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

Phase 2 Completed 25 enrolled GlaxoSmithKline

Non-randomizedSingle-groupOpen-labelTreatment

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

Timeline

Start: 2007-08
Primary completion: 2009-01
Completion: 2009-01

Publications

Background Yoshida S, Shirato K, Shimamura R, Nakahara N, Iwase T, Nakajima H. Efficacy, safety, and pharmacokinetics of ambrisentan in Japanese adults with pulmonary arterial hypertension. Curr Med Res Opin. 2011 Sep;27(9):1827-34. doi: 10.1185/03007995.2011.605440. Epub 2011 Aug 4.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ambrisentan	Small molecule	2.5 mg	Oral
Subject	Ambrisentan	Small molecule	5 mg	Oral
Subject	Ambrisentan	Small molecule	10 mg	Oral

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

Summary

Timeline

Publications

Drugs

Indications