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NCT00349180 Clinical Trial

Total Hip Replacement Study With XRP4563 (Enoxaparin Sodium)

Arthroplasty, Replacement, Hip Clinical Trial

Official title:
Multicenter, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Enoxaparin Sodium（RP54563）20mg qd and 20mg Bid for 14 Days in Patients With Total Hip Replacement

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00349180
Other study ID # EFC6770
Secondary ID
Status Completed
Phase Phase 3
First received July 4, 2006
Last updated March 26, 2009
Start date June 2006

Study information
Verified date March 2009
Source Sanofi
Contact n/a
Is FDA regulated No
Health authority Japan: Ministry of Health, Labor and Welfare
Study type Interventional

Clinical Trial Summary

This study is performed to confirm the optimal dose for THR (total hip replacement).

Recruitment information / eligibility
Status Completed
Enrollment 156
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 20 Years and older
Eligibility Inclusion Criteria:

- Patients undergoing elective primary THR (total hip replacement) surgery

Exclusion Criteria:

- Patient with risk of clinical significant bleeding

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Drug:
• Enoxaparin sodium

Locations
Country Name City State
Japan Sanofi-Aventis Tokyo

Sponsors (1)
Lead Sponsor Collaborator
Sanofi

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of VTE
Secondary Incidence of bleeding
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