AIR001 ( DrugBank: - )
1 disease
| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 86 | 肺動脈性肺高血圧症 | 13 |
86. 肺動脈性肺高血圧症
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 | EUCTR2012-000153-31-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 | ||
| 2 | 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 | ||
| 3 | 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 | ||
| 4 | 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 | ||
| 5 | 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 | ||
| 6 | 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 | ||
| 7 | NCT01725269 (ClinicalTrials.gov) | March 2013 | 8/11/2012 | Long-term Study of AIR001 in Subjects With WHO Group 1 Pulmonary Arterial Hypertension Who Completed AIR001-CS05 | A Phase 2, Multicenter, Open-Label Study to Evaluate the Intermediate/Long Term Safety and Efficacy of AIR001 in Subjects With WHO Group 1 Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension | Drug: AIR001 | Aires Pharmaceuticals, Inc. | NULL | Terminated | 18 Years | 75 Years | Both | 17 | Phase 2 | United States;Australia;Hungary |
| 8 | 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 | ||
| 9 | 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 | ||
| 10 | 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 | ||
| 11 | 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 |
| 12 | NCT01409122 (ClinicalTrials.gov) | July 2011 | 1/8/2011 | Safety, Tolerability, and PK Parameters of Sodium Nitrite Inhalation Solution in Healthy Subjects | A Phase 1, Placebo Controlled, Blinded, Multiple Dose Escalation Study of AIR001 (Sodium Nitrite Inhalation Solution) in Healthy Subjects, an Assessment of the Tolerability in Combination With Oral Sildenafil, and an Open-Label Study of Multiple Dose AIR001 in Patients With Pulmonary Arterial Hypertension | Pulmonary Hypertension;Pulmonary Arterial Hypertension | Drug: 15 mg sodium nitrite inhalation solution;Drug: 90 mg sodium nitrite inhalation solution;Drug: 45 mg sodium nitrite inhalation solution;Drug: 120 mg sodium nitrite inhalation solution;Drug: 25% MTD sodium nitrite inhalation solution | Aires Pharmaceuticals, Inc. | NULL | Completed | 18 Years | 56 Years | Both | 42 | Phase 1 | United States |
| 13 | 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 |