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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




This study will investigate the effects of the combination of bosentan and sildenafil versus sildenafil alone on time to first morbidity/mortality event in patients with symptomatic PAH. Patients must be receiving sildenafil equal to or greater tha 20 mg t.i.d. for at least 12 weeks prior to being randomized to receive either bosentan 125 mg b.i.d. or matching placebo. The study will continue until the predefined target number of morbidity/mortality events is reached.

Study Status: Active, not recruiting


Condition Intervention Phase
Pulmonary Hypertension Drug: bosentan
Drug: placebo
Phase 4

Verified by Actelion August, 2013

Sponsored by: Actelion
Information provided by: Actelion identifier: NCT00303459

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
United States

Jonathan Tolson, PhD., Study Chair

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