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ARIXTRA Local Study For Registration In China.
This study has been completed.
First Received: May 22, 2006   Last Updated: October 9, 2008   History of Changes
Sponsored by: GlaxoSmithKline
Information provided by: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00328939
  Purpose

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.


Condition Intervention Phase
Hip Replacement
Knee Replacement
Drug: ARIXTRA infusion
Drug: Enoxaparine infusion
Phase III

MedlinePlus related topics: Knee Replacement
Drug Information available for: ORG 31540 Fondaparinux sodium Enoxaparin Sodium
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Randomized, Single Blind, Parallel Assignment, Safety/Efficacy Study
Official Title: 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.

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Occurrence of overall DVT (deep vein thrombosis) events confirmed by ultrasound result within day 5-11 post operation.

Secondary Outcome Measures:
  • Occurrence of DVT with symptom and non-fatal PE (pulmonary embolism). Occurrence of fatal PE.

Estimated Enrollment: 240
Study Start Date: May 2004
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00328939

Locations
China
GSK Investigational Site
Beijing, China, 100044
GSK Investigational Site
Shanghai, China, 200025
China, Henan
GSK Investigational Site
Zhengzhou, Henan, China, 450052
China, Shaanxi
GSK Investigational Site
Xi'an, Shaanxi, China, 710032
China, Shandong
GSK Investigational Site
Qingdao, Shandong, China, 266001
China, Sichuan
GSK Investigational Site
Chengdu, Sichuan, China, 610041
China, Zhejiang
GSK Investigational Site
Hangzhou, Zhejiang, China, 310009
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials, PhD GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GSK ( Study Director )
Study ID Numbers: ITI105316, L-8541
Study First Received: May 22, 2006
Last Updated: October 9, 2008
ClinicalTrials.gov Identifier: NCT00328939     History of Changes
Health Authority: China: State Food and Drug Administration

Keywords provided by GlaxoSmithKline:
ARIXTRA
prevention of DVT

Study placed in the following topic categories:
Fibrin Modulating Agents
Anticoagulants
Fibrinolytic Agents
Fondaparinux
Cardiovascular Agents
Org 31540
Enoxaparin

Additional relevant MeSH terms:
Fibrin Modulating Agents
Anticoagulants
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Hematologic Agents
Fibrinolytic Agents
Fondaparinux
Cardiovascular Agents
Pharmacologic Actions
Org 31540
Enoxaparin

ClinicalTrials.gov processed this record on May 07, 2009