Status:
COMPLETED
Pilot Chart Review Study Of Sitaxentan Sodium (Thelin) In Patients With Pulmonary Arterial Hypertension (PAH)
Lead Sponsor:
Pfizer
Conditions:
Pulmonary Arterial Hypertension
Eligibility:
All Genders
18+ years
Brief Summary
The objectives of this study are to develop research methods and corresponding materials for a study of the effectiveness of sitaxentan sodium (Thelin) in "real-world" settings; to pilot test these me...
Detailed Description
At each centre, approximately 12-15 Pulmonary Arterial Hypertension (PAH) consecutive patients who have received Thelin and who meet all other study entry criteria.
Eligibility Criteria
Inclusion
- Idiopathic PAH, or PAH secondary to connective tissue disease
- Receipt of Thelin for treatment of PAH
- 6 months of follow-up (except in the event of death) subsequent to initial receipt of Thelin
- Minimum of one clinic visit documented in the medical record during the 6-month period subsequent to initial receipt of Thelin
Exclusion
- Participation in any investigational study of Thelin or any other medication for the treatment of PAH during the period beginning 6 months prior to initial receipt of Thelin and ending 6 months subsequent to such receipt
- Receipt of Thelin prior to January 11, 2005 (i.e., the date following the last day on which patients could be enrolled in double-blind treatment in STRIDE-1, STRIDE-2, and/or STRIDE-6); or
- Known contraindications to Thelin therapy (i.e., known hypersensitivity to sitaxsentan or any of its excipients; mild-to-severe hepatic impairment \[Child-Pugh Class A-C\]; elevated aminotransferases prior to initiation of treatment, defined as aspartate aminotransferase \[AST\] and/or alanine aminotransferase \[ALT\] \>3 times upper limit of normal \[ULN\]; concomitant use of cyclosporin A; lactation)
Key Trial Info
Start Date :
December 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 28 2011
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT01445873
Start Date
December 1 2009
End Date
March 28 2011
Last Update
September 1 2020
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