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Regulation of Coagulation in Orthopedic Surgery to Prevent DVT and PE, a Controlled, Double-blind, Randomized Study of BAY 59-7939 in the Extended Prevention of VTE in Patients Undergoing Elective Total Hip Replacement

NCT00332020 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2457

Last updated 2015-01-27

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 can help prevent blood clots forming after a hip replacement operation.

Conditions

  • Prevention
  • Venous Thromboembolism

Interventions

DRUG

Rivaroxaban (BAY59-7939)

10 mg rivaroxaban (tablet) once daily administered for 35 +/- 4 days

DRUG

Enoxaparin

40 mg enoxaparin syringe administered for 12 +/- 2 days

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-02-28
Primary Completion
2007-05-31
Completion
2007-06-30

Countries

  • United States
  • Australia
  • Brazil
  • Canada
  • China
  • Colombia
  • Denmark
  • Estonia
  • India
  • Indonesia
  • Italy
  • Latvia
  • Lithuania
  • Mexico
  • New Zealand
  • Norway
  • Peru
  • Portugal
  • South Africa
  • South Korea
  • Sweden
  • Taiwan
  • United Kingdom

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 NCT00332020 on ClinicalTrials.gov