<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/NCT02240654</url>
  </required_header>
  <id_info>
    <org_study_id>1160.144</org_study_id>
    <nct_id>NCT02240654</nct_id>
  </id_info>
  <brief_title>Evaluation of Potential Off-label Use of Dabigatran Etexilate in Europe</brief_title>
  <official_title>Evaluation of Potential Off-label Use of Dabigatran Etexilate in Europe</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boehringer Ingelheim</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boehringer Ingelheim</source>
  <brief_summary>
    <textblock>
      This is a descriptive, observational, multi-country European cross-sectional study of new&#xD;
      users of dabigatran etexilate that aims to characterise on- and off-label status and other&#xD;
      medical characteristics at the time of the first captured prescription of dabigatran&#xD;
      etexilate in each database. The study will be conducted using Cegedim Strategic Database&#xD;
      (CSD, France), Danish National Databases (Denmark) and Clinical Practice Research Datalink&#xD;
      (CPRD, UK).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study Design:&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 28, 2014</start_date>
  <completion_date type="Actual">May 20, 2016</completion_date>
  <primary_completion_date type="Actual">May 20, 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Participants With Potential Off-label Use Estimated Among New Users of Dabigatran Etexilate in Each of the Data Sources.</measure>
    <time_frame>Time period since approval of the SPAF indication in, France: 01 August 2011 to 30 June 2014; Denmark: 01 August 2011 to 30 November 2013; UK: 01 August 2011 to 30 August 2015.</time_frame>
    <description>Definition of off-label use of oral dabigatran etexilate (DE) was based on use for a disease/medical condition other than labelled indications,as described/documented in the data source used in the respective countries, taking into account the changes in the label within the study period. The prevalence of potential off-label use among new users of DE during the overall study period is calculated as the proportion of patients meeting the definition of off-label use by dividing the number of index prescriptions that represented off-label use by the total number of index prescriptions.&#xD;
Two definitions were applied to estimate potential off-label use based on either recorded diagnoses or proxies: a broad definition of on-label prescribing using codes for disease indication e.g.atrial fibrillation(AF) and a restrictive definition excluding patients with conditions for which the drug is not indicated e.g.valvular AF.&#xD;
SPAF:Stroke &amp; systemic embolism in adult patients with non-valvular AF</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">36573</enrollment>
  <condition>Atrial Fibrillation</condition>
  <arm_group>
    <arm_group_label>Dabigatran etexilate</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        New users of dabigatran etexilate in each database&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          1. Have at least 1 year of enrolment in the electronic database.&#xD;
&#xD;
          2. Have not been prescribed dabigatran etexilate during the 1-year period prior to the&#xD;
             index date.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Boehringer Ingelheim</last_name>
    <role>Study Chair</role>
    <affiliation>Boehringer Ingelheim</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>1160.144.1 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Barcelona</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <link>
    <url>http://trials.boehringer-ingelheim.com</url>
    <description>Related Info</description>
  </link>
  <verification_date>November 2017</verification_date>
  <study_first_submitted>September 15, 2014</study_first_submitted>
  <study_first_submitted_qc>September 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 16, 2014</study_first_posted>
  <results_first_submitted>May 18, 2017</results_first_submitted>
  <results_first_submitted_qc>May 19, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">October 16, 2017</results_first_posted>
  <last_update_submitted>November 6, 2017</last_update_submitted>
  <last_update_submitted_qc>November 6, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">December 15, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Atrial Fibrillation</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>This was a descriptive, observational, non-interventional (NIS) multinational, European cross-sectional study with sources of information for clinical conditions available being highly variable across countries/data sources</recruitment_details>
