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

October 1, 2009 updated by: Sanofi

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.

Study Overview

Status

Completed

Conditions

Hip Fractures

Intervention / Treatment

Drug: enoxaparin (XRP4563)

Study Type

Interventional

Enrollment (Actual)

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Japan
- - Tokyo, Japan
    - Sanofi- Aventis Administrative Office

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
bleeding events Time Frame: 28 days	28 days

Secondary Outcome Measures

Outcome Measure	Time Frame
incidence of venous thromboembolism Time Frame: 28 days	28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2006

Primary Completion (ACTUAL)

March 1, 2007

Study Completion (ACTUAL)