ClinicalTrials.gov
ClinicalTrials.gov Menu

Total Hip Replacement Study With XRP4563 (Enoxaparin Sodium)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00349180
Recruitment Status : Completed
First Posted : July 6, 2006
Last Update Posted : March 27, 2009
Sponsor:
Information provided by:
Sanofi

Brief Summary:
This study is performed to confirm the optimal dose for THR (total hip replacement).

Condition or disease Intervention/treatment Phase
Arthroplasty, Replacement, Hip Drug: Enoxaparin sodium Phase 3

Study Type : Interventional  (Clinical Trial)
Enrollment : 156 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: Multicenter, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Enoxaparin Sodium(RP54563)20mg qd and 20mg Bid for 14 Days in Patients With Total Hip Replacement
Study Start Date : June 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hip Replacement




Primary Outcome Measures :
  1. Incidence of VTE

Secondary Outcome Measures :
  1. Incidence of bleeding


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients undergoing elective primary THR (total hip replacement) surgery

Exclusion Criteria:

  • Patient with risk of clinical significant bleeding

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00349180


Locations
Japan
Sanofi-Aventis
Tokyo, Japan
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Yoshihiro IKEDA Sanofi

ClinicalTrials.gov Identifier: NCT00349180     History of Changes
Other Study ID Numbers: EFC6770
First Posted: July 6, 2006    Key Record Dates
Last Update Posted: March 27, 2009
Last Verified: March 2009

Keywords provided by Sanofi:
Total Hip Replacement
Enoxaparin

Additional relevant MeSH terms:
Enoxaparin
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action