86. 肺動脈性肺高血圧症 Pulmonary arterial hypertension Clinical trials / Disease details
臨床試験数 : 1,181 / 薬物数 : 701 - (DrugBank : 126) / 標的遺伝子数 : 105 - 標的パスウェイ数 : 192
| 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 | EUCTR2012-000166-37-CZ (EUCTR) | 18/04/2013 | 20/11/2012 | A Phase 2, Multi-Centre, unblinded, parallel dose, safety and effectiveness study of AIR001 in subjects with high blood pressure in the blood vessels in the lungs | 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 | Pulmonary Arterial Hypertension;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: AIR001 Inhalation Solution Product Code: AIR001 INN or Proposed INN: sodium nitrite Other descriptive name: SODIUM NITRITE | Aires Pharmaceuticals Inc | NULL | Not Recruiting | Female: yes Male: yes | 90 | Phase 2 | United States;France;Serbia;Hungary;Czech Republic;Poland;Australia;Germany;Italy | ||
| 2 | EUCTR2012-000153-31-CZ (EUCTR) | 18/04/2013 | 20/11/2012 | A Phase 2, Multi-Center, unblinded study to evaluate the intermediate/long term safety and effectiveness of AIR001 in subjects with high blood pressure in the blood vessels in the lungs | A Phase 2, Multi-Center, Open-Label study to evaluate the intermediate/long term safety and efficacy of AIR001 in subjects with WHO Group I Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: AIR001 Inhalation Solution Product Code: AIR001 INN or Proposed INN: sodium nitrite Other descriptive name: SODIUM NITRITE | Aires Pharmaceuticals, Inc | NULL | Not Recruiting | Female: yes Male: yes | 90 | Phase 2 | United States;France;Serbia;Hungary;Czech Republic;Poland;Australia;Germany;Italy | ||
| 3 | EUCTR2012-000166-37-PL (EUCTR) | 17/04/2013 | 28/01/2013 | A Phase 2, Multi-Centre, unblinded, parallel dose, safety and effectiveness study of AIR001 in subjects with high blood pressure in the blood vessels in the lungs | 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 | Pulmonary Arterial Hypertension;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: AIR001 Inhalation Solution Product Code: AIR001 INN or Proposed INN: sodium nitrite Other descriptive name: SODIUM NITRITE | Aires Pharmaceuticals Inc | NULL | Not Recruiting | Female: yes Male: yes | 90 | Phase 2 | France;United States;Serbia;Hungary;Czech Republic;Poland;Australia;Germany;Italy | ||
| 4 | EUCTR2012-000153-31-PL (EUCTR) | 17/04/2013 | 25/01/2013 | A Phase 2, Multi-Center, unblinded study to evaluate the intermediate/long term safety and effectiveness of AIR001 in subjects with high blood pressure in the blood vessels in the lungs | A Phase 2, Multi-Center, Open-Label study to evaluate the intermediate/long term safety and efficacy of AIR001 in subjects with WHO Group I Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: AIR001 Inhalation Solution Product Code: AIR001 INN or Proposed INN: sodium nitrite Other descriptive name: SODIUM NITRITE | Aires Pharmaceuticals, Inc | NULL | Not Recruiting | Female: yes Male: yes | 90 | Phase 2 | France;United States;Serbia;Hungary;Czech Republic;Poland;Australia;Germany;Italy | ||
| 5 | EUCTR2012-000153-31-DE (EUCTR) | 05/03/2013 | 29/11/2012 | A Phase 2, Multi-Center, unblinded study to evaluate the intermediate/long term safety and effectiveness of AIR001 in subjects with high blood pressure in the blood vessels in the lungs | A Phase 2, Multi-Center, Open-Label study to evaluate the intermediate/long term safety and efficacy of AIR001 in subjects with WHO Group I Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: AIR001 Inhalation Solution Product Code: AIR001 INN or Proposed INN: sodium nitrite Other descriptive name: SODIUM NITRITE | Aires Pharmaceuticals, Inc | NULL | Not Recruiting | Female: yes Male: yes | 90 | Phase 2 | United States;Serbia;France;Hungary;Czech Republic;Poland;Romania;Australia;Bulgaria;Germany;Italy | ||
