ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01428531
Recruitment Status : Completed
First Posted : September 5, 2011
Last Update Posted : July 15, 2015
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Brief Summary:

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 or disease Intervention/treatment
Ataxia Drug: Fondaparinux Sodium

Study Type : Observational
Actual Enrollment : 200 participants
Time Perspective: Prospective
Official Title: Special Drug Use Investigation for Arixtra® (Fondaparinux) Venous Thromboembolism Treatment
Study Start Date : January 2012
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015


Group/Cohort Intervention/treatment
Patients prescribed fondaparinux Drug: Fondaparinux Sodium



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


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
Criteria

Inclusion Criteria:

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

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01428531


Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01428531     History of Changes
Other Study ID Numbers: 115489
First Posted: September 5, 2011    Key Record Dates
Last Update Posted: July 15, 2015
Last Verified: July 2015

Additional relevant MeSH terms:
Thromboembolism
Venous Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Fondaparinux
PENTA
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents