Evaluation of AVE5026 as Compared to Placebo for the Extended Prophylaxis of Venous Thromboembolism in Patients Having Undergone Hip Fracture Surgery

• Status: Completed
• Trial end date: 2010-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: Heparin, Low-Molecular-Weight; Semuloparin

Criteria

Inclusion Criteria:

• In the run-in phase:

• Standard surgery for fracture of the upper third of the femur, including femoral head and neck

• In the double-blind phase following the run-in phase:

• Completion of the run-in phase without permanent treatment discontinuation

Exclusion Criteria:

• Any major orthopedic surgery within 3 months prior to enrolment;

• Deep vein thrombosis or pulmonary embolism within the last 12 months, or known post-phlebitic syndrome;

• High risk of bleeding;

• Known hypersensitivity to heparins;

• Any contraindication to the performance of venography;

• End stage renal disease or patient on dialysis

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.