Overview

This trial is active, not recruiting.

Condition pulmonary hypertension
Treatment sitaxsentan sodium
Phase phase 2/phase 3
Sponsor ICOS-Texas Biotechnology
Collaborator ICOS Corporation
Trial size 180 participants
Trial identifier NCT00034307, FPH01/FPH01-X

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double-blind
Primary purpose treatment

Eligibility Criteria

Male or female participants from 16 years up to 75 years old.

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

Additional Information

Official title A Randomized, Double-Blind, Placebo-Controlled Safety and Efficacy Study of Sitaxsentan Sodium Treatment in Patients With Pulmonary Arterial Hypertension
Trial information was received from ClinicalTrials.gov and was last updated in June 2005.
Information provided to ClinicalTrials.gov by ICOS-Texas Biotechnology.