drugset / Trial / NCT00554619

A Study to Evaluate GSK1325760A - a Long-Term Extension Study

NCT00554619

Phase 3 Completed 21 enrolled GlaxoSmithKline
Non-randomizedSingle-groupOpen-labelTreatment

Summary

The primary objective of this study is to evaluate the safety of long-term administration of GSK1325760A in patients with PAH. The secondary objectives of this study are to evaluate long-term administration of GSK1325760A on: * Improvement in exercise capacity (six-minutes walk distance: 6MWD), change in WHO Functional Classification and time to clinical worsening of PAH * Change in the Borg Dyspnea Index (assessed immediately following the six-minute walk test \[6MWT\]) * Change in plasma brain natriuretic peptide (BNP) levels * Cardiopulmonary hemodynamics parameters (as measured by echocardiography)

Timeline

Start
2008-02
Primary completion
2011-01
Completion
2011-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Ambrisentan Small molecule 2.5 mg Oral
Subject Ambrisentan Small molecule 5 mg Oral
Subject Ambrisentan Small molecule 10 mg Oral