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

Status Completed

Clinical Trial 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)

Clinical Trial Description

n/a

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00554619
Study type	Interventional
Source	GlaxoSmithKline
Contact
Status	Completed
Phase	Phase 3
Start date	February 2008
Completion date	January 2011

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