Back to resultsJapanese Safety and Efficacy Study of Enoxaparin in Patients With Hip Fracture Surgery
Primary Purpose
Hip Fractures
Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
enoxaparin (XRP4563)
Sponsored by
About this trial
This is an interventional treatment trial for Hip Fractures focused on measuring Blood thinner, enoxaparin, hip fracture surgery, bleeding, thromboembolism
Eligibility Criteria
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
Sites / Locations
- Sanofi- Aventis Administrative Office
Outcomes
Primary Outcome Measures
bleeding events
Secondary Outcome Measures
incidence of venous thromboembolism
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00685958
Brief Title
Japanese Safety and Efficacy Study of Enoxaparin in Patients With Hip Fracture Surgery
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2009
Overall Recruitment Status
Completed
Study Start Date
July 2006 (undefined)
Primary Completion Date
March 2007 (Actual)
Study Completion Date
March 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Sanofi
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Fractures
Keywords
Blood thinner, enoxaparin, hip fracture surgery, bleeding, thromboembolism
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
54 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
enoxaparin (XRP4563)
Intervention Description
14 days of treatment
Primary Outcome Measure Information:
Title
bleeding events
Time Frame
28 days
Secondary Outcome Measure Information:
Title
incidence of venous thromboembolism
Time Frame
28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ICD CSD
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Sanofi- Aventis Administrative Office
City
Tokyo
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
Japanese Safety and Efficacy Study of Enoxaparin in Patients With Hip Fracture Surgery
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