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ARIXTRA Local Study For Registration In China.

Primary Purpose

Thromboembolism, Knee Replacement, Hip Replacement

Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
ARIXTRA infusion
Enoxaparine infusion
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Thromboembolism focused on measuring ARIXTRA, prevention of DVT

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site

Outcomes

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.

Full Information

First Posted
May 22, 2006
Last Updated
May 31, 2012
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00328939
Brief Title
ARIXTRA Local Study For Registration In China.
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.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2011
Overall Recruitment Status
Completed
Study Start Date
May 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thromboembolism, Knee Replacement, Hip Replacement
Keywords
ARIXTRA, prevention of DVT

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
240 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
ARIXTRA infusion
Intervention Type
Drug
Intervention Name(s)
Enoxaparine infusion
Other Intervention Name(s)
ARIXTRA infusion
Primary Outcome Measure Information:
Title
Occurrence of overall DVT (deep vein thrombosis) events confirmed by ultrasound result within day 5-11 post operation.
Secondary Outcome Measure Information:
Title
Occurrence of DVT with symptom and non-fatal PE (pulmonary embolism). Occurrence of fatal PE.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450052
Country
China
Facility Name
GSK Investigational Site
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710032
Country
China
Facility Name
GSK Investigational Site
City
Qingdao
State/Province
Shandong
ZIP/Postal Code
266001
Country
China
Facility Name
GSK Investigational Site
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Facility Name
GSK Investigational Site
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310009
Country
China
Facility Name
GSK Investigational Site
City
Beijing
ZIP/Postal Code
100044
Country
China
Facility Name
GSK Investigational Site
City
Shanghai
ZIP/Postal Code
200025
Country
China

12. IPD Sharing Statement

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ARIXTRA Local Study For Registration In China.

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