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ThromboEmbolism Prevention Efficacy and Safety Trial (TEMPEST) (TEMPEST)

Primary Purpose

Arthroplasty

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
SB-424323
Placebo
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Arthroplasty focused on measuring venous thromboembolism, thromboembolism, pulmonary embolism, deep vein thrombosis

Eligibility Criteria

35 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Placebo Comparator

    Arm Label

    SB424323, 500 mg BID

    SB424323, 125 mg BID

    Placebo

    Arm Description

    Outcomes

    Primary Outcome Measures

    VTE
    Incidence of VTE during the 28-day treatment period, including death due to VTE

    Secondary Outcome Measures

    types of VTE
    The incidence of the types of VTE including, DVT (deep vein thrombosis), symptomatic VTE, PE] and anti-IIa activity

    Full Information

    First Posted
    July 9, 2002
    Last Updated
    May 24, 2017
    Sponsor
    GlaxoSmithKline
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00041509
    Brief Title
    ThromboEmbolism Prevention Efficacy and Safety Trial (TEMPEST)
    Acronym
    TEMPEST
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2002 (undefined)
    Primary Completion Date
    May 2003 (Actual)
    Study Completion Date
    May 2003 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    GlaxoSmithKline

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Arthroplasty
    Keywords
    venous thromboembolism, thromboembolism, pulmonary embolism, deep vein thrombosis

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    343 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    SB424323, 500 mg BID
    Arm Type
    Experimental
    Arm Title
    SB424323, 125 mg BID
    Arm Type
    Experimental
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    SB-424323
    Intervention Description
    500 mg, oral, BID for 28 days or 125 mg, oral, BID for 28 days
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    matching placebo, oral, BID for 28 days
    Primary Outcome Measure Information:
    Title
    VTE
    Description
    Incidence of VTE during the 28-day treatment period, including death due to VTE
    Time Frame
    28 day treatment period
    Secondary Outcome Measure Information:
    Title
    types of VTE
    Description
    The incidence of the types of VTE including, DVT (deep vein thrombosis), symptomatic VTE, PE] and anti-IIa activity
    Time Frame
    28 day treatment period

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    35 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    GSK Clinical Trials
    Organizational Affiliation
    GlaxoSmithKline
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    ThromboEmbolism Prevention Efficacy and Safety Trial (TEMPEST)

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