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

This study has been completed.

First Received: May 26, 2008 Last Updated: March 26, 2009 History of Changes

Sponsored by:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00685958

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 III

MedlinePlus related topics: Fractures Hip Injuries and Disorders Hip Replacement Surgery

Drug Information available for: Enoxaparin Sodium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment, Safety Study
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

Further study details as provided by Sanofi-Aventis:

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:

14 days of treatment

Eligibility

Ages Eligible for Study:	20 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00685958

Locations

Japan
Sanofi- Aventis Administrative Office
Tokyo, Japan

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

ICD CSD

Sanofi-Aventis

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	sanofi-aventis ( International Clinical Development, Study Director )
Study ID Numbers:	SFY6771
Study First Received:	May 26, 2008
Last Updated:	March 26, 2009
ClinicalTrials.gov Identifier:	NCT00685958 History of Changes
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Sanofi-Aventis:

Blood thinner
enoxaparin
hip fracture surgery
bleeding
thromboembolism

Study placed in the following topic categories:

Anticoagulants
Fractures, Bone
Wounds and Injuries
Disorders of Environmental Origin
Fibrinolytic Agents
Cardiovascular Agents
Hemorrhage

Thromboembolism
Enoxaparin
Hip Fractures
Femoral Fractures
Fibrin Modulating Agents
Leg Injuries

Additional relevant MeSH terms:

Anticoagulants
Molecular Mechanisms of Pharmacological Action
Fractures, Bone
Hematologic Agents
Wounds and Injuries
Disorders of Environmental Origin
Fibrinolytic Agents
Cardiovascular Agents

Hip Injuries
Pharmacologic Actions
Enoxaparin
Hip Fractures
Fibrin Modulating Agents
Femoral Fractures
Therapeutic Uses
Leg Injuries

ClinicalTrials.gov processed this record on May 07, 2009