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

This study has been completed.
Information provided by:
ClinicalTrials.gov Identifier:
First received: May 26, 2008
Last updated: October 1, 2009
Last verified: October 2009
The purpose of this study is to evaluate the effects of enoxaparin on bleeding and venous blood clots in patients with hip fracture surgery.

Condition Intervention Phase
Hip Fractures
Drug: enoxaparin (XRP4563)
Phase 3

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

Resource links provided by NLM:

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • bleeding events [ Time Frame: 28 days ]

Secondary Outcome Measures:
  • incidence of venous thromboembolism [ Time Frame: 28 days ]

Enrollment: 54
Study Start Date: July 2006
Study Completion Date: March 2007
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: enoxaparin (XRP4563)
    14 days of treatment

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00685958

Sanofi- Aventis Administrative Office
Tokyo, Japan
Sponsors and Collaborators
Study Director: ICD CSD Sanofi
  More Information

Responsible Party: International Clinical Development, Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00685958     History of Changes
Other Study ID Numbers: SFY6771 
Study First Received: May 26, 2008
Last Updated: October 1, 2009
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Sanofi:
Blood thinner
hip fracture surgery

Additional relevant MeSH terms:
Fractures, Bone
Hip Fractures
Femoral Fractures
Hip Injuries
Leg Injuries
Wounds and Injuries

ClinicalTrials.gov processed this record on May 30, 2016