2006-006748-76-BG (EUCTR) | 30/01/2009 | 06/01/2009 | A MULTINATIONAL, MULTICENTRE, RANDOMIZED, PARALLEL GROUP, DOUBLE-BLIND STUDY TO ASSESS THE EFFICACY AND SAFETY OF 1 MG, 5 MG AND 20 MG TID OF ORAL SILDENAFIL IN THE TREATMENT OF SUBJECTS AGED 18 YEARS AND OVER WITH PULMONARY ARTERIAL HYPERTENSION (PAH) - N/A | A MULTINATIONAL, MULTICENTRE, RANDOMIZED, PARALLEL GROUP, DOUBLE-BLIND STUDY TO ASSESS THE EFFICACY AND SAFETY OF 1 MG, 5 MG AND 20 MG TID OF ORAL SILDENAFIL IN THE TREATMENT OF SUBJECTS AGED 18 YEARS AND OVER WITH PULMONARY ARTERIAL HYPERTENSION (PAH) - N/A | Pulmonary arterial hypertension (PAH) | Trade Name: Revatio INN or Proposed INN: Sildenafil citrate Trade Name: Revatio INN or Proposed INN: Sildenafil citrate Trade Name: Revatio INN or Proposed INN: Sildenafil citrate | Pfizer Ltd, Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK | NULL | Not Recruiting | Female: yes Male: yes | 219 | United Kingdom;Netherlands;Belgium;Denmark;Bulgaria;Italy;Greece;Latvia | |||
| 443 | EUCTR2008-003482-68-CZ (EUCTR) | 23/01/2009 | 23/01/2009 | Study to assess the efficacy and safety of different doses of a new drug (BAY 63 2521), given orally to patients with Pulmonary Arterial Hypertension. | Randomized, double-blind, placebo-controlled, multi-centre, multi-national study to evaluate the efficacy and safety of oral BAY 63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with symptomatic Pulmonary Arterial Hypertension (PAH). - PATENT-1 Study | Pulmonary Arterial Hypertension (PAH) MedDRA version: 14.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: BAY 63-2521 tablets 0.5 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Product Name: BAY 63-2521 tablets 1 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Product Name: BAY 63-2521 tablets 1.5 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Product Name: BAY 63-2521 tablets 2 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb | Bayer HealthCare AG | NULL | Not Recruiting | Female: yes Male: yes | 462 | Germany;France;Ireland;Singapore;Austria;Sweden;Brazil;Australia;Czech Republic;Canada;New Zealand;Belgium;Korea, Republic of;United States;Greece;Poland;Portugal;Turkey;Switzerland;Netherlands;Italy;Israel;United Kingdom;Russian Federation;Taiwan;Denmark;Argentina;Mexico;China;Thailand;Spain;Japan | |||
| 444 | EUCTR2008-003482-68-BE (EUCTR) | 14/01/2009 | 13/02/2009 | Randomized, double-blind, placebo-controlled, multi-centre, multi-national study to evaluate the efficacy and safety of oral BAY 63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with symptomatic Pulmonary Arterial Hypertension (PAH). - PATENT-1 Study | Randomized, double-blind, placebo-controlled, multi-centre, multi-national study to evaluate the efficacy and safety of oral BAY 63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with symptomatic Pulmonary Arterial Hypertension (PAH). - PATENT-1 Study | Pulmonary Arterial Hypertension (PAH) MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension | Product Name: BAY 63-2521 tablets 0.5 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Product Name: BAY 63-2521 tablets 1 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Product Name: BAY 63-2521 tablets 1.5 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Product Name: BAY 63-2521 tablets 2 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb | Bayer HealthCare AG, D-51368 Leverkusen | NULL | Not Recruiting | Female: yes Male: yes | 462 | Phase 3 | Portugal;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Belgium;Denmark;Germany;Netherlands;Sweden | ||
| 445 | EUCTR2008-003610-94-FR (EUCTR) | 14/01/2009 | 07/11/2008 | Long-term extension, multi-centre, multi-national study to evaluate the safety and tolerability of oral BAY 63 2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with symptomatic Pulmonary Arterial Hypertension (PAH). - PATENT-2 | Long-term extension, multi-centre, multi-national study to evaluate the safety and tolerability of oral BAY 63 2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with symptomatic Pulmonary Arterial Hypertension (PAH). - PATENT-2 | Pulmonary Arterial Hypertension (PAH) MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension | Product Name: BAY 63-2521 tablets 0.5 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Product Name: BAY 63-2521 tablets 1 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Product Name: BAY 63-2521 tablets 1 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Product Name: BAY 63-2521 tablets 2 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat | Bayer HealthCare AG | NULL | Not Recruiting | Female: yes Male: yes | 462 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Belgium;Denmark;Germany;Netherlands;Sweden | ||
| 446 | EUCTR2008-003482-68-IE (EUCTR) | 13/01/2009 | 10/10/2008 | Randomized, double-blind, placebo-controlled, multi-centre, multi-national study to evaluate the efficacy and safety of oral BAY 63 2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with symptomatic Pulmonary Arterial Hypertension (PAH). - PATENT-1 Study | Randomized, double-blind, placebo-controlled, multi-centre, multi-national study to evaluate the efficacy and safety of oral BAY 63 2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with symptomatic Pulmonary Arterial Hypertension (PAH). - PATENT-1 Study | Pulmonary Arterial Hypertension (PAH) MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension | Product Name: BAY 63-2521 tablets 0.5 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Product Name: BAY 63-2521 tablets 1 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Product Name: BAY 63-2521 tablets 1.5 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Product Name: BAY 63-2521 tablets 2 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb | Bayer HealthCare AG | NULL | Not Recruiting | Female: yes Male: yes | 462 | Phase 3 | Portugal;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Belgium;Denmark;Germany;Netherlands;Sweden | ||
| 447 | NCT00832507 (ClinicalTrials.gov) | January 2009 | 29/1/2009 | Study of Cicletanine for Pulmonary Arterial Hypertension (PAH) | A Phase 2, Randomized, Double-blind, Placebo-controlled, Multicenter, Dose-ranging Study of Cicletanine in Subjects With Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension | Drug: Cicletanine;Drug: Cicletanine Placebo | Gilead Sciences | NULL | Terminated | 16 Years | 70 Years | Both | 162 | Phase 2 | United States;Australia;Austria;Belgium;Canada;Germany;Israel;Mexico;Spain;United Kingdom |
| 448 | EUCTR2008-003482-68-FR (EUCTR) | 27/12/2008 | 06/11/2008 | Randomized, double-blind, placebo-controlled, multi-centre, multi-national study to evaluate the efficacy and safety of oral BAY 63 2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with symptomatic Pulmonary Arterial Hypertension (PAH). - PATENT-1 Study | Randomized, double-blind, placebo-controlled, multi-centre, multi-national study to evaluate the efficacy and safety of oral BAY 63 2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with symptomatic Pulmonary Arterial Hypertension (PAH). - PATENT-1 Study | Pulmonary Arterial Hypertension (PAH) MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension | Product Name: BAY 63-2521 tablets 0.5 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Product Name: BAY 63-2521 tablets 1 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Product Name: BAY 63-2521 tablets 1.5 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Product Name: BAY 63-2521 tablets 2 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb | Bayer HealthCare AG | NULL | Not Recruiting | Female: yes Male: yes | 462 | Phase 3 | Portugal;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Belgium;Denmark;Germany;Netherlands;Sweden | ||
| 449 | EUCTR2008-003610-94-SE (EUCTR) | 08/12/2008 | 14/11/2008 | Long-term study to collect additional information to evaluate the safety and tolerability of BAY 63-2521 in different doses | Long-term extension, multi-centre, multi-national study to evaluate the safety and tolerability of oral BAY 63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with symptomatic Pulmonary Arterial Hypertension (PAH). - PATENT-2 study | Pulmonary Arterial Hypertension (PAH) MedDRA version: 18.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Adempas Product Name: BAY 63-2521 coated tablets 0.5 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: BAY 63-2521 Trade Name: Adempas Product Name: BAY 63-2521 coated tablets 1 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: BAY 63-2521 Trade Name: Adempas Product Name: BAY 63-2521 coated tablets 1.5 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: BAY 63-2521 Trade Name: Adempas Product Name: BAY 63-2521 coated tablets 2 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: BAY 63-2521 | Bayer HealthCare AG | NULL | Not Recruiting | Female: yes Male: yes | 462 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;United States;Taiwan;Greece;Thailand;Spain;Ireland;Russian Federation;Israel;Switzerland;Italy;France;Australia;Denmark;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Germany;New Zealand;Japan;Sweden | ||
| 450 | EUCTR2008-003482-68-SE (EUCTR) | 05/12/2008 | 07/11/2008 | Randomized, double-blind, placebo-controlled, multi-centre, multi-national study to evaluate the efficacy and safety of oral BAY 63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with symptomatic Pulmonary Arterial Hypertension (PAH). - PATENT-1 Study | Randomized, double-blind, placebo-controlled, multi-centre, multi-national study to evaluate the efficacy and safety of oral BAY 63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with symptomatic Pulmonary Arterial Hypertension (PAH). - PATENT-1 Study | Pulmonary Arterial Hypertension (PAH) MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension | Product Name: BAY 63-2521 tablets 0.5 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Product Name: BAY 63-2521 tablets 1 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Product Name: BAY 63-2521 tablets 1.5 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Product Name: BAY 63-2521 tablets 2 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb | Bayer HealthCare AG, D-51368 Leverkusen | NULL | Not Recruiting | Female: yes Male: yes | 462 | Portugal;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Belgium;Denmark;Germany;Netherlands;Sweden | |||
| 451 | EUCTR2007-003621-24-GB (EUCTR) | 02/12/2008 | 14/07/2008 | Double-blind, randomized, placebo-controlled, dose-finding, parallel-group study to assess the hemodynamic effects, clinical efficacy, tolerability and safety of Aviptadil (Vasoactive Intestinal Peptide) after single and repeated inhalation in patients with pulmonary arterial hypertension. | Double-blind, randomized, placebo-controlled, dose-finding, parallel-group study to assess the hemodynamic effects, clinical efficacy, tolerability and safety of Aviptadil (Vasoactive Intestinal Peptide) after single and repeated inhalation in patients with pulmonary arterial hypertension. | Pulmonary arterial hypertension (PAH) due to idiopathic pulmonary arterial hypertension (IPAH), familial PAH or PAH associated with connective tissue diseases (CTD) (e.g. systemic sclerosis, systemic lupus erythematosus) or to repaired congenital heart defects (RCHD). MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065152;Term: Familial pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065150;Term: Associated with pulmonary arterial hypertension | Product Name: Aviptadil Product Code: VIP INN or Proposed INN: Aviptadil Other descriptive name: VIP | MondoGEN AG | NULL | Not Recruiting | Female: yes Male: yes | 48 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | France;Spain;Belgium;Austria;Germany;Netherlands;Italy;United Kingdom | ||
| 452 | NCT00810693 (ClinicalTrials.gov) | December 2008 | 17/12/2008 | A Study to Evaluate Efficacy and Safety of Oral BAY63-2521 in Patients With Pulmonary Arterial Hypertension (PAH) | Randomized, Double-blind, Placebo-controlled, Multi-centre, Multi-national Study to Evaluate the Efficacy and Safety of Oral BAY63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg Tid) in Patients With Symptomatic Pulmonary Arterial Hypertension (PAH) | Pulmonary Hypertension | Drug: Riociguat (Adempas, BAY63-2521);Drug: Placebo | Bayer | NULL | Completed | 18 Years | 80 Years | All | 445 | Phase 3 | United States;Argentina;Australia;Austria;Belgium;Brazil;Canada;China;Czech Republic;Denmark;France;Germany;Greece;Ireland;Israel;Italy;Japan;Korea, Republic of;Mexico;Netherlands;New Zealand;Poland;Portugal;Russian Federation;Singapore;Spain;Sweden;Switzerland;Taiwan;Thailand;Turkey;United Kingdom;Slovakia |
| 453 | NCT00780728 (ClinicalTrials.gov) | December 2008 | 27/10/2008 | Study Evaluating the Addition of Sildenafil to Bosentan Therapy in Pulmonary Arterial Hypertension | Addition of Sildenafil to Bosentan Monotherapy in Patients With Pulmonary Arterial Hypertension (PAH) | Hypertension, Pulmonary | Drug: Sildenafil | University Health Network, Toronto | NULL | Withdrawn | 18 Years | N/A | Both | Phase 3 | Canada | |
| 454 | NCT00760916 (ClinicalTrials.gov) | December 2008 | 25/9/2008 | FREEDOM DR: Oral Treprostinil in Combination With an Endothelin Receptor Antagonist (ERA) and/or a Phosphodiesterase-5 (PDE-5) Inhibitor or as Monotherapy for the Treatment of Pulmonary Arterial Hypertension (PAH) | FREEDOM DR: An International, Multi-Center, 12-Week, Double Blind, Randomized, Placebo-Controlled, Parallel Group Study Followed by a 12-Week Open-Label Extension Study to Assess the Efficacy, Safety, and Dose Response of UT-15C SR in Subjects With Pulmonary Hypertension | Pulmonary Hypertension | Drug: UT-15C 1 mg;Drug: UT-15C 0.25 mg;Drug: UT-15C 5 mg;Drug: Placebo | United Therapeutics | NULL | Withdrawn | 18 Years | 70 Years | Both | 0 | Phase 3 | United States;Australia;Mexico |
| 455 | EUCTR2008-003610-94-DE (EUCTR) | 26/11/2008 | 31/10/2008 | Long-term study to collect additional information to evaluate the safetyand tolerability of BAY 63-2521 in different doses | Long-term extension, multi-centre, multi-national study to evaluate the safety and tolerability of oral BAY 63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with symptomatic Pulmonary Arterial Hypertension (PAH). - PATENT-2 study | Pulmonary Arterial Hypertension (PAH) MedDRA version: 15.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: BAY 63-2521 tablets 0.5 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Product Name: BAY 63-2521 tablets 1 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Product Name: BAY 63-2521 tablets 1.5 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Product Name: BAY 63-2521 tablets 2 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Product Name: BAY 63-2521 tablets 2.5 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat | Bayer HealthCare AG | NULL | Not Recruiting | Female: yes Male: yes | 462 | Phase 3 | United States;Portugal;Taiwan;Greece;Thailand;Spain;Ireland;Israel;Russian Federation;Switzerland;Italy;France;Denmark;Australia;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Singapore;Germany;Japan;New Zealand;Sweden | ||
| 456 | EUCTR2008-003482-68-DE (EUCTR) | 26/11/2008 | 02/10/2008 | Randomized, double-blind, placebo-controlled, multi-centre, multi-national study to evaluate the efficacy and safety of oral BAY 63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with symptomatic Pulmonary Arterial Hypertension (PAH). - PATENT-1 Study | Randomized, double-blind, placebo-controlled, multi-centre, multi-national study to evaluate the efficacy and safety of oral BAY 63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with symptomatic Pulmonary Arterial Hypertension (PAH). - PATENT-1 Study | Pulmonary Arterial Hypertension (PAH) MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension | Product Name: BAY 63-2521 tablets 0.5 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Product Name: BAY 63-2521 tablets 1 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Product Name: BAY 63-2521 tablets 1.5 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Product Name: BAY 63-2521 tablets 2 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb | Bayer HealthCare AG | NULL | Not Recruiting | Female: yes Male: yes | 462 | Portugal;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Belgium;Denmark;Germany;Netherlands;Sweden | |||
| 457 | EUCTR2007-003328-39-GB (EUCTR) | 05/11/2008 | 19/03/2008 | A multi-centre, multinational, open-label single-dose acute hemodynamic study followed by a multi-centre, multinational, randomized, double-blind, parallel-group, placebo controlled study to assess the safety, tolerability, pharmacokinetics and preliminary efficacy (proof-of-concept) of ACT-293987 (NS-304) in the treatment of pulmonary arterial hypertension in subjects aged 18 years and over | A multi-centre, multinational, open-label single-dose acute hemodynamic study followed by a multi-centre, multinational, randomized, double-blind, parallel-group, placebo controlled study to assess the safety, tolerability, pharmacokinetics and preliminary efficacy (proof-of-concept) of ACT-293987 (NS-304) in the treatment of pulmonary arterial hypertension in subjects aged 18 years and over | pulmonary arterial hypertension (PAH) (idiopathic PAH, familial PAH, and PAH associated with collagen disease, corrected congenital vitium or anorexigen use) MedDRA version: 9.1;Level: LLT;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065152;Term: Familial pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065150;Term: Associated with pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10064911;Term: Pulmonary arterial hypertension | Product Code: ACT-293987 (NS-304) INN or Proposed INN: 2-(4-[5,6-diphenylpyrazin-2-yl)(isopropyl)amino]butoxy)-N-(methylsulfonyl)actamide | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 44 | Hungary;Germany;United Kingdom;Belgium;France;Italy;Austria | |||
| 458 | EUCTR2006-001464-23-GR (EUCTR) | 04/11/2008 | 30/01/2009 | A multinational, multicentre, randomized, double-blind study to assess the efficacy and safety of oral sildenafil 20mg TID or placebo when added to Bosentan in the treatement of subjects , aged 18 years and above, with pulmonary arterial hypertension (PAH) - N/A | A multinational, multicentre, randomized, double-blind study to assess the efficacy and safety of oral sildenafil 20mg TID or placebo when added to Bosentan in the treatement of subjects , aged 18 years and above, with pulmonary arterial hypertension (PAH) - N/A | Pulmonary Arterial Hypertension MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension | Trade Name: Revatio Product Name: Revatio® Product Code: UK-92,480 INN or Proposed INN: Sildenafil | Pfizer Ltd,Ramsgate Road,Sandwich CT13 9NJ | NULL | Not Recruiting | Female: yes Male: yes | 106 | Czech Republic;Greece;Germany;Italy;United Kingdom | |||
| 459 | EUCTR2006-006748-76-LV (EUCTR) | 22/10/2008 | 10/06/2008 | A MULTINATIONAL, MULTICENTRE, RANDOMIZED, PARALLEL GROUP, DOUBLE-BLIND STUDY TO ASSESS THE EFFICACY AND SAFETY OF 1 MG, 5 MG AND 20 MG TID OF ORAL SILDENAFIL IN THE TREATMENT OF SUBJECTS AGED 18 YEARS AND OVER WITH PULMONARY ARTERIAL HYPERTENSION (PAH) - N/A | A MULTINATIONAL, MULTICENTRE, RANDOMIZED, PARALLEL GROUP, DOUBLE-BLIND STUDY TO ASSESS THE EFFICACY AND SAFETY OF 1 MG, 5 MG AND 20 MG TID OF ORAL SILDENAFIL IN THE TREATMENT OF SUBJECTS AGED 18 YEARS AND OVER WITH PULMONARY ARTERIAL HYPERTENSION (PAH) - N/A | Pulmonary arterial hypertension (PAH) | Trade Name: Revatio INN or Proposed INN: Sildenafil citrate Trade Name: Revatio INN or Proposed INN: Sildenafil citrate Trade Name: Revatio INN or Proposed INN: Sildenafil citrate | Pfizer Ltd, Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK | NULL | Not Recruiting | Female: yes Male: yes | 219 | United Kingdom;Netherlands;Belgium;Denmark;Bulgaria;Italy;Greece;Latvia | |||
| 460 | EUCTR2006-006748-76-GB (EUCTR) | 15/10/2008 | 02/09/2008 | A MULTINATIONAL, MULTICENTRE, RANDOMIZED, PARALLEL GROUP, DOUBLE-BLIND STUDY TO ASSESS THE EFFICACY AND SAFETY OF 1 MG, 5 MG AND 20 MG TID OF ORAL SILDENAFIL IN THE TREATMENT OF SUBJECTS AGED 18 YEARS AND OVER WITH PULMONARY ARTERIAL HYPERTENSION (PAH) - N/A | A MULTINATIONAL, MULTICENTRE, RANDOMIZED, PARALLEL GROUP, DOUBLE-BLIND STUDY TO ASSESS THE EFFICACY AND SAFETY OF 1 MG, 5 MG AND 20 MG TID OF ORAL SILDENAFIL IN THE TREATMENT OF SUBJECTS AGED 18 YEARS AND OVER WITH PULMONARY ARTERIAL HYPERTENSION (PAH) - N/A | Pulmonary arterial hypertension (PAH) | Trade Name: Revatio INN or Proposed INN: Sildenafil citrate Trade Name: Revatio INN or Proposed INN: Sildenafil citrate Trade Name: Revatio INN or Proposed INN: Sildenafil citrate | Pfizer Ltd, Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK | NULL | Not Recruiting | Female: yes Male: yes | 219 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | Greece;Belgium;Denmark;Bulgaria;Latvia;Netherlands;Italy;United Kingdom | ||
| 461 | EUCTR2007-006453-12-BE (EUCTR) | 03/10/2008 | 07/07/2008 | Study to evaluate if selexipag is safe and efficacious for the treatment of pulmonary arterial hypertension | A multi-centre, multinational, open-label study to evaluate the long-term safety, tolerability and efficacy of selexipag / ACT 293987 (NS-304) in the treatment of pulmonary arterial hypertension in subjects aged 18 years and over (open-extension study to NS 304/-02) | pulmonary arterial hypertension (PAH) (idiopathic PAH, familial PAH, and PAH associated with collagen disease, corrected congenital vitium or anorexigen use MedDRA version: 18.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Code: Selexipag, ACT-293987 (NS-304) INN or Proposed INN: Selexipag | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 40 | Phase 2 | France;Hungary;Belgium;Austria;Germany;Italy;United Kingdom | ||
| 462 | NCT00800592 (ClinicalTrials.gov) | October 2008 | 19/11/2008 | Sildenafil IV Bolus Study | An Open Single Dose Study To Assess The Safety, Tolerability And Pharmacokinetics Of An Intravenous Bolus Dose (10 Mg) Of Sildenafil In Patients With Pulmonary Arterial Hypertension (PAH). | Hypertension, Pulmonary | Drug: sildenafil | Pfizer's Upjohn has merged with Mylan to form Viatris Inc. | NULL | Completed | 18 Years | N/A | All | 12 | Phase 1 | Belgium |
