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

History of Changes

Tracking Information

First Received Date ^ICMJE

May 26, 2008

Last Updated Date

October 1, 2009

Start Date ^ICMJE

July 2006

Primary Completion Date

March 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

bleeding events [ Time Frame: 28 days ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00685958 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

incidence of venous thromboembolism [ Time Frame: 28 days ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

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

Condition ^ICMJE

Hip Fractures

Intervention ^ICMJE

Drug: enoxaparin (XRP4563)

14 days of treatment

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

March 2007

Primary Completion Date

March 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

20 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Japan

Administrative Information

NCT Number ^ICMJE

NCT00685958

Other Study ID Numbers ^ICMJE

SFY6771

Has Data Monitoring Committee

Not Provided

Responsible Party

International Clinical Development, Study Director, sanofi-aventis

Study Sponsor ^ICMJE

Sanofi

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

ICD CSD

Sanofi

Information Provided By

Sanofi

Verification Date

October 2009

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

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