Last updated: 07/21/2020 16:20:05
Volibris® Tablets 2.5 mg Special Drug Use Investigation (Post-marketing survey in Japan)
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
Official title: Volibris® Tablets 2.5 mg Special Drug Use Investigation (Post-marketing survey in Japan)
Trial description: Subjects with pulmonary arterial hypertension (PAH) are often treated with combination of anti-PAH drugs having different mechanism of action. Upfront combination therapy of ambrisentan and a phosphodiesterase type 5 (PDE5) inhibitor or sequential combination therapy (i.e. adding a drug after assessing response from initial single agent therapy) have been widely spread in Japan (JPN). However, the safety and efficacy data of these combination therapies in Japanese patients are limited. This post marketing safety (PMS), retrospective survey will be conducted to collect and evaluate the safety and efficacy data of ambrisentan in combination with a PDE5 inhibitor in subjects who received them for the first time as upfront combination therapy or sequential combination therapy. The survey will be conducted at approximately 10 medical institutions having specialties in treating PAH. Around 100 subjects will be enrolled in this survey. The survey is planned from September 2016 to March 2017. The planned observation period for each subject will be three years (January 2013 to August 2016) from the start of ambrisentan treatment as a maximum.Volibris® is a registered trade mark of Gilead.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Number of subjects for whom case record forms are collected, number of subjects included in the safety and efficacy analysis set, number of subjects excluded from the analysis and reasons for exclusion
Timeframe: Up to 36 months
Number of subjects with type, severity and occurrences of adverse drug reactions (ADRs) and infections
Timeframe: Up to 36 months
Factors affecting safety (type and occurrences of ADRs by subjects background characteristics)
Timeframe: Up to 36 months
Number of subjects requiring management of ADRs during combination therapy
Timeframe: Up to 36 months
Change from baseline in hemodynamic parameters
Timeframe: Baseline and Up to 36 months
Change from baseline in laboratory value
Timeframe: Baseline and Up to 36 months
Estimation of the survival rate and time to clinical progression
Timeframe: Up to 36 months
Factors affecting efficacy by subjects background characteristics
Timeframe: Up to 36 months
Secondary outcomes:
Not applicable
Interventions:
Drug: Sildenafil or tadalafil
Drug: Ambrisentan
Enrollment:
0
Observational study model:
Cohort
Primary completion date:
2017-18-12
Time perspective:
Retrospective
Clinical publications:
Masaharu Kataoka, Toru Satoh, Hiromi Matsubara, Koji Yamamoto, Tsukasa Inada, Kazunari Umezawa, Tomohiko Takahashi, Atsushi Nakano, Keiichi Fukuda.Safety and efficacy of ambrisentan combination therapy with a PDE-5 inhibitor for Japanese patients with pulmonary arterial hypertension in real clinical practice.Circ Rep.2019;11(6):268-275
DOI: https://doi.org/10.1253/circrep.CR-19-0029
Medical condition
Pulmonary arterial hypertension, Hypertension, Pulmonary
Product
ambrisentan
Collaborators
Not applicable
Study date(s)
March 2017 to December 2017
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
Not applicable
Accepts healthy volunteers
None
- Subjects having PAH who received ambrisentan for the first time in combination with a PDE5 inhibitor (sildenafil or tadalafil) as upfront combination therapy or sequential combination therapy between January 2013 and the end of August 2015 (regardless of the use of oral beraprost (Prostaglandin I2 [PGI2] product).
- Subjects who have been already treated with ambrisentan at other institutions will be excluded.
Inclusion and exclusion criteria
Inclusion criteria:
- Subjects having PAH who received ambrisentan for the first time in combination with a PDE5 inhibitor (sildenafil or tadalafil) as upfront combination therapy or sequential combination therapy between January 2013 and the end of August 2015 (regardless of the use of oral beraprost (Prostaglandin I2 [PGI2] product).
Exclusion criteria:
- Subjects who have been already treated with ambrisentan at other institutions will be excluded.
Trial location(s)
No location data available.
Study documents
Protocol
Available language(s): English
Scientific result summary
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
Finalized
Actual primary completion date
2017-18-12
Actual study completion date
2017-18-12
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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