Status:
COMPLETED
ARIXTRA Local Study For Registration In China.
Lead Sponsor:
GlaxoSmithKline
Conditions:
Thromboembolism
Knee Replacement
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
This is a local registration study in China to compare the safety and efficacy of ARIXTRA to Enoxaparine in patients undergoing elective major hip or knee replacement or a revision of components.
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Patients undergoing either an elective major hip or knee replacement or revision.
- Signed written informed consent. Men or women of non-child bearing potential(i.e., post menopausal or with hysterectomy of bilateral tubule ligation) or women of childbearing potential without any plan to have a child.
- Exclusion criteria:
- History of serious active bleeding in last 3 month
- Concurrent or history of thrombocytopenia ( Platelet\< 100x109/L)
- History of hypersensitivity reaction to heparin, Low molecular weight heparin or pork product
- Acute bacterial endocarditis
- Congenital or acquired bleeding disease in last 3 months
- Concurrent uncontrolled ulcer or gastrointestinal disease with blood vessel dysplasia
- Concurrent hemorrhagic cerebrovascular disease or surgical history in cerebral, spine or eye
- Conditions need to leave a tubule in intradural or extradural
- Contraindication to anticoagulant or condition required to take long term oral anticoagulant
- Abnormality in hepatic (\>1.5x UNL), renal (Clcr \< 30ml/min) or cardiac function, uncontrolled hypertension or tumor Concurrent disorder of blood vessel in lower limb
- Positive result in Human Chorionic Gonadotropin test Participated in any other investigational study on Deep Vein Thrombosis prevention in last 90 days.
- Concurrently to have hip and knee or double hip/knee replacement at the same time
Exclusion
Key Trial Info
Start Date :
May 1 2004
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT00328939
Start Date
May 1 2004
Last Update
June 4 2012
Active Locations (7)
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1
GSK Investigational Site
Zhengzhou, Henan, China, 450052
2
GSK Investigational Site
Xi'an, Shaanxi, China, 710032
3
GSK Investigational Site
Qingdao, Shandong, China, 266001
4
GSK Investigational Site
Chengdu, Sichuan, China, 610041