Phase 2 Extension Study of Ambrisentan 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

NCT00424021

AMB-220-E

Details and patient eligibility

About

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".

Enrollment

54 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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).