<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/NCT02203916</url>
  </required_header>
  <id_info>
    <org_study_id>TAK-491_307</org_study_id>
    <secondary_id>U1111-1130-9186</secondary_id>
    <nct_id>NCT02203916</nct_id>
  </id_info>
  <brief_title>Azilsartan Medoxomil (TAK-491) Compared to Placebo in Korean Adults With Hypertension</brief_title>
  <official_title>A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of TAK-491 in Korean Subjects With Essential Hypertension</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Takeda</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Takeda</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to compare the antihypertensive effect of azilsartan medoxomil&#xD;
      versus placebo in Korean adults with essential hypertension.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The drug being tested in this study is called azilsartan medoxomil. Azilsartan medoxomil is&#xD;
      being tested to treat Korean adults with hypertension. This study will look at changes in&#xD;
      blood pressure in people who take azilsartan medoxomil.&#xD;
&#xD;
      The study will enroll approximately 325 patients. Participants will be randomly assigned (by&#xD;
      chance, like flipping a coin) to one of the three treatment groups-which will remain&#xD;
      undisclosed to the patient and study doctor during the study (unless there is an urgent&#xD;
      medical need):&#xD;
&#xD;
        -  Azilsartan medoxomil 40 mg&#xD;
&#xD;
        -  Azilsartan medoxomil 80 mg&#xD;
&#xD;
        -  Placebo (dummy inactive pill) - this is a tablet that looks like the study drug but has&#xD;
           no active ingredient.&#xD;
&#xD;
      All participants will be asked to take two tablets at the same time each day throughout the&#xD;
      study.&#xD;
&#xD;
      This multi-centre trial will be conducted in Korea. The overall time to participate in this&#xD;
      study is 12 weeks. Participants will make 7 visits to the clinic, and will be contacted by&#xD;
      telephone 7 days after last dose of study drug for a follow-up assessment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">February 2016</completion_date>
  <primary_completion_date type="Actual">January 2016</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change From Baseline to Week 6 in Trough Clinic Sitting Systolic Blood Pressure (SBP)</measure>
    <time_frame>Baseline and Week 6</time_frame>
    <description>The change in trough clinic sitting systolic blood pressure measured at week 6 relative to baseline. The trough is the average of the non-missing values of 3 serial trough sitting systolic blood pressure measurements. Blood pressure was measured using a validated, automated device after the participant had been sitting for at least 5 minutes. Week 6 blood pressure was measured approximately 24 hours after the previous day's dose. An analysis of covariance (ANCOVA) model, with treatment group as a fixed effect and Baseline sitting clinic systolic blood pressure as a covariate was used for analysis.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to Week 6 in Trough Clinic Sitting Diastolic Blood Pressure (DBP)</measure>
    <time_frame>Baseline and Week 6</time_frame>
    <description>The change in trough clinic sitting diastolic blood pressure measured at week 6 relative to baseline. The trough is the average of the non-missing values of 3 serial trough sitting diastolic blood pressure measurements. Blood pressure was measured using a validated, automated device after the participant had been sitting for at least 5 minutes. Week 6 blood pressure was measured approximately 24 hours after the previous day's dose. An analysis of covariance (ANCOVA) model, with treatment group as a fixed effect and Baseline sitting clinic diastolic blood pressure as a covariate was used for analysis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Achieved a Clinic DBP Response at Week 6</measure>
    <time_frame>Baseline and Week 6</time_frame>
    <description>Clinic DBP response is defined as clinic DBP &lt;90 mmHg and/or reduction of ≥10 mmHg from Baseline. DBP is the arithmetic mean of 3 serial diastolic blood pressure measurements.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Achieved a Clinic SBP Response at Week 6</measure>
    <time_frame>Baseline and Week 6</time_frame>
    <description>SBP response is defined as clinic SBP &lt;140 mmHg and/or reduction of ≥20 mmHg from Baseline. SBP is the arithmetic mean of 3 serial systolic blood pressure measurements.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Achieved Both a Clinic DBP and SBP Response at Week 6</measure>
    <time_frame>Baseline and Week 6</time_frame>
    <description>Percentage of participants who achieved both a clinic DBP and SBP response measured at week 6 defined as clinic DBP &lt;90 mmHg and/or reduction of ≥10 mmHg from Baseline AND clinic SBP &lt;140 mmHg and/or reduction of ≥20 mmHg from Baseline. DBP and SBP are based on the arithmetic mean of 3 serial blood pressure measurements.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">328</enrollment>
  <condition>Hypertension</condition>
  <arm_group>
    <arm_group_label>Azilsartan Medoxomil 40 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Azilsartan medoxomil 40 mg, tablets, orally, once daily for 6 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Azilsartan Medoxomil 80 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Azilsartan medoxomil 80 mg, tablets, orally, once daily for 6 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Azilsartan medoxomil placebo-matching tablets, orally, once daily for 6 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Azilsartan medoxomil</intervention_name>
    <description>Azilsartan medoxomil tablets</description>
