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

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ClinicalTrials.gov Identifier: NCT00685958
Recruitment Status : Completed
First Posted : May 29, 2008
Last Update Posted : October 2, 2009
Sponsor:
Information provided by:
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.

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
Actual Primary Completion Date : March 2007
Actual 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 ]


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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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


Locations
Japan
Sanofi- Aventis Administrative Office
Tokyo, Japan
Sponsors and Collaborators
Sanofi
Investigators
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
enoxaparin
hip fracture surgery
bleeding
thromboembolism

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