Safety and Efficacy of Sitaxsentan in the Treatment of Pulmonary Arterial Hypertension

Status unconfirmed · Phase 2/Phase 3

Conditions studied: Pulmonary Hypertension

In brief

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.

Key facts

Study ID

NCT00034307

Run by

ICOS-Texas Biotechnology

People needed

180

Last updated by the study team

2005-06-24

Who can join

Age: 16 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• NYHA Class II, III or IV
• 16 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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