Status:
COMPLETED
Abdominal Surgery Study Of GSK576428 (Fondaparinux Sodium)In Japanese Patients
Lead Sponsor:
GlaxoSmithKline
Conditions:
Venous Thromboembolism
Eligibility:
All Genders
40+ years
Phase:
PHASE3
Brief Summary
This study is phase 3 study for prevention of VTE in patients with abdominal surgery.
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Patients aged \>=40 years undergoing the following abdominal (diaphragm to pelvic floor) surgery under general anesthesia lasting more than 45 minutes.
- General or urologic surgery
- Cancer surgery
- Gynecologic surgery
- Radical surgery for pelvic malignancy
- Exclusion criteria:
- Active, clinically significant bleeding Thrombocytopenia Body weight \<40kg
Exclusion
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2007
Estimated Enrollment :
127 Patients enrolled
Trial Details
Trial ID
NCT00333021
Start Date
May 1 2006
End Date
February 1 2007
Last Update
July 10 2009
Active Locations (18)
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1
GSK Investigational Site
Hiroshima, Japan, 737-0811
2
GSK Investigational Site
Hokkaido, Japan, 060-0061
3
GSK Investigational Site
Hokkaido, Japan, 060-8543
4
GSK Investigational Site
Hokkaido, Japan, 073-0164