Evaluation of AVE5026 as Compared to Enoxaparin for the Prevention of Venous Thromboembolism in Patients Undergoing Major Abdominal Surgery (SAVE-ABDO)
Tracking Information
Start Date ICMJE | May 2008 |
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Estimated Primary Completion Date | July 2010 (final data collection date for primary outcome measure) |
Current Primary Outcome Measures ICMJE (submitted: September 19, 2008) | Composite of any VTE and death from any cause [ Time Frame: From randomization up to the day of the event or the day of the mandatory venography; whichever comes first ] [ Designated as safety issue: No ] |
Original Primary Outcome Measures ICMJE (submitted: May 16, 2008) | Composite of any VTE and death from any cause [ Time Frame: From randomization up to the day of the event or the day of the mandatory venography; whichever comes first ] |
Change History | Complete list of historical versions of study NCT00679588 on ClinicalTrials.gov Archive Site |
Current Secondary Outcome Measures ICMJE (submitted: September 19, 2008) |
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Original Secondary Outcome Measures ICMJE (submitted: May 16, 2008) |
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Descriptive Information
Brief Title ICMJE | Evaluation of AVE5026 as Compared to Enoxaparin for the Prevention of Venous Thromboembolism in Patients Undergoing Major Abdominal Surgery |
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Official Title ICMJE | A Multinational, Multicenter, Randomized, Double Blind Study Comparing the Efficacy and Safety of AVE5026 With Enoxaparin for the Prevention of Venous Thromboembolism in Patients Undergoing Major Abdominal Surgery |
Brief Summary | The primary objective of the study is to compare the efficacy and safety of once daily (q.d.) subcutaneous (s.c.) injections of AVE5026 with q.d. s.c. injections of enoxaparin after surgery for the prevention of venous thromboembolic events in patients undergoing major abdominal surgery. The secondary objectives of this study are to evaluate the safety of AVE5026 and to document AVE5026 exposures in this population. |
Detailed Description | |
Study Phase | Phase III |
Study Type ICMJE | Interventional |
Study Design ICMJE | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study |
Condition ICMJE | Venous Thromboembolism |
Intervention ICMJE |
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Study Arms / Comparison Groups |
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Recruitment Information
Estimated Enrollment ICMJE | 4400 | ||||
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Estimated Completion Date | July 2010 | ||||
Estimated Primary Completion Date | July 2010 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial. | ||||
Gender | Both | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE |
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Location Countries ICMJE | United States, Argentina, Australia, Austria, Belarus, Belgium, Brazil, Bulgaria, Canada, Chile, China, Croatia, Czech Republic, Denmark, Estonia, Germany, Hungary, India, Italy, Korea, Republic of, Latvia, Lithuania, Mexico, Norway, Peru, Poland, Romania, Russian Federation, Serbia, Slovakia, Slovenia, South Africa, Spain, Sweden, Ukraine, United Kingdom |
Administrative Information
NCT ID ICMJE | NCT00679588 | ||||||||
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Responsible Party | ICD Study Director, Sanofi-aventis | ||||||||
Study ID Numbers ICMJE | EFC6520, EudraCT 2007-007942-36 | ||||||||
Study Sponsor ICMJE | Sanofi-Aventis | ||||||||
Collaborators ICMJE | |||||||||
Investigators ICMJE |
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Information Provided By | Sanofi-Aventis |
Source: http://clinicaltrials.gov/