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临床试验/NCT01669824
NCT01669824已完成不适用

Tolerability, Compliance and Indications of Aspirin Protect 100 mg in Longterm Use (12 Months) Under Everyday's Conditions - Data Collection With Questionnaires Handed Out in Pharmacies to Aspirin Protect 100 mg Consumers

Bayer0 个研究点目标入组 4,235 人开始时间: 2007年8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
发起方
Bayer
入组人数
4,235
主要终点
Overall and gastrointestinal tolerability assessed by questionnaire

研究概览

简要总结

In this non-interventional one year study, data about overall and particularly gastrointestinal tolerability, indications, cardiovascular risk factors and compliance are collected by basic questionnaires, which are handed out by pharmacists to patients who acquire (in Germany no prescription is needed) Rx (Prescription) or OTC (Over-The-counter) Aspirin protect (enteric coated aspirin) 100 mg and are willing to participate in the study. After 3, 6, 9 and 12 months follow-up questionnaires are sent out. Aim of the study is to get information about safety, usage and compliance under everyday's conditions, because in Germany low-dose aspirin is an OTC product with Rx indication.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

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

  • Patients who buy Aspirin protect 100 mg in a pharmacy and are willing to participate in the study.

排除标准

  • 未提供

研究组 & 干预措施

Group 1

干预措施: Acetylsalicylic acid (Aspirin, BAYE4465) (Drug)

结局指标

主要结局

Overall and gastrointestinal tolerability assessed by questionnaire

时间窗: After 12 months

次要结局

未报告次要终点

研究者

发起方
Bayer
申办方类型
Industry

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