NCT01669824

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
• Phase: —
• Study type: Observational
• Enrollment: 4,235 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Aspirin
• Drug Safety
• Effects, Longterm

Interventions

Type	Name	Description
DRUG	Acetylsalicylic acid (Aspirin, BAYE4465)	Aspirin protect (enteric coated aspirin) 100 mg/single dose/day as long-term medication

Timeline

• Start date: 2007-08-01
• Completion: 2009-05-01
• First posted: 2012-08-21
• Last updated: 2023-09-07

Locations

1 site across 1 country: Germany