Last updated: 07/21/2020 16:20:05

Volibris® Tablets 2.5 mg Special Drug Use Investigation (Post-marketing survey in Japan)

GSK study ID
205717
See study documents
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

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
    Primary completion date:
    2017-18-12
    Observational study model:
    Cohort
    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)

    This study does not involve prospective enrollment of participants.

    Study documents

    Protocol
    Available language(s): English
    Download document(s)
    Scientific result summary
    Available language(s): English
    Download document(s)

    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
    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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