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Pharmacy Based Pharmacoepidemiological Observational Study With Aspirin Protect 100 mg

NCT01669824 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 4235

Last updated 2023-09-07

No results posted yet for this study

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.

Conditions

  • Aspirin
  • Drug Safety
  • Effects, Longterm

Interventions

DRUG

Acetylsalicylic acid (Aspirin, BAYE4465)

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

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-08-31
Completion
2009-05-31

Countries

  • Germany

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01669824 on ClinicalTrials.gov