Clinical Trials

Toll-Free: 866.320.4573

Call Us Toll Free:

866.223.2273 x1234

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

Study:

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

Rationale:

n/a

Purpose:

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

Recruiting:
n/a

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

Verified by Actelion August, 2013

Sponsored by: Actelion
Information provided by: Actelion
ClinicalTrials.gov 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

This information is abridged to display results relevant only to Cleveland Clinic. To see complete record visit ClinicalTrials.gov
  Information obtained from ClinicalTrials.gov on
Link to the current ClinicalTrials.gov record.

Cleveland Clinic Mobile Site