Last updated: 02/14/2022 12:20:09

Drug Use Investigation for VOLIBRIS® (ambrisentan) (Pulmonary arterial hypertension)

GSK study ID
114782
See study documents
Clinicaltrials.gov ID
NCT01406327
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: Drug Use Investigation for VOLIBRIS® (ambrisentan) (Pulmonary arterial hypertension)
Trial description: The objective of this post-marketing surveillance study is to evaluate the incidence of adverse events in Japanese subjects with pulmonary arterial hypertension treated with ambrisentan basd on prescribing information under the conditions of general clinical practice and also to grasp the following items;
1）Unknown adverse drug reactions (ADRs)
2）Incidence of ADRs to medical products in actual clinical practice
3）Factors influencing safety of ambrisentan
4）Factors influencing efficacy of ambrisentan
5）Prognosis of subjects as well as efficacy and safety of ambrisentan in long-term use
(VOLIBRIS® is a trademark of Gilead Sciences, Inc,. that GSK uses under license.)
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

The number of adverse events in Japanese subjects with pulmonary arterial hypertension treated with ambrisentan

Timeframe: 1 year

The onset statuses of anemia, fluid retention, cardiac failure and hemorrhage

Timeframe: 1 year

The number of adverse events and clinical course in subjects with hepatic dysfunction

Timeframe: 1 year

Secondary outcomes:
Not applicable
Interventions:
  • Drug: Ambrisentan
    • Enrollment:
    900
    Primary completion date:
    2020-28-02
    Observational study model:
    Other
    Time perspective:
    Other
    Clinical publications:
    Yuna Onaka, Yasuo Nakajima, Kiyomi Aizawa, Ayano Fukudomi, Kyomi Kanaya, Daisaku Yasui, Naohiro Takahashi. Evaluation of safety and effectiveness of ambrisentan in patients with pulmonary arterial hypertension (PAH) – Final report of the drug use investigation (DUI). Ther Res. 2022;43(1):29-45 DOI: NULL PMID: NULL
    Medical condition
    Hypertension, Pulmonary
    Product
    ambrisentan
    Collaborators
    Not applicable
    Study date(s)
    December 2010 to February 2020
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    Not applicable
    Accepts healthy volunteers
    No
    • Must use ambrisentan for the first time
    • Subjects with hypersensitivity to ambrisentan
    • Subjects who is pregnant or might be pregnant
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Must use ambrisentan for the first time
    Exclusion criteria:
    • Subjects with hypersensitivity to ambrisentan
    • Subjects who is pregnant or might be pregnant
    • Subjects with severe hepatic disorder

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    Protocol
    Available language(s): English
    Download document(s)
    Statistical analysis plan
    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
    2020-28-02
    Actual study completion date
    2020-28-02

    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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