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NCT01669824 Clinical Trial

Pharmacy Based Pharmacoepidemiological Observational Study With Aspirin Protect 100 mg

Drug Safety Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01669824
Other study ID # 12557
Secondary ID MUE 053
Status Completed
Phase
First received
Last updated
Start date August 2007
Est. completion date May 2009

Study information
Verified date August 2012
Source Bayer
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 4235
Est. completion date May 2009
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients who buy Aspirin protect 100 mg in a pharmacy and are willing to participate in the study. Exclusion Criteria:

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Acetylsalicylic acid (Aspirin, BAYE4465)
Aspirin protect (enteric coated aspirin) 100 mg/single dose/day as long-term medication

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Bayer

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Overall and gastrointestinal tolerability assessed by questionnaire After 12 months
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