Pharmacy Based Pharmacoepidemiological Observational Stud... | NCT01669824

Studies
Pharmacy Based Pharmacoepidemiological Observational Study With Aspirin Protect 100 mg

NCT01669824

Sponsor

Bayer

Status

Completed

Last Update Posted

Sep 7, 2023Actual

Enrollment

4,235Actual

Phase

Not provided

Conditions

Aspirin
Drug Safety
Effects, Longterm

Interventions

Acetylsalicylic acid (Aspirin, BAYE4465)

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
MUE 053	Other Identifier	Company internal

Status Module

Record Verification Date

Aug 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2007

Primary Completion Date

Not provided

Completion Date

May 2009Actual

First Submitted Date

Aug 17, 2012

First Submission Date that Met QC Criteria

Aug 17, 2012

First Posted Date

Aug 21, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 6, 2023

Last Update Posted Date

Sep 7, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

4,235Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group 1			Drug: Acetylsalicylic acid (Aspirin, BAYE4465)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Acetylsalicylic acid (Aspirin, BAYE4465)	Drug	Aspirin protect (enteric coated aspirin) 100 mg/single dose/day as long-term medication	Group 1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Overall and gastrointestinal tolerability assessed by questionnaire		After 12 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Bayer Study Director	Bayer	Study Director

Intervention Browse Module

MeSH Terms

ID	Term
D001241	Aspirin

Ancestor Terms

ID	Term
D012459	Salicylates
D062385	Hydroxybenzoates
D010636	Phenols
D001555	Benzene Derivatives

Browse Leaves

Not provided

Browse Branches

Not provided