ARIXTRA® Adherence in SVT Patients.

NCT ID: NCT01691495

Last Updated: 2015-03-27

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

1 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-10-31

Study Completion Date

2014-08-31

Brief Summary

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Fondaparinux is an anticoagulant used in the prevention and treatment of thromboembolic disease. It has recently been approved in the European Union (EU) for the treatment of patients with isolated superficial vein thrombosis (SVT), i.e. without concomitant deep vein thrombosis (DVT), of the lower limbs. As part of EU approval, GlaxoSmithKline (GSK) committed to evaluate physicians' adherence to fondaparinux prescribing information regarding proper diagnosis and dosing for the treatment of SVT.

The primary objective is to evaluate physicians' adherence to fondaparinux prescribing information for the treatment of patients with SVT without concomitant DVT.

The study is designed as a non-interventional, retrospective chart review of patients prescribed fondaparinux to treat their SVT. The study will be conducted in several EU countries.

ARIXTRA® is a registered trademark of the GlaxoSmithKline group of companies.

Detailed Description

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Conditions

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Thrombosis, Venous

Study Design

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Study Time Perspective

RETROSPECTIVE

Study Groups

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Superficial Vein Thrombosis (SVT)

A representative of geographical regions of patients with Superficial Vein Thrombosis (SVT) who live in several EU countries.

Fondaparinux

Intervention Type DRUG

Physician adherence study to Fondaparinux prescribing information for patients with Superficial Vein Thrombosis (SVT) of the lower limbs

Interventions

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Fondaparinux

Physician adherence study to Fondaparinux prescribing information for patients with Superficial Vein Thrombosis (SVT) of the lower limbs

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of SVT
* Prescribed fondaparinux for the treatment of SVT
* Age 18 years or older

Exclusion Criteria

* Patients should not have been involved in any clinical trial that could influence SVT treatment during the observational period.
Minimum Eligible Age

18 Years

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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115280

Identifier Type: -

Identifier Source: org_study_id

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