Ignite Creation Date:
2025-12-24 @ 3:01 PM
Ignite Modification Date:
2026-01-01 @ 7:50 AM
Study NCT ID:
NCT01273259
Status:
COMPLETED
Last Update Posted:
2022-02-09
First Post:
2011-01-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Dehydroepiandrosterone (DHEA) in Respiratory Pulmonary Hypertension in Adults
Sponsor:
University Hospital, Bordeaux
Organization:
Study Overview
Official Title:
Study of Dehydroepiandrosterone (DHEA) in Respiratory Pulmonary Hypertension in Adults. Phase 2 Trial
Status:
COMPLETED
Status Verified Date:
2022-02
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:
DHEA prevents and reverses chronic hypoxic pulmonary hypertension in a chronic hypoxic-pulmonary hypertension model in the rat. However, no study has been performed in human. The purpose of this study is to determine if DHEA is effective in the treatment of respiratory pulmonary hypertension in adults with Chronic Obstructive Pulmonary Disease (COPD) on exercise capacity and haemodynamic variables. Patients will receive after randomisation either 25 mg/day or 200mg/day oral DHEA over a one-year period. Evaluation concerns clinical parameters, echocardiography and right catheterization after and before treatment. Primary end-point is the six-minute walk test. This is a prospective double blind, randomised, placebo controlled study which will be realized in four university hospitals in France : Bordeaux, Strasbourg, Toulouse and Limoges.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: