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

This study has been completed.
Information provided by (Responsible Party):
ClinicalTrials.gov 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 ] [ Designated as safety issue: Yes ]
  • Number of patients with any serious adverse event [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  • Number of patients with any hemorrhagic adverse event [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  • Presence or absence of reoccurrence of VTE [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

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


Genders Eligible for Study:   Both
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 ClinicalTrials.gov identifier: NCT01428531

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

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01428531     History of Changes
Other Study ID Numbers: 115489 
Study First Received: September 1, 2011
Last Updated: July 13, 2015
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:
Venous Thromboembolism
Cardiovascular Diseases
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Agents
Fibrin Modulating Agents
Fibrinolytic Agents
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on April 27, 2016