Conditions: Pulmonary Arterial Hypertension
Keywords: sildenafil Combination Drug Therapy bosentan Pulmonary Hypertension Pulmonary Arterial Hypertension Multicenter Study Antihypertensive Agents Tracleer endothelin receptor antagonist Randomized Controlled Trial Phosphodiesterase type 5 inhibitor (PDE5i) Outcome Assessment
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 334
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: Bosentan arm 2: Placebo

Interventions: intervention 1: bosentan intervention 2: placebo
Intervention descriptions: intervention 1: bosentan/62.5 mg tablet/b.i.d. for 4 weeks then bosentan/125 mg tablet/b.i.d. intervention 2: Matching bosentan placebo/b.i.d.

Protocol document: