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ThromboEmbolism Prevention Efficacy and Safety Trial (TEMPEST)

NCT00041509 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 343

Last updated 2017-05-30

No results posted yet for this study

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).

Conditions

  • Arthroplasty

Interventions

DRUG

SB-424323

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

DRUG

Placebo

matching placebo, oral, BID for 28 days

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
35 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-01-31
Primary Completion
2003-05-31
Completion
2003-05-31

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00041509 on ClinicalTrials.gov