    <arm_group_label>Azilsartan Medoxomil 40 mg</arm_group_label>
    <arm_group_label>Azilsartan Medoxomil 80 mg</arm_group_label>
    <other_name>TAK-491</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Azilsartan medoxomil placebo</intervention_name>
    <description>Azilsartan medoxomil placebo-matching tablets</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. In the opinion of the investigator, the participant is capable of understanding and&#xD;
             complying with protocol requirements.&#xD;
&#xD;
          2. The participant or, when applicable, the participant's legally acceptable&#xD;
             representative, signs and dates a written informed consent form and any required&#xD;
             privacy authorization prior to the initiation of any study procedures.&#xD;
&#xD;
          3. Is treated with antihypertensive therapy and has a post-washout mean sitting clinic&#xD;
             systolic blood pressure (SBP) ≥150 and ≤180 mm Hg on Day 1; or the patient has not&#xD;
             received antihypertensive treatment within 28 days prior to Screening and has a mean&#xD;
             sitting clinic SBP ≥150 and ≤180 mm Hg at the Screening Visit and on Day 1.&#xD;
&#xD;
          4. Is male or female aged ≥19 years.&#xD;
&#xD;
          5. A female of childbearing potential who is sexually active with a nonsterilized male&#xD;
             partner agrees to routinely use adequate contraception from signing of the informed&#xD;
             consent through 30 days after last study drug dose.&#xD;
&#xD;
          6. Is willing to discontinue current antihypertensive medications on Day -21. If on&#xD;
             amlodipine or chlorthalidone prior to Screening, the participant is willing to&#xD;
             discontinue this medication on Day -28.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Has received any investigational compound within 30 days prior to the first dose of&#xD;
             study medication.&#xD;
&#xD;
          2. Has received TAK-491 in a previous clinical study or as a therapeutic agent.&#xD;
&#xD;
          3. Is an immediate family member, study site employee, or is in a dependent relationship&#xD;
             with a study site employee who is involved in conduct of this study (eg, spouse,&#xD;
             parent, child, sibling) or may consent under duress.&#xD;
&#xD;
          4. Has sitting trough clinic diastolic blood pressure (DBP) greater than 114 mm Hg at Day&#xD;
             1 (after placebo run-in).&#xD;
&#xD;
          5. Has a history of hypersensitivity to TAK-491 (azilsartan medoxomil), any of its&#xD;
             excipients, or other angiotensin-converting enzyme (ARBs).&#xD;
&#xD;
          6. Has a history of myocardial infarction, heart failure, unstable angina, coronary&#xD;
             artery bypass graft, percutaneous coronary intervention, hypertensive encephalopathy,&#xD;
             cerebrovascular accident, or transient ischemic attack.&#xD;
&#xD;
          7. Has clinically significant cardiac conduction defects (e.g., 3rd degree&#xD;
             atrioventricular block, left bundle branch block, sick sinus syndrome, atrial&#xD;
             fibrillation, or flutter).&#xD;
&#xD;
          8. Has hemodynamically significant left ventricular outflow obstruction due to aortic&#xD;
             valvular disease and hypertrophic obstructive cardiomyopathy (HOCM).&#xD;
&#xD;
          9. Has secondary hypertension of any etiology (e.g., renovascular disease,&#xD;
             pheochromocytoma, Cushing syndrome).&#xD;
&#xD;
         10. Is noncompliant (less than 70% or greater than 130%) with study medication during&#xD;
             placebo run-in period.&#xD;
&#xD;
         11. Has severe renal dysfunction or disease (confirmed by calculated creatinine clearance&#xD;
             &lt;30 mL/min/1.73m^2) at Screening.&#xD;
&#xD;
         12. Has known or suspected unilateral or bilateral renal artery stenosis.&#xD;
&#xD;
         13. Has a history of drug or alcohol abuse within the past 2 years.&#xD;
&#xD;
         14. Has a history of cancer that has not been in remission for at least 5 years prior to&#xD;
             the first dose of study drug. (This criterion does not apply to those patients with&#xD;
             basal cell or stage I squamous cell carcinoma of the skin.)&#xD;
&#xD;
         15. Has type 1 or poorly controlled type 2 diabetes mellitus (hemoglobin A1c [HbA1c]&gt;8.0%)&#xD;
             at Screening.&#xD;
&#xD;
         16. Has an alanine aminotransferase (ALT) level greater than 2.5 times the upper limit of&#xD;
             normal, active liver disease, or jaundice at Screening.&#xD;
&#xD;
         17. Has hyperkalemia (defined as serum potassium greater than the upper limit of normal&#xD;
             per the central laboratory) at Screening.&#xD;
&#xD;
         18. Has any other serious disease or condition at screening or randomization that would&#xD;
             compromise participant safety, might affect life expectancy, or make it difficult to&#xD;
             successfully manage and follow the participant according to the protocol.&#xD;
&#xD;
         19. Is required to take excluded medications.&#xD;
&#xD;
         20. If female, is pregnant or lactating or intending to become pregnant before, during, or&#xD;
             within 30 days after participating in this study; or intending to donate ova during&#xD;
             such time period.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Medical Director Clinical Science</last_name>
    <role>Study Director</role>
    <affiliation>Takeda</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Chuncheon-Si</city>
        <state>Gangwon-do</state>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Wonju-Si</city>
        <state>Gangwon-do</state>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Anyang-si</city>
