Last updated: 11/04/2018 04:41:37
Evaluate the Efficacy, Safety and Pharmacokinetics of GSK1325760A in the Treatment of Pulmonary Arterial Hypertension
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
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>
Trial description: 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
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:
Mean change from baseline in six minutes walk distance (6MWD) at Week 12
Timeframe: Baseline and Week 12
Secondary outcomes:
Mean change from baseline in six minutes walk distance (6MWD) at Week 24/Withdrawal
Timeframe: Baseline and Week 24/Withdrawal
Mean change from baseline in the Borg Dyspnea Index (BDI) at Weeks 12 and 24
Timeframe: 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
Timeframe: 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
Timeframe: Week 24
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
Mean change from baseline in cardiac index (CI) at Weeks 12 and 24
Timeframe: Baseline and Weeks 12 and 24
Mean change from baseline in cardiac output (CO) at Weeks 12 and 24
Timeframe: Baseline and Weeks 12 and 24
Mean change from baseline in pulmonary vascular resistance (PVR) at Weeks 12 and 24
Timeframe: Baseline and Weeks 12 and 24
Mean change from baseline in B-type natriuretic peptide (BNP) values at Weeks 12 and 24
Timeframe: Baseline and Weeks 12 and 24
Interventions:
Drug: GSK1325760A
Enrollment:
25
Observational study model:
Not applicable
Primary completion date:
2008-25-12
Time perspective:
Not applicable
Clinical publications:
Shunji Yoshida, Kunio Shirato, Ryutaro Shimamura, Norie Nakahara, Takayuki Iwase and Hiromu Nakajima. Efficacy, Safety, and Pharmacokinetics of Ambrisentan in Japanese Adults with Pulmonary Arterial Hypertension. [Curr Med Res Opin]. 2011;27(9):1827-1834
Norie Nakahara, Akira Wakamatsu, Ryutaro shimamura, Shigeru Nohda, shuji Miki, Toshiyasu Hirama. Pharmacokinetics of Ambrisentan, a novel drug for treatment of pulmonary arterial hypertension(PAH), in Japan. [Jpn J Clin Pharmacol Therapeut]. 2010;41(6):301-308.
Medical condition
Hypertension, Pulmonary
Product
ambrisentan
Collaborators
Not applicable
Study date(s)
August 2007 to December 2008
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- Inclusion criteria:
- Subjects must have a diagnosis of Pulmonary Arterial Hypertension (PAH) in clinical classification of Pulmonary Hypertension Group1
Inclusion and exclusion criteria
Inclusion 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 location(s)
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2008-25-12
Actual study completion date
2008-25-12
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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