NCT00303459

Effects of the Combination of Bosentan and Sildenafil Versus Sildenafil Monotherapy on Pulmonary Arterial Hypertension (PAH)

Effects of Combination of Bosentan and Sildenafil Versus Sildenafil Monotherapy on Morbidity and Mortality in Symptomatic Patients With Pulmonary Arterial Hypertension - A Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group, Prospective, Event Driven Phase IV Study

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 334 (actual)
• Sponsor: Actelion · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

COMPASS-2 is a Phase 4, prospective, randomized, double-blind, placebo-controlled, event-driven study evaluating the effect of bosentan on the time to first confirmed morbidity/mortality event in patients with symptomatic PAH already receiving sildenafil therapy. Patients must have been receiving doses of sildenafil equal to or greater than 20 mg t.i.d. for at least 12 weeks prior to being randomized. The study continued until the predefined target number of morbidity/mortality events was reached.

Conditions

• Pulmonary Arterial Hypertension

Interventions

Type	Name	Description
DRUG	bosentan	bosentan/62.5 mg tablet/b.i.d. for 4 weeks then bosentan/125 mg tablet/b.i.d.
DRUG	placebo	Matching bosentan placebo/b.i.d.

Timeline

• Start date: 2006-05-01
• Primary completion: 2013-12-01
• Completion: 2013-12-01
• First posted: 2006-03-17
• Last updated: 2025-02-04
• Results posted: 2015-01-26