<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/NCT03021265</url>
  </required_header>
  <id_info>
    <org_study_id>1348.6</org_study_id>
    <nct_id>NCT03021265</nct_id>
  </id_info>
  <brief_title>To Evaluate Real-world Safety, Effectiveness and Appropriate Use of Micatrio® Combination Tablets Treatment in Patients With Hypertension</brief_title>
  <official_title>The Special Drug Use-results Survey on Long-term Use of Telmisartan 80 mg/Amlodipine 5 mg/Hydrochlorothiazide 12.5 mg Fixed Dose Combination Tablets in Patients With Hypertension</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boehringer Ingelheim</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boehringer Ingelheim</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Study to evaluate real-world safety, effectiveness and appropriate use of Micatrio®&#xD;
      Combination Tablets treatment in patients with hypertension&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Non-interventional study based on newly collected data. The study will consist of a baseline&#xD;
      visit and follow-up visits at Week 4, 8, 12, 24, 36 and 52 for patients who have newly&#xD;
      initiated Micatrio® Combination Tablets. The patients will be followed up until&#xD;
      discontinuation of Micatrio® Combination Tablets treatment or the end of study.&#xD;
&#xD;
      All patients administrated Micatrio® Combination Tablets after the launch at the sites&#xD;
      contracted with the sponsor will be registered.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 20, 2017</start_date>
  <completion_date type="Actual">April 11, 2019</completion_date>
  <primary_completion_date type="Actual">April 11, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Frequency of Patients With Any Suspected Adverse Drug Reactions</measure>
    <time_frame>from first intake of Micatrio combination tablet until last intake +1 day (week 52)</time_frame>
    <description>An Adverse drug reaction (ADR) is defined as an AE for which either the investigator or the sponsor (or both) assess the causal relationship to Micatrio Combination Tablets as related. The frequency of patients with any suspected ADR is presented as total number of participants with an ADR reported.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Clinic Diastolic Blood Pressure at Week 52</measure>
    <time_frame>At baseline and week 52</time_frame>
    <description>Change from baseline in clinic diastolic blood pressure (DBP) millimeters of mercury [mmHg] at Week 52</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Clinic Systolic Blood Pressure at Week 52</measure>
    <time_frame>At baseline and week 52</time_frame>
    <description>Change from baseline in clinic systolic blood pressure (SBP) millimeters of mercury at Week 52</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">676</enrollment>
  <condition>Hypertension</condition>
  <arm_group>
    <arm_group_label>T80/A5/H12.5 FDC</arm_group_label>
    <description>Patients with hypertension</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>T80/A5/H12.5 FDC</intervention_name>
    <description>Drug</description>
    <arm_group_label>T80/A5/H12.5 FDC</arm_group_label>
    <other_name>MICATRIO</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        500&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  Patients who are prescribed with Micatrio® Combination Tablets by the discretion of&#xD;
             investigators based on the Japanese package insert&#xD;
&#xD;
          -  Patients who have never been treated with Micatrio® Combination Tablets before&#xD;
             enrolment&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
        Patients who are participating/planned to participate in a clinical trial&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</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>
  <overall_official>
    <last_name>Rie Ikeda, +81364172200</last_name>
    <role>Study Chair</role>
    <affiliation>zzCDMJP_PV_PMS@boehringer-ingelheim.com</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Nippon Boehringer Ingelheim Co., Ltd</name>
      <address>
        <city>Tokyo</city>
        <zip>4570047</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <link>
    <url>http://trials.boehringer-ingelheim.com</url>
    <description>Related Info</description>
  </link>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>January 12, 2017</study_first_submitted>
  <study_first_submitted_qc>January 12, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 13, 2017</study_first_posted>
  <results_first_submitted>April 3, 2020</results_first_submitted>
  <results_first_submitted_qc>May 7, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">May 12, 2020</results_first_posted>
  <last_update_submitted>May 7, 2020</last_update_submitted>
  <last_update_submitted_qc>May 7, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 12, 2020</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>Hypertension</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>October 16, 2015</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/65/NCT03021265/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>January 31, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/65/NCT03021265/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>This was an observational study based on newly collected data under real-world practice in participants with hypertension in Japan.</recruitment_details>
      <pre_assignment_details>Non-randomized, post marketing surveillance, a prospective study using a continuous investigation system. No specific criteria (e.g. demographic, baseline concomitant drug in use) were defined for participant enrollment. Participants were enrolled from February 2017 to January 2018 (The first existed in Jan, system opened with delay on Feb).</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Micatrio® Combination Tablets</title>
          <description>Micatrio® Combination Tablets, telmisartan 80 milligram (mg)/amlodipine 5 mg/hydrochlorothiazide 12.5 mg</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="676"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="554"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="122"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="29"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Improved</title>
              <participants_list>
                <participants group_id="P1" count="17"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="67"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>No reason given</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>No visit since the first visit</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Safety Set: This patient set included all patients who did not have important protocol violations regarding safety and regulatory issues.&#xD;
