Phase 2 Extension Study of Ambrisentan in Pulmonary Arterial Hypertension

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-04-30

Study Completion Date

2009-12-31

Brief Summary

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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".

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Detailed Description

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Conditions

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Pulmonary Hypertension

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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ambrisentan

1, 2.5, 5, and 10 mg ambrisentan given orally once daily

Intervention Type DRUG

Other Intervention Names

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BSF 208075 Letairis Volibris

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No