Clinical trial NCT00540436: Evaluate the Efficacy, Safety and Pharmacokinetics of GSK1325760A in the Treatment of Pulmonary Arterial Hypertension
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>
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hypertension, Pulmonary
Keywords: Ambrisentan
Pulmonary Arterial Hypertension
6MWD
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2007-10-08
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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


Eligibility 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

Primary outcomes:
measure: Mean Change From Baseline in Six Minutes Walk Distance (6MWD) at Week 12
timeFrame: Baseline and Week 12
Secondary outcomes:
measure: Mean Change From Baseline in Six Minutes Walk Distance (6MWD) at Week 24/Withdrawal
timeFrame: Baseline and Week 24/Withdrawal
measure: Mean Change From Baseline in the Borg Dyspnea Index (BDI) at Weeks 12 and 24
timeFrame: Baseline and Weeks 12 and 24
measure: Number of Participants With a Change From Baseline in Their World Health Organization (WHO) Functional Classification (FC) at Weeks 12 and 24
timeFrame: Weeks 12 and 24
measure: 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
timeFrame: Week 24
measure: Mean Change From Baseline in Mean Pulmonary Atery Pressure (mPAP) and Mean Right Atrial Pressure (mRAP) at Weeks 12 and 24
timeFrame: Baseline and Weeks 12 and 24
measure: Mean Change From Baseline in Cardiac Index (CI) at Weeks 12 and 24
timeFrame: Baseline and Weeks 12 and 24
measure: Mean Change From Baseline in Cardiac Output (CO) at Weeks 12 and 24
timeFrame: Baseline and Weeks 12 and 24
measure: Mean Change From Baseline in Pulmonary Vascular Resistance (PVR) at Weeks 12 and 24
timeFrame: Baseline and Weeks 12 and 24
measure: Mean Change From Baseline in B-type Natriuretic Peptide (BNP) Values at Weeks 12 and 24
timeFrame: Baseline and Weeks 12 and 24
Other outcomes:
Locations:
city: Aichi
country: Japan
facility: GSK Investigational Site
city: Fukuoka
country: Japan
facility: GSK Investigational Site
city: Hokkaido
country: Japan
facility: GSK Investigational Site
city: Hokkaido
country: Japan
facility: GSK Investigational Site
city: Ishikawa
country: Japan
facility: GSK Investigational Site
city: Kanagawa
country: Japan
facility: GSK Investigational Site
city: Kyoto
country: Japan
facility: GSK Investigational Site
city: Okayama
country: Japan
facility: GSK Investigational Site
city: Okinawa
country: Japan
facility: GSK Investigational Site
city: Osaka
country: Japan
facility: GSK Investigational Site
city: Shizuoka
country: Japan
facility: GSK Investigational Site
city: Tokyo
country: Japan
facility: GSK Investigational Site
city: Tokyo
country: Japan
facility: GSK Investigational Site
city: Tokyo
country: Japan
facility: GSK Investigational Site
city: Tokyo
country: Japan
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.