A Multinational, Multicenter, Randomized, Double Blind Study Comparing the Efficacy and Safety of AVE5026 With Enoxaparin for the Prevention of Venous Thromboembolism in Patients Undergoing Major Abdominal Surgery
A Multinational, Multicenter, Randomized, Double Blind Study Comparing the Efficacy and Safety of AVE5026 With Enoxaparin for the Prevention of Venous Thromboembolism in Patients Undergoing Major Abdominal Surgery
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:
Mandatory bilateral venography of the lower limbs has to be performed between 7 to 11 days after surgery.
Inclusion Criteria:
Patient undergoing major abdominal surgery (open surgery under general anesthesia lasting more than 45 minutes in the peritoneal and/or retroperitoneal space and/or pelvis).
Patient <60 years of age had to have one of the following additional risk factors for VTE:
Exclusion Criteria:
The above information was not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Corlton, California 82324, United States
Huntingdon Beach, California 92647, United States
Sant Barbara, California 93105, United States
Capital Federal, 1039, Argentina
Capital Federal, C1408INH, Argentina
Andhra Pradesh, India
Banglore, 560054, India
Gujarat, 380006, India
Punjgutta, India