drugset / Trial / NCT00367770

BREATHE 5-OL: Tracleer (Bosentan) in Patients With Pulmonary Arterial Hypertension Related to Eisenmenger Physiology

NCT00367770

Phase 4 Completed 37 enrolled Actelion
Non-randomizedSingle-groupOpen-labelTreatment

Summary

This 6-month open label study will evaluate the long term safety of bosentan (via oxygen saturation) and efficacy (exercise capacity) in patients who have completed the BREATHE-5 study (PAH related to Eisenmenger physiology). Treatment duration is 6 months.

Timeline

Start
2004-01
Primary completion
2005-12
Completion
2005-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Bosentan Other / unclassified 62.5 mg
Subject Bosentan Other / unclassified 125 mg