Status:
COMPLETED
Evaluation of AVE5026 as Compared to Enoxaparin for the Prevention of Thromboembolism in Patients Undergoing Total Hip 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 once daily \[q.d.\] subcutaneous \[s.c.\] injections of Semuloparin sodium (AVE5026) with q.d. s.c. injections of enoxaparin for the prevention of ...
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
- Elective total hip replacement surgery or a revision of at least one component of a prosthesis implanted ≥ 6 months prior to study entry.
Exclusion
- Any major orthopedic surgery in the 3 months prior to study start;
- Deep vein thrombosis or pulmonary embolism within the last 12 months or known post-phlebitic syndrome;
- High risk of bleeding;
- Known allergy to heparin or enoxaparin;
- Any contra-indications to the performance of venography;
- 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 :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
2326 Patients enrolled
Trial Details
Trial ID
NCT00697099
Start Date
June 1 2008
End Date
June 1 2009
Last Update
January 23 2013
Active Locations (30)
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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