Status:
COMPLETED
Japanese Efficacy and Safety Study of Enoxaparin in Patients With Curative Abdominal Cancer Surgery
Lead Sponsor:
Sanofi
Conditions:
Abdominal Neoplasms
Eligibility:
All Genders
40+ years
Phase:
PHASE3
Brief Summary
The primary objective of this study is to evaluate the effects of enoxaparin on venous thromboembolism incidence and bleeding rate (major and minor bleeding) in patients undergoing curative abdominal ...
Eligibility Criteria
Inclusion
- Malignant tumor patients undergoing laparotomy for which surgery is expected to take 45 minutes or more.
Exclusion
- surgery under laparoscope and other endoscopic operations
- clinical signs of deep vein thrombosis
- use of non-steroidal anti-inflammatory drugs from surgery completion until initial administration
- severe hepatic disease or renal disease
- women of childbearing potential, pregnant or lactating.
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
151 Patients enrolled
Trial Details
Trial ID
NCT00723216
Start Date
March 1 2007
End Date
December 1 2007
Last Update
April 5 2010
Active Locations (1)
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1
Sanofi-Aventis Administrative Office
Tokyo, Japan