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

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ClinicalTrials.gov Identifier: NCT00041509
Recruitment Status : Completed
First Posted : July 12, 2002
Last Update Posted : May 30, 2017
Information provided by (Responsible Party):

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).

Condition or disease Intervention/treatment Phase
Arthroplasty Drug: SB-424323 Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 343 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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 Start Date : January 2002
Primary Completion Date : May 2003
Study Completion Date : May 2003

Arm Intervention/treatment
Experimental: SB424323, 500 mg BID Drug: SB-424323
500 mg, oral, BID for 28 days or 125 mg, oral, BID for 28 days
Experimental: SB424323, 125 mg BID Drug: SB-424323
500 mg, oral, BID for 28 days or 125 mg, oral, BID for 28 days
Placebo Comparator: Placebo Drug: Placebo
matching placebo, oral, BID for 28 days

Primary Outcome Measures :
  1. VTE [ Time Frame: 28 day treatment period ]
    Incidence of VTE during the 28-day treatment period, including death due to VTE

Secondary Outcome Measures :
  1. types of VTE [ Time Frame: 28 day treatment period ]
    The incidence of the types of VTE including, DVT (deep vein thrombosis), symptomatic VTE, PE] and anti-IIa activity

Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00041509

Sponsors and Collaborators
Study Director: GSK Clinical Trials GlaxoSmithKline

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00041509     History of Changes
Other Study ID Numbers: 424323/025
First Posted: July 12, 2002    Key Record Dates
Last Update Posted: May 30, 2017
Last Verified: May 2017

Keywords provided by GlaxoSmithKline:
venous thromboembolism
pulmonary embolism
deep vein thrombosis

Additional relevant MeSH terms:
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases