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Special Drug Use Investigation (Retrospective) for Arixtra® (Fondaparinux) Venous Thromboembolism Treatment (Over 100kg)

This study is not yet open for participant recruitment.
Verified January 2012 by GlaxoSmithKline
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01428544
First received: September 1, 2011
Last updated: March 8, 2012
Last verified: January 2012
History of Changes
  Purpose

The purpose of this post-marketing surveillance study is to collect and assess information retrospectively on safety and efficacy of fondaparinux injection in patients with venous thromboembolism (VTE) whose body weight is 100 kilograms (kg) or more, or to whom fondaparinux was injected 10 mg/day.

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


Condition Intervention
Venous Thromboembolism
 Drug: Fondaparinux sodium

Study Type: Observational
Study Design: Time Perspective: Retrospective
Official Title: Special Drug Use Investigation (Retrospective) for Arixtra® (Fondaparinux) Venous Thromboembolism Treatment (Over 100kg)

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: 30
Study Start Date: March 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 with VTE 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 whose body weight is 100 kg or more, or to whom fondaparinux was injected 10 mg/day.

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: NCT01428544

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: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01428544     History of Changes
Other Study ID Numbers: 115490
Study First Received: September 1, 2011
Last Updated: March 8, 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 23, 2013