<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/NCT04470817</url>
  </required_header>
  <id_info>
    <org_study_id>TAK-491-4001</org_study_id>
    <secondary_id>U1111-1252-3589</secondary_id>
    <nct_id>NCT04470817</nct_id>
  </id_info>
  <brief_title>A Study for Post-Marketing Surveillance of Azilsartan Medoxomil in the Treatment of Adult Participants With Essential Hypertension in South Korea</brief_title>
  <official_title>Post-Marketing Surveillance (Usage Results Study) of Azilsartan Medoxomil in the Treatment of Adult Patients With Essential Hypertension in South Korea</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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the safety by determining the incidence rates of all&#xD;
      adverse events (AEs) including serious adverse events (SAEs)/serious adverse drug reactions&#xD;
      (ADRs), unexpected AEs and ADRs that are not reflected on the precaution in the use, ADRs&#xD;
      already known, non-serious ADRs and other safety related information (laboratory values&#xD;
      changes, etc).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a long-term prospective, observational post-marketing surveillance study of&#xD;
      azilsartan medoxomil in participants with essential hypertension. This study will assess the&#xD;
      safety and effectiveness of azilsartan medoxomil prescribed as a monotherapy or taken&#xD;
      concomitantly with other anti-hypertension therapies in real-world clinical practice&#xD;
      settings.&#xD;
&#xD;
      The study will enroll approximately 3000 participants. The data will be prospectively&#xD;
      collected, at the centers from medical files and recorded into electronic case report forms&#xD;
      (e-CRFs). All the participants will be assigned to a single observational cohort:&#xD;
&#xD;
        -  Participants With Essential Hypertension&#xD;
&#xD;
      The multi-center study will be conducted in South Korea. Data collection will be based on&#xD;
      routinely scheduled and emergency visits over the surveillance period, scheduled at Visit 1&#xD;
      (Baseline), Visit 2 (6 Weeks), Visit 3 (3 Months or more less than 6 Months) and Visit 4 (6&#xD;
      Months or more [Month 9]). The overall duration of the study will be approximately 6 years.&#xD;
      All participants will be followed up for 9 months after drug administration.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">August 7, 2018</start_date>
  <completion_date type="Anticipated">May 25, 2023</completion_date>
  <primary_completion_date type="Anticipated">May 25, 2023</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>Percentage of Participants who Experience at Least one AE and SAE</measure>
    <time_frame>Baseline up to Month 9</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Blood Pressure Including Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)</measure>
    <time_frame>Baseline up to Month 9</time_frame>
    <description>Blood pressure (SBP and DBP) will be measured in millimeter of mercury (mmHg).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants who Achieve Clinic DBP Less Than (&lt;) 90 mmHg and/or Reduction of Greater Than or Equal to (&gt;=) 10 mmHg</measure>
    <time_frame>Baseline up to Month 9</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants who Achieve Clinic SBP &lt;140 mmHg and/or reduction of &gt;=20 mmHg</measure>
    <time_frame>Baseline up to Month 9</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants who Achieve Both Clinic DBP &lt;90 mmHg and/or Reduction of &gt;=10 mmHg and Clinic SBP &lt;140 mmHg and/or Reduction of &gt;=20 mmHg</measure>
    <time_frame>Baseline up to Month 9</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Serum Creatinine Level, Serum Uric Acid Level and Serum Lipid Profile</measure>
    <time_frame>Baseline up to Month 9</time_frame>
    <description>Serum creatinine level, serum uric acid level, and serum lipid profile will be measured in milligram per deciliter (mg/dL).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Blood Potassium Level</measure>
    <time_frame>Baseline up to Month 9</time_frame>
    <description>Blood potassium level will be measured in millimole per liter (mmol/L).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Blood Sodium Profiles</measure>
    <time_frame>Baseline up to Month 9</time_frame>
    <description>Blood sodium profiles will be measured in milliequivalent per liter (mEq/L).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Final Effectiveness Rate as Assessed by the Investigator</measure>
    <time_frame>Baseline up to Month 9</time_frame>
