Last updated: 11/04/2018 04:42:19

Hip Fracture Study of GSK576428 (Fondaparinux Sodium)

GSK study ID
AR3106335
See study documents
Clinicaltrials.gov ID
NCT00320424
See results summary
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: Clinical Evaluation of GSK576428 (Fondaparinux Sodium) in Prevention of Venous Thromboembolism after Hip Fracture Surgery
Trial description: This study is requested by PMDA to confirm the efficacy and the safety for HFS.
Primary purpose:
Prevention
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:

Rate of major bleeding during treatment period

Timeframe: From the first study drug injection up to Day 17

Secondary outcomes:

Rate of PE during treatment period

Timeframe: Up to Day 17

Rate of DVT during treatment period

Timeframe: Up to Day 17

Rate of proximal DVT during treatment period

Timeframe: Up to Day 17

Rate of distal only DVT during treatment period

Timeframe: Up to Day 17

Number of participants with major bleeding during treatment period

Timeframe: From the first study drug injection up to 2 days after the last study drug injection (approximately up to Day 17)

Number of participants with minor bleeding and any bleeding (major and/or minor bleeding)

Timeframe: From the first study drug injection up to 2 days after the last study drug injection (approximately up to Day 17)

Number of participants with adverse events (AE), serious adverse events (SAE) and death

Timeframe: From the first study drug injection up to 2 days after the last study drug injection (approximately up to Day 17)

Number of transfused participants

Timeframe: From the first study drug injection up to 2 days after the last study drug injection (approximately up to Day 17)

Summary of units transfused

Timeframe: From the first study drug injection up to 2 days after the last study drug injection (approximately up to Day 17)

Rate of symptomatic DVT

Timeframe: Up to Day 17

Interventions:
  • Drug: Fondaparinux
    • Enrollment:
    48
    Primary completion date:
    2006-26-10
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Thromboembolism
    Product
    fondaparinux sodium
    Collaborators
    Not applicable
    Study date(s)
    February 2006 to October 2006
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    20+ years
    Accepts healthy volunteers
    No
    • Patients undergoing hip fracture surgery within 10 days following the time of fracture of the hip (proximal femur) (or following the time of fracture estimated from trauma).
    • Active, clinically significant bleeding (excluding drainage).
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Patients undergoing hip fracture surgery within 10 days following the time of fracture of the hip (proximal femur) (or following the time of fracture estimated from trauma).
    Exclusion criteria:
    • Active, clinically significant bleeding (excluding drainage).

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Unknown, Japan
    Status
    Study Complete
    Contact us

    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

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    Actual primary completion date
    2006-26-10
    Actual study completion date
    2006-26-10

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

    Additional information
    Not applicable
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    Access to clinical trial data by researchers
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