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Total Hip Replacement Study Of GSK576428 (Fondaparinux Sodium)

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00320398
First received: May 1, 2006
Last updated: October 1, 2010
Last verified: October 2010
  Purpose

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


Condition Intervention Phase
Arthroplasty, Replacement, Hip
Venous Thromboembolism
Drug: Fondaparinux
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: Clinical Evaluation of GSK576428 (Fondaparinux Sodium) in Prevention of Venous Thromboembolism After Elective Total Hip Replacement Surgery

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Rate of VTE (venous thromboembolism) rate and major bleeding

Secondary Outcome Measures:
  • Rate of DVT(deep vein thrombosis) [proximal, distal] and PE.

Estimated Enrollment: 100
Study Start Date: January 2006
Study Completion Date: July 2006
Primary Completion Date: July 2006 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Fondaparinux
    Other Name: Fondaparinux
  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients undergoing either an elective primary THR (total hip replacement) surgery or a revision of a THR.

Exclusion Criteria:

  • Active, clinically significant bleeding (excluding drainage).
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00320398

Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Study Director, GSK
ClinicalTrials.gov Identifier: NCT00320398     History of Changes
Other Study ID Numbers: AR3106333
Study First Received: May 1, 2006
Last Updated: October 1, 2010
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by GlaxoSmithKline:
Fondaparinux
MOSLL
THR
VTE
Xa factor
pentasaccharide
Hip Replacement Arthroplasty

Additional relevant MeSH terms:
Thromboembolism
Venous Thromboembolism
Venous Thrombosis
Cardiovascular Diseases
Embolism and Thrombosis
Thrombosis
Vascular Diseases
Fondaparinux
PENTA
Anticoagulants
Cardiovascular Agents
Fibrin Modulating Agents
Fibrinolytic Agents
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014