Venous Thromboembolism Clinical Trial
Official title:
A Multicenter, Randomized, Double-Blind, Double-Dummy, Parallel Group, Dose Response Study of Subcutaneous AVE5026 With an Enoxaparin Calibrator Arm in the Prevention of Venous Thromboembolism in Patients Undergoing Elective Total Knee Replacement Surgery
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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