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NCT00034307 Clinical Trial

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

Pulmonary Hypertension Clinical Trial

Official title:
A Randomized, Double-Blind, Placebo-Controlled Safety and Efficacy Study of Sitaxsentan Sodium Treatment in Patients With Pulmonary Arterial Hypertension

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT00034307
Other study ID # FPH01/FPH01-X
Secondary ID
Status Active, not recruiting
Phase Phase 2/Phase 3
First received April 24, 2002
Last updated June 23, 2005

Study information
Verified date May 2002
Source ICOS-Texas Biotechnology
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 180
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 16 Years to 75 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• sitaxsentan sodium

Locations
Country Name City State
Canada SMBD Jewish General Hospital Montreal Quebec
United States University of Michigan Hospital, Division of Cardiology Ann Arbor Michigan
United States Emory University Hospital - McKelvey Lung Transplantation Center Atlanta Georgia
United States Medical College of Georgia Augusta Georgia
United States John Hopkins Hospital Baltimore Maryland
United States Massachusetts General Hospital Boston Massachusetts
United States Rush Heart Institute, Center for Pulmonary Heart Disease, Rush-Presbyterian-St. Luke's Medical Center Chicago Illinois
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 Dekalb Medical Center Decatur Georgia
United States The Children's Hospital Denver Colorado
United States University of Colorado/ Health Science Center Denver Colorado
United States Duke University Medical Center Durham North Carolina
United States Baylor College of Medicine Pulmonary & Critical Care Section Houston Texas
United States University of Southern California Hospital, Ambulatory Health Sciences Los Angeles California
United States University of Wisconsin Medical School Milwaukee Wisconsin
United States Vanderbilt University Medical Center Nashville Tennessee
United States LSU - School of Medicine New Orleans Louisiana
United States Columbia Presbyterian Medical Center New York New York
United States University of Pittsburgh Medical Center, CHF/Transplantation Cardiology Pittsburgh Pennsylvania
United States Maine Medical Center Portland Maine
United States Oregon Health Sciences Portland Oregon
United States Pulmonary Division - Rhode Island Hospital Providence Rhode Island
United States Mayo Clinic - Division of Cardiovascular Disease Rochester Minnesota
United States University of California, San Francisco San Francisco California
United States Harbor-UCLA Medical Center Torrance California

Sponsors (3)
Lead Sponsor Collaborator
ICOS-Texas Biotechnology ICOS Corporation, Texas Biotechnology Corporation

Countries where clinical trial is conducted

United States,  Canada, 

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