Pharmacy Based Pharmacoepidemiological Observational Study With Aspirin Protect 100 mg

Completed

• Conditions: Effects, Longterm; Aspirin; Drug Safety
• Interventions: Drug: Acetylsalicylic acid (Aspirin, BAYE4465)

• Registration Number: NCT01669824
• Lead Sponsor: Bayer

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-08
• Study Completion: 2009-05
• Status Verified: 2012-08
• Study First Submitted: 2012-08-17
• Study First Submitted QC: 2012-08-17
• Study First Posted: 2012-08-21
• Last Update Submitted: 2023-09-06
• Last Update Posted: 2023-09-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4235

Inclusion Criteria

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

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	Acetylsalicylic acid (Aspirin, BAYE4465)	-

Primary Outcome Measures

Name	Time	Method
Overall and gastrointestinal tolerability assessed by questionnaire	After 12 months