4 patients were exclude because of missing visit after baseline</population>
      <group_list>
        <group group_id="B1">
          <title>Micatrio® Combination Tablets</title>
          <description>Micatrio® Combination Tablets, telmisartan 80 milligram (mg)/amlodipine 5 mg/hydrochlorothiazide 12.5 mg</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="672"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="672"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="68.8" spread="13.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="672"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="269"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="403"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Frequency of Patients With Any Suspected Adverse Drug Reactions</title>
        <description>An Adverse drug reaction (ADR) is defined as an AE for which either the investigator or the sponsor (or both) assess the causal relationship to Micatrio Combination Tablets as related. The frequency of patients with any suspected ADR is presented as total number of participants with an ADR reported.</description>
        <time_frame>from first intake of Micatrio combination tablet until last intake +1 day (week 52)</time_frame>
        <population>Safety Set: This patient set included all patients who did not have important protocol violations regarding safety and regulatory issues.&#xD;
4 patients were excluded because of missing visits after baseline.</population>
        <group_list>
          <group group_id="O1">
            <title>Micatrio® Combination Tablets</title>
            <description>Micatrio® Combination Tablets, telmisartan 80 milligram (mg)/amlodipine 5 mg/hydrochlorothiazide 12.5 mg</description>
          </group>
        </group_list>
        <measure>
          <title>Frequency of Patients With Any Suspected Adverse Drug Reactions</title>
          <description>An Adverse drug reaction (ADR) is defined as an AE for which either the investigator or the sponsor (or both) assess the causal relationship to Micatrio Combination Tablets as related. The frequency of patients with any suspected ADR is presented as total number of participants with an ADR reported.</description>
          <population>Safety Set: This patient set included all patients who did not have important protocol violations regarding safety and regulatory issues.&#xD;
4 patients were excluded because of missing visits after baseline.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="672"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Clinic Diastolic Blood Pressure at Week 52</title>
        <description>Change from baseline in clinic diastolic blood pressure (DBP) millimeters of mercury [mmHg] at Week 52</description>
        <time_frame>At baseline and week 52</time_frame>
        <population>The effectiveness set included all patients in safety set with approved indication and had effectiveness information and no effectiveness related protocol violation. Only participants with data in baseline and week 52 were included in this analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Micatrio® Combination Tablets</title>
            <description>Micatrio® Combination Tablets, telmisartan 80 milligram (mg)/amlodipine 5 mg/hydrochlorothiazide 12.5 mg</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Clinic Diastolic Blood Pressure at Week 52</title>
          <description>Change from baseline in clinic diastolic blood pressure (DBP) millimeters of mercury [mmHg] at Week 52</description>
          <population>The effectiveness set included all patients in safety set with approved indication and had effectiveness information and no effectiveness related protocol violation. Only participants with data in baseline and week 52 were included in this analysis.</population>
          <units>millimeters of mercury (mmHG)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="654"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.0" spread="10.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Clinic Systolic Blood Pressure at Week 52</title>
        <description>Change from baseline in clinic systolic blood pressure (SBP) millimeters of mercury at Week 52</description>
        <time_frame>At baseline and week 52</time_frame>
        <population>The effectiveness set included all patients in safety set with approved indication and had effectiveness information and no effectiveness related protocol violation. Only participants with data in baseline and week 52 were included in this analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Micatrio® Combination Tablets</title>
            <description>Micatrio® Combination Tablets, telmisartan 80 milligram (mg)/amlodipine 5 mg/hydrochlorothiazide 12.5 mg</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Clinic Systolic Blood Pressure at Week 52</title>
          <description>Change from baseline in clinic systolic blood pressure (SBP) millimeters of mercury at Week 52</description>
          <population>The effectiveness set included all patients in safety set with approved indication and had effectiveness information and no effectiveness related protocol violation. Only participants with data in baseline and week 52 were included in this analysis.</population>
          <units>millimeters of mercury (mmHG)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="654"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.6" spread="15.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>from first intake of Micatrio combination tablet until last intake +1 day (week 52)</time_frame>
      <desc>Safety Set: This patient set included all patients who did not have important protocol violations regarding safety and regulatory issues.&#xD;
4 patients were excluded because of missing visits after baseline.</desc>
      <group_list>
        <group group_id="E1">
          <title>Micatrio</title>
          <description>Micatrio® Combination Tablets, telmisartan 80 milligram (mg)/amlodipine 5 mg/hydrochlorothiazide 12.5 mg</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 21.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="672"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="20" subjects_at_risk="672"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Neutropenia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="672"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Acute myocardial infarction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="672"/>
              </event>
              <event>
                <sub_title>Angina unstable</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="672"/>
              </event>
              <event>
                <sub_title>Cardiac failure chronic</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="672"/>
              </event>
              <event>
