Ignite Creation Date:
2025-12-24 @ 10:55 PM
Ignite Modification Date:
2025-12-30 @ 9:09 PM
Study NCT ID:
NCT04712669
Status:
COMPLETED
Last Update Posted:
2025-06-04
First Post:
2021-01-12
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of Rodatristat Ethyl in Patients With Pulmonary Arterial Hypertension (Core OLE)
Sponsor:
Altavant Sciences GmbH
Organization:
Study Overview
Official Title:
A Phase 2, Dose-Ranging, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Rodatristat Ethyl in Patients With Pulmonary Arterial Hypertension
Status:
COMPLETED
Status Verified Date:
2025-06
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:
The purpose of this study is to assess the safety and efficacy of Rodatristat Ethyl in pulmonary arterial hypertension (PAH) patients.
Detailed Description:
Rodatristat Ethyl is a peripherally restricted TPH inhibitor being studied as a potential treatment for PAH. This dose-ranging, randomized, double-blind, placebo-controlled, multicenter study will evaluate the effect of Rodatristat Ethyl from baseline on pulmonary vascular resistance as measured at right heart catheterization.
Patients will be enrolled into a main study with an option to enroll into an open label extension.
The study is expected to enroll patients in the USA, Canada and Europe.
Patients will be enrolled into a main study with an option to enroll into an open label extension.
The study is expected to enroll patients in the USA, Canada and Europe.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: