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 replacement surgery. The secondary objectives were to evaluate the safety of AVE5026 in patients undergoing elective knee replacement surgery, and to document AVE5026 exposure in this population.
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 follows: * 7 to 10-day double-blind treatment period; * 28 to 35-day follow-up period. Mandatory bilateral venography of the lower limbs had to be performed 7 to 11 days after surgery.
0.3 mL (0.2 mL if SRI) solution in ready-to-use 0.5 mL pre-filled syringe Subcutaneous injection
0.3 mL (0.2 mL if SRI) solution in ready-to-use 0.5 mL pre-filled syringe Subcutaneous injection
0.3 mL (0.2 mL if SRI) solution in ready-to-use 0.5 ml prefilled syringe strictly identical in appearance but without active component Subcutaneous injection
Buenos Aires, Argentina