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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00041509
First Posted: July 12, 2002
Last Update Posted: May 30, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
  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
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

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • VTE [ Time Frame: 28 day treatment period ]
    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 ]
    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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   35 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00041509     History of Changes
Other Study ID Numbers: 424323/025
First Submitted: July 9, 2002
First Posted: July 12, 2002
Last Update Posted: May 30, 2017
Last Verified: May 2017

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

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