Total Hip Replacement Study With XRP4563 (Enoxaparin Sodium) | NCT00349180

Studies
Total Hip Replacement Study With XRP4563 (Enoxaparin Sodium)

NCT00349180

Sponsor

Sanofi

Status

Completed

Last Update Posted

Mar 27, 2009Estimated

Enrollment

156

Phase

Phase 3

Conditions

Arthroplasty, Replacement, Hip

Interventions

Enoxaparin sodium

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

Mar 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

Jun 2006

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Jul 4, 2006

First Submission Date that Met QC Criteria

Jul 4, 2006

First Posted Date

Jul 6, 2006Estimated

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

Mar 26, 2009

Last Update Posted Date

Mar 27, 2009Estimated

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

156

Name	Type	Description	Arm Group Labels	Other Names
Enoxaparin sodium	Drug

Measure	Description	Time Frame
Incidence of VTE

Measure	Description	Time Frame
Incidence of bleeding

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients undergoing elective primary THR (total hip replacement) surgery

Exclusion Criteria:

Patient with risk of clinical significant bleeding

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

Name	Affiliation	Role
Yoshihiro IKEDA	Sanofi	Study Director

Intervention Browse Module

MeSH Terms

ID	Term
C000711671	enoxaparin sodium

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided