Evaluate the Efficacy, Safety and Pharmacokinetics of GSK1325760A in the Treatment of Pulmonary Arterial Hypertension
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>
1 other identifier
interventional
25
1 country
15
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Aug 2007
Shorter than P25 for phase_2
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2007
CompletedFirst Submitted
Initial submission to the registry
October 5, 2007
CompletedFirst Posted
Study publicly available on registry
October 8, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2009
CompletedResults Posted
Study results publicly available
November 10, 2009
CompletedOctober 15, 2012
October 1, 2012
1.4 years
October 5, 2007
August 10, 2009
October 11, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Baseline and Week 12
Secondary Outcomes (9)
Mean Change From Baseline in Six Minutes Walk Distance (6MWD) at Week 24/Withdrawal
Baseline and Week 24/Withdrawal
Mean Change From Baseline in the Borg Dyspnea Index (BDI) at Weeks 12 and 24
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
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
Week 24
Mean Change From Baseline in Mean Pulmonary Atery Pressure (mPAP) and Mean Right Atrial Pressure (mRAP) at Weeks 12 and 24
Baseline and Weeks 12 and 24
- +4 more secondary outcomes
Study Arms (1)
GSK1325760A
EXPERIMENTALSingle arm safety and efficacy
Interventions
Primary evaluation period: 5 mg/day, po, 12 weeks. Dose adjustment period: 2.5 mg, 5 mg or 10 mg/day, po, 12 weeks.
Eligibility Criteria
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (15)
GSK Investigational Site
Aichi, 470-1192, Japan
GSK Investigational Site
Fukuoka, 830-0011, Japan
GSK Investigational Site
Hokkaido, 060-8543, Japan
GSK Investigational Site
Hokkaido, 060-8648, Japan
GSK Investigational Site
Ishikawa, 920-8641, Japan
GSK Investigational Site
Kanagawa, 228-8555, Japan
GSK Investigational Site
Kyoto, 606-8507, Japan
GSK Investigational Site
Okayama, 701-1192, Japan
GSK Investigational Site
Okinawa, 901-0243, Japan
GSK Investigational Site
Osaka, 565-8565, Japan
GSK Investigational Site
Shizuoka, 431-3192, Japan
GSK Investigational Site
Tokyo, 113-8431, Japan
GSK Investigational Site
Tokyo, 113-8655, Japan
GSK Investigational Site
Tokyo, 143-8541, Japan
GSK Investigational Site
Tokyo, 160-8582, Japan
Related Publications (1)
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.
PMID: 21812736BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- GSK Response Center
- Organization
- GlaxoSmithKline
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 5, 2007
First Posted
October 8, 2007
Study Start
August 1, 2007
Primary Completion
January 1, 2009
Study Completion
January 1, 2009
Last Updated
October 15, 2012
Results First Posted
November 10, 2009
Record last verified: 2012-10