ARIXTRA Local Study For Registration In China.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00328939
Recruitment Status : Completed
First Posted : May 24, 2006
Last Update Posted : June 4, 2012
Information provided by (Responsible Party):

May 22, 2006
May 24, 2006
June 4, 2012
May 2004
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Occurrence of overall DVT (deep vein thrombosis) events confirmed by ultrasound result within day 5-11 post operation.
Same as current
Complete list of historical versions of study NCT00328939 on Archive Site
Occurrence of DVT with symptom and non-fatal PE (pulmonary embolism). Occurrence of fatal PE.
Same as current
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ARIXTRA Local Study For Registration In China.
Randomized, Single Blind, Parallel Study to Compare the Safety and Efficacy of ARIXTRA to Enoxaparine in Patients Undergoing Elective Major Hip or Knee Replacement or a Revision of Components.
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.
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Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Prevention
  • Thromboembolism
  • Knee Replacement
  • Hip Replacement
  • Drug: ARIXTRA infusion
  • Drug: Enoxaparine infusion
    Other Name: ARIXTRA infusion
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
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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
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
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Study Director: GSK Clinical Trials GlaxoSmithKline
February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP