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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00685958
Recruitment Status : Completed
First Posted : May 29, 2008
Last Update Posted : October 2, 2009
Information provided by:

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.

Condition or disease Intervention/treatment Phase
Hip Fractures Drug: enoxaparin (XRP4563) Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : July 2006
Primary Completion Date : March 2007
Study Completion Date : March 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Intervention Details:
    Drug: enoxaparin (XRP4563)
    14 days of treatment

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00685958

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

Responsible Party: International Clinical Development, Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00685958     History of Changes
Other Study ID Numbers: SFY6771
First Posted: May 29, 2008    Key Record Dates
Last Update Posted: October 2, 2009
Last Verified: October 2009

Keywords provided by Sanofi:
Blood thinner
hip fracture surgery

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