Pharmacy Based Pharmacoepidemiological Observational Study With Aspirin Protect 100 mg

Bayer

Status: Completed

Conditions: Effects, Longterm; Drug Safety; Aspirin

Treatments: Drug: Acetylsalicylic acid (Aspirin, BAYE4465)

Study type: Observational

Funder types: Industry

Identifiers

NCT01669824

12557

MUE 053 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 4,235 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

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

Exclusion Criteria:

Trial design

4,235 participants in 1 patient group

Group 1

Treatment:

Drug: Acetylsalicylic acid (Aspirin, BAYE4465)