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.TrialIDDate_
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Public_titleScientific_titleConditionInterventionPrimary_
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PhaseCountries
1EUCTR2012-000153-31-CZ
(EUCTR)
18/04/201320/11/2012A 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 lungsA 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, IncNULLNot RecruitingFemale: yes
Male: yes
90Phase 2United States;France;Serbia;Hungary;Czech Republic;Poland;Australia;Germany;Italy
2EUCTR2012-000166-37-CZ
(EUCTR)
18/04/201320/11/2012A 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 lungsA 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 IncNULLNot RecruitingFemale: yes
Male: yes
90Phase 2United States;France;Serbia;Hungary;Czech Republic;Poland;Australia;Germany;Italy
3EUCTR2012-000153-31-PL
(EUCTR)
17/04/201325/01/2013A 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 lungsA 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, IncNULLNot RecruitingFemale: yes
Male: yes
90Phase 2France;United States;Serbia;Hungary;Czech Republic;Poland;Australia;Germany;Italy
4EUCTR2012-000166-37-PL
(EUCTR)
17/04/201328/01/2013A 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 lungsA 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 IncNULLNot RecruitingFemale: yes
Male: yes
90Phase 2France;United States;Serbia;Hungary;Czech Republic;Poland;Australia;Germany;Italy
5EUCTR2012-000153-31-DE
(EUCTR)
05/03/201329/11/2012A 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 lungsA 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, IncNULLNot RecruitingFemale: yes
Male: yes
90Phase 2United States;Serbia;France;Hungary;Czech Republic;Poland;Romania;Australia;Bulgaria;Germany;Italy
6EUCTR2012-000166-37-DE
(EUCTR)
05/03/201329/11/2012A 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 lungsA 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 IncNULLNot RecruitingFemale: yes
Male: yes
90Phase 2United States;France;Serbia;Hungary;Czech Republic;Poland;Romania;Australia;Bulgaria;Germany;Italy
7NCT01725269
(ClinicalTrials.gov)
March 20138/11/2012Long-term Study of AIR001 in Subjects With WHO Group 1 Pulmonary Arterial Hypertension Who Completed AIR001-CS05A 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 HypertensionPulmonary Arterial HypertensionDrug: AIR001Aires Pharmaceuticals, Inc.NULLTerminated18 Years75 YearsBoth17Phase 2United States;Australia;Hungary
8EUCTR2012-000153-31-IT
(EUCTR)
27/02/201313/09/2013A 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 lungsA 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, IncNULLNot RecruitingFemale: yes
Male: yes
90Phase 2France;United States;Serbia;Hungary;Czech Republic;Poland;Australia;Germany;Italy
9EUCTR2012-000153-31-HU
(EUCTR)
22/01/201314/11/2012A 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 lungsA 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, IncNULLNot RecruitingFemale: yes
Male: yes
90Phase 2France;United States;Serbia;Czech Republic;Hungary;Poland;Australia;Germany;Italy
10EUCTR2012-000166-37-HU
(EUCTR)
22/01/201314/11/2012A 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 lungsA 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 IncNULLNot RecruitingFemale: yes
Male: yes
90Phase 2Italy;Germany;Australia;Poland;Hungary;Czech Republic;Serbia;United States;France
11NCT01725256
(ClinicalTrials.gov)
November 20128/11/2012A 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 HypertensionDrug: AIR001 (sodium nitrite inhalation solution)Aires Pharmaceuticals, Inc.NULLTerminated18 Years75 YearsBoth29Phase 2United States;Australia;Hungary
12NCT01409122
(ClinicalTrials.gov)
July 20111/8/2011Safety, Tolerability, and PK Parameters of Sodium Nitrite Inhalation Solution in Healthy SubjectsA 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 HypertensionPulmonary Hypertension;Pulmonary Arterial HypertensionDrug: 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 solutionAires Pharmaceuticals, Inc.NULLCompleted18 Years56 YearsBoth42Phase 1United States
13NCT00814645
(ClinicalTrials.gov)
December 200822/12/2008Dose-Finding, Safety, Pharmacodynamic Effect Study of Sodium Nitrite Inhalation Solution in Normal, Healthy VolunteersA Placebo-Controlled, Phase 1b, Dose-Finding, Safety, Pharmacodynamic Effect Study of Sodium Nitrite Inhalation Solution (AIR001 INHALATION SOLUTION) in Normal, Healthy VolunteersPulmonary Arterial HypertensionDrug: Sodium Nitrite Inhalation Solution;Drug: Placebo and AIR001 Inhalation Solution (Expansion arm)Aires Pharmaceuticals, Inc.NULLCompleted18 Years55 YearsBoth25Phase 1United States