Pharmacy Based Pharmacoepidemiological Observational Study With Aspirin Protect 100 mg

September 6, 2023 updated by: Bayer

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

4235

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Multiple Locations, Germany

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients who buy Aspirin protect 100 mg with or without prescription in German pharmacies and who are willing to participate in the study.

Description

Inclusion Criteria:

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

Exclusion Criteria:

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group 1
Drug: Acetylsalicylic acid (Aspirin, BAYE4465)
Aspirin protect (enteric coated aspirin) 100 mg/single dose/day as long-term medication

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall and gastrointestinal tolerability assessed by questionnaire
Time Frame: After 12 months
After 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Investigators

  • Study Director: Bayer Study Director, Bayer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2007

Study Completion (Actual)

May 1, 2009

Study Registration Dates

First Submitted

August 17, 2012

First Submitted That Met QC Criteria

August 17, 2012

First Posted (Estimated)

August 21, 2012

Study Record Updates

Last Update Posted (Actual)

September 7, 2023

Last Update Submitted That Met QC Criteria

September 6, 2023

Last Verified

August 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12557
  • MUE 053 (Other Identifier: Company internal)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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