        <state>Gyeonggi-do</state>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Goyang-si</city>
        <state>Gyeonggi-do</state>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Seongnam-si</city>
        <state>Gyeonggi-do</state>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Suwon-si</city>
        <state>Gyeonggi-do</state>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Daegu</city>
        <state>Gyeongsangbuk-do</state>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Yangsan-si</city>
        <state>Gyeongsangnam-do</state>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Jeonju-si</city>
        <state>Jeollabuk-do</state>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Gwangju</city>
        <state>Jeollanam-do</state>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Busan</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Daegu</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Daejeon</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Incheon</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>October 2016</verification_date>
  <study_first_submitted>July 28, 2014</study_first_submitted>
  <study_first_submitted_qc>July 28, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 30, 2014</study_first_posted>
  <results_first_submitted>October 25, 2016</results_first_submitted>
  <results_first_submitted_qc>October 25, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">December 19, 2016</results_first_posted>
  <last_update_submitted>October 25, 2016</last_update_submitted>
  <last_update_submitted_qc>October 25, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 19, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Drug therapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertension</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Azilsartan medoxomil</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Participants took part in the study at 29 investigative sites in Korea from 12 July 2014 to 03 February 2016.</recruitment_details>
      <pre_assignment_details>Participants with a diagnosis of essential hypertension were randomized at a ratio of 2:2:1 into 1 of 3 treatment groups, once a day azilsartan medoxomil 40 mg, 80 mg or placebo. One participant in the 80 mg group was randomized twice, counted once in the randomized set, and is excluded from the Full Analysis Set and Safety Analysis Set.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Placebo</title>
          <description>Azilsartan medoxomil placebo-matching tablets, orally, once daily for 6 weeks.</description>
        </group>
        <group group_id="P2">
          <title>Azilsartan Medoxomil 40 mg</title>
          <description>Azilsartan medoxomil 40 mg, tablets, orally, once daily for 6 weeks.</description>
        </group>
        <group group_id="P3">
          <title>Azilsartan Medoxomil 80 mg</title>
          <description>Azilsartan medoxomil 80 mg, tablets, orally, once daily for 6 weeks.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="65"/>
                <participants group_id="P2" count="132"/>
                <participants group_id="P3" count="131">1 participant was randomized twice and counted only once.</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>Full Analysis Set (FAS)</title>
              <participants_list>
                <participants group_id="P1" count="65"/>
                <participants group_id="P2" count="132"/>
                <participants group_id="P3" count="130">1 participant was randomized twice, counted once in randomized set, and excluded from the FAS.</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>Safety Analysis Set (SAS)</title>
              <participants_list>
                <participants group_id="P1" count="65"/>
                <participants group_id="P2" count="132"/>
                <participants group_id="P3" count="130">1 participant was randomized twice, counted once in randomized set, and excluded from the SAS.</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="57"/>
                <participants group_id="P2" count="122"/>
                <participants group_id="P3" count="120"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="10"/>
                <participants group_id="P3" count="11"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Pretreatment Event/Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Major Protocol Deviation</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Voluntary Withdrawal</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="8"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Reason Not Specified</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Safety Analysis Set (SAS) included all participants who received at least 1 dose of double-blind study drug and were randomized only once.</population>
      <group_list>
        <group group_id="B1">
          <title>Placebo</title>
          <description>Azilsartan medoxomil placebo-matching tablets, orally, once daily for 6 weeks.</description>
        </group>
        <group group_id="B2">
          <title>Azilsartan Medoxomil 40 mg</title>
          <description>Azilsartan medoxomil 40 mg, tablets, orally, once daily for 6 weeks.</description>
        </group>
        <group group_id="B3">
          <title>Azilsartan Medoxomil 80 mg</title>
          <description>Azilsartan medoxomil 80 mg, tablets, orally, once daily for 6 weeks.</description>
        </group>
        <group group_id="B4">
          <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="65"/>
            <count group_id="B2" value="132"/>
            <count group_id="B3" value="130"/>
            <count group_id="B4" value="327"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <title>Overall Study</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="58.8" spread="10.21"/>
                    <measurement group_id="B2" value="59.8" spread="10.75"/>
                    <measurement group_id="B3" value="58.3" spread="11.57"/>
                    <measurement group_id="B4" value="59.0" spread="10.97"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Gender</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="37"/>
                    <measurement group_id="B3" value="37"/>
                    <measurement group_id="B4" value="88"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="51"/>
                    <measurement group_id="B2" value="95"/>
                    <measurement group_id="B3" value="93"/>
                    <measurement group_id="B4" value="239"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Asian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="65"/>
                    <measurement group_id="B2" value="132"/>
                    <measurement group_id="B3" value="130"/>
                    <measurement group_id="B4" value="327"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Korea, Republic Of</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="65"/>
                    <measurement group_id="B2" value="132"/>
                    <measurement group_id="B3" value="130"/>
                    <measurement group_id="B4" value="327"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Height</title>
          <units>cm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="166.1" spread="8.43"/>
                    <measurement group_id="B2" value="164.8" spread="9.09"/>
                    <measurement group_id="B3" value="165.6" spread="8.00"/>
                    <measurement group_id="B4" value="165.4" spread="8.53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Weight</title>
          <units>kg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="70.85" spread="9.892"/>
                    <measurement group_id="B2" value="70.97" spread="12.636"/>
                    <measurement group_id="B3" value="70.32" spread="13.070"/>
                    <measurement group_id="B4" value="70.69" spread="12.291"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body Mass Index (BMI)</title>
          <units>kg/m^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="25.64" spread="2.653"/>
                    <measurement group_id="B2" value="26.02" spread="3.272"/>
                    <measurement group_id="B3" value="25.50" spread="3.460"/>
                    <measurement group_id="B4" value="25.74" spread="3.237"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Smoking Classification</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Never smoked</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="29"/>
                    <measurement group_id="B2" value="71"/>
                    <measurement group_id="B3" value="65"/>
                    <measurement group_id="B4" value="165"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Current smoker</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="22"/>
                    <measurement group_id="B3" value="26"/>
                    <measurement group_id="B4" value="60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ex-smoker</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                    <measurement group_id="B2" value="39"/>
                    <measurement group_id="B3" value="39"/>
                    <measurement group_id="B4" value="102"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Female Reproductive Status</title>
          <description>Female participants only (n=14, 37, 37)</description>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Postmenopausal</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="28"/>
                    <measurement group_id="B3" value="24"/>
                    <measurement group_id="B4" value="61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Surgically Sterile</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Of Childbearing Potential</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="10"/>
                    <measurement group_id="B4" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Estimated Glomerular Filtration Rate(eGFR)</title>
          <units>mL/min/1.73m^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="85.72" spread="14.798"/>
                    <measurement group_id="B2" value="87.44" spread="18.393"/>
                    <measurement group_id="B3" value="88.68" spread="18.443"/>
                    <measurement group_id="B4" value="87.59" spread="17.740"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Diabetes Status</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Yes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="21"/>
                    <measurement group_id="B3" value="13"/>
                    <measurement group_id="B4" value="38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="61"/>
                    <measurement group_id="B2" value="111"/>
                    <measurement group_id="B3" value="117"/>
                    <measurement group_id="B4" value="289"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline to Week 6 in Trough Clinic Sitting Systolic Blood Pressure (SBP)</title>
        <description>The change in trough clinic sitting systolic blood pressure measured at week 6 relative to baseline. The trough is the average of the non-missing values of 3 serial trough sitting systolic blood pressure measurements. Blood pressure was measured using a validated, automated device after the participant had been sitting for at least 5 minutes. Week 6 blood pressure was measured approximately 24 hours after the previous day's dose. An analysis of covariance (ANCOVA) model, with treatment group as a fixed effect and Baseline sitting clinic systolic blood pressure as a covariate was used for analysis.</description>
        <time_frame>Baseline and Week 6</time_frame>
        <population>Participants from the Full Analysis Set (FAS), including all randomized participants, who received at least 1 dose of double-blind study drug, with both a Baseline value and at least 1 post-baseline value, who were randomized only once. Missing values were imputed using last observation carried forward (LOCF).</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Azilsartan medoxomil placebo-matching tablets, orally, once daily for 6 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Azilsartan Medoxomil 40 mg</title>
            <description>Azilsartan medoxomil 40 mg, tablets, orally, once daily for 6 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Azilsartan Medoxomil 80 mg</title>
            <description>Azilsartan medoxomil 80 mg, tablets, orally, once daily for 6 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to Week 6 in Trough Clinic Sitting Systolic Blood Pressure (SBP)</title>
          <description>The change in trough clinic sitting systolic blood pressure measured at week 6 relative to baseline. The trough is the average of the non-missing values of 3 serial trough sitting systolic blood pressure measurements. Blood pressure was measured using a validated, automated device after the participant had been sitting for at least 5 minutes. Week 6 blood pressure was measured approximately 24 hours after the previous day's dose. An analysis of covariance (ANCOVA) model, with treatment group as a fixed effect and Baseline sitting clinic systolic blood pressure as a covariate was used for analysis.</description>
          <population>Participants from the Full Analysis Set (FAS), including all randomized participants, who received at least 1 dose of double-blind study drug, with both a Baseline value and at least 1 post-baseline value, who were randomized only once. Missing values were imputed using last observation carried forward (LOCF).</population>
          <units>mmHg</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="63"/>
                <count group_id="O2" value="127"/>
                <count group_id="O3" value="129"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-8.776" spread="2.0039"/>
                    <measurement group_id="O2" value="-22.093" spread="1.4117"/>
                    <measurement group_id="O3" value="-23.731" spread="1.4017"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>Overall type 1 error rate of 0.05 was controlled using principle of 'closed' testing: each pairwise comparison to placebo was conducted at 0.05 level with no p-value adjustment if hypothesis &quot;all treatment groups equal&quot; was first rejected at 0.05.</p_value_desc>
            <method>ANCOVA</method>
            <method_desc>Post-baseline p-values were from an ANCOVA model with treatment as a fixed factor and baseline values as a continuous covariate.</method_desc>
            <param_type>LS Mean Difference</param_type>
            <param_value>-13.317</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>2.4502</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-18.138</ci_lower_limit>
            <ci_upper_limit>-8.497</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>Overall type 1 error rate of 0.05 was controlled using principle of 'closed' testing: each pairwise comparison to placebo was conducted at 0.05 level with no p-value adjustment if hypothesis &quot;all treatment groups equal&quot; was first rejected at 0.05.</p_value_desc>
            <method>ANCOVA</method>
            <method_desc>Post-baseline p-values were from an ANCOVA model with treatment as a fixed factor and baseline values as a continuous covariate.</method_desc>
            <param_type>LS Mean Difference</param_type>
            <param_value>-14.955</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>2.4470</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-19.770</ci_lower_limit>
            <ci_upper_limit>-10.141</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to Week 6 in Trough Clinic Sitting Diastolic Blood Pressure (DBP)</title>
        <description>The change in trough clinic sitting diastolic blood pressure measured at week 6 relative to baseline. The trough is the average of the non-missing values of 3 serial trough sitting diastolic blood pressure measurements. Blood pressure was measured using a validated, automated device after the participant had been sitting for at least 5 minutes. Week 6 blood pressure was measured approximately 24 hours after the previous day's dose. An analysis of covariance (ANCOVA) model, with treatment group as a fixed effect and Baseline sitting clinic diastolic blood pressure as a covariate was used for analysis.</description>
        <time_frame>Baseline and Week 6</time_frame>
        <population>Participants from the FAS, including all randomized participants, who received at least 1 dose of double-blind study drug, with both a Baseline value and at least 1 post-baseline value, who were randomized only once. Missing values were imputed using last observation carried forward (LOCF).</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Azilsartan medoxomil placebo-matching tablets, orally, once daily for 6 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Azilsartan Medoxomil 40 mg</title>
            <description>Azilsartan medoxomil 40 mg, tablets, orally, once daily for 6 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Azilsartan Medoxomil 80 mg</title>
            <description>Azilsartan medoxomil 80 mg, tablets, orally, once daily for 6 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to Week 6 in Trough Clinic Sitting Diastolic Blood Pressure (DBP)</title>
