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Study of an Investigational Drug for the Prevention of Thrombosis-related Events Following Knee Replacement Surgery

NCT00452530 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 3221

Last updated 2014-07-09

Study results available
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Summary

The purpose of this study is to learn whether apixaban prevents the development of blood clots in the leg (deep vein thrombosis) and lung (pulmonary embolism), which sometimes occur after knee replacement surgery, and to compare the efficacy of apixaban with that of enoxaparin (Lovenox®) in the prevention of these clots. The safety of apixaban will also be studied.

Conditions

Interventions

DRUG

Enoxaparin

40 mg, administered once daily by subcutaneous injection, for 12 days

DRUG

Apixaban

2.5 mg, administered twice daily as tablets, for 12 days

DRUG

Enoxaparin-matching placebo

Administered once daily by subcutaneous injection

DRUG

Apixaban-matching placebo

Oral tablet administered twice daily

Sponsors & Collaborators

Principal Investigators

  • Bristol-Myers Squibb · Bristol-Myers Squibb

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-06-30
Primary Completion
2009-01-31
Completion
2009-01-31

Countries

  • Austria
  • Belgium
  • Brazil
  • Chile
  • China
  • Colombia
  • Czechia
  • Denmark
  • France
  • Germany
  • Hungary
  • India
  • Israel
  • Italy
  • Malaysia
  • Mexico
  • Norway
  • Philippines
  • Poland
  • Russia
  • Singapore
  • South Africa
  • South Korea
  • Spain
  • Sweden
  • Ukraine
  • United Kingdom

Study Locations

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Entities

Diseases
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 NCT00452530 on ClinicalTrials.gov