check_circleStudy Completed
Aspirin, Drug Safety, Effects, Longterm
Bayer Identifier:
12557
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Pharmacy based pharmacoepidemiological observational study with Aspirin protect 100 mg
Trial 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.
Key Participants Requirements
Sex
BothAge
N/ATrial summary
Enrollment Goal
4235Trial Dates
August 2007 - May 2009Phase
N/ACould I Receive a placebo
NoProducts
Aspirin (Acetylsalicylic Acid, BAYE4465)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Many Locations, Germany |
Primary Outcome
- Overall and gastrointestinal tolerability assessed by questionnairedate_rangeTime Frame:After 12 monthsenhanced_encryptionYesSafety Issue:
Trial design
Trial Type
ObservationalIntervention Type
DrugTrial Purpose
N/AAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A