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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT00423592
• Date of registration: 17/01/2007
• Prospective Registration: No
• Primary sponsor: Gilead Sciences
• Public title: Phase 2 Study of Ambrisentan for Liver Function Test Rescue in Pulmonary Arterial Hypertension
• Scientific title: A Phase 2, Open-label, Multicenter Study Evaluating Ambrisentan in Subjects With Pulmonary Arterial Hypertension Who Have Previously Discontinued Endothelin Receptor Antagonist Therapy Due to Serum Aminotransferase Abnormalities
• Date of first enrolment: May 2005
• Target sample size: 36
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00423592
• Study type: Interventional
• Phase: Phase 2

Key inclusion & 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



Age minimum: 12 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Pulmonary Hypertension

Intervention(s)

Drug: ambrisentan

Primary Outcome(s)

The Incidence of Confirmed Serum Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) Concentrations > 3 x the Upper Limit of Normal (ULN) Considered to be Related to Ambrisentan and Resulted in Discontinuation of Study Drug. [Time Frame: Week 12]

Secondary Outcome(s)

A Change From Baseline Evaluated After 12 Weeks of Ambrisentan Therapy in WHO Functional Class [Time Frame: Baseline to Week 12]

Secondary Outcome: A Change From Baseline Evaluated After 12 Weeks of Ambrisentan Therapy in SF-36 Health Survey Scale - General Health [Time Frame: Baseline to Week 12]

Secondary Outcome: A Change From Baseline Evaluated After 12 Weeks of Ambrisentan Therapy in SF-36 Health Survey Scale - Physical Functioning [Time Frame: Baseline to Week 12]

Secondary Outcome: A Change From Baseline Evaluated After 12 Weeks of Ambrisentan Therapy in SF-36 Health Survey Scale - Role Physical [Time Frame: Baseline to Week 12]

Secondary Outcome: A Change From Baseline Evaluated After 12 Weeks of Ambrisentan Therapy in SF-36 Health Survey Scale - Role Emotional [Time Frame: Baseline to Week 12]

The Incidence of Confirmed Serum ALT or AST Concentrations > 3 x ULN That Were Related to Ambrisentan and Resulted in Dose Reduction [Time Frame: Week 12]

The Incidence of Confirmed Serum ALT or AST Concentrations > 5 x ULN That Were Related to Ambrisentan and Resulted in Discontinuation of Study Drug. [Time Frame: Week 12]

A Change From Baseline Evaluated After 12 Weeks of Ambrisentan Therapy in Borg Dyspnea Index Immediately Following Exercise [Time Frame: Baseline to Week 12]

A Change From Baseline Evaluated After 12 Weeks of Ambrisentan Therapy in the 6-Minute Walk Distance Test (6MWD) [Time Frame: Baseline to Week 12]

Secondary Outcome: A Change From Baseline Evaluated After 12 Weeks of Ambrisentan Therapy in SF-36 Health Survey Scale - Bodily Pain [Time Frame: Baseline to Week 12]

Secondary Outcome: A Change From Baseline Evaluated After 12 Weeks of Ambrisentan Therapy in SF-36 Health Survey Scale - Composite Mental Health [Time Frame: Baseline to Week 12]

Secondary Outcome: A Change From Baseline Evaluated After 12 Weeks of Ambrisentan Therapy in SF-36 Health Survey Scale - Social Functioning [Time Frame: Baseline to Week 12]

A Change From Baseline Evaluated After 12 Weeks of Ambrisentan Therapy in Short Form 36 (SF-36) Health Survey Scale - Composite Physical Health [Time Frame: Baseline to Week 12]

Secondary Outcome: A Change From Baseline Evaluated After 12 Weeks of Ambrisentan Therapy in SF-36 Health Survey Scale - Mental Health [Time Frame: Baseline to Week 12]

Secondary Outcome: A Change From Baseline Evaluated After 12 Weeks of Ambrisentan Therapy in SF-36 Health Survey Scale - Vitality [Time Frame: Baseline to Week 12]

Secondary ID(s)

AMB-222

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 20/06/2012
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00423592