          <description>The change in trough clinic sitting diastolic blood pressure measured at week 6 relative to baseline. The trough is the average of the non-missing values of 3 serial trough sitting diastolic blood pressure measurements. Blood pressure was measured using a validated, automated device after the participant had been sitting for at least 5 minutes. Week 6 blood pressure was measured approximately 24 hours after the previous day's dose. An analysis of covariance (ANCOVA) model, with treatment group as a fixed effect and Baseline sitting clinic diastolic blood pressure as a covariate was used for analysis.</description>
          <population>Participants from the FAS, including all randomized participants, who received at least 1 dose of double-blind study drug, with both a Baseline value and at least 1 post-baseline value, who were randomized only once. Missing values were imputed using last observation carried forward (LOCF).</population>
          <units>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="63"/>
                <count group_id="O2" value="127"/>
                <count group_id="O3" value="129"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.6" spread="8.60"/>
                    <measurement group_id="O2" value="-10.7" spread="10.12"/>
                    <measurement group_id="O3" value="-11.6" spread="10.12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Who Achieved a Clinic DBP Response at Week 6</title>
        <description>Clinic DBP response is defined as clinic DBP &lt;90 mmHg and/or reduction of ≥10 mmHg from Baseline. DBP is the arithmetic mean of 3 serial diastolic blood pressure measurements.</description>
        <time_frame>Baseline and Week 6</time_frame>
        <population>Participants from the FAS, including all randomized participants, who received at least 1 dose of double-blind study drug, with both a Baseline value and at least 1 post-baseline value, who were randomized only once. Missing values were imputed using last observation carried forward (LOCF).</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Azilsartan medoxomil placebo-matching tablets, orally, once daily for 6 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Azilsartan Medoxomil 40 mg</title>
            <description>Azilsartan medoxomil 40 mg, tablets, orally, once daily for 6 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Azilsartan Medoxomil 80 mg</title>
            <description>Azilsartan medoxomil 80 mg, tablets, orally, once daily for 6 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Achieved a Clinic DBP Response at Week 6</title>
          <description>Clinic DBP response is defined as clinic DBP &lt;90 mmHg and/or reduction of ≥10 mmHg from Baseline. DBP is the arithmetic mean of 3 serial diastolic blood pressure measurements.</description>
          <population>Participants from the FAS, including all randomized participants, who received at least 1 dose of double-blind study drug, with both a Baseline value and at least 1 post-baseline value, who were randomized only once. Missing values were imputed using last observation carried forward (LOCF).</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="63"/>
                <count group_id="O2" value="127"/>
                <count group_id="O3" value="129"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42.9"/>
                    <measurement group_id="O2" value="83.5"/>
                    <measurement group_id="O3" value="85.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Who Achieved a Clinic SBP Response at Week 6</title>
        <description>SBP response is defined as clinic SBP &lt;140 mmHg and/or reduction of ≥20 mmHg from Baseline. SBP is the arithmetic mean of 3 serial systolic blood pressure measurements.</description>
        <time_frame>Baseline and Week 6</time_frame>
        <population>Participants from the FAS, including all randomized participants, who received at least 1 dose of double-blind study drug, with both a Baseline value and at least 1 post-baseline value, who were randomized only once. Missing values were imputed using last observation carried forward (LOCF).</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Azilsartan medoxomil placebo-matching tablets, orally, once daily for 6 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Azilsartan Medoxomil 40 mg</title>
            <description>Azilsartan medoxomil 40 mg, tablets, orally, once daily for 6 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Azilsartan Medoxomil 80 mg</title>
            <description>Azilsartan medoxomil 80 mg, tablets, orally, once daily for 6 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Achieved a Clinic SBP Response at Week 6</title>
          <description>SBP response is defined as clinic SBP &lt;140 mmHg and/or reduction of ≥20 mmHg from Baseline. SBP is the arithmetic mean of 3 serial systolic blood pressure measurements.</description>
          <population>Participants from the FAS, including all randomized participants, who received at least 1 dose of double-blind study drug, with both a Baseline value and at least 1 post-baseline value, who were randomized only once. Missing values were imputed using last observation carried forward (LOCF).</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="63"/>
                <count group_id="O2" value="127"/>
                <count group_id="O3" value="129"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38.1"/>
                    <measurement group_id="O2" value="63.0"/>
                    <measurement group_id="O3" value="65.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Who Achieved Both a Clinic DBP and SBP Response at Week 6</title>
        <description>Percentage of participants who achieved both a clinic DBP and SBP response measured at week 6 defined as clinic DBP &lt;90 mmHg and/or reduction of ≥10 mmHg from Baseline AND clinic SBP &lt;140 mmHg and/or reduction of ≥20 mmHg from Baseline. DBP and SBP are based on the arithmetic mean of 3 serial blood pressure measurements.</description>
