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Hip Fracture Study of GSK576428 (Fondaparinux Sodium)

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00320424
First received: May 1, 2006
Last updated: October 1, 2010
Last verified: October 2010
History of Changes
  Purpose

This study is requested by PMDA to confirm the efficacy and the safety for HFS.


Condition Intervention Phase
Hip Fracture
Surgery
 Drug: Fondaparinux
 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Clinical Evaluation of GSK576428 (Fondaparinux Sodium) in Prevention of Venous Thromboembolism After Hip Fracture Surgery

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Rate of adjudicated VTE (venous thromboembolism) [DVT (deep vein thrombosis) or PE] based on the assessment of venograms.

Secondary Outcome Measures:
  • Rate of PE, DVT, proximal DVT, distal only DVT

Estimated Enrollment: 50
Study Start Date: February 2006
Study Completion Date: October 2006
Primary Completion Date: October 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 hip fracture surgery within 10 days following the time of fracture of the hip (proximal femur) (or following the time of fracture estimated from trauma).

Exclusion Criteria:

  • Active, clinically significant bleeding (excluding drainage).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00320424

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: NCT00320424     History of Changes
Other Study ID Numbers: AR3106335
Study First Received: May 1, 2006
Last Updated: October 1, 2010
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by GlaxoSmithKline:
MOSLL
VTE
Xa factor
pentasaccharide

Additional relevant MeSH terms:
Fractures, Bone
Hip Fractures
Venous Thromboembolism
Wounds and Injuries
Femoral Fractures
Hip Injuries
Leg Injuries
Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
 Thrombosis
Fondaparinux
PENTA
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on May 22, 2013