Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
  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
Thromboembolism
Knee Replacement
Hip Replacement
Drug: ARIXTRA infusion
Drug: Enoxaparine infusion
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Prevention
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.

Resource links provided by NLM:


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
Intervention Details:
    Drug: ARIXTRA infusion Drug: Enoxaparine infusion
    Other Names:
    • Enoxaparine infusion
    • ARIXTRA infusion
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00328939

Locations
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
China
GSK Investigational Site
Beijing, China, 100044
GSK Investigational Site
Shanghai, China, 200025
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00328939     History of Changes
Other Study ID Numbers: ITI105316
Study First Received: May 22, 2006
Last Updated: May 31, 2012
Health Authority: China: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
ARIXTRA
prevention of DVT

Additional relevant MeSH terms:
Thromboembolism
Cardiovascular Diseases
Embolism and Thrombosis
Thrombosis
Vascular Diseases
Fondaparinux
PENTA
Anticoagulants
Cardiovascular Agents
Fibrin Modulating Agents
Fibrinolytic Agents
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014