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OpenTrials
Completed

NCT Number: NCT01428531

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

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.)

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Key information

Conditions

Ataxia Dyskinesias Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fondaparinux sodium

Drug

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Sep 5, 2011
Registry last updated
Jul 15, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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