ARIXTRA Local Study For Registration In China.

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Enoxaparin; Fondaparinux; PENTA

Criteria

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