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

NCT ID: NCT00540436

Last Updated: 2012-10-15

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-31

Study Completion Date

2009-01-31

Brief Summary

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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

Detailed Description

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Conditions

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Hypertension, Pulmonary

Keywords

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Ambrisentan Pulmonary Arterial Hypertension 6MWD

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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GSK1325760A

Single arm safety and efficacy

Group Type EXPERIMENTAL

GSK1325760A

Intervention Type DRUG

Primary evaluation period: 5 mg/day, po, 12 weeks. Dose adjustment period: 2.5 mg, 5 mg or 10 mg/day, po, 12 weeks.

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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Ambrisentan

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Aichi, , Japan

Site Status

GSK Investigational Site

Fukuoka, , Japan

Site Status

GSK Investigational Site

Hokkaido, , Japan

Site Status

GSK Investigational Site

Hokkaido, , Japan

Site Status

GSK Investigational Site

Ishikawa, , Japan

Site Status

GSK Investigational Site

Kanagawa, , Japan

Site Status

GSK Investigational Site

Kyoto, , Japan

Site Status

GSK Investigational Site

Okayama, , Japan

Site Status

GSK Investigational Site

Okinawa, , Japan

Site Status

GSK Investigational Site

Osaka, , Japan

Site Status

GSK Investigational Site

Shizuoka, , Japan

Site Status

GSK Investigational Site

Tokyo, , Japan

Site Status

GSK Investigational Site

Tokyo, , Japan

Site Status

GSK Investigational Site

Tokyo, , Japan

Site Status

GSK Investigational Site

Tokyo, , Japan

Site Status

Countries

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Japan

References

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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.

Reference Type BACKGROUND
PMID: 21812736 (View on PubMed)

Other Identifiers

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AMB107816

Identifier Type: -

Identifier Source: org_study_id