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Regulation of Coagulation in Orthopedic Surgery to Prevent Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE). A Study of BAY 59-7939 in the Prevention of VTE in Subjects Undergoing Elective Total Knee Replacement.

NCT00361894 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2531

Last updated 2014-10-27

No results posted yet for this study

Summary

The purpose of this study is to assess if 10 mg Bay 59-7939, taken once daily as a tablet, is safe and prevents blood clot which may form after a knee replacement operation.

Conditions

  • Prevention
  • Venous Thromboembolism

Interventions

DRUG

Rivaroxaban (BAY59-7939)

10 mg rivaroxaban (tablet) once daily administered for 13 +/- 2 days

DRUG

Enoxaparin

Syringe of enoxaparin at a dose of 40 mg for 13 +/- 2 days

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-02-28
Primary Completion
2007-01-31
Completion
2007-01-31

Countries

  • Austria
  • Belgium
  • Canada
  • China
  • Colombia
  • Czechia
  • Denmark
  • France
  • Germany
  • Israel
  • Italy
  • Mexico
  • Netherlands
  • Norway
  • Peru
  • Poland
  • South Africa
  • Spain
  • Sweden

Study Locations

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Entities

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 NCT00361894 on ClinicalTrials.gov