Pharmacy Based Pharmacoepidemiological Observational Study With Aspirin Protect 100 mg

Sponsor
Bayer (Industry)
Overall Status
Completed
CT.gov ID
NCT01669824
Collaborator
(none)
4,235
1
21
201.7

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
  • Drug: Acetylsalicylic acid (Aspirin, BAYE4465)

Study Design

Study Type:
Observational
Actual Enrollment :
4235 participants
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
Study Start Date :
Aug 1, 2007
Actual Study Completion Date :
May 1, 2009

Arms and Interventions

Arm Intervention/Treatment
Group 1

Drug: Acetylsalicylic acid (Aspirin, BAYE4465)
Aspirin protect (enteric coated aspirin) 100 mg/single dose/day as long-term medication

Outcome Measures

Primary Outcome Measures

  1. Overall and gastrointestinal tolerability assessed by questionnaire [After 12 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Many Locations Germany

Sponsors and Collaborators

  • Bayer

Investigators

  • Study Director: Bayer Study Director, Bayer

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT01669824
Other Study ID Numbers:
  • 12557
  • MUE 053
First Posted:
Aug 21, 2012
Last Update Posted:
Aug 21, 2012
Last Verified:
Aug 1, 2012
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 21, 2012