Pharmacy Based Pharmacoepidemiological Observational Study With Aspirin Protect 100 mg

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.

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Key information

Conditions

Aspirin Drug Safety Effects, Longterm

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Multiple Locations, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

Treatment and study plan

Acetylsalicylic acid (Aspirin, BAYE4465)

Drug

Aspirin protect (enteric coated aspirin) 100 mg/single dose/day as long-term medication

Primary outcomes

Overall and gastrointestinal tolerability assessed by questionnaire

Time frame: After 12 months

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

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

Important dates

Study start: 2007
Study completion: 2009
First posted: Aug 21, 2012
Registry last updated: Sep 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed