Clinical Trial: Effects of Tracleer (Bosentan) on Pulmonary Arterial Hypertension Related to Eisenmenger Physiology
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effects of Tracleer (Bosentan) on Oxygen Saturation and Cardiac Hemodynamics in Patients With Pulmonary Arterial Hype
Brief Summary: This study evaluates the effects of bosentan on oxygen saturation, hemodynamics and exercise capacity in patients with pulmonary arterial hypertension related to Eisenmenger physiology. Patients receive bosentan or placebo for 16 weeks.
Detailed Summary:
Sponsor: Actelion
Current Primary Outcome:
- Change from baseline to Week 16 in oxygen saturation at rest with room air
- Change from baseline to Week 16 in indexed pulmonary vascular resistance
Original Primary Outcome:
Current Secondary Outcome: Changes from baseline to Week 16 in cardiac hemodynamics
Original Secondary Outcome:
Information By: Actelion
Dates:
Date Received: April 21, 2006
Date Started: September 2003
Date Completion:
Last Updated: February 11, 2010
Last Verified: February 2010
