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

Completed · Phase 3 · Has a placebo group

Conditions studied: Venous Thromboembolism

In brief

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.

Key facts

Study ID

NCT00709904

Run by

Sanofi

People needed

469

Starts

2008-06-01

Expected to finish

2010-01-01

Last updated by the study team

2013-06-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Sanofi-Aventis Administrative Office — Bridgewater, New Jersey, United States
• Sanofi-Aventis Administrative Office — Minsk, Belarus
• Sanofi-Aventis Administrative Office — Laval, Canada
• Sanofi-Aventis Administrative Office — Santiago, Chile
• Sanofi-Aventis Administrative Office — Shangaï, China
• Sanofi-Aventis Administrative Office — Bogotá, Colombia
• Sanofi-Aventis Administrative Office — Cairo, Egypt
• Sanofi-Aventis Administrative Office — Mumbai, India
• Sanofi-Aventis Administrative Office — Vilnius, Lithuania
• Sanofi-Aventis Administrative Office — México, Mexico
• Sanofi-Aventis Administrative Office — Lima, Peru
• Sanofi-Aventis Administrative Office — Moscow, Russia
• Sanofi-Aventis Administrative Office — Midrand, South Africa
• Sanofi-Aventis Administrative Office — Seoul, South Korea
• Sanofi-Aventis Administrative Office — Istanbul, Turkey (Türkiye)
• Sanofi-Aventis Administrative Office — Kiev, Ukraine

Full record on ClinicalTrials.gov

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