Status:
COMPLETED
Evaluation of AVE5026 as Compared to Enoxaparin for the Prevention of Thromboembolism in Patients Undergoing Hip Fracture 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 V...
Detailed Description
Randomization had to take place just prior to 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 fo...
Eligibility Criteria
Inclusion
- Standard surgery for fracture of the upper third of the femur including femoral head and neck.
Exclusion
- Estimated time of injury/fracture \> 24 hours before admission to hospital;
- Any major orthopedic surgery in the 3 months prior to study start;
- Multiple trauma affecting more than one organ system;
- 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, 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 :
October 1 2009
Estimated Enrollment :
1003 Patients enrolled
Trial Details
Trial ID
NCT00721760
Start Date
July 1 2008
End Date
October 1 2009
Last Update
January 23 2013
Active Locations (25)
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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 Administrative Office
Minsk, Belarus
4
Sanofi-Aventis Administrative Office
Sofia, Bulgaria