CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 383 enrolled
Drug / intervention
ambrisentandrug
Likely dose
ambrisentan 10.0 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00578786
NCT00578786Phase 3Completed
CompareCT.gov

A Long Term Study of Ambrisentan in Pulmonary Arterial Hypertension Subjects Having Completed AMB-320 (NCT00423748) or AMB-321 (NCT00423202)

Gilead Sciences·interventional·Posted Dec 21, 2007·Updated Jan 15, 2013

In Brief

A Phase 3 clinical trial evaluating ambrisentan for Pulmonary Arterial Hypertension. Completed, enrolled 383 participants across 22 sites in 4 countries.

Detailed Summary

AMB-320/321-E was designed to provide long-term, controlled monitoring of pulmonary arterial hypertension (PAH) patients treated with ambrisentan (AMB) in order to properly define the adverse event profile associated with this endothelin receptor antagonist (ERA), including the incidence and severity of elevated serum liver function tests (LFTs). In addition, this study continued the efficacy assessments of the previous studies, examined long-term AMB treatment success, and compared long-term survival of subjects treated with AMB to the NIH registry of patients with PAH.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPulmonary Arterial Hypertension
CountriesArgentina, Brazil, Chile, Mexico
Collaborators--

Timeline

Phase 3CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 21, 2007
Enrollment StartFeb 1, 2004
Primary CompletionMar 1, 2010
TodayJul 2, 2026
Enrollment to primary: 6.1 yearsPosted 18.5 years ago

Interventions

ambrisentandrug

2.5, 5.0 or 10.0 mg ambrisentan po, qd, long-term