CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 334 enrolled
Drug / intervention
bosentan +1 moredrug
Likely dose
bosentan 62.5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00303459
NCT00303459Phase 4Completed
CompareCT.gov

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

Actelion·interventional·Posted Mar 17, 2006·Updated Feb 4, 2025

In Brief

A Phase 4 clinical trial evaluating bosentan and placebo for Pulmonary Arterial Hypertension. Completed, enrolled 334 participants.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPulmonary Arterial Hypertension
Countries--
Collaborators--

Timeline

Phase 4CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 17, 2006
Enrollment StartMay 1, 2006
Primary CompletionDec 1, 2013
TodayJul 2, 2026
Enrollment to primary: 7.6 yearsPosted 20.3 years ago

Interventions

bosentandrug

bosentan/62.5 mg tablet/b.i.d. for 4 weeks then bosentan/125 mg tablet/b.i.d.

placebodrug

Matching bosentan placebo/b.i.d.