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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01428544
First received: September 1, 2011
Last updated: June 13, 2013
Last verified: June 2013
  Purpose

The purpose of this post-marketing surveillance study is to collect and assess information retrospectively on safety and effectiveness 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
Ataxia
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:


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: No ]
  • Number of patients with any serious adverse event [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Number of patients with any hemorrhagic adverse event [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Presence or absence of reoccurrence of VTE [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: March 2012
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Patients with VTE treated with fondaparinux
Patients with VTE treated with fondaparinux
Drug: Fondaparinux sodium
For patients whose body weight is 100 kg or more, fondaparinux is injected 10 mg subcutaneously once daily for treatment of acute pulmonary thromboembolism or acute deep venous thrombosis.

  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

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: June 13, 2013
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:
Ataxia
Thromboembolism
Venous Thromboembolism
Venous Thrombosis
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
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 April 16, 2014