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

Total Hip Replacement Study Of GSK576428 (Fondaparinux Sodium)

GSK study ID
AR3106333
See study documents
Clinicaltrials.gov ID
NCT00320398
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 Elective Total Hip Replacement Surgery
Trial description: This study is requested by PMDA to confirm the optimal dose for THR (total hip replacement).
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:

Percentage of participants with venous thromboembolism (VTE) during efficacy period

Timeframe: Up to Day 17

Percentage of participants with Major bleeding

Timeframe: Up to Day 17

Secondary outcomes:

Percentage of participants with minor bleeding

Timeframe: Up to Day 17

Percentage of participants with all deep vein thrombosis (DVT)

Timeframe: Up to Day 17

Percentage of participants with proximal DVT

Timeframe: Up to Day 17

Percentage of participants with distal only DVT

Timeframe: Up to Day 17

Percentage of participants with symptomatic DVT during main efficacy period

Timeframe: Up to Day 17

Percentage of participants with pulmonary embolism during efficacy period

Timeframe: Up to Day 17

Number of participants with adverse events (AEs), serious adverse events (SAEs) and deaths

Timeframe: From first injection of study drug (Day 3) to up to 2 calendar days after last injection (Treatment period), up to Day 17.

Number of transfused participants

Timeframe: Up to Day 17.

Volume of transfusion

Timeframe: Up to Day 17

Interventions:
  • Drug: Fondaparinux
    • Enrollment:
    114
    Primary completion date:
    2006-18-07
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Thrombosis, Venous
    Product
    fondaparinux sodium
    Collaborators
    Not applicable
    Study date(s)
    January 2006 to July 2006
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    20+ years
    Accepts healthy volunteers
    No
    • Patients undergoing either an elective primary THR (total hip replacement) surgery or a revision of a THR.
    • Active, clinically significant bleeding (excluding drainage).
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Patients undergoing either an elective primary THR (total hip replacement) surgery or a revision of a THR.
    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
    2006-18-07
    Actual study completion date
    2006-18-07

    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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