Ignite Creation Date:
2024-05-06 @ 1:05 AM
Last Modification Date:
2024-10-26 @ 10:58 AM
Study NCT ID:
NCT01725256
Status:
TERMINATED
Last Update Posted:
2014-04-09
First Post:
2012-11-08
Brief Title:
A Phase 2 Study to Determine the Safety and Efficacy of AIR001 in Subjects With Pulmonary Arterial Hypertension PAH
Sponsor:
Aires Pharmaceuticals Inc
Organization:
Aires Pharmaceuticals Inc
Study Overview
Official Title:
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
Status:
TERMINATED
Status Verified Date:
2014-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Terminated early dt to acquisition of Sponsor and change in corporate priorities
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate the safety and effectiveness of an investigationalexperimental drug called AIR001
To test the effectiveness the study will evaluate how AIR001 affects the blood vessels in the lungs and the function of the heart This will be done by monitoring changes in Pulmonary Vascular Resistance PVR from BaselineDay 1 start of study drug to Week 16 of the study PVR measures the resistance to flow in the blood vessels of the lungs The study will include other assessments to evaluate the effect of the study drug on PAH including measurements of exercise ability and evaluations of PAH disease symptoms
To test the effectiveness the study will evaluate how AIR001 affects the blood vessels in the lungs and the function of the heart This will be done by monitoring changes in Pulmonary Vascular Resistance PVR from BaselineDay 1 start of study drug to Week 16 of the study PVR measures the resistance to flow in the blood vessels of the lungs The study will include other assessments to evaluate the effect of the study drug on PAH including measurements of exercise ability and evaluations of PAH disease symptoms
Detailed Description:
The primary objective of this study is to evaluate the efficacy of inhaled nebulized AIR001 administered for 16 weeks according to 3 treatment arms 80 mg once daily 46 mg 4 times daily or 80 mg 4 times daily in subjects with World Health Organization WHO Group 1 Pulmonary Arterial Hypertension PAH as determined by change in Pulmonary Vascular Resistance PVR from Baseline to Week 16 measured immediately post completion of AIR001 nebulization as soon as feasible
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None