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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)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 2 (7 locations)

    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