跳至主要内容
临床试验/NCT01691495
NCT01691495已完成不适用

ARIXTRA® Physician Adherence to the Prescribing Information in Isolated Superficial Vein Thrombosis (SVT) Patients.

GlaxoSmithKline0 个研究点目标入组 1 人开始时间: 2012年10月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
1
主要终点
The primary outcome will be a measure of physician adherence.

研究概览

简要总结

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.

研究设计

研究类型
Observational
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

研究组 & 干预措施

Superficial Vein Thrombosis (SVT)

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

干预措施: Fondaparinux (Drug)

结局指标

主要结局

The primary outcome will be a measure of physician adherence.

时间窗: 2

adherence described as the percentage of patients for whom both an ultrasound (or other objective measure) was performed in order to rule out concomitant DVT prior to patients commencing fondaparinux

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

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