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

Phase 3

Completed

• Conditions: Hip Fractures

• Registration Number: NCT00685958
• Lead Sponsor: Sanofi

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-07
• Primary Completion: 2007-03
• Study Completion: 2007-03
• Study First Submitted: 2008-05-26
• Study First Submitted QC: 2008-05-26
• Study First Posted: 2008-05-29
• Status Verified: 2009-10
• Last Update Submitted: 2009-10-01
• Last Update Posted: 2009-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
bleeding events	28 days

Secondary Outcome Measures

Name	Time	Method
incidence of venous thromboembolism	28 days

Trial Locations

Locations (1)

Sanofi- Aventis Administrative Office; 🇯🇵 Tokyo, Japan