| 463 | EUCTR2005-005068-97-GR (EUCTR) | 23/09/2008 | 20/02/2009 | Effects of combination of bosentan and sildenafil versus sildenafil monotherapy on morbidity and mortality in symptomatic patients with pulmonary arterial hypertension – A multicenter, double - blind, randomized, placebo - controlled, parallel group, prospective, event driven Phase IV study - COMPASS 2 | Effects of combination of bosentan and sildenafil versus sildenafil monotherapy on morbidity and mortality in symptomatic patients with pulmonary arterial hypertension – A multicenter, double - blind, randomized, placebo - controlled, parallel group, prospective, event driven Phase IV study - COMPASS 2 | Patients to be included must have PAH belonging to WHO Group I, in agreement with the approved indications for sildenafil in PAH by the US FDA:a.Idiopathic (IPAH)b.Familial (FPAH)c.Associated with (APAH):i.Collagen vascular disease with normal left ventricular function (ejection fraction (EF) > 50%) ii.Congenital systemic-to-pulmonary shunts at least 2 years post surgical repairiii.Drugs and toxins MedDRA version: 9.1;Level: LLT;Classification code 10064908;Term: Associated with (APAH) MedDRA version: 9.1;Classification code 10064910;Term: Familial (FPAH) MedDRA version: 9.1;Classification code 10064909;Term: Idiopathic (IPAH) | Trade Name: Tracleer Product Name: bosentan Product Code: Ro-47-0203 INN or Proposed INN: BOSENTAN Other descriptive name: Ro-47-0203/029 Trade Name: Tracleer Product Name: Bosentan Product Code: Ro-47-0203 INN or Proposed INN: BOSENTAN Other descriptive name: Ro-47-0203/029 | Actelion Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 4 | Portugal;Czech Republic;Greece;Spain;Denmark;Germany;United Kingdom;Sweden | ||
| 464 | EUCTR2007-006453-12-DE (EUCTR) | 12/09/2008 | 19/12/2008 | Study to evaluate if selexipag is safe and efficacious for the treatment of pulmonary arterial hypertension | A multi-centre, multinational, open- label study to evaluate the long-term safety, tolerability and efficacy of selexipag / ACT-293987 (NS-304) in the treatment of pulmonary arterial hypertension in subjects aged 18 years and over (open-extension study to NS-304/-02) | Pulmonary arterial hypertension (PAH) (idiopathic PAH, familial PAH, and PAH associated with collagen disease, corrected congenital vitium or anorexigen use MedDRA version: 18.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Code: Selexipag, ACT-293987 (NS-304) INN or Proposed INN: Selexipag | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 40 | Phase 2 | France;Hungary;Belgium;Austria;Germany;Italy;United Kingdom | ||
| 465 | JPRN-UMIN000001350 | 2008/09/01 | 01/10/2008 | Early intervention for mild or borderline pulmonary arterial hypertension (PAH) associated with connective tissue diseases | Early intervention for mild or borderline pulmonary arterial hypertension (PAH) associated with connective tissue diseases - Keio university clinical trial for early pulmonary arterial hypertension with connective tissue diseases (KEEP-ACTIVE study) | Pulmonary arterial hypertension (PAH) associated with connective tissue disease | Beraprost sodium Beraprost sodium and Sildenafil citrate | Keio University | NULL | Complete: follow-up complete | 18years-old | 80years-old | Male and Female | 70 | Not selected | Japan |
| 466 | NCT00741819 (ClinicalTrials.gov) | September 2008 | 23/8/2008 | Safety Evaluation of Inhaled Treprostinil Administration Following Transition From Inhaled Ventavis in Pulmonary Arterial Hypertension (PAH) Subjects | An Open Label, Multi-center Study Evaluating the Safety of Long-term Inhaled Treprostinil Administration Following Transition From Inhaled Ventavis® (Iloprost) in Subjects With Pulmonary Arterial Hypertension. | Pulmonary Arterial Hypertension | Drug: Inhaled treprostinil | United Therapeutics | NULL | Completed | 18 Years | 75 Years | All | 73 | Phase 4 | United States |
| 467 | NCT01338636 (ClinicalTrials.gov) | September 2008 | 18/4/2011 | An Open-Label Uncontrolled Study of the Safety and Efficacy of Ambrisentan in Participants With Exercise-Induced Pulmonary Arterial Hypertension (PAH) | An Open-Label Uncontrolled Study of the Safety and Efficacy of Ambrisentan in Patients With Exercise Induced Pulmonary Arterial Hypertension | Exercise-induced Pulmonary Arterial Hypertension | Drug: Ambrisentan | Brigham and Women's Hospital | Gilead Sciences | Completed | 18 Years | N/A | All | 30 | Phase 4 | United States |
| 468 | EUCTR2007-006453-12-FR (EUCTR) | 20/08/2008 | 30/06/2008 | A multi-centre, multinational, open- label study to evaluate the long-term safety, tolerability and efficacy of NS-304 in the treatment of pulmonary arterial hypertension in subjects aged 18 years and over (open-extension study to NS-304/-02) | A multi-centre, multinational, open- label study to evaluate the long-term safety, tolerability and efficacy of NS-304 in the treatment of pulmonary arterial hypertension in subjects aged 18 years and over (open-extension study to NS-304/-02) | pulmonary arterial hypertension (PAH) (idiopathic PAH, familial PAH, and PAH associated with collagen disease, corrcted congenital vitium or anorexigen MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065150;Term: Associated with pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065152;Term: Familial pulmonary arterial hypertension | Product Code: NS-304 INN or Proposed INN: 2-{4-[(5,6-diphenylpyrazin-2-yl)(isopropyl)amino]butoxy}-N-(methylsulfonyl) acetamide | Nippon Shinyaku Co., Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 20 | Phase 2 | France;Hungary;Belgium;Austria;Germany;Italy;United Kingdom | ||
| 469 | EUCTR2007-006453-12-GB (EUCTR) | 31/07/2008 | 15/07/2008 | A multi-centre, multinational, open- label study to evaluate the long-term safety, tolerability and efficacy of ACT-293987 (NS-304) in the treatment of pulmonary arterial hypertension in subjects aged 18 years and over (open-extension study to NS-304/-02) | A multi-centre, multinational, open- label study to evaluate the long-term safety, tolerability and efficacy of ACT-293987 (NS-304) in the treatment of pulmonary arterial hypertension in subjects aged 18 years and over (open-extension study to NS-304/-02) | pulmonary arterial hypertension (PAH) (idiopathic PAH, familial PAH, and PAH associated with collagen disease, corrcted congenital vitium or anorexigen MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065150;Term: Associated with pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065152;Term: Familial pulmonary arterial hypertension | Product Code: ACT-293987 (NS-304) INN or Proposed INN: 2-{4-[(5,6-diphenylpyrazin-2-yl)(isopropyl)amino]butoxy}-N-(methylsulfonyl) acetamide | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 40 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | France;Hungary;Belgium;Austria;Germany;Italy;United Kingdom | ||
| 470 | EUCTR2007-003621-24-NL (EUCTR) | 23/07/2008 | 13/03/2008 | Double-blind, randomized, placebo-controlled, dose-finding, parallel-group study to assess the hemodynamic effects, clinical efficacy, tolerability and safety of Aviptadil (Vasoactive Intestinal Peptide) after single and repeated inhalation in patients with pulmonary arterial hypertension. | Double-blind, randomized, placebo-controlled, dose-finding, parallel-group study to assess the hemodynamic effects, clinical efficacy, tolerability and safety of Aviptadil (Vasoactive Intestinal Peptide) after single and repeated inhalation in patients with pulmonary arterial hypertension. | Pulmonary arterial hypertension (PAH) due to idiopathic pulmonary arterial hypertension (IPAH), familial PAH or PAH associated with connective tissue diseases (CTD) (e.g. systemic sclerosis, systemic lupus erythematosus) or to repaired congenital heart defects (RCHD). MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065152;Term: Familial pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065150;Term: Associated with pulmonary arterial hypertension | Product Name: Aviptadil Product Code: VIP INN or Proposed INN: Aviptadil Other descriptive name: VIP | MondoGEN AG | NULL | Not Recruiting | Female: yes Male: yes | 48 | Germany;United Kingdom;Netherlands;Belgium;France;Spain;Italy;Austria | |||
| 471 | EUCTR2007-003621-24-IT (EUCTR) | 15/07/2008 | 17/11/2008 | Double-blind, randomized, placebo-controlled, dose-finding, parallel-group study to assess the hemodynamic effects, clinical efficacy, tolerability and safety of Aviptadil (Vasoactive Intestinal Peptide) after single and repeated inhalation in patients with pulmonary arterial hypertension - ND | Double-blind, randomized, placebo-controlled, dose-finding, parallel-group study to assess the hemodynamic effects, clinical efficacy, tolerability and safety of Aviptadil (Vasoactive Intestinal Peptide) after single and repeated inhalation in patients with pulmonary arterial hypertension - ND | Pulmonary arterial hypertension (PAH) due to idiopathic pulmonary arterial hypertension (IPAH), familial PAH or PAH associated with connective tissue diseases (CTD) (e.g. systemic sclerosis, systemic lupus erythematosus) or to repaired congenital heart defects (RCHD). MedDRA version: 9.1;Level: LLT;Classification code 10065150;Term: Associated with pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10064911;Term: Pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065152;Term: Familial pulmonary arterial hypertension | Product Name: Aviptadil Product Code: VIP INN or Proposed INN: Aviptadil Product Name: Aviptadil Product Code: VIP INN or Proposed INN: Aviptadil Product Name: Aviptadil Product Code: VIP INN or Proposed INN: Aviptadil | MONDOGEN AG | NULL | Not Recruiting | Female: yes Male: yes | 48 | Germany;United Kingdom;Netherlands;Belgium;France;Spain;Italy;Austria | |||
| 472 | EUCTR2007-006453-12-IT (EUCTR) | 15/07/2008 | 21/07/2008 | A multi-centre, multinational, open-label study to evaluate the long-term safety, tolerability and efficacy of NS-304 in the treatment of pulmonary arterial hypertension in subjects aged 18 years and over (open extension study to NS 304/-02) - ND | A multi-centre, multinational, open-label study to evaluate the long-term safety, tolerability and efficacy of NS-304 in the treatment of pulmonary arterial hypertension in subjects aged 18 years and over (open extension study to NS 304/-02) - ND | Pulmonary Arterial Hypertension (PHA) (idiopatic PAH, familiar PHA, and associated with collagen disease, corrected congenital vitium or anorexigen) MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065152;Term: Familial pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065150;Term: Associated with pulmonary arterial hypertension | Product Code: NS-304 | NIPPON SHINYAKU CO., LTD. | NULL | Not Recruiting | Female: yes Male: yes | 20 | Phase 2 | France;Hungary;Belgium;Austria;Germany;United Kingdom;Italy | ||
| 473 | EUCTR2006-006748-76-GR (EUCTR) | 24/06/2008 | 14/03/2008 | A MULTINATIONAL, MULTICENTRE, RANDOMIZED, PARALLEL GROUP, DOUBLE-BLIND STUDY TO ASSESS THE EFFICACY AND SAFETY OF 1 MG, 5MG AND 20 MG TID OF ORAL SILDENAFIL IN THE TREATMENT OF SUBJECTS AGED 18 YEARS AND OVER WITH PULMONARY ARTERIAL HYPERTENSION (PAH) - N/A | A MULTINATIONAL, MULTICENTRE, RANDOMIZED, PARALLEL GROUP, DOUBLE-BLIND STUDY TO ASSESS THE EFFICACY AND SAFETY OF 1 MG, 5MG AND 20 MG TID OF ORAL SILDENAFIL IN THE TREATMENT OF SUBJECTS AGED 18 YEARS AND OVER WITH PULMONARY ARTERIAL HYPERTENSION (PAH) - N/A | Pulmonary arterial hypertension (PAH). MedDRA version: 8.1;Level: LLT;Classification code 10037400;Term: Pulmonary hypertension | Trade Name: Revatio INN or Proposed INN: sildenafil citrate Other descriptive name: UK-92,480 Trade Name: Revatio INN or Proposed INN: sildenafil citrate Other descriptive name: UK-92,480 Trade Name: Revatio INN or Proposed INN: sildenafil citrate Other descriptive name: UK-92,480 | Pfizer Ltd. Ramsgate Road, Sandwich, Kent, UK | NULL | Not Recruiting | Female: yes Male: yes | 284 | United Kingdom;Netherlands;Belgium;Denmark;Bulgaria;Italy;Greece;Latvia | |||
| 474 | EUCTR2007-003621-24-BE (EUCTR) | 20/06/2008 | 08/01/2008 | Double-blind, randomized, placebo-controlled, dose-finding, parallel-group study to assess the hemodynamic effects, clinical efficacy, tolerability and safety of Aviptadil (Vasoactive Intestinal Peptide) after single and repeated inhalation in patients with pulmonary arterial hypertension. | Double-blind, randomized, placebo-controlled, dose-finding, parallel-group study to assess the hemodynamic effects, clinical efficacy, tolerability and safety of Aviptadil (Vasoactive Intestinal Peptide) after single and repeated inhalation in patients with pulmonary arterial hypertension. | Pulmonary arterial hypertension (PAH) due to idiopathic pulmonary arterial hypertension (IPAH), familial PAH or PAH associated with connective tissue diseases (CTD) (e.g. systemic sclerosis, systemic lupus erythematosus) or to repaired congenital heart defects (RCHD). MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065152;Term: Familial pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065150;Term: Associated with pulmonary arterial hypertension | Product Name: Aviptadil Product Code: VIP INN or Proposed INN: Aviptadil Other descriptive name: VIP | MondoGEN AG | NULL | Not Recruiting | Female: yes Male: yes | 48 | France;Spain;Belgium;Austria;Germany;Netherlands;Italy;United Kingdom | |||
| 475 | EUCTR2006-006748-76-BE (EUCTR) | 10/06/2008 | 29/01/2008 | A MULTINATIONAL, MULTICENTRE, RANDOMIZED, PARALLEL GROUP, DOUBLE-BLIND STUDY TO ASSESS THE EFFICACY AND SAFETY OF 1 MG, 5 MG AND 20 MG TID OF ORAL SILDENAFIL IN THE TREATMENT OF SUBJECTS AGED 18 YEARS AND OVER WITH PULMONARY ARTERIAL HYPERTENSION (PAH) - N/A | A MULTINATIONAL, MULTICENTRE, RANDOMIZED, PARALLEL GROUP, DOUBLE-BLIND STUDY TO ASSESS THE EFFICACY AND SAFETY OF 1 MG, 5 MG AND 20 MG TID OF ORAL SILDENAFIL IN THE TREATMENT OF SUBJECTS AGED 18 YEARS AND OVER WITH PULMONARY ARTERIAL HYPERTENSION (PAH) - N/A | Pulmonary arterial hypertension (PAH) | INN or Proposed INN: Sildenafil citrate INN or Proposed INN: Sildenafil citrate Trade Name: Revatio INN or Proposed INN: Sildenafil citrate | Pfizer Ltd, Ramsgate Road, Sandwich, Kent UK | NULL | Not Recruiting | Female: yes Male: yes | 219 | United Kingdom;Netherlands;Denmark;Belgium;Bulgaria;Italy;Greece;Latvia | |||
| 476 | EUCTR2005-005068-97-PT (EUCTR) | 06/06/2008 | 11/03/2008 | Effects of combination of bosentan and sildenafil versus sildenafil monotherapy on morbidity and mortality in symptomatic patients with pulmonary arterial hypertension – A multicenter, double - blind, randomized, placebo - controlled, parallel group, prospective, event driven Phase IV study - COMPASS 2 | Effects of combination of bosentan and sildenafil versus sildenafil monotherapy on morbidity and mortality in symptomatic patients with pulmonary arterial hypertension – A multicenter, double - blind, randomized, placebo - controlled, parallel group, prospective, event driven Phase IV study - COMPASS 2 | Patients to be included must have PAH belonging to WHO Group I, in agreement with the approved indications for sildenafil in PAH by the US FDA:a.Idiopathic (IPAH)b.Familial (FPAH)c.Associated with (APAH):i.Collagen vascular disease with normal left ventricular function (ejection fraction (EF) > 50%) ii.Congenital systemic-to-pulmonary shunts at least 2 years post surgical repairiii.Drugs and toxins MedDRA version: 9.1;Level: LLT;Classification code 10064908;Term: Associated with (APAH) MedDRA version: 9.1;Classification code 10064910;Term: Familial (FPAH) MedDRA version: 9.1;Classification code 10064909;Term: | Trade Name: Tracleer Product Name: bosentan Product Code: Ro-47-0203 INN or Proposed INN: BOSENTAN Other descriptive name: Ro-47-0203/029 Trade Name: Tracleer Product Name: Bosentan Product Code: Ro-47-0203 INN or Proposed INN: BOSENTAN Other descriptive name: Ro-47-0203/029 | Actelion Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 4 | Portugal;Czech Republic;Greece;Belgium;Spain;Denmark;Germany;United Kingdom;Sweden | ||
| 477 | EUCTR2007-003621-24-FR (EUCTR) | 29/05/2008 | 27/12/2007 | Double-blind, randomized, placebo-controlled, dose-finding, parallel-group study to assess the hemodynamic effects, clinical efficacy, tolerability and safety of Aviptadil (Vasoactive Intestinal Peptide) after single and repeated inhalation in patients with pulmonary arterial hypertension. | Double-blind, randomized, placebo-controlled, dose-finding, parallel-group study to assess the hemodynamic effects, clinical efficacy, tolerability and safety of Aviptadil (Vasoactive Intestinal Peptide) after single and repeated inhalation in patients with pulmonary arterial hypertension. | Pulmonary arterial hypertension (PAH) due to idiopathic pulmonary arterial hypertension (IPAH), familial PAH or PAH associated with connective tissue diseases (CTD) (e.g. systemic sclerosis, systemic lupus erythematosus) or to repaired congenital heart defects (RCHD). MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065152;Term: Familial pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065150;Term: Associated with pulmonary arterial hypertension | Product Name: Aviptadil Product Code: VIP INN or Proposed INN: Aviptadil Other descriptive name: VIP | MondoGEN AG | NULL | Not Recruiting | Female: yes Male: yes | 48 | Phase 2 | France;Spain;Belgium;Austria;Germany;Netherlands;Italy;United Kingdom | ||
| 478 | EUCTR2005-005068-97-ES (EUCTR) | 11/05/2008 | 03/03/2008 | Effects of combination of bosentan and sildenafil versus sildenafil monotherapy on morbidity and mortality in symptomatic patients with pulmonary arterial hypertension – A multicenter, double - blind, randomized, placebo - controlled, parallel group, prospective, event driven Phase IV studyEfectos de la combinación de bosentan y sildenafilo frente a sildenafilo en monoterapia sobre la morbimortalidad en pacientes sintomáticos con hipertensión arterial pulmonar – Estudio de fase IV, multicéntrico, en doble ciego, aleatorizado, controlado con placebo, de grupos paralelos, prospectivo y basado en acontecimientos. - COMPASS 2 | Effects of combination of bosentan and sildenafil versus sildenafil monotherapy on morbidity and mortality in symptomatic patients with pulmonary arterial hypertension – A multicenter, double - blind, randomized, placebo - controlled, parallel group, prospective, event driven Phase IV studyEfectos de la combinación de bosentan y sildenafilo frente a sildenafilo en monoterapia sobre la morbimortalidad en pacientes sintomáticos con hipertensión arterial pulmonar – Estudio de fase IV, multicéntrico, en doble ciego, aleatorizado, controlado con placebo, de grupos paralelos, prospectivo y basado en acontecimientos. - COMPASS 2 | Hipertensión Arterial PulmonarPatients to be included must have PAH belonging to WHO Group I, in agreement with the approved indications for sildenafil in PAH by the US FDA:a.Idiopathic (IPAH)b.Familial (FPAH)c.Associated with (APAH):i.Collagen vascular disease with normal left ventricular function (ejection fraction (EF) > 50%) ii.Congenital systemic-to-pulmonary shunts at least 2 years post surgical repairiii.Drugs and toxins MedDRA version: 9.1;Level: LLT;Classification code 10064908;Term: Associated with (APAH) MedDRA version: 9.1;Classification code 10064910;Term: Familial (FPAH) MedDRA version: 9.1;Classification code 10064909;Term: | Trade Name: Tracleer Product Name: bosentan Product Code: Ro-47-0203 INN or Proposed INN: BOSENTAN Other descriptive name: Ro-47-0203 Trade Name: Tracleer Product Name: Bosentan Product Code: Ro-47-0203 INN or Proposed INN: BOSENTAN Other descriptive name: Ro-47-0203 | Actelion Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 4 | Portugal;Czech Republic;Slovakia;Greece;Belgium;Spain;Denmark;Germany;United Kingdom;Sweden | ||
| 479 | EUCTR2007-003328-39-HU (EUCTR) | 25/04/2008 | 18/01/2008 | A multi-centre, multinational, open-label single-dose acute hemodynamic study followed by a multi-centre, multinational, randomized, double-blind, parallel-group, placebo controlled study to assess the safety, tolerability, pharmacokinetics and preliminary efficacy (proof-of-concept) of ACT-293987 (NS-304) in the treatment of pulmonary arterial hypertension in subjects aged 18 years and over | A multi-centre, multinational, open-label single-dose acute hemodynamic study followed by a multi-centre, multinational, randomized, double-blind, parallel-group, placebo controlled study to assess the safety, tolerability, pharmacokinetics and preliminary efficacy (proof-of-concept) of ACT-293987 (NS-304) in the treatment of pulmonary arterial hypertension in subjects aged 18 years and over | pulmonary arterial hypertension (PAH) (idiopathic PAH, familial PAH, and PAH associated with collagen disease, corrected congenital vitium or anorexigen use) MedDRA version: 9.1;Level: LLT;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065152;Term: Familial pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065150;Term: Associated with pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10064911;Term: Pulmonary arterial hypertension | Product Code: ACT-293987 (NS-304) INN or Proposed INN: 2-(4-[5,6-diphenylpyrazin-2-yl)(isopropyl)amino]butoxy)-N-(methylsulfonyl)actamide | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 44 | Hungary;United Kingdom;Germany;Belgium;France;Italy;Austria | |||
