Status:
COMPLETED
Evaluation of AVE5026 as Compared to Placebo for the Extended Prophylaxis of Venous Thromboembolism in Patients Having Undergone Hip Fracture Surgery
Lead Sponsor:
Sanofi
Conditions:
Venous Thromboembolism
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The primary objective is to evaluate the efficacy of once daily (QD) subcutaneous (SC) injections of Semuloparin sodium (AVE5026) versus placebo for 3 additional weeks following an initial 7 to 10-day...
Detailed Description
The total duration of observation per participant is 56-63 days from surgery broken down as follows: * 7 to 10-day initial treatment period with open-label Semuloparin sodium; * Randomization; * 19 t...
Eligibility Criteria
Inclusion
- In the run-in phase:
- Standard surgery for fracture of the upper third of the femur, including femoral head and neck
- In the double-blind phase following the run-in phase:
- Completion of the run-in phase without permanent treatment discontinuation
Exclusion
- Any major orthopedic surgery within 3 months prior to enrolment;
- Deep vein thrombosis or pulmonary embolism within the last 12 months, or known post-phlebitic syndrome;
- High risk of bleeding;
- Known hypersensitivity to heparins;
- Any contraindication 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 :
January 1 2010
Estimated Enrollment :
469 Patients enrolled
Trial Details
Trial ID
NCT00709904
Start Date
June 1 2008
End Date
January 1 2010
Last Update
June 14 2013
Active Locations (16)
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1
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States, 08807
2
Sanofi-Aventis Administrative Office
Minsk, Belarus
3
Sanofi-Aventis Administrative Office
Laval, Canada
4
Sanofi-Aventis Administrative Office
Santiago, Chile