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

Patrocinadores

Patrocinador principal: ICOS-Texas Biotechnology

Colaborador: ICOS Corporation
Texas Biotechnology Corporation

Fuente ICOS-Texas Biotechnology
Resumen breve

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.

Estado general Unknown status
Fase Phase 2/Phase 3
Tipo de estudio Interventional
Inscripción 180
Condición
Intervención

Tipo de intervención: Drug

Nombre de intervención: sitaxsentan sodium

Elegibilidad

Criterios:

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

Género: All

Edad mínima: 16 Years

Edad máxima: 75 Years

Voluntarios Saludables: No

Oficial general
Apellido Papel Afiliación
Lyn Frumkin, M.D., Ph.D. Study Director ICOS Corporation
Ubicación
Instalaciones:
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
Ubicacion Paises

Canada

United States

Fecha de verificación

May 2002

Condición Examinar
Información de diseño del estudio

Asignación: Randomized

Modelo de intervención: Parallel Assignment

Propósito primario: Treatment

Enmascaramiento: Double

Fuente: ClinicalTrials.gov