        <time_frame>Baseline and Week 6</time_frame>
        <population>Participants from the FAS, including all randomized participants, who received at least 1 dose of double-blind study drug, with both a Baseline value and at least 1 post-baseline value, who were randomized only once. Missing values were imputed using last observation carried forward (LOCF).</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Azilsartan medoxomil placebo-matching tablets, orally, once daily for 6 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Azilsartan Medoxomil 40 mg</title>
            <description>Azilsartan medoxomil 40 mg, tablets, orally, once daily for 6 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Azilsartan Medoxomil 80 mg</title>
            <description>Azilsartan medoxomil 80 mg, tablets, orally, once daily for 6 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Achieved Both a Clinic DBP and SBP Response at Week 6</title>
          <description>Percentage of participants who achieved both a clinic DBP and SBP response measured at week 6 defined as clinic DBP &lt;90 mmHg and/or reduction of ≥10 mmHg from Baseline AND clinic SBP &lt;140 mmHg and/or reduction of ≥20 mmHg from Baseline. DBP and SBP are based on the arithmetic mean of 3 serial blood pressure measurements.</description>
          <population>Participants from the FAS, including all randomized participants, who received at least 1 dose of double-blind study drug, with both a Baseline value and at least 1 post-baseline value, who were randomized only once. Missing values were imputed using last observation carried forward (LOCF).</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="63"/>
                <count group_id="O2" value="127"/>
                <count group_id="O3" value="129"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.4"/>
                    <measurement group_id="O2" value="62.2"/>
                    <measurement group_id="O3" value="65.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Treatment-emergent adverse events: from the first dose of double-blind study drug to 14 days after the last dose (up to 66 days). Serious adverse events: from the first dose of double blind study drug to 30 days after the last dose (up to 82 days).</time_frame>
      <desc>At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Data is presented for the Safety Analysis Set.</desc>
      <group_list>
        <group group_id="E1">
          <title>Placebo</title>
          <description>Azilsartan medoxomil placebo-matching tablets, orally, once daily for 6 weeks.</description>
        </group>
        <group group_id="E2">
          <title>Azilsartan Medoxomil 40 mg</title>
          <description>Azilsartan medoxomil 40 mg, tablets, orally, once daily for 6 weeks.</description>
        </group>
        <group group_id="E3">
          <title>Azilsartan Medoxomil 80 mg</title>
          <description>Azilsartan medoxomil 80 mg, tablets, orally, once daily for 6 weeks.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA (18.0)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <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="65"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="132"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="130"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Ligament sprain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="132"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="130"/>
              </event>
              <event>
                <sub_title>Patella fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="132"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="130"/>
              </event>
              <event>
                <sub_title>Road traffic accident</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="132"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="130"/>
              </event>
              <event>
                <sub_title>Tibia fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="132"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="130"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>3</frequency_threshold>
        <default_vocab>MedDRA (18.0)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="65"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="132"/>
                <counts group_id="E3" subjects_affected="14" subjects_at_risk="130"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="65"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="132"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="130"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="65"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="132"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="130"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="132"/>
                <counts group_id="E3" subjects_affected="7" subjects_at_risk="130"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="65"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="132"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="130"/>
              </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>The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Medical Director</name_or_title>
      <organization>Takeda</organization>
      <phone>+1-877-825-3327</phone>
      <email>trialdisclosures@takeda.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/NCT02203916
org study id: TAK-491_307
secondary id: U1111-1130-9186
nct id: NCT02203916
lead sponsor: 
has dmc: No
The purpose of this study is to compare the antihypertensive effect of azilsartan medoxomil
      versus placebo in Korean adults with essential hypertension.
