Venous Thromboembolism Clinical Trial
Official title:
A Multinational, Multicenter, Randomized, Double-Blind Study Comparing the Efficacy and Safety of AVE5026 With Placebo for the Extended Prevention of Venous Thromboembolism in Patients Having Undergone Hip Fracture Surgery
The primary objective is to evaluate the efficacy of once daily (QD) subcutaneous (SC)
injections of Semuloparin sodium (AVE5026) versus placebo for 3 additional weeks following
an initial 7 to 10-day venous thromboprophylaxis with open-label AVE5026 in patients having
undergone hip fracture surgery.
The secondary objective is to evaluate the safety of extended AVE5026 administration.
The total duration of observation per participant is 56-63 days from surgery broken down as
follows:
- 7 to 10-day initial treatment period with open-label Semuloparin sodium;
- Randomization;
- 19 to 23-day double-blind treatment period with Semuloparin sodium or placebo;
- 30-day follow-up period.
Mandatory bilateral venography of the lower limbs is to be performed between 19 and 24 days
after randomization.
;
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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