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

Conditions

Pulmonary Arterial Hypertension

What is the purpose of this trial?

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.



Participation Guidelines

Age:
12 Years and older
Gender:
Both

Click here for detailed information about who can participate in this trial.


Sponsor:
Actelion
Dates:
May 2006
Last Updated:
February 11, 2014
Study HIC#:
0601000965

Clinicaltrials.gov ID: NCT00303459