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.

Condition	Treatment or Intervention	Phase
Pulmonary Hypertension	Drug: sitaxsentan sodium	Phase II Phase III

Ages Eligible for Study:  16 Years   -   75 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

1.) NYHA Class II, III or IV

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:

1.) Significant lung disease

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

California
      University of California, San Francisco, San Francisco,  California,  94143,  United States
      Harbor-UCLA Medical Center, Torrance,  California,  90502,  United States
      University of Southern California Hospital, Ambulatory Health Sciences, Los Angeles,  California,  90033,  United States
Colorado
      University of Colorado/ Health Science Center, Denver,  Colorado,  80262,  United States
      The Children's Hospital, Denver,  Colorado,  80218,  United States
Georgia
      Medical College of Georgia, Augusta,  Georgia,  30912,  United States
      Emory University Hospital - McKelvey Lung Transplantation Center, Atlanta,  Georgia,  30322,  United States
      Dekalb Medical Center, Decatur,  Georgia,  30033,  United States
Illinois
      Rush Heart Institute, Center for Pulmonary Heart Disease, Rush-Presbyterian-St. Luke's Medical Center, Chicago,  Illinois,  60612,  United States
Louisiana
      LSU - School of Medicine, New Orleans,  Louisiana,  70112,  United States
Maine
      Maine Medical Center, Portland,  Maine,  04102,  United States
Maryland
      John Hopkins Hospital, Baltimore,  Maryland,  21287,  United States
Massachusetts
      Massachusetts General Hospital, Boston,  Massachusetts,  02114,  United States
Michigan
      University of Michigan Hospital, Division of Cardiology, Ann Arbor,  Michigan,  48109,  United States
Minnesota
      Mayo Clinic - Division of Cardiovascular Disease, Rochester,  Minnesota,  55905,  United States
New York
      Columbia Presbyterian Medical Center, New York,  New York,  10032,  United States
North Carolina
      Duke University Medical Center, Durham,  North Carolina,  27710,  United States
Ohio
      Division of Cardiology - The Ohio State University Medical Center, Columbus,  Ohio,  43210,  United States
      The Cleveland Clinic Foundation, Department of Pulmonary and Critical Care, Cleveland,  Ohio,  44195,  United States
Oregon
      Oregon Health Sciences, Portland,  Oregon,  97201,  United States
Pennsylvania
      University of Pittsburgh Medical Center, CHF/Transplantation Cardiology, Pittsburgh,  Pennsylvania,  15213,  United States
Rhode Island
      Pulmonary Division - Rhode Island Hospital, Providence,  Rhode Island,  02903,  United States
Tennessee
      Vanderbilt University Medical Center, Nashville,  Tennessee,  37232,  United States
Texas
      Baylor College of Medicine Pulmonary & Critical Care Section, Houston,  Texas,  77030,  United States
Wisconsin
      University of Wisconsin Medical School, Milwaukee,  Wisconsin,  53215,  United States
Canada, Quebec
      SMBD Jewish General Hospital, Montreal,  Quebec,  H3T 1E2,  Canada

Study chairs or principal investigators

Lyn Frumkin, M.D., Ph.D.,  Study Director,  ICOS   

Study ID Numbers:  FPH01/FPH01-X
Record last reviewed:  May 2002
Last Updated:  October 13, 2004
Record first received:  April 24, 2002
ClinicalTrials.gov Identifier:  NCT00034307
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08