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

Overview

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.

Full Title of Study: “A Randomized, Double-Blind, Placebo-Controlled Safety and Efficacy Study of Sitaxsentan Sodium Treatment in Patients With Pulmonary Arterial Hypertension”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double

Interventions

  • Drug: sitaxsentan sodium

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 16 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • ICOS-Texas Biotechnology
  • Collaborator
    • ICOS Corporation
  • Overall Official(s)
    • Lyn Frumkin, M.D., Ph.D., Study Director, ICOS Corporation

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.