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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00685958
First Posted: May 29, 2008
Last Update Posted: October 2, 2009
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.
Information provided by:
Sanofi
  Purpose
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: 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

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
  Eligibility

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
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
  Contacts and Locations
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
  More Information

Responsible Party: International Clinical Development, Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00685958     History of Changes
Other Study ID Numbers: SFY6771
First Submitted: May 26, 2008
First Posted: May 29, 2008
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