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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Bayer
- Enrollment
- 4,235
- Primary Endpoint
- Overall and gastrointestinal tolerability assessed by questionnaire
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients who buy Aspirin protect 100 mg in a pharmacy and are willing to participate in the study.
Exclusion Criteria
- Not provided
Arms & Interventions
Group 1
Intervention: Acetylsalicylic acid (Aspirin, BAYE4465) (Drug)
Outcomes
Primary Outcomes
Overall and gastrointestinal tolerability assessed by questionnaire
Time Frame: After 12 months
Secondary Outcomes
No secondary outcomes reported