Inhaled Nitric Oxide ( DrugBank: Nitric Oxide )
2 diseases
告示番号 | 疾患名(ページ内リンク) | 臨床試験数 |
---|---|---|
85 | 特発性間質性肺炎 | 4 |
86 | 肺動脈性肺高血圧症 | 18 |
85. 特発性間質性肺炎
臨床試験数 : 627 / 薬物数 : 443 - (DrugBank : 120) / 標的遺伝子数 : 99 - 標的パスウェイ数 : 212
Showing 1 to 4 of 4 diseases
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 | NCT05052229 (ClinicalTrials.gov) | April 21, 2022 | 2/9/2021 | Inhaled Nitric Oxide (iNO) in Idiopathic Pulmonary Fibrosis (IPF). | Pulmonary Gas Exchange and Neuro-sensory Abnormalities in Patients With Idiopathic Pulmonary Fibrosis and Mild Mechanical Restriction. Implications for Dyspnea and Exercise Intolerance Pulmonary Gas Exchange and Neuro-sensory Abnormalities in Patients With Idiopathic Pulmonary Fibrosi ... | Idiopathic Pulmonary Fibrosis | Drug: Nitric Oxide;Drug: Medical air | Queen's University | Boehringer Ingelheim | Recruiting | 40 Years | N/A | All | 40 | Early Phase 1 | Canada |
2 | NCT02267655 (ClinicalTrials.gov) | May 2015 | 7/10/2014 | 3 Part Study to Assess Inhaled Nitric Oxide on Functional Pulmonary Imaging in Subj. Pulmonary Hypertension Associated w/ COPD and IPF 3 Part Study to Assess Inhaled Nitric Oxideon Functional Pulmonary Imaging in Subj. Pulmonary Hypert ... | An Exploratory, 3-Part, Clinical Study to Assess the Effect of Pulsed, Inhaled Nitric Oxide (iNO) on Functional Pulmonary Imaging Parameters in Subjects With World Health Organization (WHO) Group 3 Pulmonary Hypertension (PH) Associated With Chronic Obstructive Pulmonary Disease (COPD) on Long-Term Oxygen Therapy (LTOT) (Part 1) and in Subjects With WHO Group 3 PH Associated With Idiopathic Pulmonary Fibrosis (IPF) on LTOT (Part 2 and Part 3) An Exploratory, 3-Part, Clinical Study to Assess the Effect of Pulsed, Inhaled Nitric Oxide(iNO) on ... | Pulmonary Hypertension;Chronic Obstructive Pulmonary Disease;Idiopathic Pulmonary Fibrosis | Drug: inhaled Nitric Oxide - 30 mcg/kg IBW/hr;Drug: inhaled Nitric Oxide 5,10,15 mcg/Kg IBW/hr;Drug: inhaled nitric oxide 75 mcg/kg IBW/hr Drug: inhaled Nitric Oxide- 30 mcg/kg IBW/hr;Drug: inhaled Nitric Oxide5,10,15 mcg/Kg IBW/hr;Drug: i ... | Bellerophon | NULL | Completed | 40 Years | 80 Years | All | 8 | Phase 1 | Belgium |
3 | EUCTR2014-003423-21-BE (EUCTR) | 29/09/2014 | 29/08/2014 | Evaluation of impact of inhaled nitric oxide on pulmonary vessel blood volume measured by high resolution computed tomography (HRCT) in subjects with World Health Organization (WHO) Group 3 Pulmonary Hypertension (PH) Associated with Chronic Obstructive Pulmonary Disease (COPD) on Long-Term Oxygen Therapy (LTOT) (Part 1) and in subjects with WHO Group 3 Pulmonary Hypertension (PH) Associated with Idiopathic pulmonary fibrosis (IPF) on Long-Term Oxygen Therapy (LTOT) (Part 2). Evaluation of impact of inhaled nitric oxideon pulmonary vessel blood volume measured by high resolu ... | An Exploratory, Two-Part, Clinical Study to Assess the Effect of Pulsed, Inhaled Nitric Oxide (iNO) on Functional Pulmonary Imaging Parameters in Subjects with World Health Organization (WHO) Group 3 Pulmonary Hypertension (PH) Associated with Chronic Obstructive Pulmonary Disease (COPD) on Long-Term Oxygen Therapy (LTOT) (Part 1) and in Subjects with WHO Group 3 PH associated with Idiopathic pulmonary fibrosis (IPF) on LTOT (Part 2). An Exploratory, Two-Part, Clinical Study to Assess the Effect of Pulsed, Inhaled Nitric Oxide(iNO) o ... | Part 1: Pulmonary Hypertension (PH) Associated with Chronic Obstructive Pulmonary Disease (COPD) Part 2: Pulmonary Hypertension (PH) Associated with Idiopathic pulmonary fibrosis (IPF) MedDRA version: 18.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 18.1;Level: LLT;Classification code 10010952;Term: COPD;Classification code 10009033;Term: Chronic obstructive pulmonary disease;Classification code 10037400;Term: Pulmonary hypertension;Level: HLT;Classification code 10037401;Term: Pulmonary hypertensions;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] Part 1: Pulmonary Hypertension (PH) Associated with Chronic Obstructive Pulmonary Disease (COPD) Par ... | Trade Name: INOmax 400ppm mol/mol inhalation gas Product Name: INO INN or Proposed INN: NITRIC OXIDE | Bellerophon Pulse Technologies LLC | NULL | Not Recruiting | Female: yes Male: yes | Phase 1;Phase 2 | Belgium | |||
