ARIXTRA Local Study For Registration In China.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00328939
First received: May 22, 2006
Last updated: May 31, 2012
Last verified: February 2011

May 22, 2006
May 31, 2012
May 2004
Not Provided
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 ClinicalTrials.gov Archive Site
Occurrence of DVT with symptom and non-fatal PE (pulmonary embolism). Occurrence of fatal PE.
Same as current
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Prevention
  • Thromboembolism
  • Knee Replacement
  • Hip Replacement
  • Drug: ARIXTRA infusion
  • Drug: Enoxaparine infusion
    Other Names:
    • Enoxaparine infusion
    • ARIXTRA infusion
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
240
Not Provided
Not Provided

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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT00328939
ITI105316
Not Provided
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
February 2011

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