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
This study will investigate the effects of the combination of bosentan and sildenafil.
Patients with symptomatic PAH treated with a stable dose of sildenafil equal to or greater
tha 20 mg t.i.d. for at least 12 weeks will be randomized to placebo or bosentan 125 mg
b.i.d. All randomized patients will be treated with study drug until the predefined target
number of morbidity/mortality events is reached.
Study Status: Recruiting
Information provided by:
Study Type: Interventional
Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
The Cleveland Clinic Foundation
Cleveland, Ohio 44195