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Special Drug Use Investigation for ARIXTRA® (Fondaparinux) Injection

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01420809
First Posted: August 22, 2011
Last Update Posted: May 16, 2017
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.
Information provided by (Responsible Party):
GlaxoSmithKline
  Purpose

This post-marketing surveillance study was designed to collect and assess the information on proper use of fondaparinux injection, such as the safety and efficacy under actual use conditions, in subjects undergoing orthopedic surgery of the lower limb at high risk of developing venous thromboembolism.

(ARIXTRA® is a trademark of the GlaxoSmithKline group of companies.)


Condition
Thromboembolism

Study Type: Observational
Study Design: Observational Model: Other
Time Perspective: Prospective
Official Title: Special Drug Use Investigation for ARIXTRA® (Fondaparinux) Injection

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • The number of incidences of adverse events in Japanese subjects undergoing orthopedic surgery of the lower limb [ Time Frame: 3 months ]
  • Occurrence of adverse events of bleeding [ Time Frame: 3 months ]
  • Presence or absence of venous thromboembolism after treatment of fondaparinux [ Time Frame: 3 months ]

Enrollment: 1280
Study Start Date: September 2007
Study Completion Date: August 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
  Eligibility

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:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Subjects undergoing orthopedic surgery of the lower limb at high risk of developing venous thromboembolism
Criteria

Inclusion Criteria:

  • Subjects undergo orthopedic surgery of the lower limb at high risk of developing venous thromboembolism

Exclusion Criteria:

  Contacts and Locations
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): NCT01420809


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

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01420809     History of Changes
Other Study ID Numbers: 112285
First Submitted: July 28, 2011
First Posted: August 22, 2011
Last Update Posted: May 16, 2017
Last Verified: May 2017

Additional relevant MeSH terms:
Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Fondaparinux
PENTA
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents