Special Drug Use Investigation for ARIXTRA® (Fondaparinux) Injection

This post-marketing surveillance study was designed to collect and assess the information on proper use of fondaparinux injection, such as the safety and efficacy under actual use conditions, in subjects undergoing orthopedic surgery of the lower limb at high risk of developing venous thromboembolism.

(ARIXTRA® is a trademark of the GlaxoSmithKline group of companies.)

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Key information

Conditions

Thromboembolism Cardiovascular Diseases Embolism and Thrombosis Vascular Diseases

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

Subjects undergo orthopedic surgery of the lower limb at high risk of developing venous thromboembolism

Exclusion criteria

Not applicable

Treatment and study plan

Primary outcomes

The number of incidences of adverse events in Japanese subjects undergoing orthopedic surgery of the lower limb

Time frame: 3 months
Occurrence of adverse events of bleeding

Time frame: 3 months
Presence or absence of venous thromboembolism after treatment of fondaparinux

Time frame: 3 months

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Important dates

Study start: 2007
Primary completion: 2009
Study completion: 2009
First posted: Aug 22, 2011
Registry last updated: May 16, 2017

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.

Published trials that share one or more normalized conditions with this study.

Completed