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Study of an Investigational Drug for the Prevention of Thrombosis-related Events Following Hip Replacement Surgery (ADVANCE-3)

NCT00423319 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 5407

Last updated 2014-05-14

Study results available
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Summary

The purpose of this study is to learn whether apixaban can prevent the blood clots in the leg (deep vein thrombosis) and lung (pulmonary embolism) that sometimes occur after hip replacement surgery and to learn how apixaban compares with enoxaparin in preventing these clots. The safety of apixaban will also be studied

Conditions

Interventions

DRUG

Enoxaparin

Subcutaneous, 40 mg, once daily, 5 weeks

DRUG

Apixaban

Oral tablets, 2.5 mg, twice daily, 5weeks

DRUG

Enoxaparin-matching placebo

Administered as injection

DRUG

Apixaban-matching placebo

Administered as oral tablets

Sponsors & Collaborators

Principal Investigators

  • Bristol-Myers Squibb · Bristol-Myers Squibb

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-03-31
Primary Completion
2009-09-30
Completion
2009-09-30

Countries

  • United States
  • Argentina
  • Australia
  • Belgium
  • Canada
  • China
  • Denmark
  • France
  • Germany
  • Hungary
  • India
  • Israel
  • Mexico
  • Norway
  • Poland
  • Romania
  • Russia
  • 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 NCT00423319 on ClinicalTrials.gov