Pharmacy Based Pharmacoepidemiological Observational Study With Aspirin Protect 100 mg

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT01669824
First received: August 17, 2012
Last updated: NA
Last verified: August 2012
History: No changes posted
  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.


Condition Intervention
Aspirin
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

  Eligibility

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.

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01669824

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

Additional Information:
No publications provided

Responsible Party: Country Medical Director, Bayer Vital GmbH
ClinicalTrials.gov 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:
Aspirin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hematologic Agents
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Central Nervous System Agents

ClinicalTrials.gov processed this record on April 17, 2014