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Special Drug Use Investigation for Arixtra® (Fondaparinux) Venous Thromboembolism Treatment

This study has been completed.
Information provided by (Responsible Party):
GlaxoSmithKline Identifier:
First received: September 1, 2011
Last updated: July 13, 2015
Last verified: July 2015

The purpose of this post-marketing surveillance study is to collect and assess information on safety and efficacy of fondaparinux injection in patients with venous thromboembolism (VTE).

("Arixtra" is a trademark of the GlaxoSmithKline group of companies.)

Condition Intervention
Drug: Fondaparinux Sodium

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Special Drug Use Investigation for Arixtra® (Fondaparinux) Venous Thromboembolism Treatment

Resource links provided by NLM:

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Number of patients with adverse drug reaction [ Time Frame: 3 months ]
  • Number of patients with any serious adverse event [ Time Frame: 3 months ]
  • Number of patients with any hemorrhagic adverse event [ Time Frame: 3 months ]
  • Presence or absence of reoccurrence of VTE [ Time Frame: 3 months ]

Enrollment: 200
Study Start Date: January 2012
Study Completion Date: June 2015
Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Patients prescribed fondaparinux Drug: Fondaparinux Sodium


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Japanese patients with acute pulmonary thromboembolism or acute deep venous thrombosis

Inclusion Criteria:

  • Patients with acute pulmonary thromboembolism or acute deep venous thrombosis
  • Fondaparinux injection must be prescribed for the first time

Exclusion Criteria:

  Contacts and Locations
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Please refer to this study by its identifier: NCT01428531

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

Responsible Party: GlaxoSmithKline Identifier: NCT01428531     History of Changes
Other Study ID Numbers: 115489
Study First Received: September 1, 2011
Last Updated: July 13, 2015

Additional relevant MeSH terms:
Venous Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action processed this record on May 25, 2017