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Total Hip Replacement Study With XRP4563 (Enoxaparin Sodium)
This study has been completed.
First Received: July 4, 2006   Last Updated: March 26, 2009   History of Changes
Sponsored by: Sanofi-Aventis
Information provided by: Sanofi-Aventis
ClinicalTrials.gov Identifier: NCT00349180
  Purpose

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


Condition Intervention Phase
Arthroplasty, Replacement, Hip
Drug: Enoxaparin sodium
Phase III

Study Type: Interventional
Study Design: Prevention, Randomized, Double-Blind, Dose Comparison, Parallel Assignment, Efficacy Study
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

Resource links provided by NLM:


Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:
  • Incidence of VTE

Secondary Outcome Measures:
  • Incidence of bleeding

Estimated Enrollment: 156
Study Start Date: June 2006
  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00349180

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

Additional Information:
No publications provided

Study ID Numbers: EFC6770
Study First Received: July 4, 2006
Last Updated: March 26, 2009
ClinicalTrials.gov Identifier: NCT00349180     History of Changes
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Sanofi-Aventis:
Total Hip Replacement
Enoxaparin

Study placed in the following topic categories:
Fibrin Modulating Agents
Anticoagulants
Fibrinolytic Agents
Cardiovascular Agents
Enoxaparin

Additional relevant MeSH terms:
Fibrin Modulating Agents
Anticoagulants
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Hematologic Agents
Fibrinolytic Agents
Cardiovascular Agents
Pharmacologic Actions
Enoxaparin

ClinicalTrials.gov processed this record on September 11, 2009