                <sub_title>Cardio-respiratory arrest</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="672"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperparathyroidism primary</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="672"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="672"/>
              </event>
              <event>
                <sub_title>Diverticulum intestinal haemorrhagic</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="672"/>
              </event>
              <event>
                <sub_title>Duodenal ulcer</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="672"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Hepatic function abnormal</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="672"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="672"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Blood pressure decreased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="672"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="672"/>
              </event>
              <event>
                <sub_title>Diabetes mellitus</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="672"/>
              </event>
              <event>
                <sub_title>Hypercalcaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="672"/>
              </event>
              <event>
                <sub_title>Hyponatraemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="672"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Osteoarthritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="672"/>
              </event>
              <event>
                <sub_title>Rhabdomyolysis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="672"/>
              </event>
              <event>
                <sub_title>Rheumatoid arthritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="672"/>
              </event>
              <event>
                <sub_title>Rotator cuff syndrome</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="672"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Bladder neoplasm</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="672"/>
              </event>
              <event>
                <sub_title>Colon cancer</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="672"/>
              </event>
              <event>
                <sub_title>Metastases to bone</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="672"/>
              </event>
              <event>
                <sub_title>Pancreatic carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="672"/>
              </event>
              <event>
                <sub_title>Brain neoplasm</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="672"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Cerebral infarction</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="672"/>
              </event>
              <event>
                <sub_title>Autonomic nervous system imbalance</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="672"/>
              </event>
              <event>
                <sub_title>Coma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="672"/>
              </event>
              <event>
                <sub_title>Brain injury</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="672"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Asphyxia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="672"/>
              </event>
              <event>
                <sub_title>Aspiration</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="672"/>
              </event>
              <event>
                <sub_title>Hypoxia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="672"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Transcatheter aortic valve implantation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="672"/>
              </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="672"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>The study was conducted in an unblinded manner and without controls. The explanatory power of the study results was limited and the study results should be interpreted with the necessary caution.</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/NCT03021265
org study id: 1348.6
nct id: NCT03021265
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Study to evaluate real-world safety, effectiveness and appropriate use of Micatrio®
      Combination Tablets treatment in patients with hypertension
Non-interventional study based on newly collected data. The study will consist of a baseline
      visit and follow-up visits at Week 4, 8, 12, 24, 36 and 52 for patients who have newly
      initiated Micatrio® Combination Tablets. The patients will be followed up until
      discontinuation of Micatrio® Combination Tablets treatment or the end of study.

      All patients administrated Micatrio® Combination Tablets after the launch at the sites
      contracted with the sponsor will be registered.
observational model: Cohort
time perspective: Prospective
measure: Frequency of Patients With Any Suspected Adverse Drug Reactions
time frame: from first intake of Micatrio combination tablet until last intake +1 day (week 52)
description: An Adverse drug reaction (ADR) is defined as an AE for which either the investigator or the sponsor (or both) assess the causal relationship to Micatrio Combination Tablets as related. The frequency of patients with any suspected ADR is presented as total number of participants with an ADR reported.
measure: Change From Baseline in Clinic Diastolic Blood Pressure at Week 52
time frame: At baseline and week 52
description: Change from baseline in clinic diastolic blood pressure (DBP) millimeters of mercury [mmHg] at Week 52
measure: Change From Baseline in Clinic Systolic Blood Pressure at Week 52
time frame: At baseline and week 52
description: Change from baseline in clinic systolic blood pressure (SBP) millimeters of mercury at Week 52
arm group label: T80/A5/H12.5 FDC
description: Patients with hypertension
intervention type: Drug
intervention name: T80/A5/H12.5 FDC
description: Drug
arm group label: T80/A5/H12.5 FDC
other name: MICATRIO
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 12 Years
maximum age: N/A
healthy volunteers: No
last name: Boehringer Ingelheim
role: Study Chair
affiliation: Boehringer Ingelheim
last name: Rie Ikeda, +81364172200
role: Study Chair
affiliation: zzCDMJP_PV_PMS@boehringer-ingelheim.com
facility: 
country: Japan
url: http://trials.boehringer-ingelheim.com
description: Related Info
responsible party type: Sponsor
mesh term: Hypertension
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: The study was conducted in an unblinded manner and without controls. The explanatory power of the study results was limited and the study results should be interpreted with the necessary caution.
point of contact: 