The primary objective was to demonstrate the dose-response of Semuloparin sodium (AVE5026) for the prevention of Venous Thromboembolism \[VTE\] in patients undergoing total knee replacement \[TKR\] surgery. Secondary objectives were to evaluate the safety (incidence of major bleeding) of AVE5026, to document the efficacy and safety of AVE5026 post-operative regimens, and to assess the pharmacokinetic parameters of AVE5026.
The randomization had to take place before the first study drug injection. The total duration of observation per participant was 27-33 days from surgery broken down as follows: * 4 to 10-day double-blind treatment period; * Follow-up period up to Day 30 ± 3 after surgery. Mandatory bilateral venography of the lower limbs had to be performed between 5 to 11 days after surgery.
0.4 mL solution in ready-to-use prefilled syringe strictly identical in appearance containing the same volume but without active component Subcutaneous injection
0.8 mL solution in Type I amber glass vials Subcutaneous injection
0.4 mL solution in ready-to-use pre-filled syringe Subcutaneous injection
0.8 ml solution in type I amber glass vials strictly identical in appearance containing the same volume but without active component Subcutaneous injection
Buenos Aires, Argentina