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

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00685958
First received: May 26, 2008
Last updated: October 1, 2009
Last verified: October 2009

May 26, 2008
October 1, 2009
July 2006
March 2007   (final data collection date for primary outcome measure)
bleeding events [ Time Frame: 28 days ]
Same as current
Complete list of historical versions of study NCT00685958 on ClinicalTrials.gov Archive Site
incidence of venous thromboembolism [ Time Frame: 28 days ]
Same as current
Not Provided
Not Provided
 
Japanese Safety and Efficacy Study of Enoxaparin in Patients With Hip Fracture Surgery
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

The purpose of this study is to evaluate the effects of enoxaparin on bleeding and venous blood clots in patients with hip fracture surgery.

Not Provided
Interventional
Phase 3
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Hip Fractures
Drug: enoxaparin (XRP4563)
14 days of treatment
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
54
March 2007
March 2007   (final data collection date for primary outcome measure)

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
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00685958
SFY6771
Not Provided
International Clinical Development, Study Director, sanofi-aventis
Sanofi
Not Provided
Study Director: ICD CSD Sanofi
Sanofi
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP