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Study of Apixaban for the Prevention of Thrombosis-related Events Following Knee Replacement Surgery

NCT00371683 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 3608

Last updated 2015-12-30

Study results available
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Summary

The purpose of this study is to learn if apixaban can prevent blood clots in the leg (deep vein Thrombosis \[DVT\]) and lung (pulmonary embolism \[PE\]) that sometimes occur after knee replacement surgery and to learn how apixaban compares to enoxaparin (Lovenox®) for preventing these clots. The safety of apixaban will also be studied.

Conditions

Interventions

DRUG

Enoxaparin + Placebo

Syringes + tablets, Subcutaneous + Oral, 30mg, twice daily, 12 day treatment period

DRUG

Apixaban + Placebo

Tablet + Syringes, Oral + subcutaneous, 2.5 mg, twice daily, 12 day treatment period

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
2006-11-30
Primary Completion
2008-05-31
Completion
2008-05-31

Countries

  • United States
  • Argentina
  • Australia
  • Brazil
  • Canada
  • Denmark
  • Hungary
  • Israel
  • Mexico
  • Poland
  • Russia
  • Sweden
  • Turkey (Türkiye)

Study Locations

More Related Trials

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 NCT00371683 on ClinicalTrials.gov