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Dose-ranging Study of Once-daily Regimen of BAY 59-7939 in the Prevention of VTE in Patients Undergoing Elective Total Hip Replacement

NCT00396786 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 877

Last updated 2014-10-28

No results posted yet for this study

Summary

The purpose of this study is to assess different doses of a new drug (BAY 59-7939), taken as a tablet, are safe and can help prevent blood clots forming after a hip replacement operation. Patients undergoing hip replacement surgery are at risk of developing blood clots. To reduce this risk treatment to prevent clots forming is routinely given. The current treatments can include injections under the skin or other treatments that need frequent blood tests to monitor levels of drug in the body. Therefore there is a need for new drugs, which are easier to give and need less monitoring.

Conditions

  • Venous Thromboembolism

Interventions

DRUG

Rivaroxaban (Xarelto, BAY59-7939)

Rivaroxaban 5 mg once daily plus placebo enoxaparin syringe

DRUG

Rivaroxaban (Xarelto, BAY59-7939)

Rivaroxaban 10 mg once daily plus placebo enoxaparin syringe

DRUG

Rivaroxaban (Xarelto, BAY59-7939)

Rivaroxaban 20 mg once daily plus placebo enoxaparin syringe

DRUG

Rivaroxaban (Xarelto, BAY59-7939)

Rivaroxaban 30 mg once daily plus placebo enoxaparin syringe

DRUG

Rivaroxaban (Xarelto, BAY59-7939)

Rivaroxaban 40 mg once daily plus placebo enoxaparin syringe

DRUG

Enoxaparin

Enoxaparin 40 mg once daily plus Rivaroxaban placebo tablets

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
2004-11-30
Primary Completion
2005-07-31
Completion
2005-07-31

Countries

  • Austria
  • Belgium
  • Denmark
  • France
  • Germany
  • Israel
  • Italy
  • Netherlands
  • Norway
  • Poland
  • Spain
  • Sweden
  • United Kingdom

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 NCT00396786 on ClinicalTrials.gov