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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2002 by ICOS-Texas Biotechnology.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
ICOS Corporation
Texas Biotechnology Corporation
Information provided by:
ICOS-Texas Biotechnology
ClinicalTrials.gov Identifier:
NCT00034307
First received: April 24, 2002
Last updated: June 23, 2005
Last verified: May 2002
  Purpose

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.


Condition Intervention Phase
Pulmonary Hypertension
Drug: sitaxsentan sodium
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled Safety and Efficacy Study of Sitaxsentan Sodium Treatment in Patients With Pulmonary Arterial Hypertension

Resource links provided by NLM:


Further study details as provided by ICOS-Texas Biotechnology:

Estimated Enrollment: 180
  Eligibility

Ages Eligible for Study:   16 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00034307

  Show 26 Study Locations
Sponsors and Collaborators
ICOS-Texas Biotechnology
ICOS Corporation
Texas Biotechnology Corporation
Investigators
Study Director: Lyn Frumkin, M.D., Ph.D. ICOS Corporation
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00034307     History of Changes
Other Study ID Numbers: FPH01/FPH01-X
Study First Received: April 24, 2002
Last Updated: June 23, 2005
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hypertension
Hypertension, Pulmonary
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on September 18, 2014