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NCT00685958 Clinical Trial

Japanese Safety and Efficacy Study of Enoxaparin in Patients With Hip Fracture Surgery

Hip Fractures Clinical Trial

Official title:
Multicenter, Non-comparative, Open-label Study to Evaluate the Safety and Efficacy of Enoxaparin Sodium (RP54563) 20 mg Bid for 14 Days in Patients With Hip Fracture Surgery

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00685958
Other study ID # SFY6771
Secondary ID
Status Completed
Phase Phase 3
First received May 26, 2008
Last updated October 1, 2009
Start date July 2006
Est. completion date March 2007

Study information
Verified date October 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

The purpose of this study is to evaluate the effects of enoxaparin on bleeding and venous blood clots in patients with hip fracture surgery.

Recruitment information / eligibility
Status Completed
Enrollment 54
Est. completion date March 2007
Est. primary completion date March 2007
Accepts healthy volunteers No
Gender Both
Age group 20 Years and older
Eligibility Inclusion Criteria:

- femoral neck inside or outside fracture

Exclusion Criteria:

- any major surgery on lower limbs within 3 months

- clinical signs of deep vein thrombosis

- use of non-steroidal anti-inflammatory drugs

- severe hepatic disease or renal insufficiency

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• enoxaparin (XRP4563)
14 days of treatment

Locations
Country Name City State
Japan Sanofi- Aventis Administrative Office Tokyo

Sponsors (1)
Lead Sponsor Collaborator
Sanofi

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary bleeding events 28 days
Secondary incidence of venous thromboembolism 28 days
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