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Hip Fracture Study of GSK576428 (Fondaparinux Sodium)

This study has been completed.
Information provided by:
GlaxoSmithKline Identifier:
First received: May 1, 2006
Last updated: October 1, 2010
Last verified: October 2010
This study is requested by PMDA to confirm the efficacy and the safety for HFS.

Condition Intervention Phase
Hip Fracture
Drug: Fondaparinux
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
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:

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)

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

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
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 identifier: NCT00320424

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

Responsible Party: Study Director, GSK Identifier: NCT00320424     History of Changes
Other Study ID Numbers: AR3106335
Study First Received: May 1, 2006
Last Updated: October 1, 2010

Keywords provided by GlaxoSmithKline:
Xa factor

Additional relevant MeSH terms:
Fractures, Bone
Hip Fractures
Wounds and Injuries
Femoral Fractures
Hip Injuries
Leg Injuries
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action processed this record on March 22, 2017