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

GlaxoSmithKline0 sites343 target enrollmentJanuary 2002

ConditionsArthroplasty

InterventionsSB-424323 Placebo

DrugsSB-424323 Placebo

Overview

Phase: Phase 2
Intervention: SB-424323
Conditions: Arthroplasty
Sponsor: GlaxoSmithKline
Enrollment: 343
Primary Endpoint: VTE
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

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).

Registry

clinicaltrials.gov

Start Date

January 2002

End Date

May 2003

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

GlaxoSmithKline

Responsible Party

Sponsor

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.