Trial intelligence / Profile preview

BREATHE-5: Bosentan in Eisenmenger Syndrome

NCT00317486Phase 4Completed

Sponsor
Actelion Pharmaceuticals Ltd
Start
Sep 2003
Primary completion
Apr 2005
Modality
Nucleic Acid-Directed Small Molecules, Orthosteric Ligands
01

Overview

Phase 4, randomised, double-blind trial in pulmonary arterial hypertension (PAH) and Eisenmenger syndrome comparing Bosentan with Placebo (2 arms). Primary endpoints: Change from baseline to Week 16 in oxygen saturation at rest with room air and Change from baseline to Week 16 in indexed pulmonary vascular resistance. Started Sep 2003; status: completed.

02

Drugs

bosentan
03

Conditions

pulmonary arterial hypertension (PAH)Eisenmenger syndrome

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