NCT00540436

Evaluate the Efficacy, Safety and Pharmacokinetics of GSK1325760A in the Treatment of Pulmonary Arterial Hypertension

Study AMB107816, Clinical Evaluation of GSK1325760A in the Treatment of Pulmonary Arterial Hypertension (PAH)- An Open-Label Phase II/III Study to Evaluate the Efficacy, Safety and Pharmacokinetics of GSK1325760A -<Classification: Exploratory and Confirmatory Clinical Trial>

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to evaluate the effect of GSK1325760A on improvement in exercise capacity in subjects with pulmonary arterial hypertension (PAH). The secondary objectives of this study are to evaluate administration of GSK1325760A on: * The safety and tolerability * Improvement of PAH * The steady-state plasma pharmacokinetics of GSK1325760A

Conditions

• Hypertension, Pulmonary

Interventions

Type	Name	Description
DRUG	GSK1325760A	Primary evaluation period: 5 mg/day, po, 12 weeks. Dose adjustment period: 2.5 mg, 5 mg or 10 mg/day, po, 12 weeks.

Timeline

• Start date: 2007-08-01
• Primary completion: 2009-01-01
• Completion: 2009-01-01
• First posted: 2007-10-08
• Last updated: 2012-10-15
• Results posted: 2009-11-10

Locations

15 sites across 1 country: Japan