Evaluation of AVE5026 as Compared to Enoxaparin for the Prevention of Thromboembolism in Patients Undergoing Total Hip Replacement Surgery

Completed · Phase 3 · Has a placebo group

Conditions studied: Venous Thromboembolism

In brief

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.

Key facts

Study ID

NCT00697099

Run by

Sanofi

People needed

2326

Starts

2008-06-01

Expected to finish

2009-06-01

Last updated by the study team

2013-01-23

Who can join

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

You may qualify if…

• Elective total hip replacement surgery or a revision of at least one component of a prosthesis implanted ≥ 6 months prior to study entry.

You may not qualify if…

• Any major orthopedic surgery in the 3 months prior to study start;
• Deep vein thrombosis or pulmonary embolism within the last 12 months or known post-phlebitic syndrome;
• High risk of bleeding;
• Known allergy to heparin or enoxaparin;
• Any contra-indications 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 — Buenos Aires, Argentina
• sanofi-aventis Australia & New Zealand administrative office — Macquarie Park, New South Wales, Australia
• Sanofi-Aventis Administrative Office — Minsk, Belarus
• Sanofi-Aventis Administrative Office — Laval, Canada
• Sanofi-Aventis Administrative Office — Santiago, Chile
• Sanofi-Aventis Administrative Office — Bogotá, Colombia
• Sanofi-Aventis Administrative Office — Prague, Czechia
• Sanofi-Aventis Administrative Office — Hørsholm, Denmark
• Sanofi-Aventis Administrative Office — Tallinn, Estonia
• Sanofi-Aventis Administrative Office — Helsinki, Finland
• Sanofi-Aventis Administrative Office — Berlin, Germany
• Sanofi-Aventis Administrative Office — Athens, Greece
• Sanofi-Aventis Administrative Office — Mumbai, India
• Sanofi-Aventis Administrative Office — Milan, Italy
• Sanofi-Aventis Administrative Office — México, Mexico
• Sanofi-Aventis Administrative Office — Lysaker, Norway
• Sanofi-Aventis Administrative Office — Lima, Peru
• Sanofi-Aventis Administrative Office — Makati City, Philippines
• Sanofi-Aventis Administrative Office — Warsaw, Poland
• Sanofi-Aventis Administrative Office — Bucharest, Romania
• Sanofi-Aventis Administrative Office — Moscow, Russia
• Sanofi-Aventis Administrative Office — Brastislava, Slovakia
• Sanofi-Aventis Administrative Office — Midrand, South Africa
• Sanofi-Aventis Administrative Office — Barcelona, Spain

Full record on ClinicalTrials.gov

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