The primary objective is to compare the efficacy and safety 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 Venous Thromboembolic Events (VTE) in patients undergoing major abdominal surgery. The secondary objectives are to evaluate the safety of Semuloparin sodium (AVE5026) and to document Semuloparin sodium (AVE5026) exposure in this population.
Randomization has to take place prior to the surgery. The total duration of observation per participant is 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 has to be performed between 7 to 11 days after surgery.
0.4 mL (0.2 mL if SRI) solution in ready-to-use 0.5 ml pre-filled syringe Subcutaneous injection
0.4 mL (0.2 mL if SRI) solution in ready-to-use 0.5 ml pre-filled syringe Subcutaneous injection
0.4 mL (0.2 mL if SRI) solution in ready-to-use 0.5 ml prefilled syringe strictly identical in appearance containing the same volume but without active component Subcutaneous injection
Buenos Aires, Argentina
Buenos Aires, Argentina
Buenos Aires, Argentina
Capital Federal, Argentina
Capital Federal, Argentina
Córdoba, Argentina
Rosario, Argentina
Santa Fe, Argentina