| 6 | EUCTR2012-000166-37-DE (EUCTR) | 05/03/2013 | 29/11/2012 | A Phase 2, Multi-Centre, unblinded, parallel dose, safety and effectiveness study of AIR001 in subjects with high blood pressure in the blood vessels in the lungs | 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 | Pulmonary Arterial Hypertension;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: AIR001 Inhalation Solution Product Code: AIR001 INN or Proposed INN: sodium nitrite Other descriptive name: SODIUM NITRITE | Aires Pharmaceuticals Inc | NULL | Not Recruiting | Female: yes Male: yes | 90 | Phase 2 | United States;France;Serbia;Hungary;Czech Republic;Poland;Romania;Australia;Bulgaria;Germany;Italy | ||
| 7 | EUCTR2012-000153-31-IT (EUCTR) | 27/02/2013 | 13/09/2013 | A Phase 2, Multi-Center, unblinded study to evaluate the intermediate/long term safety and effectiveness of AIR001 in subjects with high blood pressure in the blood vessels in the lungs | A Phase 2, Multi-Center, Open-Label study to evaluate the intermediate/long term safety and efficacy of AIR001 in subjects with WHO Group I Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension 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: AIR001 Inhalation Solution Product Code: AIR001 INN or Proposed INN: sodium nitrite Other descriptive name: SODIUM NITRITE | Aires Pharmaceuticals, Inc | NULL | Not Recruiting | Female: yes Male: yes | 90 | Phase 2 | France;United States;Serbia;Hungary;Czech Republic;Poland;Australia;Germany;Italy | ||
| 8 | EUCTR2012-000166-37-HU (EUCTR) | 22/01/2013 | 14/11/2012 | A Phase 2, Multi-Centre, unblinded, parallel dose, safety and effectiveness study of AIR001 in subjects with high blood pressure in the blood vessels in the lungs | 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 | Pulmonary Arterial Hypertension;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: AIR001 Inhalation Solution Product Code: AIR001 INN or Proposed INN: sodium nitrite Other descriptive name: SODIUM NITRITE | Aires Pharmaceuticals Inc | NULL | Not Recruiting | Female: yes Male: yes | 90 | Phase 2 | Italy;Germany;Australia;Poland;Hungary;Czech Republic;Serbia;United States;France | ||
| 9 | EUCTR2012-000153-31-HU (EUCTR) | 22/01/2013 | 14/11/2012 | A Phase 2, Multi-Center, unblinded study to evaluate the intermediate/long term safety and effectiveness of AIR001 in subjects with high blood pressure in the blood vessels in the lungs | A Phase 2, Multi-Center, Open-Label study to evaluate the intermediate/long term safety and efficacy of AIR001 in subjects with WHO Group I Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: AIR001 Inhalation Solution Product Code: AIR001 INN or Proposed INN: sodium nitrite Other descriptive name: SODIUM NITRITE | Aires Pharmaceuticals, Inc | NULL | Not Recruiting | Female: yes Male: yes | 90 | Phase 2 | France;United States;Serbia;Czech Republic;Hungary;Poland;Australia;Germany;Italy | ||
| 10 | NCT00814645 (ClinicalTrials.gov) | December 2008 | 22/12/2008 | Dose-Finding, Safety, Pharmacodynamic Effect Study of Sodium Nitrite Inhalation Solution in Normal, Healthy Volunteers | A Placebo-Controlled, Phase 1b, Dose-Finding, Safety, Pharmacodynamic Effect Study of Sodium Nitrite Inhalation Solution (AIR001 INHALATION SOLUTION) in Normal, Healthy Volunteers | Pulmonary Arterial Hypertension | Drug: Sodium Nitrite Inhalation Solution;Drug: Placebo and AIR001 Inhalation Solution (Expansion arm) | Aires Pharmaceuticals, Inc. | NULL | Completed | 18 Years | 55 Years | Both | 25 | Phase 1 | United States |