| 480 | EUCTR2007-003328-39-BE (EUCTR) | 25/04/2008 | 27/11/2007 | A multi-centre, multinational, open-label single-dose acute hemodynamic study followed by a multi-centre, multinational, randomized, double-blind, parallel-group, placebo controlled study to assess the safety, tolerability, pharmacokinetics and preliminary efficacy (proof-of-concept) of ACT-293987 (NS-304) in the treatment of pulmonary arterial hypertension in subjects aged 18 years and over | A multi-centre, multinational, open-label single-dose acute hemodynamic study followed by a multi-centre, multinational, randomized, double-blind, parallel-group, placebo controlled study to assess the safety, tolerability, pharmacokinetics and preliminary efficacy (proof-of-concept) of ACT-293987 (NS-304) in the treatment of pulmonary arterial hypertension in subjects aged 18 years and over | pulmonary arterial hypertension (PAH) (idiopathic PAH, familial PAH, and PAH associated with collagen disease, corrected congenital vitium or anorexigen use) MedDRA version: 9.1;Level: LLT;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065152;Term: Familial pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065150;Term: Associated with pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10064911;Term: Pulmonary arterial hypertension | Product Code: ACT-293987 (NS-304) INN or Proposed INN: 2-(4-[5,6-diphenylpyrazin-2-yl)(isopropyl)amino]butoxy)-N-(methylsulfonyl)actamide | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 44 | Hungary;United Kingdom;Germany;Belgium;France;Italy;Austria | |||
| 481 | EUCTR2006-006748-76-NL (EUCTR) | 23/04/2008 | 01/11/2007 | A MULTINATIONAL, MULTICENTRE, RANDOMIZED, PARALLEL GROUP, DOUBLE-BLIND STUDY TO ASSESS THE EFFICACY AND SAFETY OF 1 MG, 5MG AND 20 MG TID OF ORAL SILDENAFIL IN THE TREATMENT OF SUBJECTS AGED 18 YEARS AND OVER WITH PULMONARY ARTERIAL HYPERTENSION (PAH) - N/A | A MULTINATIONAL, MULTICENTRE, RANDOMIZED, PARALLEL GROUP, DOUBLE-BLIND STUDY TO ASSESS THE EFFICACY AND SAFETY OF 1 MG, 5MG AND 20 MG TID OF ORAL SILDENAFIL IN THE TREATMENT OF SUBJECTS AGED 18 YEARS AND OVER WITH PULMONARY ARTERIAL HYPERTENSION (PAH) - N/A | Pulmonary arterial hypertension (PAH). MedDRA version: 8.1;Level: LLT;Classification code 10037400;Term: Pulmonary hypertension | Trade Name: Revatio INN or Proposed INN: sildenafil citrate Other descriptive name: UK-92,480 Trade Name: Revatio INN or Proposed INN: sildenafil citrate Other descriptive name: UK-92,480 Trade Name: Revatio INN or Proposed INN: sildenafil citrate Other descriptive name: UK-92,480 | Pfizer Ltd. Ramsgate Road, Sandwich, Kent, UK | NULL | Not Recruiting | Female: yes Male: yes | 284 | United Kingdom;Netherlands;Belgium;Denmark;Bulgaria;Italy;Greece;Latvia | |||
| 482 | EUCTR2006-006748-76-IT (EUCTR) | 21/04/2008 | 21/02/2008 | A MULTINATIONAL, MULTICENTRE, RANDOMIZED, PARALLEL GROUP, DOUBLE-BLIND STUDY TO ASSESS THE EFFICACY AND SAFETY OF 1 MG, 5 MG AND 20 MG TID OF ORAL SILDENAFIL IN THE TREATMENT OF SUBJECTS AGED 18 YEARS AND OVER WITH PULMONARY ARTERIAL HYPERTENSION (PAH) - ND | A MULTINATIONAL, MULTICENTRE, RANDOMIZED, PARALLEL GROUP, DOUBLE-BLIND STUDY TO ASSESS THE EFFICACY AND SAFETY OF 1 MG, 5 MG AND 20 MG TID OF ORAL SILDENAFIL IN THE TREATMENT OF SUBJECTS AGED 18 YEARS AND OVER WITH PULMONARY ARTERIAL HYPERTENSION (PAH) - ND | Pulmonary arterial hypertension (PAH). MedDRA version: 9.1;Level: LLT;Classification code 10037400;Term: Pulmonary hypertension | Trade Name: Revatio INN or Proposed INN: Sildenafil Trade Name: Revatio INN or Proposed INN: Sildenafil Trade Name: Revatio INN or Proposed INN: Sildenafil | PFIZER | NULL | Not Recruiting | Female: yes Male: yes | 284 | United Kingdom;Netherlands;Belgium;Denmark;Bulgaria;Italy;Greece;Latvia | |||
| 483 | EUCTR2006-000804-18-DE (EUCTR) | 10/04/2008 | 12/12/2007 | An extension study of UT-15C tablet in subjects with high blood pressure inthe artery that carries blood to the lungs | An Open-Label Extension Trial of UT-15C SR in Subjects with Pulmonary Arterial Hypertension - FREEDOM-EXT | Idiopathic or familial pulmonary arterial hypertension (PAH), including PAH associated with:1) Appetite suppressant/toxin use) or2) Repaired congenital systemic-to-pulmonary shunts (repaired = 5 years) or3) Collagen Vascular Disease (CVD)4) Human Immunosufficiency Virus (HIV) MedDRA version: 20.0;Level: PT;Classification code 10037400;Term: Pulmonary hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Treprostinil diethanolamine Product Code: UT-15C SR INN or Proposed INN: Treprostinil diethanolamine Product Name: Treprostinil diethanolamine Product Code: UT-15C SR INN or Proposed INN: Treprostinil diethanolamine Product Name: Treprostinil diethanolamine Product Code: UT-15C SR INN or Proposed INN: Treprostinil diethanolamine Product Name: Treprostinil diethanolamine Product Code: UT-15C SR INN or Proposed INN: Treprostinil diethanolamine Product Name: Treprostinil diethanolamine Product Code: UT-15C SR INN or Proposed INN: treprostinil diethanolamine | United Therapeutics Corporation | NULL | Not Recruiting | Female: yes Male: yes | 900 | Phase 3 | Portugal;Spain;Ireland;Austria;Israel;United Kingdom;Italy;France;Mexico;Puerto Rico;Belgium;Germany;Netherlands;Sweden | ||
| 484 | NCT00430716 (ClinicalTrials.gov) | April 8, 2008 | 31/1/2007 | To Assess The Efficacy and Safety Of Oral Sildenafil in the Treatment of Pulmonary Arterial Hypertension. | A MULTINATIONAL, MULTICENTRE, RANDOMIZED, PARALLEL GROUP, DOUBLE-BLIND STUDY TO ASSESS THE EFFICACY AND SAFETY OF 1MG, 5MG AND 20 MG TID OF ORAL SILDENAFIL IN THE TREATMENT OF SUBJECTS AGED 18 YEARS AND OVER WITH PULMONARY ARTERIAL HYPERTENSION (PAH) | Pulmonary Arterial Hypertension | Drug: Sildenafil citrate | Pfizer | NULL | Terminated | 18 Years | N/A | All | 130 | Phase 4 | United States;Belgium;Brazil;Bulgaria;China;Greece;India;Italy;Latvia;Malaysia;Netherlands;Philippines;Poland;Romania;Russian Federation;Thailand;United Kingdom;Denmark;Panama |
| 485 | EUCTR2006-000800-17-DE (EUCTR) | 02/04/2008 | 19/05/2008 | A 16-Week International, Multicenter, Double-Blind, Randomized, Placebo Controlled Comparison of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Combination with an Endothelin Receptor Antagonist and/or a Phosphodiesterase-5 Inhibitor in Subjects with Pulmonary Arterial Hypertension - FREEDOM-C | A 16-Week International, Multicenter, Double-Blind, Randomized, Placebo Controlled Comparison of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Combination with an Endothelin Receptor Antagonist and/or a Phosphodiesterase-5 Inhibitor in Subjects with Pulmonary Arterial Hypertension - FREEDOM-C | Idiopathic or Familial pulmonary arterial hypertension (PAH), including PAH associated with:1) Appetite suppressant/toxin use, or2) Repaired congenital systemic-to-pulmonary shunts (repaired = 5 years), or3) Collagen Vascular Disease, or4) HIV MedDRA version: 8.1;Level: PT;Classification code 10037400;Term: Pulmonary hypertension | Product Name: Treprostinil Diethanolamine Product Code: UT-15C SR INN or Proposed INN: Treprostinil Product Name: Treprostinil Diethanolamine Product Code: UT-15C SR INN or Proposed INN: Treprostinil | United Therapeutics Corporation | NULL | Not Recruiting | Female: yes Male: yes | 300 | United Kingdom;Germany;Netherlands;Belgium;France;Spain;Ireland;Italy;Austria | |||
| 486 | EUCTR2007-003621-24-DE (EUCTR) | 20/03/2008 | 13/02/2009 | Double-blind, randomized, placebo-controlled, dose-finding, parallel-group study to assess the hemodynamic effects, clinical efficacy, tolerability and safety of Aviptadil (Vasoactive Intestinal Peptide) after single and repeated inhalation in patients with pulmonary arterial hypertension. | Double-blind, randomized, placebo-controlled, dose-finding, parallel-group study to assess the hemodynamic effects, clinical efficacy, tolerability and safety of Aviptadil (Vasoactive Intestinal Peptide) after single and repeated inhalation in patients with pulmonary arterial hypertension. | Pulmonary arterial hypertension (PAH) due to idiopathic pulmonary arterial hypertension (IPAH), familial PAH or PAH associated with connective tissue diseases (CTD) (e.g. systemic sclerosis, systemic lupus erythematosus) or to repaired congenital heart defects (RCHD). MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065152;Term: Familial pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065150;Term: Associated with pulmonary arterial hypertension | Product Name: Aviptadil Product Code: VIP INN or Proposed INN: Aviptadil Other descriptive name: VIP | MondoGEN AG | NULL | Not Recruiting | Female: yes Male: yes | 48 | United Kingdom;Germany;Netherlands;Belgium;France;Spain;Italy;Austria | |||
| 487 | EUCTR2005-005068-97-SK (EUCTR) | 06/03/2008 | 06/07/2010 | A clinical trial to investigate the safety and effectiveness of the combination of bosentan and sildenafil to treat patients with symptomatic pulmonary arterial hypertension in comparison to treatment with sildenafil on its own | Effects of combination of bosentan and sildenafil versus sildenafil monotherapy on morbidity and mortality in symptomatic patients with pulmonary arterial hypertension – A multicenter, double - blind, randomized, placebo - controlled, parallel group, prospective, event driven Phase IV study - COMPASS 2 | Patients to be included must have PAH belonging to WHO Group I, in agreement with the approved indications for sildenafil in PAH by the US FDA:a.Idiopathic (IPAH)b.Familial (FPAH)c.Associated with (APAH):i.Collagen vascular disease with normal left ventricular function (ejection fraction (EF) > 50%) ii.Congenital systemic-to-pulmonary shunts at least 2 years post surgical repairiii.Drugs and toxins MedDRA version: 14.1;Level: LLT;Classification code 10064910;Term: Familial (FPAH);System Organ Class: 100000004855 MedDRA version: 14.1;Classification code 10064909;Term: Idiopathic (IPAH);Classification code 10064908;Term: Associated with (APAH);System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Tracleer Product Name: bosentan Product Code: Ro-47-0203 INN or Proposed INN: BOSENTAN MONOHYDRATE Other descriptive name: Ro-47-0203/029 Trade Name: Tracleer Product Name: Bosentan Product Code: Ro-47-0203 INN or Proposed INN: BOSENTAN MONOHYDRATE Other descriptive name: Ro-47-0203/029 | Actelion Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 4 | Portugal;United States;Saudi Arabia;Slovakia;Greece;Spain;United Kingdom;Czech Republic;Belgium;Brazil;Denmark;Germany;Sweden | ||
| 488 | EUCTR2007-002803-42-AT (EUCTR) | 05/03/2008 | 20/02/2008 | Inhaled Iloprost for patients with pulmonary arterial hypertension and right heart failure:a pilot feasibility trial | Inhaled Iloprost for patients with pulmonary arterial hypertension and right heart failure:a pilot feasibility trial | Pulmonary arterial hypertension (PAH) is associated with poor prognosis.The most common cause of death is right heart failure. The fact that right heart failure is associated with low systemic perfusion pressures limits the systemic use of potent vasodilators in this patient population. As a consequence, no therapeutic recommendations exist for patients experiencing right heart failure in the course of PAH. | Trade Name: Ventavis(Iloprost) Product Name: Ventavis(Iloprost) | Univ.Clinic of Internal Medicine II, Department of Cardiology, Medical University of Vienna, Austria | NULL | Not Recruiting | Female: yes Male: yes | 8 | Austria | |||
| 489 | EUCTR2007-003328-39-DE (EUCTR) | 13/02/2008 | 07/12/2007 | A multi-centre, multinational, open-label single-dose acute hemodynamic study followed by a multi-centre, multinational, randomized, double-blind, parallel-group, placebo controlled study to assess the safety, tolerability, pharmacokinetics and preliminary efficacy (proof-of-concept) of ACT-293987 (NS-304) in the treatment of pulmonary arterial hypertension in subjects aged 18 years and over | A multi-centre, multinational, open-label single-dose acute hemodynamic study followed by a multi-centre, multinational, randomized, double-blind, parallel-group, placebo controlled study to assess the safety, tolerability, pharmacokinetics and preliminary efficacy (proof-of-concept) of ACT-293987 (NS-304) in the treatment of pulmonary arterial hypertension in subjects aged 18 years and over | pulmonary arterial hypertension (PAH) (idiopathic PAH, familial PAH, and PAH associated with collagen disease, corrected congenital vitium or anorexigen use) MedDRA version: 9.1;Level: LLT;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065152;Term: Familial pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065150;Term: Associated with pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10064911;Term: Pulmonary arterial hypertension | Product Code: ACT-293987 (NS-304) INN or Proposed INN: 2-(4-[5,6-diphenylpyrazin-2-yl)(isopropyl)amino]butoxy)-N-(methylsulfonyl)actamide | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 44 | Hungary;United Kingdom;Germany;Belgium;France;Italy;Austria | |||
| 490 | NCT00554619 (ClinicalTrials.gov) | February 2008 | 5/11/2007 | A Study to Evaluate GSK1325760A - a Long-Term Extension Study | Study AMB107818, Clinical Evaluation of GSK1325760A in the Treatment of Pulmonary Arterial Hypertension (PAH)- An Open Label Study of GSK1325760A to Evaluate the Safety and Efficacy of GSK1325760A - a Long-term Extension Study - | Pulmonary Arterial Hypertension;Hypertension, Pulmonary | Drug: GSK1325760A | GlaxoSmithKline | NULL | Completed | N/A | N/A | All | 21 | Phase 3 | Japan |
| 491 | EUCTR2007-003328-39-FR (EUCTR) | 23/01/2008 | 29/11/2007 | A multi-centre, multinational, open-label single-dose acute hemodynamic study followed by a multi-centre, multinational, randomized, double-blind, parallel-group, placebo controlled study to assess the safety, tolerability, pharmacokinetics and preliminary efficacy (proof-of-concept) of NS-304 in the treatment of pulmonary arterial hypertension in subjects aged 18 years and over | A multi-centre, multinational, open-label single-dose acute hemodynamic study followed by a multi-centre, multinational, randomized, double-blind, parallel-group, placebo controlled study to assess the safety, tolerability, pharmacokinetics and preliminary efficacy (proof-of-concept) of NS-304 in the treatment of pulmonary arterial hypertension in subjects aged 18 years and over | pulmonary arterial hypertension (PAH) (idiopathic PAH, familial PAH, and PAH associated with collagen disease, corrected congenital vitium or anorexigen use) MedDRA version: 9.1;Level: LLT;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065152;Term: Familial pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065150;Term: Associated with pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10064911;Term: Pulmonary arterial hypertension | Product Code: NS-304 INN or Proposed INN: 2-(4-[5,6-diphenylpyrazin-2-yl)(isopropyl)amino]butoxy)-N-(methylsulfonyl)actamide | Nippon Shinyaku Co., LTD | NULL | Not Recruiting | Female: yes Male: yes | 44 | Phase 2 | France;Hungary;Belgium;Austria;Germany;Italy;United Kingdom | ||
| 492 | EUCTR2006-006748-76-DK (EUCTR) | 21/01/2008 | 09/01/2008 | A MULTINATIONAL, MULTICENTRE, RANDOMIZED, PARALLEL GROUP, DOUBLE-BLIND STUDY TO ASSESS THE EFFICACY AND SAFETY OF 1 MG, 5 MG AND 20 MG TID OF ORAL SILDENAFIL IN THE TREATMENT OF SUBJECTS AGED 18 YEARS AND OVER WITH PULMONARY ARTERIAL HYPERTENSION (PAH) - N/A | A MULTINATIONAL, MULTICENTRE, RANDOMIZED, PARALLEL GROUP, DOUBLE-BLIND STUDY TO ASSESS THE EFFICACY AND SAFETY OF 1 MG, 5 MG AND 20 MG TID OF ORAL SILDENAFIL IN THE TREATMENT OF SUBJECTS AGED 18 YEARS AND OVER WITH PULMONARY ARTERIAL HYPERTENSION (PAH) - N/A | Pulmonary arterial hypertension (PAH) | Trade Name: Revatio INN or Proposed INN: Sildenafil citrate Trade Name: Revatio INN or Proposed INN: Sildenafil citrate Trade Name: Revatio INN or Proposed INN: Sildenafil citrate | Pfizer Ltd, Ramsgate Road, Sandwich, Kent UK | NULL | Not Recruiting | Female: yes Male: yes | 219 | Greece;Belgium;Denmark;Bulgaria;Latvia;Netherlands;United Kingdom;Italy | |||
| 493 | EUCTR2007-002774-64-DE (EUCTR) | 04/12/2007 | 20/08/2007 | Therapy of PAH – Treatment with Sildenafil in Eisenmenger Patients - Sildenafil | Therapy of PAH – Treatment with Sildenafil in Eisenmenger Patients - Sildenafil | Patients with pre-existing congenital heart disease may develop Eisenmenger physiology (EP), characterized by development of pulmonary arterial hypertension and intracardiac right to left shunt. This Patients suffer from cyanosis and reduced quality of life. While EP has been regarded as not amenable to conventional treatments, new oral drugs as Sildenafil have been used successfully to improve primary arterial hypertension. Thus may be an important treatment option for patients with EP, too. | Trade Name: Revatio INN or Proposed INN: SILDENAFIL | Deutsches Herzzentrum Berlin, Kompetenznetz Angeborene Herzfehler | NULL | Not Recruiting | Female: yes Male: yes | 80 | Germany | |||
| 494 | NCT00586794 (ClinicalTrials.gov) | December 2007 | 21/12/2007 | Therapy of Pulmonary Arterial Hypertension (PAH) - Treatment With Sildenafil in Eisenmenger Patients | Therapy of Pulmonary Arterial Hypertension (PAH) - Treatment With Sildenafil in Eisenmenger Patients | Pulmonary Arterial Hypertension (PAH) | Drug: Sildenafil;Drug: Placebo | Competence Network for Congenital Heart Defects | German Federal Ministry of Education and Research | Terminated | 14 Years | N/A | Both | 24 | Phase 3 | Germany |
| 495 | EUCTR2005-005068-97-GB (EUCTR) | 30/10/2007 | 14/06/2007 | Effects of combination of bosentan and sildenafil versus sildenafil monotherapy on morbidity and mortality in symptomatic patients with pulmonary arterial hypertension – A multicenter, double - blind, randomized, placebo - controlled, parallel group, prospective, event driven Phase IV study - COMPASS 2 | Effects of combination of bosentan and sildenafil versus sildenafil monotherapy on morbidity and mortality in symptomatic patients with pulmonary arterial hypertension – A multicenter, double - blind, randomized, placebo - controlled, parallel group, prospective, event driven Phase IV study - COMPASS 2 | Patients to be included must have PAH belonging to WHO Group I, in agreement with the approved indications for sildenafil in PAH by the US FDA:a.Idiopathic (IPAH)b.Familial (FPAH)c.Associated with (APAH):i.Collagen vascular disease with normal left ventricular function (ejection fraction (EF) > 50%) ii.Congenital systemic-to-pulmonary shunts at least 2 years post surgical repairiii.Drugs and toxins MedDRA version: 9.1;Level: LLT;Classification code 10064908;Term: Associated with (APAH) MedDRA version: 9.1;Classification code 10064909;Term: Idiopathic (IPAH) MedDRA version: 9.1;Classification code 10064910;Term: Familial (FPAH) | Trade Name: Tracleer Product Name: bosentan Product Code: Ro-47-0203 INN or Proposed INN: bosentan monohydrate Trade Name: Tracleer Product Name: bosentan Product Code: Ro-47-0203 INN or Proposed INN: bosentan monohydrate | Actelion Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 4 | Portugal;Czech Republic;Greece;Spain;Denmark;Germany;United Kingdom;Sweden | ||
| 496 | EUCTR2005-005068-97-DK (EUCTR) | 12/09/2007 | 11/05/2007 | Effects of combination of bosentan and sildenafil versus sildenafil monotherapy on morbidity and mortality in symptomatic patients with pulmonary arterial hypertension – A multicenter, double - blind, randomized, placebo - controlled, parallel group, prospective, event driven Phase IV study - COMPASS 2 | Effects of combination of bosentan and sildenafil versus sildenafil monotherapy on morbidity and mortality in symptomatic patients with pulmonary arterial hypertension – A multicenter, double - blind, randomized, placebo - controlled, parallel group, prospective, event driven Phase IV study - COMPASS 2 | Patients to be included must have PAH belonging to WHO Group I, in agreement with the approved indications for sildenafil in PAH by the US FDA:a.Idiopathic (IPAH)b.Familial (FPAH)c.Associated with (APAH):i.Collagen vascular disease with normal left ventricular function (ejection fraction (EF) > 50%) ii.Congenital systemic-to-pulmonary shunts at least 2 years post surgical repairiii.Drugs and toxins MedDRA version: 9.1;Level: LLT;Classification code 10064908;Term: Associated with (APAH) MedDRA version: 9.1;Classification code 10064909;Term: Idiopathic (IPAH) MedDRA version: 9.1;Classification code 10064910;Term: Familial (FPAH) | Trade Name: Tracleer Product Name: bosentan Product Code: Ro-47-0203 INN or Proposed INN: bosentan monohydrate Trade Name: Tracleer Product Name: bosentan Product Code: Ro-47-0203 INN or Proposed INN: bosentan monohydrate | Actelion Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 4 | Portugal;Czech Republic;Greece;Belgium;Spain;Denmark;Germany;United Kingdom;Sweden | ||
| 497 | EUCTR2006-000800-17-IT (EUCTR) | 27/08/2007 | 10/05/2007 | A 16-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Comparison of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Combination with an Endothelin Receptor Antagonist and/or a Phosphodiesterase-5 Inhibitor in Subjects with Pulmonary Arterial Hypertension - FREEDOM-C | A 16-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Comparison of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Combination with an Endothelin Receptor Antagonist and/or a Phosphodiesterase-5 Inhibitor in Subjects with Pulmonary Arterial Hypertension - FREEDOM-C | Pulmonary Arterial Hypertension (PAH) MedDRA version: 9.1;Level: LLT;Classification code 10037400;Term: Pulmonary hypertension | Product Code: UT-15C SR INN or Proposed INN: Treprostinil Diethanolamine Product Code: UT-15C SR INN or Proposed INN: Treprostinil Diethanolamine Product Code: UT-15C SR INN or Proposed INN: Treprostinil Diethanolamine | UNITED THERAPEUTICS | NULL | Not Recruiting | Female: yes Male: yes | 300 | Germany;United Kingdom;Netherlands;Belgium;France;Spain;Ireland;Italy;Austria | |||
| 498 | EUCTR2006-000804-18-IT (EUCTR) | 27/08/2007 | 03/04/2007 | An Open-Label Extension Trial of UT-15C SR in Subjects with Pulmonary Arterial Hypertension - FREEDOM-EXT | An Open-Label Extension Trial of UT-15C SR in Subjects with Pulmonary Arterial Hypertension - FREEDOM-EXT | Pulmonary Arterial Hypertension PAH MedDRA version: 9.1;Level: LLT;Classification code 10037400;Term: Pulmonary hypertension | Product Code: UT-15C SR Product Code: UT-15C SR Product Code: UT-15C SR Product Name: UT-15C SR | UNITED THERAPEUTICS | NULL | Not Recruiting | Female: yes Male: yes | 450 | Phase 3 | Portugal;France;Spain;Belgium;Ireland;Austria;Germany;Netherlands;United Kingdom;Italy;Sweden | ||
| 499 | NCT00540436 (ClinicalTrials.gov) | August 2007 | 5/10/2007 | Evaluate the Efficacy, Safety and Pharmacokinetics of GSK1325760A in the Treatment of Pulmonary Arterial Hypertension | Study AMB107816, Clinical Evaluation of GSK1325760A in the Treatment of Pulmonary Arterial Hypertension (PAH)- An Open-Label Phase II/III Study to Evaluate the Efficacy, Safety and Pharmacokinetics of GSK1325760A - | Hypertension, Pulmonary | Drug: GSK1325760A | GlaxoSmithKline | NULL | Completed | 18 Years | N/A | All | 25 | Phase 2 | Japan |
| 500 | EUCTR2006-000801-50-NL (EUCTR) | 03/07/2007 | 02/04/2007 | A 12-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Comparison of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Subjects with Pulmonary Arterial Hypertension - FREEDOM-M | A 12-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Comparison of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Subjects with Pulmonary Arterial Hypertension - FREEDOM-M | Idiopathic or Familial pulmonary arterial hypertension (PAH), including PAH associated with:1) Appetite suppressant/toxin use, or2) Repaired congenital systemic-to-pulmonary shunts (repaired = 5 years), or3) Collagen Vascular Disease (CVD), or 4) Human Immunodeficiency virus (HIV) MedDRA version: 8.1;Level: PT;Classification code 10037400;Term: Pulmonary hypertension | Product Name: Treprostinil Diethanolamine Product Code: UT-15C SR INN or Proposed INN: Treprostinil diethanolamine Product Name: Treprostinil Diethanolamine Product Code: UT-15C SR INN or Proposed INN: Treprostinil diethanolamine Product Name: Treprostinil Diethanolamine Product Code: UT-15C SR INN or Proposed INN: Treprostinil Diethanolamine | United Therapeutics Corporation | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | France;Belgium;Austria;Netherlands;Italy | ||
| 501 | EUCTR2006-000800-17-NL (EUCTR) | 19/06/2007 | 01/12/2006 | A 16-Week International, Multicenter, Double-Blind, Randomized, Placebo Controlled Comparison of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Combination with an Endothelin Receptor Antagonist and/or a Phosphodiesterase-5 Inhibitor in Subjects with Pulmonary Arterial Hypertension - FREEDOM-C | A 16-Week International, Multicenter, Double-Blind, Randomized, Placebo Controlled Comparison of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Combination with an Endothelin Receptor Antagonist and/or a Phosphodiesterase-5 Inhibitor in Subjects with Pulmonary Arterial Hypertension - FREEDOM-C | Idiopathic or Familial pulmonary arterial hypertension (PAH), including PAH associated with:1) Appetite suppressant/toxin use, or2) Repaired congenital systemic-to-pulmonary shunts (repaired = 5 years), or3) Collagen Vascular Disease, or4) HIV MedDRA version: 8.1;Level: PT;Classification code 10037400;Term: Pulmonary hypertension | Product Name: Treprostinil Diethanolamine Product Code: UT-15C SR INN or Proposed INN: Treprostinil diethanolamine Product Name: Treprostinil Diethanolamine Product Code: UT-15C SR INN or Proposed INN: Treprostinil diethanolamine | United Therapeutics Corporation | NULL | Not Recruiting | Female: yes Male: yes | 300 | Germany;United Kingdom;Netherlands;Belgium;France;Spain;Ireland;Italy;Austria | |||
| 502 | EUCTR2006-000804-18-NL (EUCTR) | 19/06/2007 | 01/12/2006 | An extension studyof UT-15C tablet in subjects with high blood pressure in the artery that carries blood to the lungs | An Open-Label Extension Trial of UT-15C SR in Subjects with Pulmonary Arterial Hypertension - FREEDOM-EXT | Idiopathic or familial pulmonary arterial hypertension (PAH), including PAH associated with :1) Appetite suppressant use or 2) Repaired congenital systemic-to-pulmonary shunts (repaired = 5 years) or 3) Collagen Vascular Disease (CVD) or 4) Human Immunodeficiency Virus (HIV) MedDRA version: 16.0;Level: PT;Classification code 10037400;Term: Pulmonary hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Treprostinil diethanolamine Product Code: UT-15C SR INN or Proposed INN: Treprostinil diethanolamine Product Name: Treprostinil diethanolamine Product Code: UT-15C SR INN or Proposed INN: Treprostinil diethanolamine Product Name: Treprostinil diethanolamine Product Code: UT-15C SR INN or Proposed INN: Treprostinil diethanolamine Product Name: Treprostinil diethanolamine Product Code: UT-15C SR INN or Proposed INN: Treprostinil diethanolamine Product Name: Treprostinil diethanolamine Product Code: UT-15C SR INN or Proposed INN: treprostinil diethanolamine | United Therapeutics Corporation | NULL | Not Recruiting | Female: yes Male: yes | 900 | Phase 3 | Portugal;Spain;Ireland;Austria;Israel;United Kingdom;Italy;France;Mexico;Puerto Rico;Belgium;Netherlands;Germany;Sweden | ||
| 503 | EUCTR2005-005068-97-SE (EUCTR) | 18/06/2007 | 02/04/2007 | Effects of combination of bosentan and sildenafil versus sildenafil monotherapy on morbidity and mortality in symptomatic patients with pulmonary arterial hypertension – A multicenter, double - blind, randomized, placebo - controlled, parallel group, prospective, event driven Phase IV study - COMPASS 2 | Effects of combination of bosentan and sildenafil versus sildenafil monotherapy on morbidity and mortality in symptomatic patients with pulmonary arterial hypertension – A multicenter, double - blind, randomized, placebo - controlled, parallel group, prospective, event driven Phase IV study - COMPASS 2 | Patients to be included must have PAH belonging to WHO Group I, in agreement with the approved indications for sildenafil in PAH by the US FDA:a.Idiopathic (IPAH)b.Familial (FPAH)c.Associated with (APAH):i.Collagen vascular disease with normal left ventricular function (ejection fraction (EF) > 50%) ii.Congenital systemic-to-pulmonary shunts at least 2 years post surgical repairiii.Drugs and toxins MedDRA version: 9.1;Level: LLT;Classification code 10064908;Term: Associated with (APAH) MedDRA version: 9.1;Classification code 10064909;Term: Idiopathic (IPAH) MedDRA version: 9.1;Classification code 10064910;Term: Familial (FPAH) | Trade Name: Tracleer Product Name: bosentan Product Code: Ro-47-0203 INN or Proposed INN: bosentan monohydrate Trade Name: Tracleer Product Name: bosentan Product Code: Ro-47-0203 INN or Proposed INN: bosentan monohydrate | Actelion Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 4 | Portugal;Czech Republic;Greece;Belgium;Spain;Denmark;Germany;United Kingdom;Sweden | ||
| 504 | EUCTR2006-000801-50-IT (EUCTR) | 12/06/2007 | 21/06/2007 | A 12-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Comparison of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Subjects with Pulmonary Arterial Hypertension - FREEDOM-M | A 12-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Comparison of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Subjects with Pulmonary Arterial Hypertension - FREEDOM-M | Pulmonary Arterial Hypertension (PAH) MedDRA version: 6.1;Level: PT;Classification code 10037400 | Product Name: treprostinil Product Code: UT-15C SR INN or Proposed INN: Treprostinil diethanolamine Product Name: treprostinil Product Code: UT-15C SR INN or Proposed INN: Treprostinil diethanolamine | UNITED THERAPEUTICS | NULL | Not Recruiting | Female: yes Male: yes | 150 | Netherlands;Belgium;France;Italy;Austria | |||
| 505 | EUCTR2006-000804-18-FR (EUCTR) | 11/06/2007 | 19/01/2007 | An Open-Label Extension Trial of UT-15C SR in Subjects with Pulmonary Arterial Hypertension - FREEDOM-EXT | An Open-Label Extension Trial of UT-15C SR in Subjects with Pulmonary Arterial Hypertension - FREEDOM-EXT | Idiopathic or familial pulmonary arterial hypertension (PAH), including PAH associated with :1) Appetite suppressant use or 2) Repaired congenital systemic-to-pulmonary shunts (repaired = 5 years) or 3) Collagen Vascular Disease (CVD) or 4) Human Immunodeficiency Virus (HIV) MedDRA version: 8.1;Level: PT;Classification code 10037400;Term: Pulmonary hypertension | Product Name: Treprostinil diethanolamine Product Code: UT-15C SR INN or Proposed INN: Treprostinil diethanolamine Product Name: Treprostinil diethanolamine Product Code: UT-15C SR INN or Proposed INN: Treprostinil diethanolamine | United Therapeutics Corporation | NULL | Not Recruiting | Female: yes Male: yes | 450 | Phase 3 | Portugal;France;Spain;Belgium;Ireland;Austria;Germany;Netherlands;Italy;United Kingdom;Sweden | ||
| 506 | EUCTR2006-000801-50-FR (EUCTR) | 21/05/2007 | 19/01/2007 | A 12-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Comparison of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Subjects with Pulmonary Arterial Hypertension - FREEDOM-M | A 12-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Comparison of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Subjects with Pulmonary Arterial Hypertension - FREEDOM-M | Idiopathic or Familial pulmonary arterial hypertension (PAH), including PAH associated with:1) Appetite suppressant use, or2) Repaired congenital systemic-to-pulmonary shunts (repaired = 5 years), or3) Collagen Vascular Disease (CVD), or 4) Human Immunodeficiency virus (HIV) MedDRA version: 8.1;Level: PT;Classification code 10037400;Term: Pulmonary hypertension | Product Name: Treprostinil Diethanolamine Product Code: UT-15C SR INN or Proposed INN: Treprostinil diethanolamine Product Name: Treprostinil Diethanolamine Product Code: UT-15C SR INN or Proposed INN: Treprostinil diethanolamine | United Therapeutics Corporation | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | France;Belgium;Austria;Netherlands;Italy | ||
| 507 | EUCTR2006-000800-17-FR (EUCTR) | 21/05/2007 | 19/01/2007 | A 16-Week International, Multicenter, Double-Blind, Randomized, Placebo Controlled Comparison of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Combination with an Endothelin Receptor Antagonist and/or a Phosphodiesterase-5 Inhibitor in Subjects with Pulmonary Arterial Hypertension - FREEDOM-C | A 16-Week International, Multicenter, Double-Blind, Randomized, Placebo Controlled Comparison of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Combination with an Endothelin Receptor Antagonist and/or a Phosphodiesterase-5 Inhibitor in Subjects with Pulmonary Arterial Hypertension - FREEDOM-C | Idiopathic or Familial pulmonary arterial hypertension (PAH), including PAH associated with:1) Appetite suppressant use, or2) Repaired congenital systemic-to-pulmonary shunts (repaired = 5 years), or3) Collagen Vascular Disease (CVD), or 4) Human Immunodeficiency virus (HIV) MedDRA version: 8.1;Level: PT;Classification code 10037400;Term: Pulmonary hypertension | Product Name: Treprostinil Diethanolamine Product Code: UT-15C SR INN or Proposed INN: Treprostinil diethanolamine Product Name: Treprostinil Diethanolamine Product Code: UT-15C SR INN or Proposed INN: Treprostinil diethanolamine | United Therapeutics Corporation | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 3 | France;Spain;Belgium;Ireland;Austria;Germany;Netherlands;Italy;United Kingdom | ||
| 508 | EUCTR2006-000804-18-GB (EUCTR) | 04/05/2007 | 22/11/2006 | An extension study of UT-15C tablet in subjects with high blood pressure in the artery that carries blood to the lungs | An Open-Label Extension Trial of UT-15C SR in Subjects with Pulmonary Arterial Hypertension - FREEDOM-EXT | Idiopathic or familial pulmonary arterial hypertension (PAH), including PAH associated with :1) Appetite suppressant use or 2) Repaired congenital systemic-to-pulmonary shunts (repaired = 5 years) or 3) Collagen Vascular Disease (CVD) or 4) Human Immunodeficiency Virus (HIV) MedDRA version: 20.0;Level: PT;Classification code 10037400;Term: Pulmonary hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Treprostinil diethanolamine Product Code: UT-15C SR INN or Proposed INN: Treprostinil diethanolamine Product Name: Treprostinil diethanolamine Product Code: UT-15C SR INN or Proposed INN: Treprostinil diethanolamine Product Name: Treprostinil diethanolamine Product Code: UT-15C SR INN or Proposed INN: Treprostinil diethanolamine Product Name: Treprostinil diethanolamine Product Code: UT-15C SR INN or Proposed INN: Treprostinil diethanolamine Product Name: Treprostinil diethanolamine Product Code: UT-15C SR INN or Proposed INN: treprostinil diethanolamine | United Therapeutics Corporation | NULL | Not Recruiting | Female: yes Male: yes | 900 | Phase 3 | Portugal;Spain;Ireland;Austria;Israel;United Kingdom;Italy;France;Mexico;Puerto Rico;Belgium;Netherlands;Germany;Sweden | ||
| 509 | EUCTR2005-006192-13-PT (EUCTR) | 26/04/2007 | 30/11/2006 | A randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of the addition of inhaled iloprost in patients with pulmonary arterial hypertension (PAH) receiving oral sildenafil - VISION | A randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of the addition of inhaled iloprost in patients with pulmonary arterial hypertension (PAH) receiving oral sildenafil - VISION | Pulmonary Arterial Hypertension (PAH) is a condition that is characterized by increased pulmonary arterial pressure and vascular resistance that can lead to right ventricular failure and death. MedDRA version: 8.1;Level: LLT;Classification code 10037400;Term: Pulmonary hypertension | Trade Name: Ventavis Product Name: Iloprost (Ventavis®) INN or Proposed INN: Iloprost | CoTherix, Inc | NULL | Not Recruiting | Female: yes Male: yes | 180 | Portugal;Germany;United Kingdom;Spain;Italy;Austria | |||
| 510 | EUCTR2006-000804-18-BE (EUCTR) | 23/04/2007 | 25/01/2007 | An Open-Label Extension Trial of UT-15C SR in Subjects with Pulmonary Arterial Hypertension - FREEDOM-EXT | An Open-Label Extension Trial of UT-15C SR in Subjects with Pulmonary Arterial Hypertension - FREEDOM-EXT | Idiopathic or familial pulmonary arterial hypertension (PAH), including PAH associated with :1) Appetite suppressant use or 2) Repaired congenital systemic-to-pulmonary shunts (repaired = 5 years) or 3) Collagen Vascular Disease (CVD) or 4) Human Immunodeficiency Virus (HIV) MedDRA version: 13.1;Level: PT;Classification code 10037400;Term: Pulmonary hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders | Product Name: Treprostinil diethanolamine Product Code: UT-15C SR INN or Proposed INN: Treprostinil diethanolamine Product Name: Treprostinil diethanolamine Product Code: UT-15C SR INN or Proposed INN: Treprostinil diethanolamine Product Name: Treprostinil diethanolamine Product Code: UT-15C SR INN or Proposed INN: Treprostinil diethanolamine Product Name: Treprostinil diethanolamine Product Code: UT-15C SR INN or Proposed INN: Treprostinil diethanolamine Product Name: Treprostinil diethanolamine Product Code: UT-15C SR INN or Proposed INN: Treprostinil diethanolamine | United Therapeutics Corporation | NULL | Not Recruiting | Female: yes Male: yes | 900 | Phase 3 | Portugal;France;Spain;Belgium;Ireland;Austria;Germany;Netherlands;Italy;United Kingdom;Sweden | ||
| 511 | EUCTR2006-000801-50-BE (EUCTR) | 23/04/2007 | 25/01/2007 | A 12-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Comparison of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Subjects with Pulmonary Arterial Hypertension - FREEDOM-M | A 12-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Comparison of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Subjects with Pulmonary Arterial Hypertension - FREEDOM-M | Idiopathic or Familial pulmonary arterial hypertension (PAH), including PAH associated with:1) Appetite suppressant/toxin use, or2) Repaired congenital systemic-to-pulmonary shunts (repaired = 5 years), or3) Collagen Vascular Disease (CVD), or 4) Human Immunodeficiency virus (HIV) MedDRA version: 8.1;Level: PT;Classification code 10037400;Term: Pulmonary hypertension | Product Name: Treprostinil Product Code: UT-15C SR INN or Proposed INN: Treprostinil Product Name: Treprostinil Product Code: UT-15C SR INN or Proposed INN: Treprostinil Product Name: Treprostinil Product Code: UT-15C SR INN or Proposed INN: Treprostinil | United Therapeutics Corporation | NULL | Not Recruiting | Female: yes Male: yes | 150 | France;Belgium;Austria;Netherlands;Italy | |||
| 512 | EUCTR2006-000800-17-BE (EUCTR) | 23/04/2007 | 25/01/2007 | A 16-Week International, Multicenter, Double-Blind, Randomized, Placebo Controlled Comparison of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Combination with an Endothelin Receptor Antagonist and/or a Phosphodiesterase-5 Inhibitor in Subjects with Pulmonary Arterial Hypertension - FREEDOM-C | A 16-Week International, Multicenter, Double-Blind, Randomized, Placebo Controlled Comparison of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Combination with an Endothelin Receptor Antagonist and/or a Phosphodiesterase-5 Inhibitor in Subjects with Pulmonary Arterial Hypertension - FREEDOM-C | Idiopathic or Familial pulmonary arterial hypertension (PAH), including PAH associated with:1) Appetite suppressant/toxin use, or2) Repaired congenital systemic-to-pulmonary shunts (repaired = 5 years), or3) Collagen Vascular Disease, or4) HIV MedDRA version: 8.1;Level: PT;Classification code 10037400;Term: Pulmonary hypertension | Product Name: Treprostinil Product Code: UT-15C SR INN or Proposed INN: Treprostinil Product Name: Treprostinil Product Code: UT-15C SR INN or Proposed INN: Treprostinil Product Name: Treprostinil Product Code: UT-15C SR INN or Proposed INN: Treprostinil | United Therapeutics Corporation | NULL | Not Recruiting | Female: yes Male: yes | 300 | France;Spain;Belgium;Ireland;Austria;Germany;Netherlands;Italy;United Kingdom | |||
| 513 | NCT00458042 (ClinicalTrials.gov) | March 2007 | 5/4/2007 | Transitioning To IV Remodulin From Ventavis in Patients With PAH: Safety, Efficacy and Treatment Satisfaction | Transitioning To Intravenous Remodulin® (Treprostinil Sodium) From Inhaled Iloprost (Ventavis®) in Patients With Pulmonary Arterial Hypertension: Safety, Efficacy and Treatment Satisfaction | Hypertension, Pulmonary | Drug: treprostinil sodium | United Therapeutics | NULL | Terminated | 18 Years | 65 Years | Both | 10 | Phase 4 | United States |
| 514 | NCT00452218 (ClinicalTrials.gov) | March 2007 | 26/3/2007 | Sorafenib Study: Dosing in Patients With Pulmonary Arterial Hypertension (PAH) | Sorafenib Study: Dosing in Patients With Pulmonary Arterial Hypertension (PAH) | Pulmonary Arterial Hypertension | Drug: Sorafenib | University of Chicago | Bayer | Completed | 18 Years | N/A | Both | 12 | Phase 1 | United States |
| 515 | EUCTR2006-000804-18-AT (EUCTR) | 19/02/2007 | 17/01/2007 | An extension study of UT-15C tablet in subjects with high blood pressure inthe artery that carries blood to the lungs | An Open-Label Extension Trial of UT-15C SR in Subjects with Pulmonary Arterial Hypertension - FREEDOM-EXT | Idiopathic or familial pulmonary arterial hypertension (PAH), including PAH associated with:1) Appetite suppressant/toxin use) or2) Repaired congenital systemic-to-pulmonary shunts (repaired = 5 years) or3) Collagen Vascular Disease (CVD)4) Human Immunosufficiency Virus (HIV) MedDRA version: 20.0;Level: PT;Classification code 10037400;Term: Pulmonary hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Treprostinil diethanolamine Product Code: UT-15C SR INN or Proposed INN: Treprostinil diethanolamine Product Name: Treprostinil diethanolamine Product Code: UT-15C SR INN or Proposed INN: Treprostinil diethanolamine Product Name: Treprostinil diethanolamine Product Code: UT-15C SR INN or Proposed INN: Treprostinil diethanolamine Product Name: Treprostinil diethanolamine Product Code: UT-15C SR INN or Proposed INN: Treprostinil diethanolamine Product Name: Treprostinil diethanolamine Product Code: UT-15C SR INN or Proposed INN: treprostinil diethanolamine | United Therapeutics Corporation | NULL | Not Recruiting | Female: yes Male: yes | 900 | Phase 3 | Portugal;Spain;Ireland;Austria;Israel;United Kingdom;Italy;France;Mexico;Puerto Rico;Belgium;Netherlands;Germany;Sweden | ||
| 516 | EUCTR2006-000801-50-AT (EUCTR) | 19/02/2007 | 17/01/2007 | A 12-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Comparison of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Subjects with Pulmonary Arterial Hypertension - FREEDOM-M | A 12-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Comparison of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Subjects with Pulmonary Arterial Hypertension - FREEDOM-M | Idiopathic or Familial pulmonary arterial hypertension (PAH), including PAH associated with:1) Appetite suppressant/toxin use, or2) Repaired congenital systemic-to-pulmonary shunts (repaired = 5 years), or3) Collagen Vascular Disease (CVD), or 4) Human Immunodeficiency virus (HIV) MedDRA version: 8.1;Level: PT;Classification code 10037400;Term: Pulmonary hypertension | Product Name: Treprostinil Diethanolamine Product Code: UT-15C SR INN or Proposed INN: Treprostinil Product Name: Treprostinil Diethanolamine Product Code: UT-15C SR INN or Proposed INN: Treprostinil Product Name: Treprostinil Diethanolamine Product Code: UT-15C SR INN or Proposed INN: Treprostinil Product Name: Treprostinil Diethanolamine Product Code: UT-15C SR INN or Proposed INN: Treprostinil | United Therapeutics Corporation | NULL | Not Recruiting | Female: yes Male: yes | 150 | Netherlands;Belgium;France;Italy;Austria | |||
| 517 | EUCTR2006-000804-18-IE (EUCTR) | 15/02/2007 | 09/11/2006 | An Open-Label Extension Trial of UT-15C SR in Subjects with Pulmonary Arterial Hypertension - FREEDOM-EXT | An Open-Label Extension Trial of UT-15C SR in Subjects with Pulmonary Arterial Hypertension - FREEDOM-EXT | Idiopathic or familial pulmonary arterial hypertension (PAH), including PAH associated with :1) Appetite suppressant use or 2) Repaired congenital systemic-to-pulmonary shunts (repaired = 5 years) or 3) Collagen Vascular Disease (CVD) or 4) Human Immunodeficiency Virus (HIV) MedDRA version: 8.1;Level: PT;Classification code 10037400;Term: Pulmonary hypertension | Product Name: Treprostinil diethanolamine Product Code: UT-15C SR INN or Proposed INN: Treprostinil diethanolamine Product Name: Treprostinil diethanolamine Product Code: UT-15C SR INN or Proposed INN: Treprostinil diethanolamine Product Name: Treprostinil diethanolamine Product Code: UT-15C SR INN or Proposed INN: Treprostinil diethanolamine | United Therapeutics Corporation | NULL | Not Recruiting | Female: yes Male: yes | 450 | Phase 3 | Portugal;France;Spain;Belgium;Ireland;Austria;Germany;Netherlands;Italy;United Kingdom;Sweden | ||
