ARIXTRA Local Study For Registration In China.

GlaxoSmithKline (GSK)

Status and phase

Completed

Phase 3

Conditions

Thromboembolism

Knee Replacement

Hip Replacement

Treatments

Drug: ARIXTRA infusion

Drug: Enoxaparine infusion

Study type

Interventional

Funder types

Industry

Identifiers

NCT00328939

ITI105316

Details and patient eligibility

About

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.

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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