Status:
TERMINATED
A Long-Term, Open-Label Study to Evaluate the Safety of Sitaxsentan Sodium Treatment in Patients With Pulmonary Arterial Hypertension
Lead Sponsor:
Pfizer
Conditions:
Pulmonary Arterial Hypertension
Eligibility:
All Genders
12-75 years
Phase:
PHASE3
Brief Summary
This is a multi-center, open-label study of sitaxsentan sodium 100 mg taken orally once daily by subjects with PAH until sitaxsentan, in a particular country or region, is commercially available for t...
Detailed Description
Open-label extension
Eligibility Criteria
Inclusion
- Diagnosis of Pulmonary Arterial Hypertension (PAH) confirmed by cardiac catheterization.
- Current diagnosis of WHO group 1 PAH with functional class 2, 3, or 4 symptoms.
Exclusion
- Has portal hypertension or chronic liver disease.
- Has history of left sided heart disease or significant cardiac disease.
Key Trial Info
Start Date :
March 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
1192 Patients enrolled
Trial Details
Trial ID
NCT00811018
Start Date
March 1 2003
End Date
July 1 2011
Last Update
April 24 2012
Active Locations (91)
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1
Pfizer Investigational Site
Birmingham, Alabama, United States, 35233
2
Pfizer Investigational Site
Birmingham, Alabama, United States, 35294
3
Pfizer Investigational Site
Phoenix, Arizona, United States, 85013
4
Pfizer Investigational Site
Los Angeles, California, United States, 90073