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 Elective Total Hip Replacement Surgery
The primary objective was to compare the efficacy 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 elective total hip
replacement surgery.
The secondary objectives were to evaluate the safety of AVE5026 in patients undergoing
elective total hip 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.
;
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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