Ignite Creation Date:
2024-05-06 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 1:54 PM
Study NCT ID:
NCT04712669
Status:
COMPLETED
Last Update Posted:
2023-10-05
First Post:
2021-01-12
Brief Title:
A Study of Rodatristat Ethyl in Patients With Pulmonary Arterial Hypertension ELEVATE 2
Sponsor:
Altavant Sciences GmbH
Organization:
Altavant Sciences GmbH
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:
2023-10
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:
None
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?:
None