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Clinical Trials/NCT01420809
NCT01420809CompletedNot Applicable

Special Drug Use Investigation for ARIXTRA® (Fondaparinux) Injection

GlaxoSmithKline0 sites1,280 target enrollmentStarted: September 2007Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
1,280
Primary Endpoint
Occurrence of adverse events of bleeding
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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.)

Study Design

Study Type
Observational
Observational Model
Other
Time Perspective
Prospective

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

  • •Not applicable

Outcomes

Primary Outcomes

Occurrence of adverse events of bleeding

Time Frame: 3 months

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

Time Frame: 3 months

Presence or absence of venous thromboembolism after treatment of fondaparinux

Time Frame: 3 months

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

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