4 | 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. A Phase 2, Open-Label, Dose-Escalation Study in Subjects With Pulmonary Arterial Hypertension, (PAH, ... | Pulmonary Arterial Hypertension;Idiopathic Pulmonary Fibrosis | Drug: Inhaled Nitric Oxide | Geno LLC | NULL | Completed | 18 Years | 80 Years | Both | 31 | Phase 2 | United States |
86. 肺動脈性肺高血圧症
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
Showing 1 to 10 of 18 diseases
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 | NCT05587400 (ClinicalTrials.gov) | July 27, 2022 | 23/9/2022 | Consistency of Electrical Cardiometry and Pulmonary Artery Catheter | The Consistency of Cardiac Output Measured by Electrical Cardiometry and Pulmonary Artery Catheter in Cardiac Surgery Patients With Pulmonary Arterial Hypertension or Right Heart Dysfunction The Consistency of Cardiac Output Measured by Electrical Cardiometry and Pulmonary Artery Catheter i ... | Pulmonary Arterial Hypertension;Right Ventricular Dysfunction | Behavioral: passive leg raising;Drug: dobutamine test;Drug: inhaled nitric oxide | Shanghai Zhongshan Hospital | NULL | Recruiting | 18 Years | 80 Years | All | 199 | N/A | China |
2 | 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 A Single-Center, Randomised, Controlled Trial of the Efficacy and Safety of Inhaled Nitric Oxidether ... | Pulmonary arterial hypertension (PAH), and Chronic thromboembolic pulmonary hypertension (CTEPH) PH, Nitric oxide, PAH, CTEPH, Right heart failure;D006976 Pulmonary arterial hypertension (PAH), and Chronic thromboembolic pulmonary hypertension (CTEPH) PH, ... | 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. Study drug: Nitric Oxide (INOflo for inhalation 800ppm) Start inhalation at a concentration of 20 ppm ... | Ogo Takeshi | NULL | Pending | >= 18age old | Not applicable | Both | 30 | Phase 2 | Japan |
3 | 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. This is a multicenter, double-blind, randomized, placebo-controlled, parallel-group study to investi ... | 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) A PHASE 3, PLACEBO CONTROLLED, DOUBLE-BLIND, RANDOMIZED, CLINICAL STUDY TO DETERMINE EFFICACY, SAFET ... | 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] Pulmonary Arterial Hypertension MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pu ... | Product Name: inhaled nitric oxide & INOpulse delivery Product Code: iNO INN or Proposed INN: NITRIC OXIDE Other descriptive name: inhaled NO with pulsed delivery Product Name: inhaled nitric oxide& INOpulse delivery Product Code: iNO INN or Proposed INN: NITRIC OX ... | 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 Serbia;Portugal;United States;Spain;Ukraine;Austria;Israel;Colombia;Italy;United Kingdom;France;Czec ... | ||
4 | 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 Study of PAH Subjects With LTOT Use That Have Demonstrated Improved Exercise Tolerance With the Use ... | 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) Phase 3, Multicenter, Randomized, Double-blind, Placebo Controlled Withdrawal Study of Pulmonary Art ... | 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 |
5 | 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. This is a multicenter, double-blind, randomized, placebo-controlled,parallel-group study to investig ... | 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) A PHASE 3, PLACEBO CONTROLLED, DOUBLE-BLIND, RANDOMIZED,CLINICAL STUDY TO DETERMINE EFFICACY, SAFETY ... | 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] Pulmonary Arterial Hypertension MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pu ... | Product Name: inhaled nitric oxide & INOpulse delivery Product Code: iNO INN or Proposed INN: NITRIC OXIDE Other descriptive name: inhaled NO with pulsed delivery Product Name: inhaled nitric oxide& INOpulse delivery Product Code: iNO INN or Proposed INN: NITRIC OX ... | 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 Serbia;Portugal;United States;Spain;Ukraine;Austria;Israel;Colombia;Italy;United Kingdom;France;Czec ... | ||