      <pre_assignment_details>Because it is not possible to rule out duplicate patients across the 2 French panels, all numbers were calculated stratified by data source, and for France further stratified by panel - i.e., not overall.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Dabigatran Etexilate (Pradaxa®)_France (Cardiologists)</title>
          <description>New users of Dabigatran etexilate (Pradaxa capsules, 75 mg, 110 mg and 150 mg) identified from panels of cardiologists in Cegedim Strategic Data Longitudinal Patient Database (CSD-LPD) in France (primary care information)</description>
        </group>
        <group group_id="P2">
          <title>Dabigatran Etexilate (Pradaxa®)_France (GPs)</title>
          <description>New users of Dabigatran etexilate (Pradaxa capsules, 75 mg, 110 mg and 150 mg) identified from panels of general practitioners (GPs) in Cegedim Strategic Data Longitudinal Patient Database (CSD-LPD) in France (primary care information)</description>
        </group>
        <group group_id="P3">
          <title>Dabigatran Etexilate (Pradaxa®)_Denmark</title>
          <description>New users of Dabigatran etexilate (Pradaxa capsules, 75 mg, 110 mg and 150 mg) in National Health Databases in Denmark (DK) (hospital episodes, dispensed ambulatory medications)</description>
        </group>
        <group group_id="P4">
          <title>Dabigatran Etexilate (Pradaxa®)_UK (HES Linkable)</title>
          <description>New users of Dabigatran etexilate (Pradaxa capsules, 75 mg, 110 mg and 150 mg) in Clinical Practice Research Datalink (CPRD) in the United Kingdom (UK) Hospital Episode Statistics (HES) linkable (primary care information, hospital episodes, dispensed ambulatory medications)</description>
        </group>
        <group group_id="P5">
          <title>Dabigatran Etexilate (Pradaxa®)_UK (HES Non-linkable)</title>
          <description>New users of Dabigatran etexilate (Pradaxa capsules, 75 mg, 110 mg and 150 mg) in Clinical Practice Research Datalink (CPRD) in the United Kingdom (UK) non-linkable HES (primary care information)</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="1706"/>
                <participants group_id="P2" count="2813"/>
                <participants group_id="P3" count="28619"/>
                <participants group_id="P4" count="2150"/>
                <participants group_id="P5" count="1285"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1706"/>
                <participants group_id="P2" count="2813"/>
                <participants group_id="P3" count="28619"/>
                <participants group_id="P4" count="2150"/>
                <participants group_id="P5" count="1285"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>The study population included new users of dabigatran etexilate in the study period. New users were defined as those patients who initiated treatment with dabigatran etexilate during the study period and who had not used it during the previous year.</population>
      <group_list>
        <group group_id="B1">
          <title>Dabigatran Etexilate (Pradaxa®)_France (Cardiologists)</title>
          <description>New users of Dabigatran etexilate (Pradaxa capsules, 75 mg, 110 mg and 150 mg) identified from panels of cardiologists in Cegedim Strategic Data Longitudinal Patient Database (CSD-LPD) in France (primary care information)</description>
        </group>
        <group group_id="B2">
          <title>Dabigatran Etexilate (Pradaxa®)_France (GPs)</title>
          <description>New users of Dabigatran etexilate (Pradaxa capsules, 75 mg, 110 mg and 150 mg) identified from panels of general practitioners (GPs) in Cegedim Strategic Data Longitudinal Patient Database (CSD-LPD) in France (primary care information)</description>
        </group>
        <group group_id="B3">
          <title>Dabigatran Etexilate (Pradaxa®)_Denmark</title>
          <description>New users of Dabigatran etexilate (Pradaxa capsules, 75 mg, 110 mg and 150 mg) in National Health Databases in Denmark (DK) (hospital episodes, dispensed ambulatory medications)</description>
        </group>
        <group group_id="B4">
          <title>Dabigatran Etexilate (Pradaxa®)_UK (HES Linkable)</title>
          <description>New users of Dabigatran etexilate (Pradaxa capsules, 75 mg, 110 mg and 150 mg) in Clinical Practice Research Datalink (CPRD) in the United Kingdom (UK) Hospital Episode Statistics (HES) linkable (primary care information, hospital episodes, dispensed ambulatory medications)</description>
        </group>
        <group group_id="B5">
          <title>Dabigatran Etexilate (Pradaxa®)_UK (HES Non-linkable)</title>
          <description>New users of Dabigatran etexilate (Pradaxa capsules, 75 mg, 110 mg and 150 mg) in Clinical Practice Research Datalink (CPRD) in the United Kingdom (UK) non-linkable HES (primary care information)</description>
        </group>
        <group group_id="B6">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="1706"/>
            <count group_id="B2" value="2813"/>
            <count group_id="B3" value="28619"/>
            <count group_id="B4" value="2150"/>
            <count group_id="B5" value="1285"/>
            <count group_id="B6" value="36573"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <description>Because it is not possible to rule out duplicate patients across the 2 French panels, all numbers were calculated stratified by data source, and for France further stratified by panel - i.e., not overall. Totals computed here may not be correct, as those assume that there were no duplicate patients in CSD-LPD.</description>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="75.5" spread="10.0"/>
                    <measurement group_id="B2" value="74.0" spread="10.4"/>
                    <measurement group_id="B3" value="71.8" spread="10.9"/>
                    <measurement group_id="B4" value="74.1" spread="11.2"/>
                    <measurement group_id="B5" value="73.1" spread="11.5"/>
                    <measurement group_id="B6" value="NA" spread="NA">Because it is not possible to rule out duplicate patients across the 2 French panels, all numbers were calculated stratified by data source, and for France further stratified by panel - i.e., not overall.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <description>For 282 patients, information on gender was missing. Because it is not possible to rule out duplicate patients across the 2 French panels, all numbers were calculated stratified by data source, and for France further stratified by panel - i.e., not overall.&#xD;
Total (men, women) may not be correct, as those assume that there were no duplicate patients in CSD-LPD.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="NA">599 female patients and gender for 282 patients was missing</measurement>
                    <measurement group_id="B2" value="1272"/>
                    <measurement group_id="B3" value="13567"/>
                    <measurement group_id="B4" value="938"/>
                    <measurement group_id="B5" value="571"/>
                    <measurement group_id="B6" value="NA">Total not calculated because data are not available (NA) in one or more arms.</measurement>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="NA">825 patients and gender for 282 patients was missing</measurement>
                    <measurement group_id="B2" value="1541"/>
                    <measurement group_id="B3" value="15052"/>
                    <measurement group_id="B4" value="1212"/>
                    <measurement group_id="B5" value="714"/>
                    <measurement group_id="B6" value="NA">Total not calculated because data are not available (NA) in one or more arms.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With Potential Off-label Use Estimated Among New Users of Dabigatran Etexilate in Each of the Data Sources.</title>
        <description>Definition of off-label use of oral dabigatran etexilate (DE) was based on use for a disease/medical condition other than labelled indications,as described/documented in the data source used in the respective countries, taking into account the changes in the label within the study period. The prevalence of potential off-label use among new users of DE during the overall study period is calculated as the proportion of patients meeting the definition of off-label use by dividing the number of index prescriptions that represented off-label use by the total number of index prescriptions.&#xD;
Two definitions were applied to estimate potential off-label use based on either recorded diagnoses or proxies: a broad definition of on-label prescribing using codes for disease indication e.g.atrial fibrillation(AF) and a restrictive definition excluding patients with conditions for which the drug is not indicated e.g.valvular AF.&#xD;
SPAF:Stroke &amp; systemic embolism in adult patients with non-valvular AF</description>
        <time_frame>Time period since approval of the SPAF indication in, France: 01 August 2011 to 30 June 2014; Denmark: 01 August 2011 to 30 November 2013; UK: 01 August 2011 to 30 August 2015.</time_frame>
        <population>The study population included new users of dabigatran etexilate in the study period. New users were defined as those patients who initiated treatment with dabigatran etexilate during the study period and who had not used it during the previous year.</population>
        <group_list>
          <group group_id="O1">
            <title>Dabigatran Etexilate (Pradaxa®)_France (Cardiologists)</title>
            <description>New users of Dabigatran etexilate (Pradaxa capsules, 75 mg, 110 mg and 150 mg) identified from panels of cardiologists in Cegedim Strategic Data Longitudinal Patient Database (CSD-LPD) in France (primary care information)</description>
          </group>
          <group group_id="O2">
            <title>Dabigatran Etexilate (Pradaxa®)_France (GPs)</title>
            <description>New users of Dabigatran etexilate (Pradaxa capsules, 75 mg, 110 mg and 150 mg) identified from panels of general practitioners (GPs) in Cegedim Strategic Data Longitudinal Patient Database (CSD-LPD) in France (primary care information)</description>
          </group>
          <group group_id="O3">
            <title>Dabigatran Etexilate (Pradaxa®)_Denmark</title>
            <description>New users of Dabigatran etexilate (Pradaxa capsules, 75 mg, 110 mg and 150 mg) in National Health Databases in Denmark (DK) (hospital episodes, dispensed ambulatory medications)</description>
          </group>
          <group group_id="O4">
            <title>Dabigatran Etexilate (Pradaxa®)_UK (HES Linkable)</title>
            <description>New users of Dabigatran etexilate (Pradaxa capsules, 75 mg, 110 mg and 150 mg) in Clinical Practice Research Datalink (CPRD) in the United Kingdom (UK) Hospital Episode Statistics (HES) linkable (primary care information, hospital episodes, dispensed ambulatory medications)</description>
          </group>
          <group group_id="O5">
            <title>Dabigatran Etexilate (Pradaxa®)_UK (HES Non-linkable)</title>
            <description>New users of Dabigatran etexilate (Pradaxa capsules, 75 mg, 110 mg and 150 mg) in Clinical Practice Research Datalink (CPRD) in the United Kingdom (UK) non-linkable HES (primary care information)</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Potential Off-label Use Estimated Among New Users of Dabigatran Etexilate in Each of the Data Sources.</title>
          <description>Definition of off-label use of oral dabigatran etexilate (DE) was based on use for a disease/medical condition other than labelled indications,as described/documented in the data source used in the respective countries, taking into account the changes in the label within the study period. The prevalence of potential off-label use among new users of DE during the overall study period is calculated as the proportion of patients meeting the definition of off-label use by dividing the number of index prescriptions that represented off-label use by the total number of index prescriptions.&#xD;
Two definitions were applied to estimate potential off-label use based on either recorded diagnoses or proxies: a broad definition of on-label prescribing using codes for disease indication e.g.atrial fibrillation(AF) and a restrictive definition excluding patients with conditions for which the drug is not indicated e.g.valvular AF.&#xD;
SPAF:Stroke &amp; systemic embolism in adult patients with non-valvular AF</description>
          <population>The study population included new users of dabigatran etexilate in the study period. New users were defined as those patients who initiated treatment with dabigatran etexilate during the study period and who had not used it during the previous year.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1706"/>
                <count group_id="O2" value="2813"/>
                <count group_id="O3" value="28619"/>
                <count group_id="O4" value="2150"/>
                <count group_id="O5" value="1285"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Broad definition</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24.1" lower_limit="22.1" upper_limit="26.1"/>
                    <measurement group_id="O2" value="34.0" lower_limit="32.3" upper_limit="35.8"/>
                    <measurement group_id="O3" value="17.1" lower_limit="16.6" upper_limit="17.5"/>
                    <measurement group_id="O4" value="5.7" lower_limit="4.7" upper_limit="6.7"/>
                    <measurement group_id="O5" value="11.5" lower_limit="9.8" upper_limit="13.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Restrictive definition</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="37.5" lower_limit="35.2" upper_limit="39.8"/>
                    <measurement group_id="O2" value="44.1" lower_limit="42.2" upper_limit="45.9"/>
                    <measurement group_id="O3" value="29.1" lower_limit="28.4" upper_limit="29.7"/>
                    <measurement group_id="O4" value="17.4" lower_limit="15.8" upper_limit="19.1"/>
                    <measurement group_id="O5" value="25.6" lower_limit="23.2" upper_limit="28.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <desc>International Society for Pharmacoepidemiology and European Medicines Agency guidelines state that NIS studies conducted using medical chart reviews/electronic claims/health care records do not require expedited reporting of suspected Adverse events (AEs)/reactions.Given the type of data used for this study,no suspected AEs/reactions were reported</desc>
      <group_list>
        <group group_id="E1">
          <title>Dabigatran Etexilate (Pradaxa®)_France (Cardiologists)</title>
