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Clinical Trials/NCT01428531
NCT01428531CompletedNot Applicable

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

GlaxoSmithKline0 sites200 target enrollmentStarted: January 2012Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
200
Primary Endpoint
Number of patients with adverse drug reaction
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

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.)

Study Design

Study Type
Observational
Time Perspective
Prospective

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Patients prescribed fondaparinux

Intervention: Fondaparinux Sodium (Drug)

Outcomes

Primary Outcomes

Number of patients with adverse drug reaction

Time Frame: 3 months

Number of patients with any serious adverse event

Time Frame: 3 months

Number of patients with any hemorrhagic adverse event

Time Frame: 3 months

Presence or absence of reoccurrence of VTE

Time Frame: 3 months

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

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