Study Completed

Aspirin, Drug Safety, Effects, Longterm

Bayer Identifier:

12557

ClinicalTrials.gov Identifier:

NCT01669824

EudraCT Number:

Not Available

EU CT Number:

Not Available

Pharmacy based pharmacoepidemiological observational study with Aspirin protect 100 mg

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.

Key Participants Requirements

Sex

Both

Age

N/A

Inclusion Criteria
- Patients who buy Aspirin protect 100 mg in a pharmacy and are willing to participate in the study.
Exclusion Criteria

Trial summary

Enrollment Goal

4235

Trial Dates

August 2007 - May 2009

Phase

N/A

Could I Receive a placebo

Products

Aspirin (Acetylsalicylic Acid, BAYE4465)

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
Completed		Many Locations, Germany

Primary Outcome

Overall and gastrointestinal tolerability assessed by questionnaire
Time Frame:
After 12 months
Safety Issue:
Yes

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

N/A

Additional Information

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