Evaluate the Efficacy, Safety and Pharmacokinetics of GSK1325760A in the Treatment of Pulmonary Arterial Hypertension - Full Text View

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00540436

Purpose

The primary objective of this study is to evaluate the effect of GSK1325760A on improvement in exercise capacity in subjects with PAH.

The secondary objectives of this study are to evaluate administration of GSK1325760A on:

Condition	Intervention	Phase
Pulmonary Arterial Hypertension	Drug: GSK1325760A	Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
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 - <Classification: Exploratory and Confirmatory Clinical Trial>

Resource links provided by NLM:

Drug Information available for: Ambrisentan

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Exercise capacity (six-minutes walk distance : 6MWD) [ Time Frame: every 4 weeks up to 24 weeks ]

Secondary Outcome Measures:

WHO Functional Classification, time to clinical worsening of PAH, Borg Dyspnea Index [ Time Frame: every 4 weeks up to 24 weeks ]

Enrollment:	25
Study Start Date:	August 2007
Study Completion Date:	January 2009
Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
GSK1325760A: Experimental	Drug: GSK1325760A Primary evaluation period: 5mg/day, po, 12 weeks. Dose adjustment period: 2.5mg, 5mg or 10mg/day, po, 12 weeks.

Eligibility

Criteria

Inclusion criteria:

Subjects must have a diagnosis of PAH in clinical classification of PH 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 of >25 mmHg
Pulmonary vascular resistance of >3 mmHg/L/min
Mean pulmonary capillary wedge pressure or left ventricular end diastolic pressure of <15 mmHg (if measurable)
The measured 6MWD at screening visit is in the range of >150m and <450m

Exclusion criteria:

Subjects who do not have a diagnosis of PAH in clinical classification of PH Group1

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00540436

Locations

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	AMB107816
Study First Received:	October 5, 2007
Last Updated:	July 9, 2009
ClinicalTrials.gov Identifier:	NCT00540436 History of Changes
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by GlaxoSmithKline:

Ambrisentan
Pulmonary Arterial Hypertension
6MWD

Study placed in the following topic categories:

Respiratory Tract Diseases
Hypertension, Pulmonary
Lung Diseases

Idiopathic Pulmonary Hypertension
Vascular Diseases
Hypertension

Additional relevant MeSH terms:

Respiratory Tract Diseases
Hypertension, Pulmonary
Lung Diseases

Vascular Diseases
Cardiovascular Diseases
Hypertension

ClinicalTrials.gov processed this record on August 28, 2009