Status:
COMPLETED
Phase 2 Study of Ambrisentan for Liver Function Test Rescue in Pulmonary Arterial Hypertension
Lead Sponsor:
Gilead Sciences
Conditions:
Pulmonary Hypertension
Eligibility:
All Genders
12-75 years
Phase:
PHASE2
Brief Summary
This Phase 2 study was to determine the incidence of increased serum aminotransferase concentrations (alanine aminotransferase \[ALT\] and/or aspartate aminotransferase \[AST\]), as well as the overal...
Eligibility Criteria
Inclusion
- Summary of Inclusion Criteria:
- Males and Females between 12 and 75 years of age
- Current diagnosis of IPAH, FPAH, or PAH associated with collagen vascular disease, congenital systemic-to-pulmonary shunts, anorexigen use, HIV infection
- Must have previously discontinued bosentan or sitaxsentan therapy due to serum aminotransferase (ALT and/or AST) concentrations \> 3 x ULN
- Must have normal (\< 1 x ULN) serum ALT and AST concentrations at screening
- Six-minute Walk distance of at least 150 meters at screening
- If receiving sildenafil or a clinically approved prostanoid for PAH, must have been on stable therapy for at least 4 weeks prior to screening
- Subjects with a diagnosis of HIV must have stable disease status during the screening period
Exclusion
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT00423592
Start Date
May 1 2005
End Date
March 1 2009
Last Update
June 17 2013
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