Last updated: 11/04/2018 02:40:57

ThromboEmbolism Prevention Efficacy and Safety Trial (TEMPEST)TEMPEST

GSK study ID
424323/025
Clinicaltrials.gov ID
NCT00041509
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: ThromboEMbolism Prevention Efficacy and Safety Trial (TEMPEST): A Double-blind Four-week Study to Assess the Efficacy, Safety, and Tolerability of SB-424323 in the Extended Prophylaxis of Patients Following Total Hip Arthroplasty
Trial description: The purpose of this study is to gain additional safety information as well as to determine after the study drug has been given to patients who have undergone total hip replacement surgery, whether the study drug is effective in preventing late deep vein thrombosis (blood clots in legs) or pulmonary embolism (blood clots in lungs).
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:

VTE

Timeframe: 28 day treatment period

Secondary outcomes:

types of VTE

Timeframe: 28 day treatment period

Interventions:
  • Drug: SB-424323
  • Drug: Placebo
    • Enrollment:
    343
    Primary completion date:
    2003-31-05
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Arthroplasty
    Product
    odiparcil
    Collaborators
    Not applicable
    Study date(s)
    January 2002 to May 2003
    Type
    Interventional
    Phase
    2

    Participation criteria

    Sex
    Female & Male
    Age
    35+ years
    Accepts healthy volunteers
    No
    • Patients scheduled for primary elective unilateral total hip arthroplasty (i.e. first time the hip is being replaced on the operative side).
    • Patients who have given written informed consent to participate in this study.
    • Patients with a contraindication to contrast venography
    • Patients with an increased risk of bleeding.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Patients scheduled for primary elective unilateral total hip arthroplasty (i.e. first time the hip is being replaced on the operative side).
    • Patients who have given written informed consent to participate in this study.
    Exclusion criteria:
    • Patients with a contraindication to contrast venography
    • Patients with an increased risk of bleeding.
    • Patients with a predefined risk for prethrombotic episodes or a history of thrombophilia.
    • Other inclusion or exclusion criteria to be determined by the physician and study sponsor.

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    No study documents available.

    Results overview

    Study Results yet to be posted

    Recruitment status
    Study complete
    Actual primary completion date
    2003-31-05
    Actual study completion date
    2003-31-05

    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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