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Special Drug Use Investigation for ARIXTRA® (Fondaparinux) Injection

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01420809
First received: July 28, 2011
Last updated: August 18, 2011
Last verified: August 2011
History of Changes
  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: Time Perspective: Prospective
Official Title: Special Drug Use Investigation for ARIXTRA® (Fondaparinux) Injection

Resource links provided by NLM:

U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]
  • Occurrence of adverse events of bleeding [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  • Presence or absence of venous thromboembolism after treatment of fondaparinux [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

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

Genders Eligible for Study:   Both
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:

  • Not applicable
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01420809

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

No publications provided

Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT01420809     History of Changes
Other Study ID Numbers: 112285
Study First Received: July 28, 2011
Last Updated: August 18, 2011
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:
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