Trial Condition(s):
Aspirin, Drug Safety, Effects, Longterm
Pharmacy based pharmacoepidemiological observational study with Aspirin protect 100 mg
Bayer Identifier:
12557
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
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.
Inclusion Criteria
No Inclusion Criteria Available
Exclusion Criteria
Inclusion Criteria: - Patients who buy Aspirin protect 100 mg in a pharmacy and are willing to participate in the study.
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Investigative Site Many Locations, Germany | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
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 consuments
Trial Type:
Observational
Intervention Type:
Drug
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
1
Primary Outcome
- Overall and gastrointestinal tolerability assessed by questionnaireTimeframe: After 12 months
Additional Information
Copyright © Bayer
Powered by
