Last updated: 11/03/2018 17:47:10

ARIXTRA® Adherence in SVT Patients.

GSK study ID
115280
Clinicaltrials.gov ID
NCT01691495
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: ARIXTRA® Physician Adherence to the Prescribing Information in isolated superficial vein thrombosis (SVT) Patients.
Trial description: Fondaparinux is an anticoagulant used in the prevention and treatment of thromboembolic disease. It has recently been approved in the European Union (EU) for the treatment of patients with isolated superficial vein thrombosis (SVT), i.e. without concomitant deep vein thrombosis (DVT), of the lower limbs. As part of EU approval, GlaxoSmithKline (GSK) committed to evaluate physicians’ adherence to fondaparinux prescribing information regarding proper diagnosis and dosing for the treatment of SVT.
The primary objective is to evaluate physicians’ adherence to fondaparinux prescribing information for the treatment of patients with SVT without concomitant DVT.
The study is designed as a non-interventional, retrospective chart review of patients prescribed fondaparinux to treat their SVT. The study will be conducted in several EU countries.
ARIXTRA® is a registered trademark of the GlaxoSmithKline group of companies.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

The primary outcome will be a measure of physician adherence.

Timeframe: 2

Secondary outcomes:
Not applicable
Interventions:
  • Drug: Fondaparinux
    • Enrollment:
    1
    Primary completion date:
    Not applicable
    Observational study model:
    Other
    Time perspective:
    Retrospective
    Clinical publications:
    Not applicable
    Medical condition
    Thrombosis, Venous
    Product
    fondaparinux sodium
    Collaborators
    Not applicable
    Study date(s)
    October 2012 to August 2014
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    18+ years
    Accepts healthy volunteers
    No
    • Diagnosis of SVT
    • Prescribed fondaparinux for the treatment of SVT
    • Patients should not have been involved in any clinical trial that
    • could influence SVT treatment during the observational period.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Diagnosis of SVT
    • Prescribed fondaparinux for the treatment of SVT
    • Age 18 years or older
    Exclusion criteria:
    • Patients should not have been involved in any clinical trial that could influence SVT treatment during the observational period.

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    No study documents available.

    Results overview

    No study documents available

    Recruitment status
    Study complete
    Actual primary completion date
    Not applicable
    Actual study completion date
    2014-26-08

    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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