Safety and Efficacy of Sitaxsentan in the Treatment of Pulmonary Arterial Hypertension
NCT ID: NCT00034307
Last Updated: 2005-06-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2/PHASE3
180 participants
INTERVENTIONAL
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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sitaxsentan sodium
Eligibility Criteria
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Inclusion Criteria
2. 16 to 75 years of age
3. Specific peak VO2 range
4. PPH, PAH due to connective tissue disease or select congenital heart disease
5. Qualifying cardiac catheterization
6. History of CXR and qualifying pulmonary function test
7. History of qualifying ventilation-perfusion lung scan
8. History of qualifying echocardiogram
9. Women of childbearing potential must use contraceptives
10. Stable dose of corticosteroids if prescribed
Exclusion Criteria
2. Chronic liver disease
3. Uncontrolled sleep apnea
4. History of specific types of left heart disease
5. Any disorder that compromises ability to give informed consent
6. Uncontrolled sleep apnea
7. Inability to perform bicycle exercise test
8. On-going treatment with an experimental drug or device within the last 30 days
9. HIV infection
10. Specific liver dysfunction
11. Chronic renal disease
12. Pregnancy/Nursing
13. Chronic active hepatitis B or C
14. Chronic Flolan or Tracleer use within the last 30 days
16 Years
75 Years
ALL
No
Sponsors
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ICOS Corporation
INDUSTRY
Texas Biotechnology Corporation
INDUSTRY
ICOS-Texas Biotechnology
INDUSTRY
Principal Investigators
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Lyn Frumkin, M.D., Ph.D.
Role: STUDY_DIRECTOR
ICOS Corporation
Locations
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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
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
Maine Medical Center
Portland, Maine, United States
John Hopkins Hospital
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
University of Michigan Hospital, Division of Cardiology
Ann Arbor, Michigan, United States
Mayo Clinic - Division of Cardiovascular Disease
Rochester, Minnesota, United States
Columbia Presbyterian Medical Center
New York, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
The Cleveland Clinic Foundation, Department of Pulmonary and Critical Care
Cleveland, Ohio, United States
Division of Cardiology - The Ohio State University Medical Center
Columbus, Ohio, United States
Oregon Health Sciences
Portland, Oregon, United States
University of Pittsburgh Medical Center, CHF/Transplantation Cardiology
Pittsburgh, Pennsylvania, United States
Pulmonary Division - Rhode Island Hospital
Providence, Rhode Island, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Baylor College of Medicine Pulmonary & Critical Care Section
Houston, Texas, United States
University of Wisconsin Medical School
Milwaukee, Wisconsin, United States
SMBD Jewish General Hospital
Montreal, Quebec, Canada
Countries
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Related Links
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Pulmonary Hypertension Association
Other Identifiers
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FPH01/FPH01-X
Identifier Type: -
Identifier Source: org_study_id