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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00034307
Recruitment Status : Unknown
Verified May 2002 by ICOS-Texas Biotechnology.
Recruitment status was:  Active, not recruiting
First Posted : April 25, 2002
Last Update Posted : June 24, 2005
Sponsor:
Collaborators:
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment Phase
Pulmonary Hypertension Drug: sitaxsentan sodium Phase 2 Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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


Arms and Interventions


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 75 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
ClinicalTrials.gov Identifier: NCT00034307     History of Changes
Other Study ID Numbers: FPH01/FPH01-X
First Posted: April 25, 2002    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: May 2002

Additional relevant MeSH terms:
Hypertension
Hypertension, Pulmonary
Familial Primary Pulmonary Hypertension
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Sitaxsentan
Endothelin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action