Status:
COMPLETED
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.
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 prevents blood clot which may form after a knee replacement operation.
Eligibility Criteria
Inclusion
- Male and female patients aged 18 years or above- Patients scheduled for elective total knee replacement
Exclusion
- Active bleeding or high risk of bleeding contraindicating treatment with LMWH- Contraindication listed in the labeling or conditions precluding subject treatment with enoxaparin or requiring dose adjustment (e.g. severe renal impairment, please refer to the local label of enoxaparin in your country)- Conditions prohibiting bilateral venography (e.g. amputation of 1 leg, allergy to contrast media)
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2007
Estimated Enrollment :
2531 Patients enrolled
Trial Details
Trial ID
NCT00361894
Start Date
February 1 2006
End Date
January 1 2007
Last Update
October 27 2014
Active Locations (143)
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1
Graz, Styria, Austria, 8036
2
Innsbruck, Tyrol, Austria, 6020
3
Linz, Upper Austria, Austria, 4010
4
Vienna, Vienna, Austria, 1140