6 | 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. This is a multicenter, double-blind, randomized, placebo-controlled, parallel-group study to investi ... | 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) A PHASE 3, PLACEBO CONTROLLED, DOUBLE-BLIND, RANDOMIZED, CLINICAL STUDY TO DETERMINE EFFICACY, SAFET ... | 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] Pulmonary Arterial Hypertension MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pu ... | Product Name: inhaled nitric oxide & INOpulse delivery Product Code: iNO INN or Proposed INN: NITRIC OXIDE Other descriptive name: inhaled NO with pulsed delivery Product Name: inhaled nitric oxide& INOpulse delivery Product Code: iNO INN or Proposed INN: NITRIC OX ... | 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 Serbia;Portugal;United States;Spain;Ukraine;Austria;Israel;Colombia;Italy;United Kingdom;France;Hung ... | ||
7 | 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. This is a multicenter, double-blind, randomized, placebo-controlled, parallel-group study to investi ... | 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) A PHASE 3, PLACEBO CONTROLLED, DOUBLE-BLIND, RANDOMIZED, CLINICAL STUDY TO DETERMINE EFFICACY, SAFET ... | 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] Pulmonary Arterial Hypertension MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pu ... | Product Name: inhaled nitric oxide & INOpulse delivery Product Code: iNO INN or Proposed INN: NITRIC OXIDE Other descriptive name: inhaled NO with pulsed delivery Product Name: inhaled nitric oxide& INOpulse delivery Product Code: iNO INN or Proposed INN: NITRIC OX ... | 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 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (P ... | 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 Serbia;Portugal;United States;Spain;Ukraine;Austria;Israel;Colombia;Italy;United Kingdom;France;Hung ... | ||
8 | 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. This is a multicenter, double-blind, randomized, placebo-controlled, parallel-group study to investi ... | 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) A PHASE 3, PLACEBO CONTROLLED, DOUBLE-BLIND, RANDOMIZED, CLINICAL STUDY TO DETERMINE EFFICACY, SAFET ... | 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] Pulmonary Arterial Hypertension MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pu ... | Product Name: inhaled nitric oxide & INOpulse delivery Product Code: iNO INN or Proposed INN: NITRIC OXIDE Other descriptive name: inhaled NO with pulsed delivery Product Name: inhaled nitric oxide& INOpulse delivery Product Code: iNO INN or Proposed INN: NITRIC OX ... | 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 Colombia;Hungary;United States;Ukraine;United Kingdom;Portugal;Spain;Canada;Czech Republic;Netherlan ... | ||
9 | 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. This is a multicenter, double-blind, randomized, placebo-controlled, parallel-group study to investi ... | 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 A PHASE 3, PLACEBO CONTROLLED, DOUBLE-BLIND, RANDOMIZED, CLINICAL STUDY TO DETERMINE EFFICACY, SAFET ... | 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] Pulmonary Arterial Hypertension MedDRA version: 19.0;Level: PT;Classification code 10064911;Term: Pu ... | Product Name: inhaled nitric oxide & INOpulse delivery Product Code: iNO INN or Proposed INN: NITRIC OXIDE Other descriptive name: inhaled NO with pulsed delivery Product Name: inhaled nitric oxide& INOpulse delivery Product Code: iNO INN or Proposed INN: NITRIC OX ... | 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 Serbia;Portugal;United States;Spain;Ukraine;Austria;Israel;Italy;United Kingdom;France;Czech Republi ... | ||
10 | 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. This is a multicenter, double-blind, randomized, placebo-controlled, parallel-group study to investi ... | 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) A PHASE 3, PLACEBO CONTROLLED, DOUBLE-BLIND, RANDOMIZED, CLINICAL STUDY TO DETERMINE EFFICACY, SAFET ... | 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] Pulmonary Arterial Hypertension MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pu ... | Product Name: inhaled nitric oxide & INOpulse delivery Product Code: iNO INN or Proposed INN: NITRIC OXIDE Other descriptive name: inhaled NO with pulsed delivery Product Name: inhaled nitric oxide& INOpulse delivery Product Code: iNO INN or Proposed INN: NITRIC OX ... | 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 Serbia;Portugal;United States;Spain;Ukraine;Austria;Israel;Colombia;Italy;United Kingdom;France;Czec ... |