Pharmacy Based Pharmacoepidemiological Observational Study With Aspirin Protect 100 mg

This study has been completed.
Information provided by:
Bayer Identifier:
First received: August 17, 2012
Last updated: NA
Last verified: August 2012
History: No changes posted
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.

Condition Intervention
Drug Safety
Effects, Longterm
Drug: Acetylsalicylic acid (Aspirin, BAYE4465)

Study Type: Observational
Study Design: Time Perspective: Prospective
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

Resource links provided by NLM:

Further study details as provided by Bayer:

Primary Outcome Measures:
  • Overall and gastrointestinal tolerability assessed by questionnaire [ Time Frame: After 12 months ] [ Designated as safety issue: Yes ]

Enrollment: 4235
Study Start Date: August 2007
Study Completion Date: May 2009
Groups/Cohorts Assigned Interventions
Group 1 Drug: Acetylsalicylic acid (Aspirin, BAYE4465)
Aspirin protect (enteric coated aspirin) 100 mg/single dose/day as long-term medication


Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who buy Aspirin protect 100 mg with or without prescription in German pharmacies and who are willing to participate in the study.

Inclusion Criteria:

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

Exclusion Criteria:

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01669824

Many Locations, Germany
Sponsors and Collaborators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Country Medical Director, Bayer Vital GmbH Identifier: NCT01669824     History of Changes
Other Study ID Numbers: 12557  MUE 053 
Study First Received: August 17, 2012
Last Updated: August 17, 2012
Health Authority: Germany: none

Additional relevant MeSH terms:
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Cardiovascular Agents
Central Nervous System Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Fibrin Modulating Agents
Fibrinolytic Agents
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Platelet Aggregation Inhibitors
Sensory System Agents
Therapeutic Uses processed this record on February 10, 2016