| 518 | EUCTR2006-000800-17-IE (EUCTR) | 15/02/2007 | 13/11/2006 | A 16-Week International, Multicenter, Double-Blind, Randomized, Placebo Controlled Comparison of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Combination with an Endothelin Receptor Antagonist and/or a Phosphodiesterase-5 Inhibitor in Subjects with Pulmonary Arterial Hypertension - FREEDOM-C | A 16-Week International, Multicenter, Double-Blind, Randomized, Placebo Controlled Comparison of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Combination with an Endothelin Receptor Antagonist and/or a Phosphodiesterase-5 Inhibitor in Subjects with Pulmonary Arterial Hypertension - FREEDOM-C | Idiopathic or Familial pulmonary arterial hypertension (PAH), including PAH associated with:1) Appetite suppressant use, or2) Repaired congenital systemic-to-pulmonary shunts (repaired = 5 years), or3) Collagen Vascular Disease (CVD), or 4) Human Immunodeficiency virus (HIV) MedDRA version: 8.1;Level: PT;Classification code 10037400;Term: Pulmonary hypertension | Product Name: Treprostinil Diethanolamine Product Code: UT-15C SR INN or Proposed INN: Treprostinil diethanolamine Product Name: Treprostinil Diethanolamine Product Code: UT-15C SR INN or Proposed INN: Treprostinil diethanolamine | United Therapeutics Corporation | NULL | Not Recruiting | Female: yes Male: yes | 300 | Germany;United Kingdom;Netherlands;Belgium;France;Spain;Ireland;Italy;Austria | |||
| 519 | EUCTR2004-003236-59-ES (EUCTR) | 14/02/2007 | 05/05/2010 | Investigación clínica doble ciego controlada con placebo sobre la efficacia y la tolerabilidad de Treprostinil sódico inhaldo en pacientes con Hipertensión Pulmonar Graves.Double blind placebo controlled clinical investigation into the efficacy and tolerability of inhaled treprostinil in patients with severe pulmonary arterial hypertension. - | Hipertensión Arterial Pulmonar Grave de clase III y IV de la NYHANYHA Class III and IV patients with severe Pulmonary Arterial Hypertension (PAH) | Product Name: Treprostinil Sodium Solution for Inhalation Product Code: N/A INN or Proposed INN: N/A Other descriptive name: Treprostinil, UT-15, LRX-15, 15AU81, BW A15AU, U-62, 840 | United Therapeutics Corporation | NULL | Not Recruiting | Female: yes Male: yes | 220 | Germany;United Kingdom;Ireland;Spain;Italy | ||||
| 520 | NCT00439946 (ClinicalTrials.gov) | February 2007 | 22/2/2007 | Safety, Efficacy, and Treatment Satisfaction Switching From Flolan to Remodulin Using the Crono Five Ambulatory Pump in Patients With PAH | Rapid Switch From Intravenous Epoprostenol to Intravenous Remodulin® (Treprostinil Sodium) Using the Crono Five Ambulatory Infusion Pump in Patients With Stable Pulmonary Arterial Hypertension (PAH): Safety, Efficacy and Treatment Satisfaction | Pulmonary Arterial Hypertension | Drug: treprostinil;Device: Crono Five ambulatory pump | United Therapeutics | NULL | Terminated | 18 Years | 65 Years | All | 8 | Phase 4 | United States |
| 521 | EUCTR2006-000800-17-AT (EUCTR) | 19/01/2007 | 17/01/2007 | A 16-Week International, Multicenter, Double-Blind, Randomized, Placebo Controlled Comparison of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Combination with an Endothelin Receptor Antagonist and/or a Phosphodiesterase-5 Inhibitor in Subjects with Pulmonary Arterial Hypertension - FREEDOM-C | A 16-Week International, Multicenter, Double-Blind, Randomized, Placebo Controlled Comparison of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Combination with an Endothelin Receptor Antagonist and/or a Phosphodiesterase-5 Inhibitor in Subjects with Pulmonary Arterial Hypertension - FREEDOM-C | Idiopathic or Familial pulmonary arterial hypertension (PAH), including PAH associated with:1) Appetite suppressant/toxin use, or2) Repaired congenital systemic-to-pulmonary shunts (repaired = 5 years), or3) Collagen Vascular Disease, or4) HIV MedDRA version: 8.1;Level: PT;Classification code 10037400;Term: Pulmonary hypertension | Product Name: Treprostinil Diethanolamine Product Code: UT-15C SR INN or Proposed INN: Treprostinil diethanolamine Product Name: Treprostinil Diethanolamine Product Code: UT-15C SR INN or Proposed INN: Treprostinil diethanolamine | United Therapeutics Corporation | NULL | Not Recruiting | Female: yes Male: yes | 300 | Germany;United Kingdom;Netherlands;Belgium;France;Spain;Ireland;Italy;Austria | |||
| 522 | EUCTR2006-000800-17-GB (EUCTR) | 18/01/2007 | 22/11/2006 | A 16-Week International, Multicenter, Double-Blind, Randomized, Placebo Controlled Comparison of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Combination with an Endothelin Receptor Antagonist and/or a Phosphodiesterase-5 Inhibitor in Subjects with Pulmonary Arterial Hypertension - FREEDOM-C | A 16-Week International, Multicenter, Double-Blind, Randomized, Placebo Controlled Comparison of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Combination with an Endothelin Receptor Antagonist and/or a Phosphodiesterase-5 Inhibitor in Subjects with Pulmonary Arterial Hypertension - FREEDOM-C | Idiopathic or Familial pulmonary arterial hypertension (PAH), including PAH associated with: 1) Appetite suppressant use, or 2) Repaired congenital systemic-to-pulmonary shunts (repaired = 5 years), or 3) Collagen Vascular Disease (CVD), or 4) Human Immunodeficiency virus (HIV) MedDRA version: 8.1;Level: PT;Classification code 10037400;Term: Pulmonary hypertension | Product Name: Treprostinil Diethanolamine Product Code: UT-15C SR INN or Proposed INN: Treprostinil diethanolamine Product Name: Treprosinil Diethanolamine Product Code: UT-15C-SR INN or Proposed INN: Treprostinil diethanolamine Product Name: Treprosinil Diethanolamine Product Code: UT-15C-SR INN or Proposed INN: Treprostinil diethanolamine | United Therapeutics Corporation | NULL | Not Recruiting | Female: yes Male: yes | 300 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;Spain;Belgium;Ireland;Austria;Germany;Netherlands;Italy;United Kingdom | ||
| 523 | EUCTR2006-001464-23-IT (EUCTR) | 03/11/2006 | 19/02/2007 | A MULTINATIONAL, MULTICENTRE, RANDOMIZED, DOUBLE-BLIND STUDY TO ASSESS THE EFFICACY AND SAFETY OF ORAL SILDENAFIL 20MG TID OR PLACEBO WHEN ADDED TO BOSENTAN IN THE TREATMENT OF SUBJECTS, AGED 18 YEARS AND ABOVE, WITH PULMONARY ARTERIAL HYPERTENSION PAH - ND | A MULTINATIONAL, MULTICENTRE, RANDOMIZED, DOUBLE-BLIND STUDY TO ASSESS THE EFFICACY AND SAFETY OF ORAL SILDENAFIL 20MG TID OR PLACEBO WHEN ADDED TO BOSENTAN IN THE TREATMENT OF SUBJECTS, AGED 18 YEARS AND ABOVE, WITH PULMONARY ARTERIAL HYPERTENSION PAH - ND | Pulmonary Arterial Hypertension PAH . MedDRA version: 6.1;Level: PT;Classification code 10037400 | Trade Name: G04BE03- Sildenafil - sildenafil (citrato) Product Name: Sildenafil INN or Proposed INN: Sildenafil | PFIZER | NULL | Not Recruiting | Female: yes Male: yes | 106 | Czech Republic;Greece;Germany;United Kingdom;Italy | |||
| 524 | EUCTR2006-003520-10-DE (EUCTR) | 20/10/2006 | 23/08/2006 | Long-term study to collect additional information to evaluate the saftey and tolerability of BAY 63-2521 in different doses | A multicenter, non-randomized, non-blinded, non-controlled study to investigate the impact of multiple doses of BAY 63 2521 on safety, tolerability, pharmacokinetics, and pharmacodynamics in patients with pulmonary hypertension in a 12 week 3 times a day individual dose titration scheme | Subjects with PH due to• Pulmonary arterial hypertension (PAH) [Venice protocol] or• Chronic thrombembolic PH (CTEPH) MedDRA version: 19.0;Level: PT;Classification code 10037400;Term: Pulmonary hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: BAY 63-2521 Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl [4,6-diamino-2-[1-[(2-fluorophenyl)methyl]-1H-pyrazolo[3,4-b]pyridin-3-yl]-5-pyrimidinyl]meth Product Name: BAY 63-2521 Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl [4,6-diamino-2-[1-[(2-fluorophenyl)methyl]-1H-pyrazolo[3,4-b]pyridin-3-yl]-5-pyrimidinyl]meth Product Name: BAY 63-2521 Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl [4,6-diamino-2-[1-[(2-fluorophenyl)methyl]-1H-pyrazolo[3,4-b]pyridin-3-yl]-5-pyrimidinyl]meth Product Name: BAY 63-2521 Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl [4,6-diamino-2-[1-[(2-fluorophenyl)methyl]-1H-pyrazolo[3,4-b]pyridin-3-yl]-5-pyrimidinyl]meth Product Name: BAY 63-2521 Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl [4,6-diamino-2-[1-[(2-fluorophenyl)methyl]-1H-pyrazolo[3,4-b]pyridin-3-yl]-5-pyrimidinyl]meth | Bayer HealthCare AG | NULL | Not Recruiting | Female: yes Male: yes | 0 | Phase 1;Phase 2 | Germany | ||
| 525 | EUCTR2006-001464-23-GB (EUCTR) | 18/10/2006 | 11/06/2006 | A multinational, multicentre, randomized, double-blind study to assess the efficacy and safety of oral sildenafil 20mg TID or placebo when added to Bosentan in the treatement of subjects, aged 18 years and above, with pulmonary arterial hypertension (PAH) - N/A | A multinational, multicentre, randomized, double-blind study to assess the efficacy and safety of oral sildenafil 20mg TID or placebo when added to Bosentan in the treatement of subjects, aged 18 years and above, with pulmonary arterial hypertension (PAH) - N/A | Pulmonary Arterial Hypertension MedDRA version: 8.0;Level: LLT;Classification code 10064911 | Product Name: Revatio® Product Code: UK-92,480 INN or Proposed INN: Sildenafil | Pfizer Ltd | NULL | Not Recruiting | Female: yes Male: yes | 106 | Human pharmacology (Phase 1): Therapeutic exploratory (Phase 2): Therapeutic confirmatory - (Phase 3): Therapeutic use (Phase 4): yes | Czech Republic;Greece;Germany;Italy;United Kingdom | ||
| 526 | EUCTR2006-002081-19-NL (EUCTR) | 16/10/2006 | 21/07/2006 | The Effects of EGFR Inhibition on Pulmonary Arterial Hypertension Associated with Systemic SclerosisA phase II open-label safety and efficacy study. - EGFR Inhibition in SSc-PAH | The Effects of EGFR Inhibition on Pulmonary Arterial Hypertension Associated with Systemic SclerosisA phase II open-label safety and efficacy study. - EGFR Inhibition in SSc-PAH | Pulmonary arterial hypertension associated with systemic sclerosis | Trade Name: Erbitux Product Name: Cetuximab Product Code: C225 | VU University Medical Centre | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 20 | Phase 2 | Netherlands | ||
| 527 | EUCTR2004-000745-37-GB (EUCTR) | 10/10/2006 | 23/02/2005 | Uncontrolled extension trial to protocol AC-052-406 to evaluate the long-term effects of bosentan therapy in patients with pulmonary arterial hypertension related to connective tissue disease (TRUST-Extension) - TRUST - Extension | Uncontrolled extension trial to protocol AC-052-406 to evaluate the long-term effects of bosentan therapy in patients with pulmonary arterial hypertension related to connective tissue disease (TRUST-Extension) - TRUST - Extension | Pulmonary arterial hypertension (PAH) is characterized by increased pulmonary arterial pressure and pulmonary vascular resistance leading to right ventricular failure. PAH is a serious complication of many types of connective tissue disease (CTD). PAH is an important cause of morbidity in patients with connective tissue diseases . Once it is diagnosed, it is difficult to treat and has a very poor prognosis | Trade Name: Tracleer Product Name: bosentan Product Code: Ro 47-0203 INN or Proposed INN: bosentan monohydrate Other descriptive name: ------------ | Actelion Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 50 | Spain;Italy;United Kingdom | |||
| 528 | NCT00325442 (ClinicalTrials.gov) | October 2006 | 11/5/2006 | FREEDOM-C: Oral Treprostinil in Combination With an Endothelin Receptor Antagonist (ERA) and/or a Phosphodiesterase-5 (PDE-5) Inhibitor for the Treatment of Pulmonary Arterial Hypertension (PAH) | A 16-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Comparison of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Combination With an Endothelin Receptor Antagonist and/or a Phosphodiesterase-5 Inhibitor in Subjects With Pulmonary Arterial Hypertension | Pulmonary Hypertension | Drug: Oral treprostinil (UT-15C) sustained release tablets;Drug: Placebo | United Therapeutics | NULL | Completed | 12 Years | 70 Years | All | 354 | Phase 3 | United States;Australia;Austria;Belgium;Canada;France;Germany;Ireland;Israel;Italy;Netherlands;Poland;Spain;United Kingdom |
| 529 | NCT00325403 (ClinicalTrials.gov) | October 2006 | 11/5/2006 | FREEDOM - M: Oral Treprostinil as Monotherapy for the Treatment of Pulmonary Arterial Hypertension (PAH) | A 12-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Comparison of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Subjects With Pulmonary Arterial Hypertension | Pulmonary Hypertension | Drug: Oral treprostinil (UT-15C) Sustained Release Tablets;Other: Placebo | United Therapeutics | NULL | Completed | 12 Years | 75 Years | All | 349 | Phase 3 | United States;Austria;Belgium;Canada;China;France;India;Israel;Italy;Mexico;Netherlands;Poland;Puerto Rico |
| 530 | NCT00323297 (ClinicalTrials.gov) | September 2006 | 5/5/2006 | Assess the Efficacy and Safety of Sildenafil When Added to Bosentan in the Treatment of Pulmonary Arterial Hypertension | A Multinational, Multicentre, Randomized, Double-blind Study To Assess The Efficacy And Safety Of Oral Sildenafil 20mg Tid Or Placebo When Added To Bosentan In The Treatment Of Subjects, Aged 18 Years And Above, With Pulmonary Arterial Hypertension (Pah) | Pulmonary Arterial Hypertension | Drug: Bosentan;Other: Placebo;Drug: Sildenafil Citrate | Pfizer's Upjohn has merged with Mylan to form Viatris Inc. | NULL | Completed | 18 Years | N/A | All | 105 | Phase 4 | United States;Australia;Czechia;France;Germany;Greece;Israel;Italy;Taiwan;United Kingdom;Belgium;Czech Republic |
| 531 | NCT00373360 (ClinicalTrials.gov) | September 2006 | 7/9/2006 | Safety, Efficacy and Treatment Satisfaction in Patients With PAH Rapidly Switched From Epoprostenol to Remodulin | Rapid Switch From Intravenous Epoprostenol to Intravenous Remodulin® (Treprostinil Sodium) in Patients With Stable Pulmonary Arterial Hypertension: Safety, Efficacy and Treatment Satisfaction | Pulmonary Hypertension | Drug: treprostinil sodium | United Therapeutics | NULL | Completed | 18 Years | 70 Years | All | 10 | Phase 4 | United States |
| 532 | EUCTR2005-006192-13-DE (EUCTR) | 06/07/2006 | 03/05/2006 | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE SAFETY AND EFFICACY OF THE ADDITION OF INHALED ILOPROST IN PATIENTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH) RECEIVING ORAL SILDENAFIL - VISION | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE SAFETY AND EFFICACY OF THE ADDITION OF INHALED ILOPROST IN PATIENTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH) RECEIVING ORAL SILDENAFIL - VISION | Pulmonary Arterial Hypertension (PAH) is a condition that is characterized by increased pulmonary arterial pressure and vascular resistance that can lead to right ventricular failure and death. MedDRA version: 8.1;Level: LLT;Classification code 10037400;Term: Pulmonary hypertension | Trade Name: Ventavis Product Name: Iloprost (Ventavis®) INN or Proposed INN: Iloprost | Actelion Pharmaceuticals US, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 180 | Portugal;United Kingdom;Germany;Spain;Italy;Austria | |||
| 533 | EUCTR2006-001464-23-DE (EUCTR) | 04/07/2006 | 05/05/2006 | A multinational, multicentre, randomized, double-blind study to assess the efficacy and safety of oral sildenafil 20mg three times daily or placebo when added to bosentan in the treatment of adult subjects, withpulmonary arterial hypertension. | A multinational, multicentre, randomized, double-blind study to assess the efficacy and safety of oral sildenafil 20mg TID or placebo when added to Bosentan in the treatement of subjects , aged 18 years and above, with pulmonary arterial hypertension (PAH) - N/A | Pulmonary Arterial Hypertension MedDRA version: 14.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09] | Trade Name: Revatio Product Name: Revatio® Product Code: UK-92,480 INN or Proposed INN: Sildenafil Other descriptive name: n/a | Pfizer Ltd, Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK | NULL | Not Recruiting | Female: yes Male: yes | 106 | France;Czech Republic;Taiwan;Greece;Belgium;Australia;Israel;Germany;Italy;United Kingdom | |||
| 534 | EUCTR2005-006192-13-GB (EUCTR) | 22/06/2006 | 21/03/2006 | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE SAFETY AND EFFICACY OF THE ADDITION OF INHALED ILOPROST IN PATIENTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH) RECEIVING ORAL SILDENAFIL - VISION | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE SAFETY AND EFFICACY OF THE ADDITION OF INHALED ILOPROST IN PATIENTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH) RECEIVING ORAL SILDENAFIL - VISION | Pulmonary Arterial Hypertension (PAH) is a condition that is characterized by increased pulmonary arterial pressure and vascular resistance that can lead to right ventricular failure and death. MedDRA version: 8.1;Level: LLT;Classification code 10037400;Term: Pulmonary hypertension | Trade Name: Ventavis Product Name: Iloprost (Ventavis®) INN or Proposed INN: Iloprost | Actelion Pharmaceuticals US, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 180 | Portugal;Germany;United Kingdom;Spain;Italy;Austria | |||
| 535 | EUCTR2005-006192-13-ES (EUCTR) | 09/06/2006 | 12/05/2006 | Estudio aleatorio, doble-ciego, controlado con placebo para evaluar la seguridad y eficacia de la adición de Iloprost inhalado en pacientes con hipertensión arterial pulmonar que reciben Sildenafilo por vía oral - VISION | Estudio aleatorio, doble-ciego, controlado con placebo para evaluar la seguridad y eficacia de la adición de Iloprost inhalado en pacientes con hipertensión arterial pulmonar que reciben Sildenafilo por vía oral - VISION | Spanish: hipertensión arterial pulmonar English: Pulmonary Arterial Hypertension (PAH) is a condition that is characterized by increased pulmonary arterial pressure and vascular resistance that can lead to right ventricular failure and death. MedDRA version: 8.1;Classification code 10037400 | Trade Name: **Comment**- IMP inhalation solution identical to ventavis inhalation solution, but IMP is in a different volume presentation. Please see covering letter. Product Name: Iloprost (Ventavis®) INN or Proposed INN: Iloprost | CoTherix, Inc | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 3 | Portugal;Spain;Austria;Germany;Italy;United Kingdom | ||
| 536 | EUCTR2006-001464-23-CZ (EUCTR) | 08/06/2006 | 21/04/2006 | A multinational, multicentre, randomized, double-blind study to assess the efficacy and safety of oral sildenafil 20mg TID or placebo when added to Bosentan in the treatement of subjects , aged 18 years and above, with pulmonary arterial hypertension (PAH) - N/A | A multinational, multicentre, randomized, double-blind study to assess the efficacy and safety of oral sildenafil 20mg TID or placebo when added to Bosentan in the treatement of subjects , aged 18 years and above, with pulmonary arterial hypertension (PAH) - N/A | Pulmonary Arterial Hypertension MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension | Trade Name: Revatio Product Name: Revatio® Product Code: UK-92,480 INN or Proposed INN: Sildenafil | Pfizer Ltd,Ramsgate Road,Sandwich CT13 9NJ | NULL | Not Recruiting | Female: yes Male: yes | 106 | Czech Republic;Greece;Germany;Italy;United Kingdom | |||
| 537 | EUCTR2005-006192-13-AT (EUCTR) | 15/05/2006 | 05/05/2006 | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE SAFETY AND EFFICACY OF THE ADDITION OF INHALED ILOPROST IN PATIENTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH) RECEIVING ORAL SILDENAFIL - VISION | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE SAFETY AND EFFICACY OF THE ADDITION OF INHALED ILOPROST IN PATIENTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH) RECEIVING ORAL SILDENAFIL - VISION | Pulmonary Arterial Hypertension (PAH) is a condition that is characterized by increased pulmonary arterial pressure and vascular resistance that can lead to right ventricular failure and death. MedDRA version: 8.1;Level: LLT;Classification code 10037400;Term: Pulmonary hypertension | Trade Name: Ventavis Product Name: Iloprost (Ventavis®) INN or Proposed INN: Iloprost | Actelion Pharmaceuticals US, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 180 | Portugal;Germany;United Kingdom;Spain;Italy;Austria | |||
| 538 | NCT00303459 (ClinicalTrials.gov) | May 2006 | 16/3/2006 | Effects of the Combination of Bosentan and Sildenafil Versus Sildenafil Monotherapy on Pulmonary Arterial Hypertension (PAH) | Effects of Combination of Bosentan and Sildenafil Versus Sildenafil Monotherapy on Morbidity and Mortality in Symptomatic Patients With Pulmonary Arterial Hypertension - A Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group, Prospective, Event Driven Phase IV Study | Pulmonary Arterial Hypertension | Drug: bosentan;Drug: placebo | Actelion | NULL | Completed | 12 Years | N/A | All | 334 | Phase 4 | United States;Brazil;Czech Republic;Denmark;Germany;Greece;Portugal;Saudi Arabia;Slovakia;Spain;Sweden;United Kingdom |
| 539 | NCT00469027 (ClinicalTrials.gov) | May 2006 | 2/5/2007 | Pulmonary Hypertension: Assessment of Cell Therapy | Phase I Trial to Establish Safety of Autologous Progenitor Cell-based Gene Therapy Delivery of heNOS in Patients With Severe Pulmonary Arterial Hypertension(PAH)Refractory to Conventional Treatment | Hypertension, Pulmonary | Biological: eNOS transfected EPCs will be delivered via a PA line | Northern Therapeutics | St. Michael's Hospital, Toronto;Sir Mortimer B. Davis - Jewish General Hospital;St. Michael's Hospital, Toronto;Sir Mortimer B. Davis - Jewish General Hospital | Completed | 18 Years | 80 Years | Both | 7 | Phase 1 | Canada |
| 540 | NCT00595049 (ClinicalTrials.gov) | May 2006 | 7/1/2008 | Pulmonary Artery Remodelling With Bosentan | Open Label, Non Comparative Study to Investigate the Effect of Bosentan on Pulmonary Artery Remodelling in Pulmonary Arterial Hypertension (PAH). | Hypertension, Pulmonary | Drug: bosentan | Actelion | NULL | Completed | 18 Years | N/A | Both | 11 | Phase 4 | Australia;United States |
