38
Participants
Start Date
April 30, 2008
Primary Completion Date
February 28, 2011
Study Completion Date
July 31, 2011
Ambrisentan
Ambrisentan was administered orally once daily; dose level was 5 mg for the first 4 weeks, followed by 10 mg for the remainder of the study; ambrisentan was supplied as 5-mg and 10-mg tablets.
Placebo
Placebo to match ambrisentan was administered orally once daily.
Sildenafil
Sildenafil was administered at the dose previously established for each subject (20-100 mg) orally three times daily. Sildenafil was supplied as 20-mg tablets, or formulated as sildenafil citrate in 25-, 50-, or 100-mg tablets.
Tadalafil
Tadalafil was administered at the dose previously established for each subject (not to exceed 40 mg per day) orally once daily. Tadalafil was supplied as 20-mg tablets.
Weill Cornell Medical Center, New York
Allegheny General Hospital, Pittsburgh
University of Pittsburgh Medical Center, Pittsburgh
Altoona Center for Clinical Research, Duncansville
University of Maryland, Baltimore
Sentara Norfolk General Hospital, Norfolk
University of North Carolina at Chapel Hill, Chapel Hill
Asheville Cardiology Associates, Asheville
Atlanta Institute for Medical Research, Decatur
Emory University, Atlanta
University of Florida, Gainesville
Orlando Heart Center, Orlando
Mount Sinai Medical Center, Miami Beach
Cleveland Clinic, Fort Lauderdale
University of South Alabama, Mobile
Ohio State University, Columbus
University Hospitals of Cleveland, Cleveland
The Lindner Clinical Trial Center, Cincinnati
Wayne State University, Detroit
University of Iowa, Iowa City
Mayo Clinic, Rochester
UT Southwestern Medical Center, Dallas
Scott & White Memorial Hospital, Temple
Baylor College of Medicine, Houston
Arizona Pulmonary Specialists, Phoenix
West Los Angeles Healthcare Center, Los Angeles
Harbor - UCLA, Torrance
BACH Cardiology, Boston
Brigham & Women's Hospital, Boston
Rhode Island Hospital, Providence
Lead Sponsor
Gilead Sciences
INDUSTRY