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Regulation of Coagulation in Orthopedic Surgery to Prevent Deep Vein Thromboembolism (DVT) and Pulmonary Embolism (PE). A Study of BAY59-7939 in the Prevention of Venous Thrombo Embolism (VTE) in Subjects Undergoing Elective Total Knee Replacement.

NCT00362232 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 3148

Last updated 2014-11-04

Study results available
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Summary

The purpose of this study is to assess if 10 mg BAY59-7939, taken once daily as a tablet, is safe and prevents blood clot which may form after a knee replacement operation.

Conditions

  • Venous Thromboembolism

Interventions

DRUG

Rivaroxaban (Xarelto, BAY59-7939)

Rivaroxaban (Xarelto, BAY59-7939) 10 mg tablet administered once daily (od) in the evening.

DRUG

Enoxaparin

Syringes of enoxaparin active substance 30 mg twice a day administered once in the morning and once in the evening.

DRUG

Placebo: tablet of Rivaroxaban

Placebo tablet of rivaroxaban administered once daily in the evening.

DRUG

Placebo: syringes of Enoxaparin

Placebo syringes of enoxaparin twice a day (bid) administered once in the morning and once in the evening.

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-06-30
Primary Completion
2007-01-31
Completion
2008-01-31

Countries

  • United States
  • Bulgaria
  • Canada
  • Denmark
  • India
  • Israel
  • Lithuania
  • Mexico
  • Norway
  • Pakistan
  • Poland
  • Sri Lanka
  • Sweden

Study Locations

More Related Trials

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 NCT00362232 on ClinicalTrials.gov