    <description>Effectiveness rate: percentage of participants who achieved effectiveness over total number of assessable effectiveness analysis population, and is calculated as number of effective participants/total number of participants in group, multiplied by 100. Final effectiveness will be assessed based on: Improved (symptoms have improved or it is considered to have had a maintenance effect); Unchanged (no significant change from pre-administration, not considered to have had a maintenance effect); Worsened (symptoms have worsened compared to pre-administration); Unassessable (unable to assess due to grounds such as missing effectiveness variables, follow up loss, etc.). Maintenance effect: cases where the likelihood of worsened symptoms is high with discontinuation of medication, or equivalent effect to existing drugs is sustained when substituted with existing drugs. Effectiveness rate is determined by classifying 'Improved' as &quot;Effective&quot; and 'Unchanged' and 'Worsened' as &quot;Ineffective&quot;.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">3000</enrollment>
  <condition>Essential Hypertension</condition>
  <arm_group>
    <arm_group_label>Participants With Essential Hypertension</arm_group_label>
    <description>Participants diagnosed with essential hypertension and whom have been prescribed azilsartan medoxomil as a monotherapy or taken concomitantly with other anti-hypertension therapies in a routine clinical practical setting, will be observed prospectively over a period of 6 years.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Participants diagnosed with essential hypertension and whom have been prescribed azilsartan&#xD;
        medoxomil as a monotherapy or taken concomitantly with other anti-hypertension therapies in&#xD;
        a routine clinical practical setting.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. With Essential Hypertension.&#xD;
&#xD;
               -  Newly diagnosed with essential hypertension or who have no long-term history of&#xD;
                  hypertension medication after diagnosis (The participant has a SBP or DBP &gt;=140&#xD;
                  or 90 mmHG, respectively).&#xD;
&#xD;
               -  Receiving treatment with other hypertension medications.&#xD;
&#xD;
          2. Newly prescribed and initiates azilsartan medoxomil for the treatment of hypertension,&#xD;
             as a monotherapy or taken concomitantly with other anti-hypertension therapies.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Treated with azilsartan medoxomil outside of the locally approved label in South&#xD;
             Korea.&#xD;
&#xD;
          2. With known hypersensitivity or presence of any contraindication to azilsartan&#xD;
             medoxomil.&#xD;
&#xD;
          3. Use of aliskiren in combination with azilsartan medoxomil in participants with&#xD;
             diabetes or with moderate to severe renal impairment (glomerular filtration rate [GFR&#xD;
             ] &lt; 60 milliliter per minute [mL/min]/1.73 m^2).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Medical Director</last_name>
    <role>Study Director</role>
    <affiliation>Takeda</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Takeda Study Registration Call Center</last_name>
    <phone>1-877-825-3327</phone>
    <email>medinfoUS@takeda.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Myongji Hospital</name>
      <address>
        <city>Goyang-si</city>
        <state>Gyeonggi-do</state>
        <zip>10475</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 13, 2020</study_first_submitted>
  <study_first_submitted_qc>July 13, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 14, 2020</study_first_posted>
  <last_update_submitted>July 17, 2020</last_update_submitted>
  <last_update_submitted_qc>July 17, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 21, 2020</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>
    <mesh_term>Essential Hypertension</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Takeda makes patient-level, de-identified data sets and associated documents available for all interventional studies after applicable marketing approvals and commercial availability have been received (or program is completely terminated), an opportunity for the primary publication of the research and final report development has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04470817
org study id: TAK-491-4001
secondary id: U1111-1252-3589
nct id: NCT04470817
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to evaluate the safety by determining the incidence rates of all
      adverse events (AEs) including serious adverse events (SAEs)/serious adverse drug reactions
      (ADRs), unexpected AEs and ADRs that are not reflected on the precaution in the use, ADRs
      already known, non-serious ADRs and other safety related information (laboratory values
      changes, etc).
This is a long-term prospective, observational post-marketing surveillance study of
      azilsartan medoxomil in participants with essential hypertension. This study will assess the
      safety and effectiveness of azilsartan medoxomil prescribed as a monotherapy or taken
      concomitantly with other anti-hypertension therapies in real-world clinical practice
      settings.