The drug being tested in this study is called azilsartan medoxomil. Azilsartan medoxomil is
      being tested to treat Korean adults with hypertension. This study will look at changes in
      blood pressure in people who take azilsartan medoxomil.

      The study will enroll approximately 325 patients. Participants will be randomly assigned (by
      chance, like flipping a coin) to one of the three treatment groups-which will remain
      undisclosed to the patient and study doctor during the study (unless there is an urgent
      medical need):

        -  Azilsartan medoxomil 40 mg

        -  Azilsartan medoxomil 80 mg

        -  Placebo (dummy inactive pill) - this is a tablet that looks like the study drug but has
           no active ingredient.

      All participants will be asked to take two tablets at the same time each day throughout the
      study.

      This multi-centre trial will be conducted in Korea. The overall time to participate in this
      study is 12 weeks. Participants will make 7 visits to the clinic, and will be contacted by
      telephone 7 days after last dose of study drug for a follow-up assessment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Change From Baseline to Week 6 in Trough Clinic Sitting Systolic Blood Pressure (SBP)
time frame: Baseline and Week 6
description: The change in trough clinic sitting systolic blood pressure measured at week 6 relative to baseline. The trough is the average of the non-missing values of 3 serial trough sitting systolic blood pressure measurements. Blood pressure was measured using a validated, automated device after the participant had been sitting for at least 5 minutes. Week 6 blood pressure was measured approximately 24 hours after the previous day's dose. An analysis of covariance (ANCOVA) model, with treatment group as a fixed effect and Baseline sitting clinic systolic blood pressure as a covariate was used for analysis.
measure: Change From Baseline to Week 6 in Trough Clinic Sitting Diastolic Blood Pressure (DBP)
time frame: Baseline and Week 6
description: The change in trough clinic sitting diastolic blood pressure measured at week 6 relative to baseline. The trough is the average of the non-missing values of 3 serial trough sitting diastolic blood pressure measurements. Blood pressure was measured using a validated, automated device after the participant had been sitting for at least 5 minutes. Week 6 blood pressure was measured approximately 24 hours after the previous day's dose. An analysis of covariance (ANCOVA) model, with treatment group as a fixed effect and Baseline sitting clinic diastolic blood pressure as a covariate was used for analysis.
measure: Percentage of Participants Who Achieved a Clinic DBP Response at Week 6
time frame: Baseline and Week 6
description: Clinic DBP response is defined as clinic DBP <90 mmHg and/or reduction of ≥10 mmHg from Baseline. DBP is the arithmetic mean of 3 serial diastolic blood pressure measurements.
measure: Percentage of Participants Who Achieved a Clinic SBP Response at Week 6
time frame: Baseline and Week 6
description: SBP response is defined as clinic SBP <140 mmHg and/or reduction of ≥20 mmHg from Baseline. SBP is the arithmetic mean of 3 serial systolic blood pressure measurements.
measure: Percentage of Participants Who Achieved Both a Clinic DBP and SBP Response at Week 6
time frame: Baseline and Week 6
description: Percentage of participants who achieved both a clinic DBP and SBP response measured at week 6 defined as clinic DBP <90 mmHg and/or reduction of ≥10 mmHg from Baseline AND clinic SBP <140 mmHg and/or reduction of ≥20 mmHg from Baseline. DBP and SBP are based on the arithmetic mean of 3 serial blood pressure measurements.
arm group label: Azilsartan Medoxomil 40 mg
arm group type: Experimental
description: Azilsartan medoxomil 40 mg, tablets, orally, once daily for 6 weeks.
arm group label: Azilsartan Medoxomil 80 mg
arm group type: Experimental
description: Azilsartan medoxomil 80 mg, tablets, orally, once daily for 6 weeks.
arm group label: Placebo
arm group type: Placebo Comparator
description: Azilsartan medoxomil placebo-matching tablets, orally, once daily for 6 weeks.
intervention type: Drug
intervention name: Azilsartan medoxomil
description: Azilsartan medoxomil tablets
arm group label: Azilsartan Medoxomil 40 mg
arm group label: Azilsartan Medoxomil 80 mg
other name: TAK-491
intervention type: Drug
intervention name: Azilsartan medoxomil placebo
description: Azilsartan medoxomil placebo-matching tablets
arm group label: Placebo
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
healthy volunteers: No
last name: Medical Director Clinical Science
role: Study Director
affiliation: Takeda
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country: Korea, Republic of
responsible party type: Sponsor
mesh term: Hypertension
mesh term: Azilsartan medoxomil
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 