Pharmacy Based Pharmacoepidemiological Observational Study With Aspirin Protect 100 mg

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01669824

Enrollment

4235

Registered

2012-08-21

Start date

2007-08-31

Completion date

2009-05-31

Last updated

2023-09-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aspirin, Drug Safety, Effects, Longterm

Brief summary

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.

Interventions

DRUGAcetylsalicylic acid (Aspirin, BAYE4465)

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

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Overall and gastrointestinal tolerability assessed by questionnaire	After 12 months

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026