Pharmacy Based Pharmacoepidemiological Observational Study With Aspirin Protect 100 mg
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
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Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Group 1
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Drug: Acetylsalicylic acid (Aspirin, BAYE4465)
Aspirin protect (enteric coated aspirin) 100 mg/single dose/day as long-term medication
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Outcome Measures
Primary Outcome Measures
- Overall and gastrointestinal tolerability assessed by questionnaire [After 12 months]
Eligibility Criteria
Criteria
Inclusion Criteria:
- Patients who buy Aspirin protect 100 mg in a pharmacy and are willing to participate in the study.
Exclusion Criteria:
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Many Locations | Germany |
Sponsors and Collaborators
- Bayer
Investigators
- Study Director: Bayer Study Director, Bayer
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 12557
- MUE 053