This is a clinical research study designed to evaluate an investigational new medication called sitaxsentan for the treatment of pulmonary arterial hypertension (patients with NYHA functional class II, III or IV). The purpose of this study is to evaluate the safety and effectiveness of two different doses of sitaxsentan, compared to placebo (inactive treatment) for the treatment of pulmonary arterial hypertension. Patients who complete this trial may be eligible to take part in an extension trial (Protocol FPH01-X). Eligible patients who receive placebo in the 12-week study cross over to receive sitaxsentan for the extension trial.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
180
University of Southern California Hospital, Ambulatory Health Sciences
Los Angeles, California, United States
University of California, San Francisco
San Francisco, California, United States
Harbor-UCLA Medical Center
Torrance, California, United States
The Children's Hospital
Denver, Colorado, United States
University of Colorado/ Health Science Center
Denver, Colorado, United States
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Emory University Hospital - McKelvey Lung Transplantation Center
Atlanta, Georgia, United States
Medical College of Georgia
Augusta, Georgia, United States
Dekalb Medical Center
Decatur, Georgia, United States
Rush Heart Institute, Center for Pulmonary Heart Disease, Rush-Presbyterian-St. Luke's Medical Center
Chicago, Illinois, United States
LSU - School of Medicine
New Orleans, Louisiana, United States
...and 16 more locations