NCT00554619

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

Study AMB107818, Clinical Evaluation of GSK1325760A in the Treatment of Pulmonary Arterial Hypertension (PAH)- An Open Label Study of GSK1325760A to Evaluate the Safety and Efficacy of GSK1325760A - a Long-term Extension Study -

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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)

Conditions

• Pulmonary Arterial Hypertension
• Hypertension, Pulmonary

Interventions

Type	Name	Description
DRUG	GSK1325760A	2.5mg, 5mg or 10mg/day, po, GSK1325760A treatment will be continued until its approval by the MHLW.

Timeline

• Start date: 2008-02-01
• Primary completion: 2011-01-01
• Completion: 2011-01-01
• First posted: 2007-11-07
• Last updated: 2012-11-05
• Results posted: 2012-02-13

Locations

11 sites across 1 country: Japan