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

This study is not yet open for participant recruitment.
Verified January 2012 by GlaxoSmithKline
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01428531
First received: September 1, 2011
Last updated: January 12, 2012
Last verified: January 2012
History of Changes
  Purpose

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
Venous Thromboembolism
 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:

U.S. FDA Resources

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 ]

Estimated Enrollment: 200
Study Start Date: January 2012
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Patients prescribed fondaparinux Drug: Fondaparinux Sodium

  Eligibility

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

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Not applicable
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01428531

Contacts
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com

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: NCT01428531     History of Changes
Other Study ID Numbers: 115489
Study First Received: September 1, 2011
Last Updated: January 12, 2012
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:
Thromboembolism
Venous Thromboembolism
Venous Thrombosis
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 16, 2013