Last updated: 11/07/2018 04:39:40

Drug Use Investigation for FLOLAN (Epoprostenol) Injection 0.5mg・1.5mg

GSK study ID
112300
See study documents
Clinicaltrials.gov ID
NCT01387191
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 FLOLAN (Epoprostenol) Injection 0.5mg・1.5mg
Trial description: The objective of this study is to evaluate the incidence of adverse events in Japanese pulmonary arterial hypertension subjects treated with epoprostenol injection based on prescribing information under the conditions of general clinical practice and also to grasp the following items;
1) Unknown adverse reactions (especially, significant adverse reactions)
2) Adverse reaction onset status under practical drug use conditions
3) Factors possibly influential on safety
4) Factors possibly influential on efficacy
5) Patient’s prognosis, efficacy and safety in long-term use
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

The number of incidence of adverse events in Japanese subjects with pulmonary arterial hypertension treated with epoprostenol injection

Timeframe: 12 weeks

Secondary outcomes:
Not applicable
Interventions:
  • Drug: Epoprostenol
    • Enrollment:
    748
    Primary completion date:
    Not applicable
    Observational study model:
    Other
    Time perspective:
    Prospective
    Clinical publications:
    Toru Satoh, Hideyuki Okano, Terufumi Hara. Effectiveness and Safety of Long-term Epoprostenol Treatment in Japanese Patients with Pulmonary Hypertension – Multicenter Prospective Study. Prog Med. 2015;35(8):1333-1341
    Medical condition
    Cardiovascular Disease
    Product
    epoprostenol
    Collaborators
    Not applicable
    Study date(s)
    August 1999 to July 2009
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    Not applicable+ years
    Accepts healthy volunteers
    None
    • Subjects with cardiovascular disease
    • Subjects with hypersensitivity to epoprostenol
    • Subjects with right cardiac failure during an acute exacerbation
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Subjects with cardiovascular disease
    Exclusion criteria:
    • Subjects with hypersensitivity to epoprostenol
    • Subjects with right cardiac failure during an acute exacerbation
    • Subjects with severe left ventricular systolic dysfunction
    • Subjects with serious left ventricular dysfunction
    • Subjects whose pulmonary edema getting worse during dose initiation

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    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
    Not applicable
    Actual study completion date
    2009-24-07

    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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