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

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 2

Conditions: Hypertension, Pulmonary

Treatments: Drug: GSK1325760A

Study type: Interventional

Funder types: Industry

Identifiers

NCT00540436

AMB107816

Details and patient eligibility

About

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

Enrollment: 25 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

GSK1325760A

Experimental group

Description:

Single arm safety and efficacy

Treatment:

Drug: GSK1325760A