          <description>New users of Dabigatran etexilate (Pradaxa capsules, 75 mg, 110 mg and 150 mg) identified from panels of cardiologists in Cegedim Strategic Data Longitudinal Patient Database (CSD-LPD) in France (primary care information)</description>
        </group>
        <group group_id="E2">
          <title>Dabigatran Etexilate (Pradaxa®)_France (GPs)</title>
          <description>New users of Dabigatran etexilate (Pradaxa capsules, 75 mg, 110 mg and 150 mg) identified from panels of general practitioners (GPs) in Cegedim Strategic Data Longitudinal Patient Database (CSD-LPD) in France (primary care information)</description>
        </group>
        <group group_id="E3">
          <title>Dabigatran Etexilate (Pradaxa®)_Denmark</title>
          <description>New users of Dabigatran etexilate (Pradaxa capsules, 75 mg, 110 mg and 150 mg) in National Health Databases in Denmark (DK) (hospital episodes, dispensed ambulatory medications)</description>
        </group>
        <group group_id="E4">
          <title>Dabigatran Etexilate (Pradaxa®)_UK (HES Linkable)</title>
          <description>New users of Dabigatran etexilate (Pradaxa capsules, 75 mg, 110 mg and 150 mg) in Clinical Practice Research Datalink (CPRD) in the United Kingdom (UK) Hospital Episode Statistics (HES) linkable (primary care information, hospital episodes, dispensed ambulatory medications)</description>
        </group>
        <group group_id="E5">
          <title>Dabigatran Etexilate (Pradaxa®)_UK (HES Non-linkable)</title>
          <description>New users of Dabigatran etexilate (Pradaxa capsules, 75 mg, 110 mg and 150 mg) in Clinical Practice Research Datalink (CPRD) in the United Kingdom (UK) non-linkable HES (primary care information)</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.</restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>Clinical information being highly variable across countries was likely to be major driver of different proportions.UK(HES link) is likely to provide most accurate estimate(France and DK data need to be interpreted cautiously because of limited info)</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Boehringer Ingelheim Call Center</name_or_title>
      <organization>Boehringer Ingelheim</organization>
      <phone>1-800-243-0127</phone>
      <email>clintriage.rdg@boehringer-ingelheim.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02240654
org study id: 1160.144
nct id: NCT02240654
lead sponsor: 
This is a descriptive, observational, multi-country European cross-sectional study of new
      users of dabigatran etexilate that aims to characterise on- and off-label status and other
      medical characteristics at the time of the first captured prescription of dabigatran
      etexilate in each database. The study will be conducted using Cegedim Strategic Database
      (CSD, France), Danish National Databases (Denmark) and Clinical Practice Research Datalink
      (CPRD, UK).
Study Design:
observational model: Other
time perspective: Cross-Sectional
measure: Percentage of Participants With Potential Off-label Use Estimated Among New Users of Dabigatran Etexilate in Each of the Data Sources.
time frame: Time period since approval of the SPAF indication in, France: 01 August 2011 to 30 June 2014; Denmark: 01 August 2011 to 30 November 2013; UK: 01 August 2011 to 30 August 2015.
description: Definition of off-label use of oral dabigatran etexilate (DE) was based on use for a disease/medical condition other than labelled indications,as described/documented in the data source used in the respective countries, taking into account the changes in the label within the study period. The prevalence of potential off-label use among new users of DE during the overall study period is calculated as the proportion of patients meeting the definition of off-label use by dividing the number of index prescriptions that represented off-label use by the total number of index prescriptions.
Two definitions were applied to estimate potential off-label use based on either recorded diagnoses or proxies: a broad definition of on-label prescribing using codes for disease indication e.g.atrial fibrillation(AF) and a restrictive definition excluding patients with conditions for which the drug is not indicated e.g.valvular AF.
SPAF:Stroke & systemic embolism in adult patients with non-valvular AF
arm group label: Dabigatran etexilate
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Boehringer Ingelheim
role: Study Chair
affiliation: Boehringer Ingelheim
facility: 
country: Spain
url: http://trials.boehringer-ingelheim.com
description: Related Info
responsible party type: Sponsor
mesh term: Atrial Fibrillation
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Clinical information being highly variable across countries was likely to be major driver of different proportions.UK(HES link) is likely to provide most accurate estimate(France and DK data need to be interpreted cautiously because of limited info)
point of contact: 