Japanese Safety and Efficacy Study of Enoxaparin in Patie... | NCT00685958

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

NCT00685958

Sponsor

Sanofi

Status

Completed

Last Update Posted

Oct 2, 2009Estimated

Enrollment

54Actual

Phase

Phase 3

Conditions

Hip Fractures

Interventions

enoxaparin (XRP4563)

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2006

Primary Completion Date

Mar 2007Actual

Completion Date

Mar 2007Actual

First Submitted Date

May 26, 2008

First Submission Date that Met QC Criteria

May 26, 2008

First Posted Date

May 29, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 1, 2009

Last Update Posted Date

Oct 2, 2009Estimated

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

54Actual

Name	Type	Description	Arm Group Labels	Other Names
enoxaparin (XRP4563)	Drug	14 days of treatment

Measure	Description	Time Frame
bleeding events		28 days

Measure	Description	Time Frame
incidence of venous thromboembolism		28 days

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
ICD CSD	Sanofi	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sanofi- Aventis Administrative Office		Tokyo			Japan

Condition Browse Module

MeSH Terms

ID	Term
D006620	Hip Fractures
D006470	Hemorrhage
D013923	Thromboembolism

Ancestor Terms

ID	Term
D005264	Femoral Fractures
D050723	Fractures, Bone
D014947	Wounds and Injuries
D025981	Hip Injuries

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D017984	Enoxaparin

Ancestor Terms

ID	Term
D006495	Heparin, Low-Molecular-Weight
D006493	Heparin
D006025	Glycosaminoglycans
D011134	Polysaccharides

Browse Leaves

Not provided

Browse Branches

Not provided