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ThromboEmbolism Prevention Efficacy and Safety Trial (TEMPEST)

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00041509
First received: July 9, 2002
Last updated: June 30, 2011
Last verified: June 2011
History of Changes
  Purpose

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 Intervention Phase
Arthroplasty
 Drug: SB-424323
Drug: Placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • VTE [ Time Frame: 28 day treatment period ] [ Designated as safety issue: No ]
    Incidence of VTE during the 28-day treatment period, including death due to VTE


Secondary Outcome Measures:
  • types of VTE [ Time Frame: 28 day treatment period ] [ Designated as safety issue: No ]
    The incidence of the types of VTE including, DVT (deep vein thrombosis), symptomatic VTE, PE] and anti-IIa activity


Enrollment: 343
Study Start Date: January 2002
Study Completion Date: May 2003
Primary Completion Date: May 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   35 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00041509

Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT00041509     History of Changes
Other Study ID Numbers: 424323/025
Study First Received: July 9, 2002
Last Updated: June 30, 2011
Health Authority: United States: Food and Drug Administration
Australia: Department of Health and Ageing Therapeutic Goods Administration

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

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

ClinicalTrials.gov processed this record on May 16, 2013