ARIXTRA Local Study For Registration In China.

Phase 3

Completed

• Conditions: Thromboembolism; Knee Replacement; Hip Replacement

• Registration Number: NCT00328939
• Lead Sponsor: GlaxoSmithKline

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-05
• Study First Submitted: 2006-05-22
• Study First Submitted QC: 2006-05-22
• Study First Posted: 2006-05-24
• Status Verified: 2011-02
• Last Update Submitted: 2012-05-31
• Last Update Posted: 2012-06-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Occurrence of overall DVT (deep vein thrombosis) events confirmed by ultrasound result within day 5-11 post operation.

Secondary Outcome Measures

Name	Time	Method
Occurrence of DVT with symptom and non-fatal PE (pulmonary embolism). Occurrence of fatal PE.

Trial Locations

Locations (1)

GSK Investigational Site; 🇨🇳 Shanghai, China