Status:
TERMINATED
Evaluation of AVE5026 in the Prevention of Venous Thromboembolism in Acutely Ill Medical Patients With Restricted Mobility
Lead Sponsor:
Sanofi
Conditions:
Venous Thromboembolism
Eligibility:
All Genders
40+ years
Phase:
PHASE3
Brief Summary
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 primary prevent...
Detailed Description
Randomization had to take place just prior to the first study drug injection. The total duration of observation per participant was 35-42 days from randomization broken down as follows: * 10 to 14-d...
Eligibility Criteria
Inclusion
- Patient with an acute medical condition requiring bed rest for at least 3 days, and hospitalized for at least one of the following medical conditions:
- Congestive heart failure (New York Heart Association \[NYHA\] class III/IV);
- Acute respiratory failure (not requiring mechanical ventilation);
- Acute infection (without septic shock)\*;
- Acute rheumatic disorder\*;
- Acute episode of inflammatory bowel disease\*.
- Patient with one of these conditions should have at least one additional risk factor for venous thromboembolism (VTE) among the following:
- Age ≥ 75 years;
- Active cancer or myeloproliferative disorders (having received treatment for cancer within the last 6 months);
- Previous VTE;
- Obesity;
- Oral hormone therapy (antiandrogen or estrogen);
- Chronic heart failure;
- Chronic respiratory failure.
Exclusion
- Previous surgery with general anesthesia within 30 days before inclusion in the study;
- Patient requiring a curative anticoagulant or thrombolytic treatment;
- Patient at risk of bleeding;
- Stroke;
- Known hypersensitivity to heparin or enoxaparin sodium;
- 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.
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
421 Patients enrolled
Trial Details
Trial ID
NCT00714597
Start Date
July 1 2008
End Date
March 1 2009
Last Update
January 23 2013
Active Locations (22)
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1
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States, 08807
2
sanofi-aventis Australia & New Zealand administrative office
Macquarie Park, New South Wales, Australia
3
Sanofi-Aventis Administrative Office
Vienna, Austria
4
Sanofi-Aventis Administrative Office
Laval, Canada