Clinical trial NCT00034307: Safety and Efficacy of Sitaxsentan in the Treatment of Pulmonary Arterial Hypertension
Official title: A Randomized, Double-Blind, Placebo-Controlled Safety and Efficacy Study of Sitaxsentan Sodium Treatment in Patients With Pulmonary Arterial Hypertension
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Pulmonary Hypertension
Lead sponsor: ICOS-Texas Biotechnology
Sponsor class: INDUSTRY
Collaborators: name: ICOS Corporation
name: Texas Biotechnology Corporation
First posted: 2002-04-25
Enrollment: 180
Sex: ALL
Minimum age (years): 16
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of Southern California Hospital, Ambulatory Health Sciences
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: Torrance
country: United States
facility: Harbor-UCLA Medical Center
state: California
city: Denver
country: United States
facility: The Children's Hospital
state: Colorado
city: Denver
country: United States
facility: University of Colorado/ Health Science Center
state: Colorado
city: Atlanta
country: United States
facility: Emory University Hospital - McKelvey Lung Transplantation Center
state: Georgia
city: Augusta
country: United States
facility: Medical College of Georgia
state: Georgia
city: Decatur
country: United States
facility: Dekalb Medical Center
state: Georgia
city: Chicago
country: United States
facility: Rush Heart Institute, Center for Pulmonary Heart Disease, Rush-Presbyterian-St. Luke's Medical Center
state: Illinois
city: New Orleans
country: United States
facility: LSU - School of Medicine
state: Louisiana
city: Portland
country: United States
facility: Maine Medical Center
state: Maine
city: Baltimore
country: United States
facility: John Hopkins Hospital
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan Hospital, Division of Cardiology
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic - Division of Cardiovascular Disease
state: Minnesota
city: New York
country: United States
facility: Columbia Presbyterian Medical Center
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Cleveland
country: United States
facility: The Cleveland Clinic Foundation, Department of Pulmonary and Critical Care
state: Ohio
city: Columbus
country: United States
facility: Division of Cardiology - The Ohio State University Medical Center
state: Ohio
city: Portland
country: United States
facility: Oregon Health Sciences
state: Oregon
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center, CHF/Transplantation Cardiology
state: Pennsylvania
city: Providence
country: United States
facility: Pulmonary Division - Rhode Island Hospital
state: Rhode Island
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Houston
country: United States
facility: Baylor College of Medicine Pulmonary & Critical Care Section
state: Texas
city: Milwaukee
country: United States
facility: University of Wisconsin Medical School
state: Wisconsin
city: Montreal
country: Canada
facility: SMBD Jewish General Hospital
state: Quebec
Study officials:
affiliation: ICOS Corporation
name: Lyn Frumkin, M.D., Ph.D.
role: STUDY_DIRECTOR
References: