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

Trial summary

Enrollment Goal
4235
Trial Dates
August 2007 - May 2009
Phase
N/A
Could I Receive a placebo
No
Products
Aspirin (Acetylsalicylic Acid, BAYE4465)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many Locations, Germany

Primary Outcome

  • Overall and gastrointestinal tolerability assessed by questionnaire
    date_rangeTime Frame:
    After 12 months
    enhanced_encryption
    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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