Last updated: 11/04/2018 04:42:03

Abdominal Surgery Study Of GSK576428 (Fondaparinux Sodium)In Japanese patients

GSK study ID
AR3106116
See study documents
Clinicaltrials.gov ID
NCT00333021
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 (VTE) after Abdominal Surgery
Trial description: This study is phase 3 study for prevention of VTE in patients with abdominal surgery.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:

Incidence of Venous thromboembolism and Major bleeding

Timeframe: Throughout entire study

Secondary outcomes:

Incidence of Pulmonary embolism Incidence of Deep vein thrombosis Incidence of symptomatic Venous thromboembolism

Timeframe: Throughout entire study

Interventions:
  • Drug: Fondaparinux sodium
  • Drug: GSK576428
    • Enrollment:
    127
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Venous thromboembolism
    Product
    fondaparinux sodium
    Collaborators
    Not applicable
    Study date(s)
    May 2006 to February 2007
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    40+ years
    Accepts healthy volunteers
    No
    • Patients aged >=40 years undergoing the following abdominal (diaphragm to pelvic floor) surgery under general anesthesia lasting more than 45 minutes.
    • General or urologic surgery
    • Active, clinically significant bleeding
    • Thrombocytopenia
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Patients aged >=40 years undergoing the following abdominal (diaphragm to pelvic floor) surgery under general anesthesia lasting more than 45 minutes.
    • General or urologic surgery
    • Cancer surgery
    • Gynecologic surgery
    • Radical surgery for pelvic malignancy
    Exclusion criteria:
    • Active, clinically significant bleeding Thrombocytopenia Body weight <40kg

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Osaka, Japan, 589-8511
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Osaka, Japan, 565-0871
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Kagawa, Japan, 760-0017
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Hiroshima, Japan, 737-0811
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Ibaraki, Japan, 300-0053
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Hyogo, Japan, 655-0004
    Status
    Study Complete
    Contact us
    Showing 1 - 6 of 18 Results

    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
    2007-16-02

    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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