ThromboEmbolism Prevention Efficacy and Safety Trial (TEMPEST)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

343 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-01-31

Study Completion Date

2003-05-31

Brief Summary

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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).

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Detailed Description

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Conditions

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Arthroplasty

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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SB424323, 500 mg BID

Group Type EXPERIMENTAL

SB-424323

Intervention Type DRUG

500 mg, oral, BID for 28 days or 125 mg, oral, BID for 28 days

SB424323, 125 mg BID

Group Type EXPERIMENTAL

SB-424323

Intervention Type DRUG

500 mg, oral, BID for 28 days or 125 mg, oral, BID for 28 days

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

matching placebo, oral, BID for 28 days

Interventions

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SB-424323

500 mg, oral, BID for 28 days or 125 mg, oral, BID for 28 days

Intervention Type DRUG

Placebo

matching placebo, oral, BID for 28 days

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No