      The study will enroll approximately 3000 participants. The data will be prospectively
      collected, at the centers from medical files and recorded into electronic case report forms
      (e-CRFs). All the participants will be assigned to a single observational cohort:

        -  Participants With Essential Hypertension

      The multi-center study will be conducted in South Korea. Data collection will be based on
      routinely scheduled and emergency visits over the surveillance period, scheduled at Visit 1
      (Baseline), Visit 2 (6 Weeks), Visit 3 (3 Months or more less than 6 Months) and Visit 4 (6
      Months or more [Month 9]). The overall duration of the study will be approximately 6 years.
      All participants will be followed up for 9 months after drug administration.
observational model: Cohort
time perspective: Prospective
measure: Percentage of Participants who Experience at Least one AE and SAE
time frame: Baseline up to Month 9
measure: Change From Baseline in Blood Pressure Including Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
time frame: Baseline up to Month 9
description: Blood pressure (SBP and DBP) will be measured in millimeter of mercury (mmHg).
measure: Percentage of Participants who Achieve Clinic DBP Less Than (<) 90 mmHg and/or Reduction of Greater Than or Equal to (>=) 10 mmHg
time frame: Baseline up to Month 9
measure: Percentage of Participants who Achieve Clinic SBP <140 mmHg and/or reduction of >=20 mmHg
time frame: Baseline up to Month 9
measure: Percentage of Participants who Achieve Both Clinic DBP <90 mmHg and/or Reduction of >=10 mmHg and Clinic SBP <140 mmHg and/or Reduction of >=20 mmHg
time frame: Baseline up to Month 9
measure: Change From Baseline in Serum Creatinine Level, Serum Uric Acid Level and Serum Lipid Profile
time frame: Baseline up to Month 9
description: Serum creatinine level, serum uric acid level, and serum lipid profile will be measured in milligram per deciliter (mg/dL).
measure: Change From Baseline in Blood Potassium Level
time frame: Baseline up to Month 9
description: Blood potassium level will be measured in millimole per liter (mmol/L).
measure: Change From Baseline in Blood Sodium Profiles
time frame: Baseline up to Month 9
description: Blood sodium profiles will be measured in milliequivalent per liter (mEq/L).
measure: Final Effectiveness Rate as Assessed by the Investigator
time frame: Baseline up to Month 9
description: Effectiveness rate: percentage of participants who achieved effectiveness over total number of assessable effectiveness analysis population, and is calculated as number of effective participants/total number of participants in group, multiplied by 100. Final effectiveness will be assessed based on: Improved (symptoms have improved or it is considered to have had a maintenance effect); Unchanged (no significant change from pre-administration, not considered to have had a maintenance effect); Worsened (symptoms have worsened compared to pre-administration); Unassessable (unable to assess due to grounds such as missing effectiveness variables, follow up loss, etc.). Maintenance effect: cases where the likelihood of worsened symptoms is high with discontinuation of medication, or equivalent effect to existing drugs is sustained when substituted with existing drugs. Effectiveness rate is determined by classifying 'Improved' as "Effective" and 'Unchanged' and 'Worsened' as "Ineffective".
arm group label: Participants With Essential Hypertension
description: Participants diagnosed with essential hypertension and whom have been prescribed azilsartan medoxomil as a monotherapy or taken concomitantly with other anti-hypertension therapies in a routine clinical practical setting, will be observed prospectively over a period of 6 years.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Medical Director
role: Study Director
affiliation: Takeda
last name: Takeda Study Registration Call Center
phone: 1-877-825-3327
email: medinfoUS@takeda.com
facility: 
status: Recruiting
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Hypertension
mesh term: Essential Hypertension
sharing ipd: Yes
ipd description: Takeda makes patient-level, de-identified data sets and associated documents available for all interventional studies after applicable marketing approvals and commercial availability have been received (or program is completely terminated), an opportunity for the primary publication of the research and final report development has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.