Ignite Creation Date:
2024-05-06 @ 2:16 PM
Last Modification Date:
2024-10-26 @ 1:28 PM
Study NCT ID:
NCT04266197
Status:
RECRUITING
Last Update Posted:
2024-05-08
First Post:
2020-01-22
Brief Title:
Vardenafil Inhaled for Pulmonary Arterial Hypertension PRN Phase 2B Study
Sponsor:
Respira Therapeutics Inc
Organization:
Respira Therapeutics Inc
Study Overview
Official Title:
A Phase 2b Open-label Single Dose Study to Evaluate the Safety and Efficacy of RT234 on Exercise Parameters Assessed by Cardiopulmonary Exercise Testing CPET in Subjects with Pulmonary Arterial Hypertension PAH
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VIPAH-PRN 2B
Brief Summary:
The objectives of this study are to evaluate the safety of RT234 and the effects of RT234 on exercise capacity as assessed by Cardiopulmonary Exercise Testing CPET and six minute walk testing 6MWT as well as exertional symptoms in patients with pulmonary arterial hypertension PAH
Detailed Description:
PAH results in are significant limitations in cardiorespiratory fitness CRF exercise capacity and profound dyspnea with physical exertion The objective of this study is to assess the ability of a single inhaled dose of RT234 to acutely improve primary CPET measures of CRF and exercise capacity and to decrease the experience of lower the sensation of dyspnea with physical exertion compared to baseline CPET measures
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None