| 541 | EUCTR2005-002844-24-GB (EUCTR) | 10/04/2006 | 12/09/2005 | A Double-Blind, Extension Study to Evaluate the Long-Term Safety and Efficacy of the Phosphodiesterase Type 5 (PDE5) Inhibitor Tadalafil in the Treatment of Patients with Pulmonary Arterial Hypertension - LVGX | A Double-Blind, Extension Study to Evaluate the Long-Term Safety and Efficacy of the Phosphodiesterase Type 5 (PDE5) Inhibitor Tadalafil in the Treatment of Patients with Pulmonary Arterial Hypertension - LVGX | Pulmonary arterial hypertension (PAH) is a chronic and progressive disease characterised by elevation of pulmonary artery pressure and pulmonary vascular resistance, leading to right heart failure and death. | Product Name: Cialis INN or Proposed INN: Tadalafil | Lilly ICOS LLC | NULL | Not Recruiting | Female: yes Male: yes | 350 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Spain;Belgium;Ireland;Germany;Italy;United Kingdom | ||
| 542 | EUCTR2005-002692-33-GB (EUCTR) | 10/04/2006 | 12/09/2005 | A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of the Phosphodiesterase Type 5 (PDE5) Inhibitor Tadalafil in the Treatment of Patients with Pulmonary Arterial Hypertension - LVGY | A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of the Phosphodiesterase Type 5 (PDE5) Inhibitor Tadalafil in the Treatment of Patients with Pulmonary Arterial Hypertension - LVGY | Pulmonary arterial hypertension (PAH) is a chronic and progressive disease characterised by elevation of pulmonary artery pressure and pulmonary vascular resistance, leading to right heart failure and death. | Product Name: Cialis INN or Proposed INN: Tadalafil | Lilly ICOS LLC | NULL | Not Recruiting | Female: yes Male: yes | 400 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Spain;Belgium;Ireland;Germany;Italy;United Kingdom | ||
| 543 | NCT00477269 (ClinicalTrials.gov) | April 2006 | 22/5/2007 | Safety and Efficacy of Imatinib Mesylate in Patients With Pulmonary Arterial Hypertension | A Randomised, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of the Six Months Treatment With the Tyrosine Kinase Inhibitor STI571 for the Treatment of Pulmonary Arterial Hypertension (PAH) | Pulmonary Arterial Hypertension | Drug: Imatinib mesylate;Drug: Placebo | Novartis Pharmaceuticals | NULL | Completed | 18 Years | N/A | All | 59 | Phase 2/Phase 3 | United States;Austria;Germany;United Kingdom |
| 544 | EUCTR2005-005066-37-IT (EUCTR) | 21/03/2006 | 05/06/2006 | Hemodynamic effects of a single dose of sildenafil in symptomatic patients on bosentan treatment for pulmonary arterial hypertension A multicenter, open-label, non-comparative, prospective, phase II study - COMPASS 1 | Hemodynamic effects of a single dose of sildenafil in symptomatic patients on bosentan treatment for pulmonary arterial hypertension A multicenter, open-label, non-comparative, prospective, phase II study - COMPASS 1 | Patients suffering from pulmonary arterial hypertension PAH MedDRA version: 6.1;Level: PT;Classification code 10037400 | INN or Proposed INN: Sildenafil | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 44 | Phase 2 | Germany;United Kingdom;Italy | ||
| 545 | NCT00310830 (ClinicalTrials.gov) | March 2006 | 3/4/2006 | Efficacy and Safety of Bosentan in Sickle Cell Disease (SCD) Patients With Pulmonary Arterial Hypertension (PAH) | Randomized, Placebo-controlled, Double-blind, Multicenter, Parallel Group Study to Assess the Efficacy, Safety and Tolerability of Bosentan in Patients With Symptomatic Pulmonary Arterial Hypertension Associated With Sickle Cell Disease | Pulmonary Hypertension | Drug: Bosentan | Actelion | NULL | Terminated | 12 Years | N/A | Both | 14 | Phase 3 | United States;France;Netherlands;United Kingdom |
| 546 | EUCTR2005-002844-24-IE (EUCTR) | 23/02/2006 | 12/10/2005 | A Double-Blind, Extension Study to Evaluate the Long-Term Safety and Efficacy of the Phosphodiesterase Type 5 (PDE5) Inhibitor Tadalafil in the Treatment of Patients with Pulmonary Arterial Hypertension - LVGX | A Double-Blind, Extension Study to Evaluate the Long-Term Safety and Efficacy of the Phosphodiesterase Type 5 (PDE5) Inhibitor Tadalafil in the Treatment of Patients with Pulmonary Arterial Hypertension - LVGX | Pulmonary arterial hypertension (PAH) is a chronic and progressive disease characterised by elevation of pulmonary artery pressure and pulmonary vascular resistance, leading to right heart failure and death. | Trade Name: Cialis Product Name: Cialis INN or Proposed INN: Tadalafil | Lilly ICOS LLC | NULL | Not Recruiting | Female: yes Male: yes | 350 | Germany;United Kingdom;Spain;Ireland;Italy | |||
| 547 | EUCTR2005-002692-33-IE (EUCTR) | 23/02/2006 | 12/10/2005 | A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of the Phosphodiesterase Type 5 (PDE5) Inhibitor Tadalafil in the Treatment of Patients with Pulmonary Arterial Hypertension - LVGY | A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of the Phosphodiesterase Type 5 (PDE5) Inhibitor Tadalafil in the Treatment of Patients with Pulmonary Arterial Hypertension - LVGY | Pulmonary arterial hypertension (PAH) is a chronic and progressive disease characterized by elevation of pulmonary artery pressure and pulmonary vascular resistance, leading to right heart failure and death. | Trade Name: Cialis Product Name: Cialis INN or Proposed INN: Tadalafil | Lilly ICOS LLC | NULL | Not Recruiting | Female: yes Male: yes | 400 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Spain;Belgium;Ireland;Germany;Italy;United Kingdom | ||
| 548 | EUCTR2005-002692-33-DE (EUCTR) | 17/02/2006 | 21/10/2005 | A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of the Phosphodiesterase Type 5 (PDE5) Inhibitor Tadalafil in the Treatment of Patients with Pulmonary Arterial Hypertension - LVGY | A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of the Phosphodiesterase Type 5 (PDE5) Inhibitor Tadalafil in the Treatment of Patients with Pulmonary Arterial Hypertension - LVGY | Pulmonary arterial hypertension (PAH) is a chronic and progressive disease characterized by elevation of pulmonary artery pressure and pulmonary vascular resistance, leading to right heart failure and death. | Product Name: Cialis INN or Proposed INN: Tadalafil Product Name: Cialis INN or Proposed INN: Tadalafil Product Name: Tadalafil INN or Proposed INN: Tadalafil | Lilly ICOS LLC | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 3 | Spain;Ireland;Germany;Italy;United Kingdom | ||
| 549 | EUCTR2005-002692-33-BE (EUCTR) | 25/01/2006 | 26/10/2005 | A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of the Phosphodiesterase Type 5 (PDE5) Inhibitor Tadalafil in the Treatment of Patients with Pulmonary Arterial Hypertension - LVGY | A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of the Phosphodiesterase Type 5 (PDE5) Inhibitor Tadalafil in the Treatment of Patients with Pulmonary Arterial Hypertension - LVGY | Pulmonary arterial hypertension (PAH) is a chronic and progressive disease characterized by elevation of pulmonary artery pressure and pulmonary vascular resistance, leading to right heart failure and death. | Trade Name: Cialis Product Name: Cialis INN or Proposed INN: Tadalafil | Lilly ICOS LLC | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 3 | Spain;Belgium;Ireland;Germany;Italy;United Kingdom | ||
| 550 | EUCTR2005-002844-24-BE (EUCTR) | 25/01/2006 | 26/10/2005 | An Extension Study to Evaluate the Long-Term Safety and Efficacy of the Phosphodiesterase Type 5 (PDE5) Inhibitor Tadalafil in the Treatment of Patients with Pulmonary Arterial Hypertension - LVGX | An Extension Study to Evaluate the Long-Term Safety and Efficacy of the Phosphodiesterase Type 5 (PDE5) Inhibitor Tadalafil in the Treatment of Patients with Pulmonary Arterial Hypertension - LVGX | Pulmonary arterial hypertension (PAH) is a chronic and progressive disease characterized by elevation of pulmonary artery pressure and pulmonary vascular resistance, leading to right heart failure and death. MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension | Trade Name: Cialis Product Name: Cialis INN or Proposed INN: Tadalafil | Eli Lilly and Company Limited | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 3;Phase 4 | Spain;Belgium;Ireland;Germany;Italy;United Kingdom | ||
| 551 | EUCTR2005-002844-24-DE (EUCTR) | 17/01/2006 | 11/10/2005 | An Extension Study to Evaluate the Long-Term Safety and Efficacy of the Phosphodiesterase Type 5 (PDE5) Inhibitor Tadalafil in the Treatment of Patients with Pulmonary Arterial Hypertension - LVGX | An Extension Study to Evaluate the Long-Term Safety and Efficacy of the Phosphodiesterase Type 5 (PDE5) Inhibitor Tadalafil in the Treatment of Patients with Pulmonary Arterial Hypertension - LVGX | Pulmonary arterial hypertension (PAH) is a chronic and progressive disease characterized by elevation of pulmonary artery pressure and pulmonary vascular resistance, leading to right heart failure and death. | Trade Name: Cialis Product Name: Cialis INN or Proposed INN: Tadalafil | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 350 | Spain;Ireland;Germany;Italy;United Kingdom | |||
| 552 | EUCTR2005-000812-29-IT (EUCTR) | 15/11/2005 | 15/02/2006 | ARIES-1 - Ambrisentan in PAH A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Efficacy Study of Ambrisentan in Subjects with Pulmonary Arterial Hypertension | ARIES-1 - Ambrisentan in PAH A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Efficacy Study of Ambrisentan in Subjects with Pulmonary Arterial Hypertension | PULMONARY ARTERIAL HYPERTENSION MedDRA version: 6.1;Level: PT;Classification code 10037400 | Product Name: Ambrisentan | MYOGEN INC. | NULL | Not Recruiting | Female: yes Male: yes | 186 | Phase 3 | Hungary;Germany;Belgium;Spain;Italy | ||
| 553 | EUCTR2005-000812-29-AT (EUCTR) | 08/11/2005 | 04/10/2005 | ARIES-1 Ambrisentan in PAH - A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Efficacy Study of Ambrisentan in Subjects with Pulmonary Arterial Hypertension” - ARIES-1 | ARIES-1 Ambrisentan in PAH - A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Efficacy Study of Ambrisentan in Subjects with Pulmonary Arterial Hypertension” - ARIES-1 | Pulmonary Arterial Hypertension | Product Name: Ambrisentan Product Code: BSF 208075 INN or Proposed INN: Ambrisentan Product Name: Ambrisentan Product Code: BSF 208075 INN or Proposed INN: Ambrisentan Product Name: Ambrisentan Product Code: BSF 208075 INN or Proposed INN: Ambrisentan | Myogen, Inc | NULL | Not Recruiting | Female: yes Male: yes | 186 | Phase 3 | Hungary;Belgium;Spain;Austria;Germany;Italy | ||
| 554 | EUCTR2005-000812-29-DE (EUCTR) | 07/11/2005 | 02/03/2007 | ARIES-1 Ambrisentan in PAH - A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Efficacy Study of Ambrisentan in Subjects with Pulmonary Arterial Hypertension” - ARIES-1 | ARIES-1 Ambrisentan in PAH - A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Efficacy Study of Ambrisentan in Subjects with Pulmonary Arterial Hypertension” - ARIES-1 | Pulmonary Arterial Hypertension | Product Name: Ambrisentan Product Code: BSF 208075 INN or Proposed INN: Ambrisentan Product Name: Ambrisentan Product Code: BSF 208075 INN or Proposed INN: Ambrisentan Product Name: Ambrisentan Product Code: BSF 208075 INN or Proposed INN: Ambrisentan | Myogen, Inc | NULL | Not Recruiting | Female: yes Male: yes | 186 | Phase 3 | Hungary;Germany;Belgium;Spain;Italy | ||
| 555 | EUCTR2005-000812-29-ES (EUCTR) | 21/10/2005 | 19/09/2005 | ARIES-1 Ambrisentan in PAH - A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Efficacy Study of Ambrisentan in Subjects with Pulmonary Arterial Hypertension” - ARIES-1 | ARIES-1 Ambrisentan in PAH - A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Efficacy Study of Ambrisentan in Subjects with Pulmonary Arterial Hypertension” - ARIES-1 | Pulmonary Arterial Hypertension | Product Name: Ambrisentan Product Code: BSF 208075 INN or Proposed INN: Ambrisentan Product Name: Ambrisentan Product Code: BSF 208075 INN or Proposed INN: Ambrisentan Product Name: Ambrisentan Product Code: BSF 208075 INN or Proposed INN: Ambrisentan | Myogen, Inc | NULL | Not Recruiting | Female: yes Male: yes | 186 | Phase 3 | Hungary;Belgium;Spain;Austria;Germany;Italy | ||
| 556 | EUCTR2005-000812-29-HU (EUCTR) | 21/09/2005 | 11/08/2005 | Ambrisentan in PAH - A Phase III, Randomised, Double- Blind, Placebo- Controlled, Multicenter, Efficacy Study of Ambrisentan in Subjects with Pulmonary Arterial Hypertension - ARIES-1 | Ambrisentan in PAH - A Phase III, Randomised, Double- Blind, Placebo- Controlled, Multicenter, Efficacy Study of Ambrisentan in Subjects with Pulmonary Arterial Hypertension - ARIES-1 | Pulmonary Arterial Hypertension MedDRA version: 7.0;Level: low;Classification code 10037400 | Product Name: Ambrisentan Product Code: BSF 208075 INN or Proposed INN: Ambrisentan Product Name: Ambrisentan Product Code: BSF 208075 INN or Proposed INN: Ambrisentan Product Name: Ambrisentan Product Code: BSF 208075 INN or Proposed INN: Ambrisentan | Myogen, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 186 | Phase 3 | Hungary;Belgium;Spain;Austria;Germany;Italy | ||
| 557 | EUCTR2005-000812-29-BE (EUCTR) | 16/09/2005 | 08/02/2006 | ARIES-1 Ambrisentan in PAH - A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Efficacy Study of Ambrisentan in Subjects with Pulmonary Arterial Hypertension” - ARIES-1 | ARIES-1 Ambrisentan in PAH - A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Efficacy Study of Ambrisentan in Subjects with Pulmonary Arterial Hypertension” - ARIES-1 | Pulmonary Arterial Hypertension | Product Name: Ambrisentan Product Code: BSF 208075 INN or Proposed INN: Ambrisentan Product Name: Ambrisentan Product Code: BSF 208075 INN or Proposed INN: Ambrisentan Product Name: Ambrisentan Product Code: BSF 208075 INN or Proposed INN: Ambrisentan | Myogen, Inc | NULL | Not Recruiting | Female: yes Male: yes | 186 | Phase 3 | Hungary;Germany;Belgium;Spain;Italy | ||
| 558 | EUCTR2004-003236-59-IE (EUCTR) | 09/09/2005 | 06/07/2005 | Double blind placebo controlled clinical investigation into the efficacy and tolerability of inhaled treprostinil in patients with severe pulmonary arterial hypertension. - | NYHA Class III and IV patients with severe Pulmonary Arterial Hypertension (PAH) | Product Name: Treprostinil Sodium Solution for Inhalation Product Code: N/A INN or Proposed INN: N/A Other descriptive name: Treprostinil, UT-15, LRX-15, 15AU81, BW A15AU, U-62, 840 | Lung Rx Inc. | NULL | Not Recruiting | Female: yes Male: yes | 165 | Germany;United Kingdom;Spain;Ireland;Italy | ||||
| 559 | EUCTR2004-003236-59-AT (EUCTR) | 24/08/2005 | 20/07/2005 | Double blind placebo controlled clinical investigation into the efficacy and tolerability of inhaled treprostinil in patients with severe pulmonary arterial hypertension. | Double blind placebo controlled clinical investigation into the efficacy and tolerability of inhaled treprostinil in patients with severe pulmonary arterial hypertension. | NYHA Class III and IV patients with severe Pulmonary Arterial Hypertension (PAH) | Product Name: Treprostinil Sodium Solution for Inhalation Product Code: N/A INN or Proposed INN: N/A Other descriptive name: Treprostinil, UT-15, LRX-15, 15AU81, BW A15AU, U-62, 840 | United Therapeutics Corporation | NULL | Not Recruiting | Female: yes Male: yes | 220 | Spain;Ireland;Austria;Germany;Italy;United Kingdom | |||
| 560 | EUCTR2004-003236-59-BE (EUCTR) | 20/08/2005 | 15/12/2005 | Double blind placebo controlled clinical investigation into the efficacy and tolerability of inhaled treprostinil in patients with severe pulmonary arterial hypertension. | Double blind placebo controlled clinical investigation into the efficacy and tolerability of inhaled treprostinil in patients with severe pulmonary arterial hypertension. | NYHA Class III and IV patients with severe Pulmonary Arterial Hypertension (PAH) | Product Name: Treprostinil Sodium Solution for Inhalation Product Code: N/A INN or Proposed INN: N/A Other descriptive name: Treprostinil, UT-15, LRX-15, 15AU81, BW A15AU, U-62, 840 | United Therapeutics Corporation | NULL | Not Recruiting | Female: yes Male: yes | 220 | Phase 3 | Spain;Belgium;Ireland;Austria;Germany;Italy;United Kingdom | ||
| 561 | NCT00593905 (ClinicalTrials.gov) | July 2005 | 3/1/2008 | Pharmacogenomics in Pulmonary Arterial Hypertension | Pharmacogenomics in Pulmonary Arterial Hypertension: A Multi-Center International Study to Determine Whether in PAH Patients Clinical Associations Exist Between the Efficacy and Toxicity of Endothelin Receptor Antagonists and Several Gene Polymorphisms in Several Key Disease-Specific and Therapy Specific Genes | Pulmonary Arterial Hypertension;Pulmonary Hypertension;PAH WHO Group I | Drug: Sitaxsentan;Drug: Bosentan, Ambrisentan | West Penn Allegheny Health System | National Institutes of Health (NIH);Baylor College of Medicine;Emory University;University of Chicago;Johns Hopkins University;Tufts Medical Center;Sir Mortimer B. Davis - Jewish General Hospital;London Health Sciences Centre;University of Maryland, College Park;University of California, San Francisco;University of Calgary;Chest Medical Associates;Columbia University;Lung Diagnostics, Ltd.;Duke University;University of California, Los Angeles;Latter Day Saints Hospital;Louisiana State University Health Sciences Center in New Orleans;Massachusetts General Hospital;Mayo Clinic;Medical College of Wisconsin;Southeastern Lung Care;Suncoast Lung Center;Children's Hospital Colorado;University Hospitals Cleveland Medical Center;University of Colorado, Denver;University of Michigan;University of Pittsburgh Medical Center;University of Southern California;The University of Texas Medical Branch, Galveston;Vanderbilt University;Wayne State University;Ohio State University;University of Alabama at Birmingham;Washington University School of Medicine;Sentara Norfolk General Hospital;University of Texas Southwestern Medical Center;Bay Area Chest Physicians | Withdrawn | N/A | N/A | All | 0 | United States | |
| 562 | EUCTR2004-003236-59-GB (EUCTR) | 30/06/2005 | 13/06/2005 | Double blind placebo controlled clinical investigation into the efficacy and tolerability of inhaled treprostinil in patients with severe pulmonary arterial hypertension. | Double blind placebo controlled clinical investigation into the efficacy and tolerability of inhaled treprostinil in patients with severe pulmonary arterial hypertension. | NYHA Class III and IV patients with severe Pulmonary Arterial Hypertension (PAH) | Product Name: Treprostinil Sodium Solution for Inhalation Product Code: N/A INN or Proposed INN: N/A Other descriptive name: Treprostinil, UT-15, LRX-15, 15AU81, BW A15AU, U-62, 840 | United Therapeutics Corporation | NULL | Not Recruiting | Female: yes Male: yes | 220 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Spain;Belgium;Ireland;Austria;Germany;Italy;United Kingdom | ||
| 563 | EUCTR2004-005157-63-GB (EUCTR) | 15/06/2005 | 19/04/2005 | An open label, multicenter study to assess the pharmacokinetics, tolerability, and safety of a pediatric formulation of bosentan in children with idiopathic or familial pulmonary arterial hypertension. - FUTURE 1 | An open label, multicenter study to assess the pharmacokinetics, tolerability, and safety of a pediatric formulation of bosentan in children with idiopathic or familial pulmonary arterial hypertension. - FUTURE 1 | Idiopathic or familial PAH | Product Name: bosentan Product Code: Ro 47-0203 INN or Proposed INN: bosentan monohydrate | Actelion Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 33 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Italy;United Kingdom | ||
| 564 | NCT03055221 (ClinicalTrials.gov) | June 10, 2005 | 9/2/2017 | TRUST-2: Safety and Efficacy of Intravenous Remodulin® in Patients in India With Pulmonary Arterial Hypertension (PAH) | TRUST-2: An Open-label Continuation Trial of the Safety and Efficacy of Intravenous Remodulin® in Patients in India With Pulmonary Arterial Hypertension (PAH) | Pulmonary Arterial Hypertension | Drug: Intravenous Treprostinil | United Therapeutics | NULL | Completed | 16 Years | 75 Years | All | 20 | Phase 4 | NULL |
| 565 | NCT00147199 (ClinicalTrials.gov) | June 2005 | 2/9/2005 | Clinical Investigation Into Inhaled Treprostinil Sodium in Patients With Severe Pulmonary Arterial Hypertension (PAH) | TRIUMPH I: Double Blind Placebo Controlled Clinical Investigation Into the Efficacy and Tolerability of Inhaled Treprostinil Sodium in Patients With Severe Pulmonary Arterial Hypertension | Pulmonary Hypertension | Drug: Inhaled treprostinil;Drug: Placebo inhalation solution | United Therapeutics | NULL | Completed | 18 Years | 75 Years | All | 235 | Phase 3 | United States;Austria;Belgium;France;Germany;Ireland;Israel;Italy;Spain;United Kingdom |
| 566 | EUCTR2005-000963-25-SE (EUCTR) | 30/05/2005 | 06/04/2005 | Oral Revatio in Pediatric PAH- Long term follow on study to A1481131 | A Multicenter, Long-Term Extension Study to Assess Safety of Oral Sildenafil in the Treatment of Subjects Who Have Completed Study A1481131 - N/A | Pulmonary Arterial Hypertension MedDRA version: 14.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09] | INN or Proposed INN: sildenafil (as citrate) Other descriptive name: UK-92,480 Trade Name: Revatio INN or Proposed INN: sildenafil (as citrate) Other descriptive name: UK-92,480 | Pfizer Limited, Ramsgate Road, Sandwich, Kent, UK | NULL | Not Recruiting | Female: yes Male: yes | 200 | Taiwan;Finland;Thailand;Costa Rica;Guatemala;Chile;Russian Federation;Colombia;United Kingdom;Italy;India;Hungary;Mexico;Brazil;Malaysia;Poland;Sweden | |||
| 567 | NCT00494533 (ClinicalTrials.gov) | March 2005 | 27/6/2007 | Study of Intravenous Remodulin in Patients in India With Pulmonary Arterial Hypertension | Treprostinil for Untreated Symptomatic PAH Trial: A 12-Week Multicenter Randomized Double-Blind Placebo-Controlled Trial of the Safety and Efficacy of Intravenous Remodulin® in Patients in India With Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension | Drug: Remodulin (treprostinil sodium) | United Therapeutics | Asian Clinical Trials | Terminated | 16 Years | 75 Years | Both | 45 | Phase 4 | India |
