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

Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypertension, Pulmonary

Intervention: GSK1325760A (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline

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

Clinical Details

Official title: 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 -

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

Primary outcome: Mean Change From Baseline in Six Minutes Walk Distance (6MWD) at Week 12

Secondary outcome:

Mean Change From Baseline in Six Minutes Walk Distance (6MWD) at Week 24/Withdrawal

Mean Change From Baseline in the Borg Dyspnea Index (BDI) at Weeks 12 and 24

Number of Participants With a Change From Baseline in Their World Health Organization (WHO) Functional Classification (FC) at Weeks 12 and 24

Number of Participants With the Indicated Event, as an Assessment of Time to Clinical Worsening of Pulmonary Arterial Hypertension (PAH) at Week 24, Assessed as the First Occurrence of a Particular Event

Mean Change From Baseline in Mean Pulmonary Atery Pressure (mPAP) and Mean Right Atrial Pressure (mRAP) at Weeks 12 and 24

Mean Change From Baseline in Cardiac Index (CI) at Weeks 12 and 24

Mean Change From Baseline in Cardiac Output (CO) at Weeks 12 and 24

Mean Change From Baseline in Pulmonary Vascular Resistance (PVR) at Weeks 12 and 24

Mean Change From Baseline in B-type Natriuretic Peptide (BNP) Values at Weeks 12 and 24

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion criteria:

- Subjects must have a diagnosis of Pulmonary Arterial Hypertension (PAH) in clinical

classification of Pulmonary Hypertension Group1

- The mean right heart catheterization parameters measured from 6 months prior to the

administration of the investigational drug must meet the criteria below:

- Mean pulmonary arterial pressure (mPAP) of >25 mmHg

- Pulmonary vascular resistance (PVR) of >3 mmHg/L/min

- Mean pulmonary capillary wedge pressure or left ventricular end diastolic pressure

of <15 mmHg (if measurable)

- The measured six minutes walk distance (6MWD) at screening visit is in the range of

=>150m and <=450m

Locations and Contacts

GSK Investigational Site, Aichi 470-1192, Japan

GSK Investigational Site, Fukuoka 830-0011, Japan

GSK Investigational Site, Hokkaido 060-8543, Japan

GSK Investigational Site, Hokkaido 060-8648, Japan

GSK Investigational Site, Ishikawa 920-8641, Japan

GSK Investigational Site, Kanagawa 228-8555, Japan

GSK Investigational Site, Kyoto 606-8507, Japan

GSK Investigational Site, Okayama 701-1192, Japan

GSK Investigational Site, Okinawa 901-0243, Japan

GSK Investigational Site, Osaka 565-8565, Japan

GSK Investigational Site, Shizuoka 431-3192, Japan

GSK Investigational Site, Tokyo 113-8431, Japan

GSK Investigational Site, Tokyo 113-8655, Japan

GSK Investigational Site, Tokyo 143-8541, Japan

GSK Investigational Site, Tokyo 160-8582, Japan

Additional Information

Related publications:

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.

Starting date: August 2007
Last updated: October 11, 2012

Page last updated: August 23, 2015

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