Safety and Efficacy of Sitaxsentan in the Treatment of Pulmonary Arterial Hypertension
A Randomized, Double-Blind, Placebo-Controlled Safety and Efficacy Study of Sitaxsentan Sodium Treatment in Patients With Pulmonary Arterial Hypertension
1 other identifier
interventional
180
2 countries
26
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 24, 2002
CompletedFirst Posted
Study publicly available on registry
April 25, 2002
CompletedJune 24, 2005
May 1, 2002
April 24, 2002
June 23, 2005
Conditions
Interventions
Eligibility Criteria
You may qualify if:
- NYHA Class II, III or IV
- to 75 years of age
- Specific peak VO2 range
- PPH, PAH due to connective tissue disease or select congenital heart disease
- Qualifying cardiac catheterization
- History of CXR and qualifying pulmonary function test
- History of qualifying ventilation-perfusion lung scan
- History of qualifying echocardiogram
- Women of childbearing potential must use contraceptives
- Stable dose of corticosteroids if prescribed
You may not qualify if:
- Significant lung disease
- Chronic liver disease
- Uncontrolled sleep apnea
- History of specific types of left heart disease
- Any disorder that compromises ability to give informed consent
- Uncontrolled sleep apnea
- Inability to perform bicycle exercise test
- On-going treatment with an experimental drug or device within the last 30 days
- HIV infection
- Specific liver dysfunction
- Chronic renal disease
- Pregnancy/Nursing
- Chronic active hepatitis B or C
- Chronic Flolan or Tracleer use within the last 30 days
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ICOS-Texas Biotechnologylead
- ICOS Corporationcollaborator
- Texas Biotechnology Corporationcollaborator
Study Sites (26)
University of Southern California Hospital, Ambulatory Health Sciences
Los Angeles, California, 90033, United States
University of California, San Francisco
San Francisco, California, 94143, United States
Harbor-UCLA Medical Center
Torrance, California, 90502, United States
The Children's Hospital
Denver, Colorado, 80218, United States
University of Colorado/ Health Science Center
Denver, Colorado, 80262, United States
Emory University Hospital - McKelvey Lung Transplantation Center
Atlanta, Georgia, 30322, United States
Medical College of Georgia
Augusta, Georgia, 30912, United States
Dekalb Medical Center
Decatur, Georgia, 30033, United States
Rush Heart Institute, Center for Pulmonary Heart Disease, Rush-Presbyterian-St. Luke's Medical Center
Chicago, Illinois, 60612, United States
LSU - School of Medicine
New Orleans, Louisiana, 70112, United States
Maine Medical Center
Portland, Maine, 04102, United States
John Hopkins Hospital
Baltimore, Maryland, 21287, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
University of Michigan Hospital, Division of Cardiology
Ann Arbor, Michigan, 48109, United States
Mayo Clinic - Division of Cardiovascular Disease
Rochester, Minnesota, 55905, United States
Columbia Presbyterian Medical Center
New York, New York, 10032, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
The Cleveland Clinic Foundation, Department of Pulmonary and Critical Care
Cleveland, Ohio, 44195, United States
Division of Cardiology - The Ohio State University Medical Center
Columbus, Ohio, 43210, United States
Oregon Health Sciences
Portland, Oregon, 97201, United States
University of Pittsburgh Medical Center, CHF/Transplantation Cardiology
Pittsburgh, Pennsylvania, 15213, United States
Pulmonary Division - Rhode Island Hospital
Providence, Rhode Island, 02903, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
Baylor College of Medicine Pulmonary & Critical Care Section
Houston, Texas, 77030, United States
University of Wisconsin Medical School
Milwaukee, Wisconsin, 53215, United States
SMBD Jewish General Hospital
Montreal, Quebec, H3T 1E2, Canada
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Lyn Frumkin, M.D., Ph.D.
ICOS Corporation