| 568 | EUCTR2004-000478-30-ES (EUCTR) | 10/02/2005 | 03/11/2004 | Endothelin antagonist trial in mildly symptomatic PAH patients. A randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy, safety, and tolerability of bosentan in patients with mildly symptomatic pulmonary arterial hypertension. - EARLY | Endothelin antagonist trial in mildly symptomatic PAH patients. A randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy, safety, and tolerability of bosentan in patients with mildly symptomatic pulmonary arterial hypertension. - EARLY | Patients with modified NYHA functional Class II PAH have mild symptoms, but their pulmonary artery pressures are elevated which leads to increased wall stress and silent heart damage progression. Therefore Class I-II patients have a better survival rate than Class III-IV patients (Odds ratio = 1.9) but will eventually deteriorate if untreated.There are no approved drug therapies for Class II PAH and the EARLY study is the first trial designed to enroll exclusively class II patients. | Trade Name: Tracleer Product Name: bosentan Product Code: Ro 47-0203 INN or Proposed INN: bosentan monohydrate Other descriptive name: ------------ | Actelion Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 170 | Phase 3 | Czech Republic;Belgium;Spain;Denmark;Austria;Italy;United Kingdom;Sweden | ||
| 569 | EUCTR2004-000478-30-BE (EUCTR) | 14/12/2004 | 24/08/2005 | Endothelin antagonist trial in mildly symptomatic PAH patients. A randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy, safety, and tolerability of bosentan in patients with mildly symptomatic pulmonary arterial hypertension. - EARLY | Endothelin antagonist trial in mildly symptomatic PAH patients. A randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy, safety, and tolerability of bosentan in patients with mildly symptomatic pulmonary arterial hypertension. - EARLY | Patients with modified NYHA functional Class II PAH have mild symptoms, but their pulmonary artery pressures are elevated which leads to increased wall stress and silent heart damage progression. Therefore Class I-II patients have a better survival rate than Class III-IV patients (Odds ratio = 1.9) but will eventually deteriorate if untreated. MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension | Trade Name: Tracleer Product Name: bosentan Product Code: Ro 47-0203 INN or Proposed INN: bosentan monohydrate Other descriptive name: ------------ Trade Name: Tracleer Product Name: bosentan Product Code: Ro 47-0203 INN or Proposed INN: bosentan monohydrate Other descriptive name: ------------ | Actelion Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 170 | Czech Republic;Spain;Belgium;Denmark;Austria;Italy;United Kingdom;Sweden | |||
| 570 | EUCTR2004-000478-30-AT (EUCTR) | 08/12/2004 | 03/11/2004 | Endothelin antagonist trial in mildly symptomatic PAH patients. A randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy, safety, and tolerability of bosentan in patients with mildly symptomatic pulmonary arterial hypertension. - EARLY | Endothelin antagonist trial in mildly symptomatic PAH patients. A randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy, safety, and tolerability of bosentan in patients with mildly symptomatic pulmonary arterial hypertension. - EARLY | Patients with modified NYHA functional Class II PAH have mild symptoms, but their pulmonary artery pressures are elevated which leads to increased wall stress and silent heart damage progression. Therefore Class I-II patients have a better survival rate than Class III-IV patients (Odds ratio = 1.9) but will eventually deteriorate if untreated. MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension | Trade Name: Tracleer Product Name: bosentan Product Code: Ro 47-0203 INN or Proposed INN: bosentan monohydrate Other descriptive name: ------------ Trade Name: Tracleer Product Name: bosentan Product Code: Ro 47-0203 INN or Proposed INN: bosentan monohydrate | Actelion Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 170 | Czech Republic;Spain;Denmark;Austria;Italy;United Kingdom;Sweden | |||
| 571 | EUCTR2004-000478-30-CZ (EUCTR) | 26/11/2004 | 26/11/2004 | Endothelin antagonist trial in mildly symptomatic PAH patients. A randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy, safety, and tolerability of bosentan in patients with mildly symptomatic pulmonary arterial hypertension. - EARLY | Endothelin antagonist trial in mildly symptomatic PAH patients. A randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy, safety, and tolerability of bosentan in patients with mildly symptomatic pulmonary arterial hypertension. - EARLY | Patients with modified NYHA functional Class II PAH have mild symptoms, but their pulmonary artery pressures are elevated which leads to increased wall stress and silent heart damage progression. Therefore Class I-II patients have a better survival rate than Class III-IV patients (Odds ratio = 1.9) but will eventually deteriorate if untreated. MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension | Trade Name: Tracleer Product Name: bosentan Product Code: Ro 47-0203 INN or Proposed INN: bosentan monohydrate Other descriptive name: ------------ Trade Name: Tracleer Product Name: bosentan Product Code: Ro 47-0203 INN or Proposed INN: bosentan monohydrate | Actelion Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 170 | United Kingdom;Czech Republic;Denmark;Spain;Italy;Sweden | |||
| 572 | EUCTR2004-000478-30-SE (EUCTR) | 28/10/2004 | 20/07/2004 | Endothelin antagonist trial in mildly symptomatic PAH patients. A randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy, safety, and tolerability of bosentan in patients with mildly symptomatic pulmonary arterial hypertension. - EARLY | Endothelin antagonist trial in mildly symptomatic PAH patients. A randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy, safety, and tolerability of bosentan in patients with mildly symptomatic pulmonary arterial hypertension. - EARLY | Patients with modified NYHA functional Class II PAH have mild symptoms, but their pulmonary artery pressures are elevated which leads to increased wall stress and silent heart damage progression. Therefore Class I-II patients have a better survival rate than Class III-IV patients (Odds ratio = 1.9) but will eventually deteriorate if untreated. MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension | Trade Name: Tracleer Product Name: bosentan Product Code: Ro 47-0203 INN or Proposed INN: bosentan monohydrate Other descriptive name: ------------ Trade Name: Tracleer Product Name: bosentan Product Code: Ro 47-0203 INN or Proposed INN: bosentan monohydrate | Actelion Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 170 | United Kingdom;Czech Republic;Denmark;Spain;Italy;Sweden | |||
| 573 | EUCTR2004-000745-37-ES (EUCTR) | 11/10/2004 | 07/10/2004 | Uncontrolled extension trial to protocol AC-052-406 to evaluate the long-term effects of bosentan therapy in patients with pulmonary arterial hypertension related to connective tissue disease (TRUST-Extension) - TRUST - Extension | Uncontrolled extension trial to protocol AC-052-406 to evaluate the long-term effects of bosentan therapy in patients with pulmonary arterial hypertension related to connective tissue disease (TRUST-Extension) - TRUST - Extension | Pulmonary arterial hypertension (PAH) is characterized by increased pulmonary arterial pressure and pulmonary vascular resistance leading to right ventricular failure. PAH is a serious complication of many types of connective tissue disease (CTD). PAH is an important cause of morbidity in patients with connective tissue diseases . Once it is diagnosed, it is difficult to treat and has a very poor prognosis | Trade Name: Tracleer Product Name: bosentan Product Code: Ro 47-0203 INN or Proposed INN: bosentan monohydrate Other descriptive name: ------------ | Actelion Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 4 | Spain;Italy;United Kingdom | ||
| 574 | EUCTR2004-000478-30-DK (EUCTR) | 10/09/2004 | 10/01/2007 | Endothelin antagonist trial in mildly symptomatic PAH patients. A randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy, safety, and tolerability of bosentan in patients with mildly symptomatic pulmonary arterial hypertension. - EARLY | Endothelin antagonist trial in mildly symptomatic PAH patients. A randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy, safety, and tolerability of bosentan in patients with mildly symptomatic pulmonary arterial hypertension. - EARLY | Patients with modified NYHA functional Class II PAH have mild symptoms, but their pulmonary artery pressures are elevated which leads to increased wall stress and silent heart damage progression. Therefore Class I-II patients have a better survival rate than Class III-IV patients (Odds ratio = 1.9) but will eventually deteriorate if untreated. MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension | Trade Name: Tracleer Product Name: bosentan Product Code: Ro 47-0203 INN or Proposed INN: bosentan monohydrate Other descriptive name: ------------ Trade Name: Tracleer Product Name: bosentan Product Code: Ro-47-0203 INN or Proposed INN: bosentan monohydrate | Actelion Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 170 | United Kingdom;Czech Republic;Denmark;Spain;Italy;Sweden | |||
| 575 | EUCTR2004-000478-30-IT (EUCTR) | 09/09/2004 | 11/07/2007 | A randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy, safety, and tolerability of bosentan in patients with mildly symptomatic pulmonary arterial hypertension. - EARLY | A randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy, safety, and tolerability of bosentan in patients with mildly symptomatic pulmonary arterial hypertension. - EARLY | Treatment of pulmonary arterial hypertension (PAH) in patients with grade II modified NYHA MedDRA version: 14.1;Level: PT;Classification code 10037400;Term: Pulmonary hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: TRACLEER*56CPR RIV 125MG INN or Proposed INN: Bosentan | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 170 | Czech Republic;Spain;Denmark;United Kingdom;Italy;Sweden | |||
| 576 | NCT00266162 (ClinicalTrials.gov) | August 2004 | 15/12/2005 | Bosentan in Treatment of Pulmonary Arterial Hypertension | Therapy of Pulmonary Arterial Hypertension (PAH) With Bosentan in Patients With Eisenmenger Syndrome | Eisenmenger Syndrome | Drug: Bosentan administration | Competence Network for Congenital Heart Defects | German Federal Ministry of Education and Research;Actelion | Completed | 18 Years | N/A | Both | 60 | Phase 4 | Germany |
| 577 | EUCTR2004-000478-30-GB (EUCTR) | 15/07/2004 | 21/06/2005 | Endothelin antagonist trial in mildly symptomatic PAH patients. A randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy, safety, and tolerability of bosentan in patients with mildly symptomatic pulmonary arterial hypertension. - EARLY | Endothelin antagonist trial in mildly symptomatic PAH patients. A randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy, safety, and tolerability of bosentan in patients with mildly symptomatic pulmonary arterial hypertension. - EARLY | Patients with modified NYHA functional Class II PAH have mild symptoms, but their pulmonary artery pressures are elevated which leads to increased wall stress and silent heart damage progression. Therefore Class I-II patients have a better survival rate than Class III-IV patients (Odds ratio = 1.9) but will eventually deteriorate if untreated. There are no approved drug therapies for Class II PAH and the EARLY study is the first trial designed to enroll exclusively class II patients. | Trade Name: Tracleer Product Name: bosentan Product Code: Ro 47-0203 INN or Proposed INN: bosentan monohydrate Other descriptive name: ------------ | Actelion Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 170 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Czech Republic;Belgium;Spain;Denmark;Austria;Italy;United Kingdom;Sweden | ||
| 578 | NCT00086463 (ClinicalTrials.gov) | June 2004 | 1/7/2004 | Trial of Iloprost Inhaled Solution as Add-On Therapy With Bosentan in Subjects With Pulmonary Arterial Hypertension (PAH) | A Safety and Pilot Efficacy Trial of Iloprost Inhaled Solution as Add-On Therapy With Bosentan in Subjects With PAH | Pulmonary Arterial Hypertension;Ayerza Syndrome;Pulmonary Hypertension | Drug: Iloprost or placebo | Actelion | NULL | Completed | 12 Years | 75 Years | Both | 60 | Phase 2 | United States |
| 579 | NCT00091715 (ClinicalTrials.gov) | April 2004 | 16/9/2004 | Efficacy and Safety of Oral Bosentan in Pulmonary Arterial Hypertension Class II | A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Assess the Efficacy, Safety, and Tolerability of Bosentan in Patients With Mildly Symptomatic Pulmonary Arterial Hypertension (PAH) | Pulmonary Hypertension | Drug: bosentan;Drug: placebo | Actelion | NULL | Completed | 12 Years | N/A | Both | 185 | Phase 3 | United States;Australia;Austria;Belgium;Canada;China;Czech Republic;France;Germany;Italy;Netherlands;Spain;Switzerland;United Kingdom |
| 580 | NCT00159874 (ClinicalTrials.gov) | January 2004 | 8/9/2005 | A Long Term Extension Study Evaluating Safety Of Sildenafil Citrate When Used To Treat Pulmonary Arterial Hypertension (PAH) In Children | A Multicenter, Long-Term Extension Study to Assess Safety of Oral Sildenafil Citrate In The Treatment Of Subjects Who Have Completed Study A1481131 | Pulmonary Arterial Hypertension | Drug: Sildenafil citrate | Pfizer's Upjohn has merged with Mylan to form Viatris Inc. | NULL | Completed | 1 Year | 17 Years | All | 234 | Phase 3 | United States;Brazil;Chile;Colombia;Guatemala;Hungary;India;Italy;Japan;Malaysia;Mexico;Poland;Russian Federation;Sweden;Taiwan;Canada;Costa Rica;Panama;Singapore |
| 581 | NCT00091598 (ClinicalTrials.gov) | January 2004 | 10/9/2004 | ARIES - Ambrisentan in Patients With Moderate to Severe Pulmonary Arterial Hypertension (PAH) | ARIES 1 and ARIES 2: Ambrisentan in PAH - A Phase III, Randomized, Double-blind, Placebo-controlled, Multicenter, Efficacy Study of Ambrisentan in Subjects With Pulmonary Arterial Hypertension | Pulmonary Hypertension | Drug: Ambrisentan | Gilead Sciences | NULL | Completed | 18 Years | N/A | Both | 372 | Phase 3 | United States;Australia;Canada |
| 582 | NCT00423202 (ClinicalTrials.gov) | December 2003 | 17/1/2007 | A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Assess Safety and Efficacy of Ambrisentan in Subjects With Pulmonary Arterial Hypertension. | Ambrisentan in PAH - A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Efficacy Study of Ambrisentan in Subjects With Pulmonary Arterial Hypertension. | Pulmonary Arterial Hypertension | Drug: ambrisentan | Gilead Sciences | NULL | Completed | 18 Years | N/A | Both | 186 | Phase 3 | NULL |
| 583 | NCT00423748 (ClinicalTrials.gov) | December 2003 | 17/1/2007 | Study to Assess Safety and Efficacy of Ambrisentan in Subjects With Pulmonary Arterial Hypertension. | Ambrisentan in PAH - A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Efficacy Study of Ambrisentan in Subjects With Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension | Drug: ambrisentan | Gilead Sciences | NULL | Completed | 18 Years | N/A | Both | 186 | Phase 3 | NULL |
| 584 | NCT00159861 (ClinicalTrials.gov) | July 2003 | 8/9/2005 | The Efficacy and Safety of Sildenafil Citrate Used in Combination With Intravenous Epoprostenol in PAH | A Multinational, Multi-Center, Randomised, Double-Bind, Placebo-Controlled, Parallel Group Study to Assess the Safety and Efficacy of a Subject Optimised Dose of Sildenafil Citrate (20, 40, or 80 mg. Sildenafil Citrate TID) Based on the Toleration, When Used in Combination With Intravenous Prostacyclin( Epoprostenol) in the Treatment of Pulmonary Arterial Hypertension. | Pulmonary Hypertension | Drug: Sildenafil citrate | Pfizer's Upjohn has merged with Mylan to form Viatris Inc. | Pfizer | Completed | 16 Years | N/A | All | 267 | Phase 3 | United States;Belgium;Canada;Czechia;Denmark;France;Israel;Italy;Netherlands;Spain;United Kingdom;Czech Republic |
| 585 | NCT00080457 (ClinicalTrials.gov) | May 2003 | 1/4/2004 | Safety and Efficacy Study of Sitaxentan Sodium (Thelin™) in Patients With Pulmonary Arterial Hypertension | A Phase 3, Randomized, Double-Blind, Placebo-Controlled Safety and Efficacy Study of Sitaxsentan Sodium (Thelin™) Treatment With an Open-Label Bosentan Arm in Patients With Pulmonary Arterial Hypertension (PAH) | Pulmonary Hypertension | Drug: sitaxsentan sodium | Encysive Pharmaceuticals | NULL | Completed | 12 Years | 75 Years | Both | 240 | Phase 3 | United States |
| 586 | NCT02784808 (ClinicalTrials.gov) | January 2000 | 25/5/2016 | Retrospective Analysis of Pulmonary Arterial Hypertension (PAH) and Related Complications in Juvenile Idiopathic Arthritis (JIA) Participants Treated With Biologic and Non-biologic Disease-modifying Anti-rheumatic Drugs (DMARDs) | Juvenile Idiopathic Arthritis | Drug: Biological DMARDs;Drug: Non-Biologic DMARDs | Hoffmann-La Roche | NULL | Completed | N/A | 18 Years | Both | 4557 | N/A | NULL | |
| 587 | EUCTR2011-004612-31-FR (EUCTR) | 27/08/2012 | A 12-month research project for children who have gone through the FUTURE 5 research project and who want to continue treatment to see how well bosentan is tolerated when administered over a long period of time. | A prospective, multicenter, non-comparative, open label extension of the FUTURE 5 study to assess safety and tolerability of the pediatric formulation of bosentan in children with pulmonary arterial hypertension - FUTURE 6 | Pulmonary arterial hypertension (PAH) in children MedDRA version: 15.0;Level: LLT;Classification code 10064910;Term: Familial (FPAH);System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 15.0;Classification code 10064909;Term: Idiopathic (IPAH);Classification code 10064908;Term: Associated with (APAH);System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Tracleer Product Name: bosentan INN or Proposed INN: bosentan Other descriptive name: BOSENTAN MONOHYDRATE | Actelion pharmaceuticals Ltd | NULL | NA | Female: yes Male: yes | 105 | Phase 3 | Portugal;Serbia;United States;Philippines;Taiwan;Guatemala;Ukraine;Chile;Russian Federation;Colombia;India;Vietnam;France;Mexico;Argentina;Malaysia;Singapore;Croatia;Peru;Bulgaria;South Africa;Netherlands;China | |||
| 588 | EUCTR2020-005061-13-GR (EUCTR) | 14/03/2022 | A Long-term Follow-up Study of Sotatercept for PAH Treatment | An Open-Label Long-term Follow-up Study to Evaluate the Effects of Sotatercept When Added to Background Pulmonary Arterial Hypertension (PAH) Therapy for the Treatment of PAH - A Long-term Follow-up Study of Sotatercept for PAH | Pulmonary Arterial Hypertension (PAH) MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Sotatercept - 60 mg/vial Product Code: ACE-011 INN or Proposed INN: SOTATERCEPT Other descriptive name: ActRIIA-IgG1Fc Product Name: Sotatercept - 45 mg/vial Product Code: ACE-011 INN or Proposed INN: SOTATERCEPT Other descriptive name: ActRIIA-IgG1Fc | Acceleron Pharma Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 700 | Phase 3 | Serbia;Portugal;United States;Taiwan;Greece;Spain;Israel;Colombia;Switzerland;Italy;France;Australia;Denmark;Netherlands;Korea, Republic of;Czechia;Austria;United Kingdom;Mexico;Canada;Argentina;Brazil;Poland;Belgium;Croatia;Germany;New Zealand;Sweden | |||
| 589 | EUCTR2016-001062-28-FR (EUCTR) | 03/07/2018 | A study to find out whether the medicine macitentan works in children with pulmonary arterial hypertension (PAH) | A multicenter, open-label, randomized, event-driven study to assess efficacy, safety and pharmacokinetics of macitentan versus standard of care in children with pulmonary arterial hypertension - TOMORROW: pediaTric use Of Macitentan tO delay disease pRogRessiOn in PAH Worldwide | Pulmonary arterial hypertension MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: macitentan Product Code: ACT-064992 INN or Proposed INN: MACITENTAN Product Name: macitentan Product Code: ACT-064992 INN or Proposed INN: MACITENTAN Product Name: macitentan Product Code: ACT-064992 INN or Proposed INN: MACITENTAN | ACTELION Pharmaceuticals Ltd | NULL | NA | Female: yes Male: yes | 300 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;United States;Philippines;Finland;Spain;Thailand;Ukraine;Austria;Russian Federation;Israel;Colombia;Vietnam;France;Hungary;Mexico;Canada;Poland;Australia;South Africa;Germany;China;Korea, Republic of | |||
| 590 | EUCTR2019-002817-21-FR (EUCTR) | 14/10/2019 | A study to see if it is safe and helpful to add Selexipag to other PAH medication in children and adolescents. | A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Parallel-Group, Event-Driven, Group-Sequential Study with Open-Label Extension Period to Assess the Efficacy and Safety of Selexipag as Add-On Treatment to Standard of Care in Children Aged =2 to <18 years with Pulmonary Arterial Hypertension. - SALTO | Pulmonary Arterial Hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Uptravi Product Name: Selexipag Product Code: JNJ-67896049 (ACT-293987) INN or Proposed INN: SELEXIPAG Product Name: Selexipag Product Code: JNJ-67896049 (ACT-293987) INN or Proposed INN: SELEXIPAG | Actelion Pharmaceuticals Ltd. | NULL | NA | Female: yes Male: yes | 237 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Portugal;United States;Belarus;Taiwan;Thailand;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Switzerland;Vietnam;France;Malaysia;Australia;Denmark;Netherlands;China;Korea, Republic of;Finland;Lithuania;Turkey;Austria;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany;Sweden | |||
| 591 | EUCTR2019-002817-21-SE (EUCTR) | 29/10/2019 | A study to see if it is safe and helpful to add Selexipag to other PAH medication in children and adolescents. | A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Parallel-Group, Event-Driven, Group-Sequential Study with Open-Label Extension Period to Assess the Efficacy and Safety of Selexipag as Add-On Treatment to Standard of Care in Children Aged =2 to <18 years with Pulmonary Arterial Hypertension. - SALTO | Pulmonary Arterial Hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Uptravi Product Name: Selexipag Product Code: JNJ-67896049 (ACT-293987) INN or Proposed INN: SELEXIPAG Product Name: Selexipag Product Code: JNJ-67896049 (ACT-293987) INN or Proposed INN: SELEXIPAG | Actelion Pharmaceuticals Ltd. | NULL | NA | Female: yes Male: yes | 237 | Phase 3 | Portugal;Serbia;Belarus;United States;Taiwan;Spain;Thailand;Ukraine;Russian Federation;Israel;Colombia;Switzerland;Italy;Vietnam;France;Malaysia;Australia;Denmark;China;Korea, Republic of;Finland;Lithuania;Turkey;Austria;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;Sweden | |||
