Japanese Safety and Efficacy Study of Enoxaparin in Patients With Hip Fracture Surgery
Information source: Sanofi
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hip Fractures
Intervention: enoxaparin (XRP4563) (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Sanofi Official(s) and/or principal investigator(s): ICD CSD, Study Director, Affiliation: Sanofi
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.
Clinical Details
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 design: Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: bleeding events
Secondary outcome: incidence of venous thromboembolism
Eligibility
Minimum age: 20 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Sanofi- Aventis Administrative Office, Tokyo, Japan
Additional Information
Starting date: July 2006
Last updated: October 1, 2009
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