Phase 2 Study of Ambrisentan for Liver Function Test Rescue in Pulmonary Arterial Hypertension

Gilead Sciences

Status and phase

Completed

Phase 2

Conditions

Pulmonary Hypertension

Treatments

Drug: ambrisentan

Study type

Interventional

Funder types

Industry

Identifiers

NCT00423592

AMB-222

Details and patient eligibility

About

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 overall safety and tolerability of ambrisentan, in participants with pulmonary arterial hypertension (PAH), idiopathic PAH (IPAH), or familial PAH (FPAH) who had previously discontinued ERA therapy (bosentan or sitaxsentan) due to increased serum ALT or AST concentrations.

Enrollment

36 patients

Sex

All

Ages

12 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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