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

Status

UNKNOWN

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00034307

Enrollment

180

Registered

2002-04-25

Start date

Unknown

Completion date

Unknown

Last updated

2005-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Hypertension

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.

Interventions

DRUGsitaxsentan sodium

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

16 Years to 75 Years

Healthy volunteers

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

Countries

Canada, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026