Ignite Creation Date:
2024-05-06 @ 5:32 PM
Last Modification Date:
2024-10-26 @ 2:31 PM
Study NCT ID:
NCT05343637
Status:
COMPLETED
Last Update Posted:
2022-04-25
First Post:
2022-04-04
Brief Title:
A Dose Escalation Study to Evaluate the Effect of RT234 in Subjects With Pulmonary Arterial Hypertension
Sponsor:
Respira Therapeutics Inc
Organization:
Respira Therapeutics Inc
Study Overview
Official Title:
A Phase 2a Dose Escalation Study to Evaluate the Effect of RT234 on Cardiopulmonary Hemodynamics in Subjects With Pulmonary Arterial Hypertension
Status:
COMPLETED
Status Verified Date:
2022-04
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:
None
Brief Summary:
This multicenter open label Phase 2a study is designed to evaluate the effect of inhaled RT234 delivered in a dose escalation manner on the change in pulmonary vascular resistance PVR in subjects with Pulmonary Arterial Hypertension PAH undergoing Right heart catheterization RHC
This study is also known as Vardenafil Inhaled for Pulmonary Arterial Hypertension PRN Phase 2a VIPAH-PRN 2a study
This study is also known as Vardenafil Inhaled for Pulmonary Arterial Hypertension PRN Phase 2a VIPAH-PRN 2a study
Detailed Description:
The drawbacks of current therapies and the lack of an approved as needed PRN treatment for PAH that improves exercise ability and quality of life form the basis for development of RT234 inhaled vardenafil The current study will identify the effective doses of RT234 to acutely improve pulmonary vascular hemodynamics when delivered in a dose escalation manner in subjects with World Health Organization WHO Group 1 PAH undergoing RHC In addition this study will also provide valuable efficacy and safety insights into the interactions between RT234 and background disease-specific PAH therapy on pulmonary hemodynamics and right heart function
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ACTRN12619001178134 | REGISTRY | Australian New Zealand Clinical Trials Registry ANZCTR | None |