NCT01669824

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,235

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2007

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

August 17, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 21, 2012

Completed
Last Updated

September 7, 2023

Status Verified

August 1, 2012

First QC Date

August 17, 2012

Last Update Submit

September 6, 2023

Conditions

AspirinDrug SafetyEffects, Longterm

Outcome Measures

Primary Outcomes (1)

  • Overall and gastrointestinal tolerability assessed by questionnaire

    After 12 months

Study Arms (1)

Group 1

Drug: Acetylsalicylic acid (Aspirin, BAYE4465)

Interventions

Acetylsalicylic acid (Aspirin, BAYE4465)DRUG

Aspirin protect (enteric coated aspirin) 100 mg/single dose/day as long-term medication

Group 1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Multiple Locations, Germany

Location

MeSH Terms

Interventions

Aspirin

Intervention Hierarchy (Ancestors)

SalicylatesHydroxybenzoatesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 17, 2012

First Posted

August 21, 2012

Study Start

August 1, 2007

Study Completion

May 1, 2009

Last Updated

September 7, 2023

Record last verified: 2012-08

Locations

DE(1)