Status:
COMPLETED
Evaluation of AVE5026 as Compared to Enoxaparin for the Prevention of Venous Thromboembolism in Patients Undergoing Major Abdominal Surgery
Lead Sponsor:
Sanofi
Conditions:
Venous Thromboembolism
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 preventi...
Detailed Description
Randomization has to take place prior to the surgery. The total duration of observation per participant is 35-42 days from surgery broken down as follows: * 7 to 10-day double-blind treatment period...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2010
Estimated Enrollment :
4413 Patients enrolled
Trial Details
Trial ID
NCT00679588
Start Date
April 1 2008
End Date
August 1 2010
Last Update
December 16 2013
Active Locations (270)
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1
Investigational Site Number 840026
Birmingham, Alabama, United States, 35209
2
Investigational Site Number 840035
Birmingham, Alabama, United States, 35209
3
Investigational Site Number 840042
Birmingham, Alabama, United States, 35209
4
Investigational Site Number 840002
Birmingham, Alabama, United States, 35234