Last updated: 04/22/2019 19:22:35
Effects of oral ambrisentan on echocardiographic measures of right ventricular structure and function in Chinese patients with pulmonary arterial hypertension
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Effects of oral ambrisentan on echocardiographic measures of right ventricular structure and function in Chinese patients with pulmonary arterial hypertension
Trial description: Echocardiography is a non-invasive assessment and gives real-time images useful in PAH management. Hence, this non-interventional study is planned to evaluate the echocardiogram parameters in subjects with PAH who underwent prospective treatment in AMB115812, a study conducted to evaluate efficacy and safety of Ambrisentan in Chinese subjects with PAH. The study will retrospectively collect and analyze echocardiogram data from 21-DEC-2012 to 15-AUG-2014, based on echocardiogram report which was centrally reviewed. Approximately 134 subjects who participated and were treated with at least one dose of Ambrisentan in AMB115812 study will be included in this retrospective study.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Change from Baseline in left ventricular end-diastolic diameter or mitral valve E
Timeframe: Baseline up to Week 12
Change from Baseline in A peak systolic mitral annular velocity (Sm) or early diastolic mitral annular velocity (Em) or late diastolic mitral annular velocity (Am)
Timeframe: Baseline up to Week 12
Change from Baseline in right atrium diameter
Timeframe: Baseline up to Week 12
Change from Baseline in right ventricular diameter
Timeframe: Baseline up to Week 12
Change from Baseline in tricuspid E
Timeframe: Baseline up to Week 12
Change from Baseline in A peak
Timeframe: Baseline up to Week 12
Change from Baseline in tricuspid Sm
Timeframe: Baseline up to Week 12
Change from Baseline in pulmonary artery systolic pressure
Timeframe: Baseline up to Week 12
Change from Baseline in estimated right atrium pressure
Timeframe: Baseline up to Week 12
Secondary outcomes:
Change from Baseline in left ventricular end-diastolic diameter or mitral valve E
Timeframe: Baseline up to Week 24
Change from Baseline in mitral valve Sm or Em or Am
Timeframe: Baseline up to Week 24
Change from Baseline in right atrium diameter
Timeframe: Baseline up to Week 24
Change from Baseline in right ventricular diameter
Timeframe: Baseline up to Week 24
Change from Baseline in tricuspid E
Timeframe: Baseline up to Week 24
Change from Baseline in A peak
Timeframe: Baseline up to Week 24
Change from Baseline in tricuspid Sm
Timeframe: Baseline up to Week 24
Change from Baseline in pulmonary artery systolic pressure
Timeframe: Baseline up to Week 24
Change from Baseline in estimated right atrium pressure
Timeframe: Baseline up to Week 24
Interventions:
Not applicable
Enrollment:
133
Primary completion date:
Not applicable
Observational study model:
Cohort
Time perspective:
Retrospective
Clinical publications:
Not applicable
Medical condition
Hypertension, Pulmonary
Product
ambrisentan
Collaborators
Not applicable
Study date(s)
April 2018 to April 2018
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
None
- Subjects who have been enrolled in AMB115812 study and received ambrisentan 5 milligram (mg) or 10 mg treatment.
- Subjects who previously provided written informed consent for AMB115812 study. In which was allowed to collect subject’s any parameters of echocardiogram at the day of first dosing and afterwards follow up duration at Week 12 and Week 24.
- Subjects who were not enrolled in the AMB115812 study.
- Subjects who did not receive at least one dose of ambrisentan 5 mg or 10 mg treatment.
Inclusion and exclusion criteria
Inclusion criteria:
- Subjects who have been enrolled in AMB115812 study and received ambrisentan 5 milligram (mg) or 10 mg treatment.
- Subjects who previously provided written informed consent for AMB115812 study. In which was allowed to collect subject’s any parameters of echocardiogram at the day of first dosing and afterwards follow up duration at Week 12 and Week 24.
Exclusion criteria:
- Subjects who were not enrolled in the AMB115812 study.
- Subjects who did not receive at least one dose of ambrisentan 5 mg or 10 mg treatment.
Trial location(s)
Location
GSK Investigational Site
Guangzhou, Guangdong, China, 510080
Status
Terminated/Withdrawn
Showing 1 - 6 of 14 Results
Study documents
Statistical analysis plan
Available language(s): English
Scientific result summary
Available language(s): English
Protocol
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
2018-26-04
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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