| 592 | EUCTR2011-004612-31-NL (EUCTR) | 07/05/2012 | A 12-month research project for children who have gone through the FUTURE 5 research project and who want to continue treatment to see how well bosentan is tolerated when administered over a long period of time. | A prospective, multicenter, non-comparative, open label extension of the FUTURE 5 study to assess safety and tolerability of the pediatric formulation of bosentan in children with pulmonary arterial hypertension - FUTURE 6 | Pulmonary arterial hypertension (PAH) in children MedDRA version: 14.1;Level: LLT;Classification code 10064908;Term: Associated with (APAH);System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 14.1;Classification code 10064909;Term: Idiopathic (IPAH);Classification code 10064910;Term: Familial (FPAH);System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Tracleer Product Name: bosentan INN or Proposed INN: bosentan Other descriptive name: BOSENTAN MONOHYDRATE | Actelion pharmaceuticals Ltd | NULL | NA | Female: yes Male: yes | 105 | Phase 3 | Portugal;Serbia;United States;Philippines;Taiwan;Guatemala;Ukraine;Chile;Russian Federation;Colombia;India;Vietnam;France;Mexico;Argentina;Malaysia;Singapore;Croatia;Peru;Bulgaria;South Africa;Netherlands;China | |||
| 593 | EUCTR2010-021793-12-PL (EUCTR) | 25/07/2011 | A 1 year follow-up research project for children with pulmonary arterial hypertension (PAH) that participated in the FUTURE 3 core study. This is to find out how well bosentan is tolerated and safe when taken either two or three times a day | A prospective, multicenter, open-label extension of FUTURE 3 to assess the safety, tolerability and efficacy of the pediatric formulation of bosentan two versus three times a day in children with pulmonary arterial hypertension - FUTURE 3 study extension | Pulmonary arterial hypertension (PAH) in children MedDRA version: 14.0;Level: LLT;Classification code 10064908;Term: Associated with (APAH);System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 14.0;Classification code 10064909;Term: Idiopathic (IPAH);Classification code 10064910;Term: Familial (FPAH);System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Tracleer Product Name: bosentan INN or Proposed INN: BOSENTAN MONOHYDRATE Other descriptive name: Ro-47-0203/029 | Actelion Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 64 | Phase 3 | Serbia;United States;Belarus;Spain;Ukraine;Israel;Russian Federation;Italy;India;France;Czech Republic;Hungary;Mexico;Poland;South Africa;Netherlands;Germany;China | |||
| 594 | EUCTR2014-003952-29-Outside-EU/EEA (EUCTR) | 07/12/2016 | Riociguat for treatment of PAH in children from 6 to less than 18 years old | Open-label, individual dose titration study to evaluate safety, tolerability and pharmacokinetics of riociguat in children from 6 to less than 18 years of age with pulmonary arterial hypertension (PAH) - PATENT-CHILD | Pulmonary arterial hypertension (PAH) MedDRA version: 19.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Adempas Product Name: Adempas 0.5 mg Product Code: BAY63-2521 INN or Proposed INN: riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas 1.0 mg Product Code: BAY63-2521 INN or Proposed INN: riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas 1.5 mg Product Code: BAY63-2521 INN or Proposed INN: riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas 2.0 mg Product Code: BAY63-2521 INN or Proposed INN: riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas 2.5 mg Product Code: BAY63-2521 INN or Proposed INN: riociguat Other descriptive name: RIOCIGUAT Product Name: Riociguat granules 0.3% for oral application Product Code: BAY63-2521 INN or Proposed INN: riociguat Other descriptive name: RIOCIGUAT | Bayer AG | NULL | NA | Female: yes Male: yes | 20 | Phase 3 | Turkey;Japan | |||
| 595 | EUCTR2016-001062-28-PL (EUCTR) | 06/03/2018 | A study to find out whether the medicine macitentan works in children with pulmonary arterial hypertension (PAH) | A multicenter, open-label, randomized, study with single-arm extension period to assess the pharmacokinetics, safety and efficacy of macitentan versus standard of care in children with pulmonary arterial hypertension - TOMORROW: pediaTric use Of Macitentan tO delay disease pRogRessiOn in PAH Worldwide | Pulmonary arterial hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: macitentan Product Code: ACT-064992 / JNJ-67896062 INN or Proposed INN: MACITENTAN Product Name: macitentan Product Code: ACT-064992 / JNJ-67896062 INN or Proposed INN: MACITENTAN Product Name: macitentan Product Code: ACT-064992 / JNJ-67896062 INN or Proposed INN: MACITENTAN Product Name: macitentan Product Code: ACT-064992 / JNJ-67896062 INN or Proposed INN: MACITENTAN Product Name: macitentan Product Code: ACT-064992 / JNJ-67896062 INN or Proposed INN: MACITENTAN | ACTELION Pharmaceuticals Ltd | NULL | NA | Female: yes Male: yes | 300 | Phase 3 | Portugal;United States;Philippines;Finland;Spain;Thailand;Ukraine;Austria;Israel;Russian Federation;Colombia;France;Hungary;Mexico;Canada;Poland;Brazil;Malaysia;Viet Nam;Australia;South Africa;China;Korea, Republic of | |||
| 596 | EUCTR2014-003952-29-FR (EUCTR) | 04/12/2015 | Riociguat for treatment of PAH in children from 6 to less than 18 years old | Open-label, individual dose titration study to evaluate safety, tolerability and pharmacokinetics of riociguat in children from 6 to less than 18 years of age with pulmonary arterial hypertension (PAH) - PATENT-CHILD | Pulmonary arterial hypertension (PAH) MedDRA version: 18.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Adempas Product Name: Adempas 0.5 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas 1.0 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas 1.5 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas 2.0 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas 2.5 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Product Name: Riociguat granules 0.3% for oral application Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT | Bayer Healthcare AG | NULL | NA | Female: yes Male: yes | 20 | Phase 3 | France;Hungary;Belgium;Spain;Poland;Turkey;Netherlands;Germany;Japan;Italy;United Kingdom | |||
| 597 | EUCTR2019-002817-21-IE (EUCTR) | 11/11/2021 | A study to see if it is safe and helpful to add Selexipag to other PAH medication in children and adolescents. | A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Parallel-Group, Event-Driven, Group-Sequential Study with Open-Label Extension Period to Assess the Efficacy and Safety of Selexipag as Add-On Treatment to Standard of Care in Children Aged =2 to <18 years with Pulmonary Arterial Hypertension. - SALTO | Pulmonary Arterial Hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Uptravi Product Name: Selexipag Product Code: JNJ-67896049 (ACT-293987) INN or Proposed INN: SELEXIPAG Product Name: Selexipag Product Code: JNJ-67896049 (ACT-293987) INN or Proposed INN: SELEXIPAG | Actelion Pharmaceuticals Ltd. | NULL | NA | Female: yes Male: yes | 237 | Phase 3 | Portugal;Serbia;Belarus;United States;Taiwan;Spain;Thailand;Ukraine;Ireland;Russian Federation;Israel;Colombia;Switzerland;Italy;Vietnam;France;Malaysia;Australia;China;Korea, Republic of;Finland;Lithuania;Turkey;Hungary;Mexico;Canada;Poland;Brazil;Belgium;Bulgaria;Germany;Sweden | |||
| 598 | EUCTR2005-000963-25-Outside-EU/EEA (EUCTR) | 07/03/2012 | Oral Revatio in Pediatric PAH - Long-term follow-on Study to A1481131. | A Multicenter, Long-Term Extension Study to Assess Safety of Oral Sildenafil in the Treatment of Subjects Who Have Completed Study A1481131 - N/A | Pulmonary Arterial Hypertension MedDRA version: 14.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09] | Product Name: Sildenafil Citrate Product Code: UK-92,480-10 INN or Proposed INN: sildenafil (as citrate) Other descriptive name: UK-92,480 Trade Name: Revatio INN or Proposed INN: sildenafil (as citrate) Other descriptive name: UK-92,480 Product Name: Sildenafil Citrate Product Code: UK-92,480-10 INN or Proposed INN: sildenafil (as citrate) Other descriptive name: UK-92,480 Product Name: Sildenafil Citrate Product Code: UK-92,480-10 INN or Proposed INN: sildenafil (as citrate) Other descriptive name: UK-92,480 | Pfizer Limited, Ramsgate Road, Sandwich, Kent, UK | NULL | NA | Female: yes Male: yes | 220 | Russian Federation;Taiwan;United States;Brazil;Chile;Colombia;Guatemala;India;Japan;Malaysia;Mexico | ||||
| 599 | EUCTR2011-004106-16-FR (EUCTR) | 17/02/2012 | A 5-month research project for children aged from 1 year to 17 years who have high blood pressure in the lung, to see how well bosentan decreases this high blood pressure and improves children's physical capabilities compared to an inactive compound | A randomized, prospective, double-blind, placebo-controlled, group sequential multicenter study to assess efficacy, safety, and tolerability of the pediatric formulation of bosentan in children with pulmonary arterial hypertension - FUTURE 5 | Pulmonary arterial hypertension (PAH) in children MedDRA version: 14.1;Level: LLT;Classification code 10064908;Term: Associated with (APAH);System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 14.1;Classification code 10064909;Term: Idiopathic (IPAH);Classification code 10064910;Term: Familial (FPAH);System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Tracleer Product Name: bosentan INN or Proposed INN: bosentan Other descriptive name: BOSENTAN MONOHYDRATE | Actelion pharmaceuticals Ltd | NULL | NA | Female: yes Male: yes | 105 | Phase 3 | Portugal;Serbia;United States;Philippines;Taiwan;Guatemala;Ukraine;Chile;Russian Federation;Colombia;India;Vietnam;France;Mexico;Argentina;Malaysia;Singapore;Croatia;Peru;Bulgaria;South Africa;Netherlands;China | |||
| 600 | EUCTR2009-014453-32-DE (EUCTR) | 11/12/2009 | An open-label extension of BPS-MR-PAH-203 in pulmonary arterial hypertension (PAH) patients | An open-label extension of BPS-MR-PAH-203 in pulmonary arterial hypertension (PAH) patients | Pulmonary Arterial Hypertension MedDRA version: 12.0;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension | Product Name: Beraprost Sodium Modified Release Product Code: BPS-MR INN or Proposed INN: Beraprost Sodium Other descriptive name: TRK-100STP | Lung RX | NULL | Not Recruiting | Female: yes Male: yes | 36 | Phase 2 | Czech Republic;Belgium;Ireland;Germany | |||
| 601 | EUCTR2004-003236-59-DE (EUCTR) | 16/05/2006 | Double blind placebo controlled clinical investigation into the efficacy and tolerability of inhaled treprostinil in patients with severe pulmonary arterial hypertension. | Double blind placebo controlled clinical investigation into the efficacy and tolerability of inhaled treprostinil in patients with severe pulmonary arterial hypertension. | NYHA Class III and IV patients with severe Pulmonary Arterial Hypertension (PAH) | Product Name: Treprostinil Sodium Solution for Inhalation Product Code: N/A INN or Proposed INN: N/A Other descriptive name: Treprostinil, UT-15, LRX-15, 15AU81, BW A15AU, U-62, 840 | United Therapeutics Corporation | NULL | Not Recruiting | Female: yes Male: yes | 220 | Spain;Ireland;Germany;Italy;United Kingdom | ||||
| 602 | EUCTR2010-021572-29-FR (EUCTR) | 11/10/2011 | Testing medicines to treat children with pulmonary arterial hypertension (PAH)Testing medicines to treat teens with pulmonary arterial hypertension (PAH) | An open-label, long term extension study for treatment of pulmonary arterial hypertension in paediatric patients aged 8 years up to 18 years who have participated in AMB112529 and in whom continued treatment with ambrisentan is desired - Safety FU Study of Amb in 8-17yr olds | Pulmonary Arterial Hypertension MedDRA version: 14.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 14.0;Level: LLT;Classification code 10065150;Term: Associated with pulmonary arterial hypertension;Classification code 10065152;Term: Familial pulmonary arterial hypertension;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: VOLIBRIS® (ambrisentan) Product Name: ambrisentan Product Code: GSK1325760 INN or Proposed INN: AMBRISENTAN Trade Name: VOLIBRIS® (ambrisentan) Product Name: ambrisentan Product Code: GSK1325760 INN or Proposed INN: AMBRISENTAN Product Name: ambrisentan Product Code: GSK1325760 INN or Proposed INN: AMBRISENTAN | GlaxoSmithKline Research & Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 66 | Phase 2 | United States;France;Hungary;Greece;Spain;Netherlands;Germany;Italy;Japan | |||
| 603 | EUCTR2010-021793-12-FR (EUCTR) | 04/02/2011 | A prospective, multicenter, open-label extension of FUTURE 3 to assess thesafety, tolerability and efficacy of the pediatric formulation of bosentan twoversus three times a day in children with pulmonary arterial hypertension - FUTURE 3 study extension | A prospective, multicenter, open-label extension of FUTURE 3 to assess thesafety, tolerability and efficacy of the pediatric formulation of bosentan twoversus three times a day in children with pulmonary arterial hypertension - FUTURE 3 study extension | Pulmonary arterial hypertension (PAH) in children MedDRA version: 12.1;Level: LLT;Classification code 10064908;Term: Associated with (APAH) MedDRA version: 12.1;Classification code 10064909;Term: Idiopathic (IPAH) MedDRA version: 12.1;Classification code 10064910;Term: Familial (FPAH) | Trade Name: Tracleer Product Name: bosentan INN or Proposed INN: BOSENTAN MONOHYDRATE Other descriptive name: Ro-47-0203/029 | Actelion Pharmaceuticals Ltd. | NULL | NA | Female: yes Male: yes | 64 | Phase 3 | France;Czech Republic;Hungary;Poland;Spain;Netherlands;Germany;Italy | |||
| 604 | EUCTR2005-005068-97-DE (EUCTR) | 13/02/2006 | Effects of combination of bosentan and sildenafil versus sildenafil monotherapy on morbidity and mortality in symptomatic patients with pulmonary arterial hypertension – A multicenter, double - blind, randomized, placebo - controlled, parallel group, prospective, event driven Phase IV study - COMPASS 2 | Effects of combination of bosentan and sildenafil versus sildenafil monotherapy on morbidity and mortality in symptomatic patients with pulmonary arterial hypertension – A multicenter, double - blind, randomized, placebo - controlled, parallel group, prospective, event driven Phase IV study - COMPASS 2 | Patients to be included must have PAH belonging to WHO Group I, in agreement with the approved indications for sildenafil in PAH by the US FDA:a.Idiopathic (IPAH)b.Familial (FPAH)c.Associated with (APAH):i.Collagen vascular disease with normal left ventricular function (ejection fraction (EF) > 50%) ii.Congenital systemic-to-pulmonary shunts at least 2 years post surgical repairiii.Drugs and toxins MedDRA version: 9.1;Level: LLT;Classification code 10064908;Term: Associated with (APAH) MedDRA version: 9.1;Classification code 10064909;Term: Idiopathic (IPAH) MedDRA version: 9.1;Classification code 10064910;Term: Familial (FPAH) | Trade Name: Tracleer Product Name: bosentan Product Code: Ro-47-0203 INN or Proposed INN: bosentan monohydrate Trade Name: Tracleer Product Name: bosentan Product Code: Ro-47-0203 INN or Proposed INN: bosentan monohydrate Trade Name: Viagra INN or Proposed INN: sildenafil (as citrate) Trade Name: Viagra INN or Proposed INN: sildenafil (as citrate) Trade Name: Viagra INN or Proposed INN: sildenafil Trade Name: Revatio INN or Proposed INN: sildenafil (as citrate) | Actelion Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 4 | Portugal;Czech Republic;Greece;Belgium;Spain;Denmark;Germany;United Kingdom;Sweden | |||
| 605 | EUCTR2010-019547-19-Outside-EU/EEA (EUCTR) | 16/03/2012 | Testing medicines to treat children with pulmonary arterial hypertension(PAH) | A randomized, open label study comparing safety and efficacyparameters for a high and a low dose of ambrisentan (adjustedfor body weight) for the treatment of pulmonary arterialhypertension in paediatric patients aged 8 years up to 18 years. - Efficacy and Safety of Ambrisentan in Children 8-17yrs | Pulmonary Arterial Hypertension MedDRA version: 14.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 14.1;Level: LLT;Classification code 10065150;Term: Associated with pulmonary arterial hypertension;Classification code 10065152;Term: Familial pulmonary arterial hypertension;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Ambrisentan Product Code: GSK1325760 INN or Proposed INN: AMBRISENTAN Other descriptive name: VOLIBRIS Trade Name: VOLIBRIS™ tablets Product Name: Ambrisentan Product Code: GSK1325760 INN or Proposed INN: AMBRISENTAN Other descriptive name: VOLIBRIS Trade Name: VOLIBRIS™ tablets Product Name: Ambrisentan Product Code: GSK1325760 INN or Proposed INN: AMBRISENTAN Other descriptive name: VOLIBRIS | GlaxoSmithKline Research & Development Limited | NULL | NA | Female: yes Male: yes | 66 | Russian Federation;United States;Argentina;Brazil;Canada;Japan;Mexico | ||||
| 606 | EUCTR2019-002817-21-BE (EUCTR) | 02/12/2019 | A study to see if it is safe and helpful to add Selexipag to other PAH medication in children and adolescents. | A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Parallel-Group, Event-Driven, Group-Sequential Study with Open-Label Extension Period to Assess the Efficacy and Safety of Selexipag as Add-On Treatment to Standard of Care in Children Aged =2 to <18 years with Pulmonary Arterial Hypertension. - SALTO | Pulmonary Arterial Hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Uptravi Product Name: Selexipag Product Code: JNJ-67896049 (ACT-293987) INN or Proposed INN: SELEXIPAG Product Name: Selexipag Product Code: JNJ-67896049 (ACT-293987) INN or Proposed INN: SELEXIPAG | Actelion Pharmaceuticals Ltd. | NULL | NA | Female: yes Male: yes | 237 | Phase 3 | Portugal;Serbia;Belarus;United States;Taiwan;Spain;Thailand;Ukraine;Russian Federation;Israel;Colombia;Switzerland;Italy;Vietnam;France;Malaysia;Australia;Denmark;China;Korea, Republic of;Finland;Lithuania;Turkey;Austria;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;Sweden | |||
| 607 | EUCTR2010-021825-11-FR (EUCTR) | 13/12/2010 | An open label, prospective multicenter study to assess the pharmacokinetics, tolerability, safety and efficacy of the pediatric formulation of bosentan two versus three times a day in children with pulmonary arterial hypertension - FUTURE 3 | An open label, prospective multicenter study to assess the pharmacokinetics, tolerability, safety and efficacy of the pediatric formulation of bosentan two versus three times a day in children with pulmonary arterial hypertension - FUTURE 3 | Pulmonary arterial hypertension (PAH) in children MedDRA version: 12.1;Level: LLT;Classification code 10064908;Term: Associated with (APAH) MedDRA version: 12.1;Classification code 10064909;Term: Idiopathic (IPAH) MedDRA version: 12.1;Classification code 10064910;Term: Familial (FPAH) | Trade Name: Tracleer Product Name: bosentan INN or Proposed INN: BOSENTAN MONOHYDRATE Other descriptive name: Ro-47-0203/029 | Actelion Pharmaceuticals Ltd. | NULL | NA | Female: yes Male: yes | 64 | Phase 3 | France;Czech Republic;Hungary;Spain;Bulgaria;Germany;Netherlands;Italy | |||
| 608 | EUCTR2011-004106-16-NL (EUCTR) | 10/02/2012 | A 5-month research project for children aged from 1 year to 17 years who have high blood pressure in the lung, to see how well bosentan decreases this high blood pressure and improves children's physical capabilities compared to an inactive compound | A randomized, prospective, double-blind, placebo-controlled, group sequential multicenter study to assess efficacy, safety, and tolerability of the pediatric formulation of bosentan in children with pulmonary arterial hypertension - FUTURE 5 | Pulmonary arterial hypertension (PAH) in children MedDRA version: 14.1;Level: LLT;Classification code 10064908;Term: Associated with (APAH);System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 14.1;Classification code 10064909;Term: Idiopathic (IPAH);Classification code 10064910;Term: Familial (FPAH);System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Tracleer Product Name: bosentan INN or Proposed INN: bosentan Other descriptive name: BOSENTAN MONOHYDRATE | Actelion pharmaceuticals Ltd | NULL | NA | Female: yes Male: yes | 105 | Phase 3 | Portugal;Serbia;United States;Philippines;Guatemala;Ukraine;Russian Federation;Chile;Colombia;India;Vietnam;France;Mexico;Argentina;Croatia;Peru;South Africa;Bulgaria;Netherlands;China | |||
| 609 | EUCTR2019-002817-21-PL (EUCTR) | 15/10/2019 | A study to see if it is safe and helpful to add Selexipag to other PAH medication in children and adolescents. | A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Parallel-Group, Event-Driven, Group-Sequential Study with Open-Label Extension Period to Assess the Efficacy and Safety of Selexipag as Add-On Treatment to Standard of Care in Children Aged =2 to <18 years with Pulmonary Arterial Hypertension. - SALTO | Pulmonary Arterial Hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Uptravi Product Name: Selexipag Product Code: JNJ-67896049 (ACT-293987) INN or Proposed INN: SELEXIPAG Product Name: Selexipag Product Code: JNJ-67896049 (ACT-293987) INN or Proposed INN: SELEXIPAG Product Name: Selexipag Product Code: JNJ-67896049 (ACT-293987) INN or Proposed INN: Selexipag Product Name: Selexipag Product Code: JNJ-67896049 (ACT-293987) INN or Proposed INN: Selexipag | Actelion Pharmaceuticals Ltd. | NULL | NA | Female: yes Male: yes | 237 | Phase 3 | Serbia;Portugal;United States;Belarus;Taiwan;Thailand;Spain;Ukraine;Ireland;Russian Federation;Israel;Colombia;Switzerland;Italy;France;Malaysia;Viet Nam;Australia;China;Korea, Republic of;Finland;Turkey;Lithuania;Hungary;Mexico;Canada;Brazil;Poland;Belgium;Bulgaria;Germany;Sweden |