drugset / Trial / NCT01273259

Study of Dehydroepiandrosterone (DHEA) in Respiratory Pulmonary Hypertension in Adults (DHEA-HTAP)

NCT01273259

Phase 2 Completed 51 enrolled University Hospital, Bordeaux
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2008-05-06
Primary completion
2015-06-05
Completion
2015-06-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Dehydroepiandrosterone Other / unclassified 25 mg Oral
Subject Dehydroepiandrosterone Other / unclassified 200 mg Oral