Last updated: 11/07/2018 09:34:14

Special Drug Use Investigation (retrospective) for Arixtra® (fondaparinux) Venous Thromboembolism Treatment (over 100kg)

GSK study ID
115490
See study documents
Clinicaltrials.gov ID
NCT01428544
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: Special Drug Use Investigation (retrospective) for Arixtra® (fondaparinux) Venous Thromboembolism Treatment (over 100kg)
Trial description: The purpose of this post-marketing surveillance study is to collect and assess information retrospectively on safety and effectiveness of fondaparinux injection in patients with venous thromboembolism (VTE) whose body weight is 100 kilograms (kg) or more, or to whom fondaparinux was injected 10 mg/day.
("Arixtra" is a trademark of the GlaxoSmithKline group of companies.)
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Number of patients with adverse drug reaction

Timeframe: 3 months

Number of patients with any serious adverse event

Timeframe: 3 months

Number of patients with any hemorrhagic adverse event

Timeframe: 3 months

Presence or absence of reoccurrence of VTE

Timeframe: 3 months

Secondary outcomes:
Not applicable
Interventions:
  • Drug: Fondaparinux sodium
    • Enrollment:
    5
    Primary completion date:
    Not applicable
    Observational study model:
    Other
    Time perspective:
    Retrospective
    Clinical publications:
    Rie Otake, Takeshi Ebihara, Terufumi Hara, Pascal Yoshida.Evaluation of the Safety and Effectiveness of Fondaparinux Sodium (Arixtra®) Injection in Clinical Practice in Patients with Acute Pulmonary Embolism and Acute Deep Vein Thrombosis - The Report of Special Drug Use Investigation -.J Clin Therapeut Med.2016;33(1):21-32
    Medical condition
    Ataxia
    Product
    fondaparinux sodium
    Collaborators
    Not applicable
    Study date(s)
    March 2012 to June 2015
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    Not applicable
    Accepts healthy volunteers
    No
    • Patients with acute pulmonary thromboembolism or acute deep venous thrombosis
    • Fondaparinux injection must be prescribed for the first time
    • Not applicable
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Patients with acute pulmonary thromboembolism or acute deep venous thrombosis
    • Fondaparinux injection must be prescribed for the first time
    Exclusion criteria:
    • Not applicable

    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
    2015-05-06

    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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