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.
1 other identifier
interventional
240
1 country
7
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2004
CompletedFirst Submitted
Initial submission to the registry
May 22, 2006
CompletedFirst Posted
Study publicly available on registry
May 24, 2006
CompletedJune 4, 2012
February 1, 2011
May 22, 2006
May 31, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Occurrence of overall DVT (deep vein thrombosis) events confirmed by ultrasound result within day 5-11 post operation.
Secondary Outcomes (1)
Occurrence of DVT with symptom and non-fatal PE (pulmonary embolism). Occurrence of fatal PE.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (7)
GSK Investigational Site
Zhengzhou, Henan, 450052, China
GSK Investigational Site
Xi'an, Shaanxi, 710032, China
GSK Investigational Site
Qingdao, Shandong, 266001, China
GSK Investigational Site
Chengdu, Sichuan, 610041, China
GSK Investigational Site
Hangzhou, Zhejiang, 310009, China
GSK Investigational Site
Beijing, 100044, China
GSK Investigational Site
Shanghai, 200025, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 22, 2006
First Posted
May 24, 2006
Study Start
May 1, 2004
Last Updated
June 4, 2012
Record last verified: 2011-02