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
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
25
Primary evaluation period: 5 mg/day, po, 12 weeks. Dose adjustment period: 2.5 mg, 5 mg or 10 mg/day, po, 12 weeks.
GSK Investigational Site
Aichi, Japan
GSK Investigational Site
Fukuoka, Japan
GSK Investigational Site
Hokkaido, Japan
Mean Change From Baseline in Six Minutes Walk Distance (6MWD) at Week 12
Mean change from baseline was calculated as the Week 12 value minus the baseline value. 6MWD was measured by a 6 minute walk test. This test measures the distance that a subject can walk in a period of 6 minutes.
Time frame: Baseline and Week 12
Mean Change From Baseline in Six Minutes Walk Distance (6MWD) at Week 24/Withdrawal
Change from baseline was calculated as the Week 24/Withdrawal value minus the basline value. 6MWD was measured by a 6 minute walk test. This test measures the distance that a subject can walk in a period of 6 minutes. Imputation technique was last observation carried forward.
Time frame: Baseline and Week 24/Withdrawal
Mean Change From Baseline in the Borg Dyspnea Index (BDI) at Weeks 12 and 24
The BDI was calculated by using a 10-point scale (0 = None, 10 = Maximum). Change from baseline was calculated as the Week 12 and 24 values minus the baseline values. The BDI indicates the degree of breathlessness after completion of the 6 minute walk test. The BDI scale was assessed by each participant. Imputation technique was last observation carried forward.
Time frame: Baseline and 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
There are four grades for WHO FC (class I = none, Class IV = most severe). The WHO FC indicates the severity of Pulmonary Arterial Hypertension and is an adaptation of the New York Heart Association classification. It was assessed by the investigator. Imputation technique was last observation carried forward.
Time frame: 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
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GSK Investigational Site
Hokkaido, Japan
GSK Investigational Site
Ishikawa, Japan
GSK Investigational Site
Kanagawa, Japan
GSK Investigational Site
Kyoto, Japan
GSK Investigational Site
Okayama, Japan
GSK Investigational Site
Okinawa, Japan
GSK Investigational Site
Osaka, Japan
...and 5 more locations
Time to clinical worsening is defined as the time from baseline to the first occurrence of death, lung transplantation, hospitalization for PAH treatment, atrial septostomy, or study discontinuation due to change to other PAH treatment. Time to clinical worsening is measured as the number of participants who experienced these events during 24 weeks.
Time frame: Week 24
Mean Change From Baseline in Mean Pulmonary Atery Pressure (mPAP) and Mean Right Atrial Pressure (mRAP) at Weeks 12 and 24
mPAP and mRAP are measures of cardiopulmonary hemodynamics. Change from baseline was calculated as the Week 12 and 24 values minus the baseline value. Observed data analysis (no imputation techniques).
Time frame: Baseline and Weeks 12 and 24
Mean Change From Baseline in Cardiac Index (CI) at Weeks 12 and 24
CI is a measure of cardiopulmonary hemodynamics. Change from baseline was calculated as the Week 12 and 24 values minus the baseline value. Observed data analysis (no imputation techniques).
Time frame: Baseline and Weeks 12 and 24
Mean Change From Baseline in Cardiac Output (CO) at Weeks 12 and 24
CO is a measure of cardiopulmonary hemodynamics. Change from baseline was calculated as the Week 12 and 24 values minus the baseline value. Observed data analysis (no imputation techniques).
Time frame: Baseline and Weeks 12 and 24
Mean Change From Baseline in Pulmonary Vascular Resistance (PVR) at Weeks 12 and 24
PVR is a measure of cardiopulmonary hemodynamics. Change from baseline was calculated as the Week 12 and 24 values minus the baseline value. Observed data analysis (no imputation techniques).
Time frame: Baseline and Weeks 12 and 24
Mean Change From Baseline in B-type Natriuretic Peptide (BNP) Values at Weeks 12 and 24
Change from baseline was calculated as the Week 12 and 24 values minus the baseline value. BNP is a surrogate maker of heart failure and was measured by a central laboratory. Observed data analysis (no imputation techniques).
Time frame: Baseline and Weeks 12 and 24