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Pharmacy Based Pharmacoepidemiological Observational Study With Aspirin Protect 100 mg

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01669824
First Posted: August 21, 2012
Last Update Posted: August 21, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Bayer
  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 ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01669824


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

Additional Information:
Responsible Party: Country Medical Director, Bayer Vital GmbH
ClinicalTrials.gov Identifier: NCT01669824     History of Changes
Other Study ID Numbers: 12557
MUE 053 ( Other Identifier: Company internal )
First Submitted: August 17, 2012
First Posted: August 21, 2012
Last Update Posted: August 21, 2012
Last Verified: August 2012

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
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics