<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01669824</url>
  </required_header>
  <id_info>
    <org_study_id>12557</org_study_id>
    <secondary_id>MUE 053</secondary_id>
    <nct_id>NCT01669824</nct_id>
  </id_info>
  <brief_title>Pharmacy Based Pharmacoepidemiological Observational Study With Aspirin Protect 100 mg</brief_title>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bayer</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bayer</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In this non-interventional one year study, data about overall and particularly&#xD;
      gastrointestinal tolerability, indications, cardiovascular risk factors and compliance are&#xD;
      collected by basic questionnaires, which are handed out by pharmacists to patients who&#xD;
      acquire (in Germany no prescription is needed) Rx (Prescription) or OTC (Over-The-counter)&#xD;
      Aspirin protect (enteric coated aspirin) 100 mg and are willing to participate in the study.&#xD;
      After 3, 6, 9 and 12 months follow-up questionnaires are sent out. Aim of the study is to get&#xD;
      information about safety, usage and compliance under everyday's conditions, because in&#xD;
      Germany low-dose aspirin is an OTC product with Rx indication.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2007</start_date>
  <completion_date type="Actual">May 2009</completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Overall and gastrointestinal tolerability assessed by questionnaire</measure>
    <time_frame>After 12 months</time_frame>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">4235</enrollment>
  <condition>Aspirin</condition>
  <condition>Drug Safety</condition>
  <condition>Effects, Longterm</condition>
  <arm_group>
    <arm_group_label>Group 1</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Acetylsalicylic acid (Aspirin, BAYE4465)</intervention_name>
    <description>Aspirin protect (enteric coated aspirin) 100 mg/single dose/day as long-term medication</description>
    <arm_group_label>Group 1</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients who buy Aspirin protect 100 mg with or without prescription in German pharmacies&#xD;
        and who are willing to participate in the study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients who buy Aspirin protect 100 mg in a pharmacy and are willing to participate&#xD;
             in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bayer Study Director</last_name>
    <role>Study Director</role>
    <affiliation>Bayer</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Multiple Locations</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>August 17, 2012</study_first_submitted>
  <study_first_submitted_qc>August 17, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 21, 2012</study_first_posted>
  <last_update_submitted>September 6, 2023</last_update_submitted>
  <last_update_submitted_qc>September 6, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 7, 2023</last_update_posted>
  <responsible_party>
    <name_title>Country Medical Director</name_title>
    <organization>Bayer Vital GmbH</organization>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aspirin</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01669824
org study id: 12557
secondary id: MUE 053
nct id: NCT01669824
lead sponsor: 
has dmc: No
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.
observational model: Other
time perspective: Prospective
measure: Overall and gastrointestinal tolerability assessed by questionnaire
time frame: After 12 months
arm group label: Group 1
intervention type: Drug
intervention name: Acetylsalicylic acid (Aspirin, BAYE4465)
description: Aspirin protect (enteric coated aspirin) 100 mg/single dose/day as long-term medication
arm group label: Group 1
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Bayer Study Director
role: Study Director
affiliation: Bayer
facility: 
country: Germany
name title: Country Medical Director
organization: Bayer Vital GmbH
mesh term: Aspirin