Venous Thromboembolism Clinical Trial
Official title:
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:
- 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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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