Phase 2 Extension Study of Ambrisentan in Pulmonary Arterial Hypertension

• Status: Completed
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: All

Summary

AMB-220-E is an international, multicenter, open-label study examining the long-term safety of ambrisentan (BSF 208075) in subjects who have previously completed Myogen study NCT00046319, "A Phase II, Randomized, Double-Blind, Dose-Controlled, Dose-Ranging, Multicenter Study of BSF 208075 Evaluating Exercise Capacity in Subjects with Moderate to Severe Pulmonary Arterial Hypertension".

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gilead Sciences
• Treatments: Ambrisentan

Criteria

Inclusion Criteria:

• Must have completed Visit 14/Week 24 of the NCT00046319 study.

• Women of childbearing potential must have a negative urine pregnancy test at the Screening/Enrollment Visit and agree to use a reliable double barrier method of contraception until study completion and for >=4 weeks following their final study visit.

• Must have completed the Down-titration Period of NCT00046319 prior to enrollment in AMB-220-E and will meet the following additional criteria:

• Subjects with a diagnosis of HIV must have stable disease status at the time of Screening/Enrollment.

• Must be stable on conventional therapy for PAH for >=4 weeks prior to the Screening Visit.

Exclusion Criteria:

• Chronic prostanoid therapy, or other investigational prostacyclin derivative within 4 weeks prior to the Screening Visit.

• Intravenous inotrope use within 2 weeks prior to the Screening Visit.

• Females who are pregnant or breastfeeding.

• Contraindication to treatment with an endothelin receptor antagonist (ERA).