ThromboEmbolism Prevention Efficacy and Safety Trial (TEMPEST)

Phase 2

Completed

• Conditions: Arthroplasty
• Interventions: Drug: Placebo; Drug: SB-424323

• Registration Number: NCT00041509
• Lead Sponsor: GlaxoSmithKline

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2002-01
• Study First Submitted: 2002-07-09
• Study First Submitted QC: 2002-07-11
• Study First Posted: 2002-07-12
• Primary Completion: 2003-05
• Study Completion: 2003-05
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-24
• Last Update Posted: 2017-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 343

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
SB424323, 500 mg BID	SB-424323	-
SB424323, 125 mg BID	SB-424323	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
types of VTE	28 day treatment period	The incidence of the types of VTE including, DVT (deep vein thrombosis), symptomatic VTE, PE\] and anti-IIa activity