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Special Drug Use Investigation for ARIXTRA® (Fondaparinux) Injection

NCT ID: NCT01420809

Last Updated: 2017-05-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1280 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-09-30

Study Completion Date

2009-08-31

Brief Summary

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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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Detailed Description

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Conditions

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Thromboembolism

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Not applicable
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Other Identifiers

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112285

Identifier Type: -

Identifier Source: org_study_id

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