Status:
COMPLETED
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
Lead Sponsor:
Bayer
Conditions:
Prevention
Venous Thromboembolism
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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.
Eligibility Criteria
Inclusion
- Male and female patients aged 18 years or above
- Patients scheduled for elective total hip replacement
Exclusion
- Planned, staged total bilateral hip replacement
- Active bleeding or high risk of bleeding contraindicating treatment with low molecular weight heparin
- Contraindication listed in the labeling or conditions precluding patient treatment with enoxaparin
- Conditions prohibiting bilateral venography (e.g. amputation of one leg, allergy to contrast media)
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2007
Estimated Enrollment :
2457 Patients enrolled
Trial Details
Trial ID
NCT00332020
Start Date
February 1 2006
End Date
June 1 2007
Last Update
January 27 2015
Active Locations (126)
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1
Birmingham, Alabama, United States, 35205
2
Denver, Colorado, United States, 80222
3
Bay Pines, Florida, United States, 33744
4
Miami, Florida, United States, 33186