Title
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
Phase
Phase 2/Phase 3Lead Sponsor
ICOSStudy Type
InterventionalStatus
Unknown statusIndication/Condition
Pulmonary HypertensionIntervention/Treatment
sitaxentan ...Study Participants
180This 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.
Inclusion Criteria: 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 Exclusion Criteria: 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
