Evaluation of AVE5026 as Compared to Enoxaparin for the Prevention of Venous Thromboembolism in Patients Undergoing Major Abdominal Surgery

Completed · Phase 3 · Has a placebo group

Conditions studied: Venous Thromboembolism

In brief

The primary objective is to compare the efficacy and safety 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 major abdominal surgery. The secondary objectives are to evaluate the safety of Semuloparin sodium (AVE5026) and to document Semuloparin sodium (AVE5026) exposure in this population.

Key facts

Study ID

NCT00679588

Run by

Sanofi

People needed

4413

Starts

2008-04-01

Expected to finish

2010-08-01

Last updated by the study team

2013-12-16

Who can join

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

You may qualify if…

• Patient undergoing major abdominal surgery (open surgery under general anesthesia lasting more than 45 minutes in the peritoneal and/or retroperitoneal space and/or pelvis).
• Patient <60 years of age had to have one of the following additional risk factors for VTE:
• History of VTE,
• Obesity,
• Chronic Heart failure,
• Chronic Respiratory Failure,
• Inflammatory Bowel Disease,
• Cancer Surgery.

You may not qualify if…

• Any major orthopedic or general surgery in the 3 months prior to study start;
• Clinical signs or symptoms of DVT or PE within the last 12 months or known post phlebitic syndrome;
• Any contra-indications to the performance of venography;
• High risk of bleeding;
• Known hypersensitivity to heparin or Enoxaparin sodium;
• End stage renal disease or patient on dialysis.
• The above information was not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Where it is running

• Investigational Site Number 840035 — Birmingham, Alabama, United States
• Investigational Site Number 840042 — Birmingham, Alabama, United States
• Investigational Site Number 840002 — Birmingham, Alabama, United States
• Investigational Site Number 840031 — Corlton, California, United States
• Investigational Site Number 840007 — Huntingdon Beach, California, United States
• Investigational Site Number 840014 — Los Angeles, California, United States
• Investigational Site Number 840011 — Sant Barbara, California, United States
• Investigational Site Number 840021 — Denver, Colorado, United States
• Investigational Site Number 840029 — Clearwater, Florida, United States
• Investigational Site Number 840017 — Jacksonville, Florida, United States
• Investigational Site Number 840044 — Miami, Florida, United States
• Investigational Site Number 840015 — Orlando, Florida, United States
• Investigational Site Number 840009 — Columbus, Georgia, United States
• Investigational Site Number 840019 — Maywood, Illinois, United States
• Investigational Site Number 840036 — Springfield, Illinois, United States
• Investigational Site Number 840037 — Hazard, Kentucky, United States
• Investigational Site Number 840008 — St Louis, Missouri, United States
• Investigational Site Number 840020 — Teaneck, New Jersey, United States
• Investigational Site Number 840051 — Columbus, Ohio, United States
• Investigational Site Number 840006 — Pittsburgh, Pennsylvania, United States
• Investigational Site Number 840025 — Houston, Texas, United States
• Investigational Site Number 840050 — Houston, Texas, United States
• Investigational Site Number 840032 — Lubbock, Texas, United States
• Investigational Site Number 840043 — Morgantown, West Virginia, United States
• Investigational Site Number 840026 — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.