Status:
COMPLETED
Evaluation of AVE5026 as Compared to Enoxaparin for the Prevention of Thromboembolism in Patients Undergoing Elective Knee Replacement Surgery
Lead Sponsor:
Sanofi
Conditions:
Venous Thromboembolism
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The primary objective was to compare the efficacy of Semuloparin sodium (AVE5026) with Enoxaparin for the prevention of Venous Thromboembolic Events \[VTE\] in patients undergoing elective knee replac...
Detailed Description
Randomization had to take place just prior the first study drug injection (randomization ratio 1:1). The total duration of observation per participant was 35-42 days from surgery broken down as follo...
Eligibility Criteria
Inclusion
- \- Knee replacement surgery or revision of at least one component of a knee prosthesis implanted ≥ 6 months prior to study entry.
Exclusion
- Any major orthopedic surgeries in the 3 months prior to study;
- Deep vein thrombosis or pulmonary embolism within the last 12 months, or known post-phlebitic syndrome;
- Any contraindications to the performance of venography;
- High risk of bleeding;
- Know allergy to heparin, or enoxaparin, or pork products;
- End stage renal disease or patient on dialysis.
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2009
Estimated Enrollment :
1150 Patients enrolled
Trial Details
Trial ID
NCT00718224
Start Date
July 1 2008
End Date
May 1 2009
Last Update
January 23 2013
Active Locations (17)
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1
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States, 08807
2
Sanofi-Aventis Administrative Office
Buenos Aires, Argentina
3
sanofi-aventis Australia & New Zealand administrative office
Macquarie Park, New South Wales, Australia
4
Sanofi-Aventis Administrative Office
Minsk, Belarus