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 | 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 | ||
| 2 | EUCTR2018-003414-40-DE (EUCTR) | 31/01/2019 | 06/11/2018 | A Two Part Clinical Study to Evaluate the Effect of Different Doses and the Safety of Inhaled Treprostinil Dry Powder in Pulmonary Arterial Hypertension Patients | A Two Part, Phase 2 Open-label, Multi-Centre, Dose Escalation Hemodynamic Study to Evaluate Dose-Response and Safety of Inhaled LIQ861 (Treprostinil) in Pulmonary Arterial Hypertension (WHO Group 1) Subjects | Pulmonary Arterial Hypertension (WHO Group 1) 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: LIQ861 26.5 µg INN or Proposed INN: Treprostinil Sodium Other descriptive name: TREPROSTINIL SODIUM Product Name: LIQ861 53 µg INN or Proposed INN: Treprostinil Sodium Other descriptive name: TREPROSTINIL SODIUM Product Name: LIQ861 79.5 µg INN or Proposed INN: Treprostinil Sodium Other descriptive name: TREPROSTINIL SODIUM Product Name: LIQ861 106 µg INN or Proposed INN: Treprostinil Sodium Other descriptive name: TREPROSTINIL SODIUM Product Name: Nitric Oxide INN or Proposed INN: NITRIC OXIDE | Liquidia Technologies, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 32 | Phase 2 | France;Germany | ||
| 3 | EUCTR2018-003414-40-FR (EUCTR) | 21/01/2019 | 06/11/2018 | A Two Part Clinical Study to Evaluate the Effect of Different Doses and the Safety of Inhaled Treprostinil Dry Powder in Pulmonary Arterial Hypertension Patients | A Two Part, Phase 2 Open-label, Multi-Centre, Dose Escalation Hemodynamic Study to Evaluate Dose-Response and Safety of Inhaled LIQ861 (Treprostinil) in Pulmonary Arterial Hypertension (WHO Group 1) Subjects | Pulmonary Arterial Hypertension (WHO Group 1) 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: LIQ861 25 µg INN or Proposed INN: Treprostinil Sodium Other descriptive name: TREPROSTINIL SODIUM Product Name: LIQ861 50 µg INN or Proposed INN: Treprostinil Sodium Other descriptive name: TREPROSTINIL SODIUM Product Name: LIQ861 75 µg INN or Proposed INN: Treprostinil Sodium Other descriptive name: TREPROSTINIL SODIUM Product Name: LIQ861 100 µg INN or Proposed INN: Treprostinil Sodium Other descriptive name: TREPROSTINIL SODIUM | Liquidia Technologies, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 32 | Phase 2 | France;Germany | ||
| 4 | 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 | |||
| 5 | 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 | |||
| 6 | NCT00643604 (ClinicalTrials.gov) | March 2008 | 20/3/2008 | Rapid Switch From Flolan to Remodulin in the Outpatient Clinic | Rapid Switch From Intravenous Epoprostenol to Intravenous Remodulin® (Treprostinil Sodium) in Patients With Stable Pulmonary Arterial Hypertension in the Outpatient Clinic: Safety, Efficacy and Treatment Satisfaction | Hypertension, Pulmonary | Drug: treprostinil sodium | United Therapeutics | NULL | Terminated | 18 Years | 70 Years | All | 7 | Phase 4 | United States |
| 7 | 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 |
| 8 | 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 | ||||
| 9 | 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 |
| 10 | 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 |
| 11 | 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 | ||||
| 12 | 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 | |||
| 13 | 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 | ||
| 14 | 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 | ||
| 15 | 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 |
| 16 | EUCTR2004-003236-59-IT (EUCTR) | 30/05/2005 | 09/11/2009 | Double Blind Placebo Controlled Clinical Investigation into the Efficacy and Tolerability of Inhaled Treprostinil Sodium in Patients with Severe Pulmonary Arterial Hypertension | Double Blind Placebo Controlled Clinical Investigation into the Efficacy and Tolerability of Inhaled Treprostinil Sodium in Patients with Severe Pulmonary Arterial Hypertension | NYHA Class III and IV patients with severe Pulmonary Arterial Hypertensio 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] | Product Name: Treprostinil Sodium Solution for Inhalation Product Code: TRE INN or Proposed INN: Treprostinil Sodium Solution for Inhalation | United Therapeutics Corporation | NULL | Not Recruiting | Female: yes Male: yes | 220 | Spain;Ireland;Germany;United Kingdom;Italy | |||
| 17 | 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 |
| 18 | NCT00058929 (ClinicalTrials.gov) | October 2002 | 14/4/2003 | A Transition Study From Flolan® to Remodulin® in Patients With Pulmonary Arterial Hypertension | A Multicenter, Randomized, Parallel Placebo-Controlled Study of the Safety and Efficacy of Subcutaneous Remodulin® Therapy After Transition From Flolan® in Patients With Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension;Pulmonary Hypertension | Drug: treprostinil sodium | United Therapeutics | NULL | Completed | 18 Years | 75 Years | Both | 39 | Phase 4 | United States |
| 19 | 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 |