<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/NCT04488978</url>
  </required_header>
  <id_info>
    <org_study_id>AI-C201</org_study_id>
    <nct_id>NCT04488978</nct_id>
  </id_info>
  <brief_title>Phase 2 Study to Evaluate the Efficacy and Safety of Irbesartan and Amlodipine Combined or Alone in Patients With Essential Hypetension</brief_title>
  <official_title>A Randomized, Double-blind, Multicenter, Factorial Design, Phase II Study to Evaluate the Efficacy and Safety of Irbesartan and Amlodipine Combined or Alone in Patients With Essential Hypertension</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Handok Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Handok Inc.</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      A Randomized, Double-blind, Multicenter, Factorial Design, Phase II Study to Evaluate the&#xD;
      Efficacy and Safety of Irbesartan and Amlodipine Combined or Alone in Patients With Essential&#xD;
      Hypertension&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 21, 2020</start_date>
  <completion_date type="Actual">November 9, 2021</completion_date>
  <primary_completion_date type="Actual">November 9, 2021</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Factorial Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The change in MSSBP between baseline and Week8.</measure>
    <time_frame>Baseline and Week8</time_frame>
    <description>The primary efficacy variable was the change in Mean Sitting Systolic Blood Pressure between baseline and Week8.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The change in MSSBP between baseline and Week4.</measure>
    <time_frame>Baseline and Week4</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The change in Mean Sitting Diastolic Blood Pressure between baseline and Week4 / Week8.</measure>
    <time_frame>Baseline and Week4/8</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The proportion of patients having reached MSSBP &lt; 140 mmHg and MSDBP &lt; 90 mmHg at W4 and at W8.</measure>
    <time_frame>Baseline and Week4/8</time_frame>
  </secondary_outcome>
  <number_of_arms>8</number_of_arms>
  <enrollment type="Actual">440</enrollment>
  <condition>Essential Hypertension</condition>
  <arm_group>
    <arm_group_label>Irbesartan low/Amlodipine low</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Irbesartan low &amp; Amlodipine low, once daily for 8 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Irbesartan low/Amlodipine high</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Irbesartan low &amp; Amlodipine high, once daily for 8 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Irbesartan high/Amlodipine low</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Irbesartan high &amp; Amlodipine low, once daily for 8 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Irbesartan high/Amlodipine high</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Irbesartan high &amp; Amlodipine high, once daily for 8 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Amlodipine low</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Amlodipine low, once daily for 8 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Amlodipine high</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Amlodipine high, once daily for 8 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Irbesartan low</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Irbesartan low, once daily for 8 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Irbesartan high</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Irbesartan high, once daily for 8 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Irbesartan/Amlodipine</intervention_name>
    <description>QID</description>
    <arm_group_label>Amlodipine high</arm_group_label>
    <arm_group_label>Amlodipine low</arm_group_label>
    <arm_group_label>Irbesartan high</arm_group_label>
    <arm_group_label>Irbesartan high/Amlodipine high</arm_group_label>
    <arm_group_label>Irbesartan high/Amlodipine low</arm_group_label>
    <arm_group_label>Irbesartan low</arm_group_label>
    <arm_group_label>Irbesartan low/Amlodipine high</arm_group_label>
    <arm_group_label>Irbesartan low/Amlodipine low</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients who are 19 years or older / 75 years or younger on screening&#xD;
&#xD;
          -  Signed informed consent&#xD;
&#xD;
          -  Patients with Essential Hypertension&#xD;
&#xD;
          -  Other inclusion applied&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Orthostatic hypertension with symptom&#xD;
&#xD;
          -  Other exclusion applied&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Yonsei University Health System, Severance Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>03722</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>June 2022</verification_date>
  <study_first_submitted>July 21, 2020</study_first_submitted>
  <study_first_submitted_qc>July 24, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 28, 2020</study_first_posted>
  <last_update_submitted>June 28, 2022</last_update_submitted>
  <last_update_submitted_qc>June 28, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">June 30, 2022</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>
    <mesh_term>Essential Hypertension</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Amlodipine</mesh_term>
    <mesh_term>Irbesartan</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04488978
org study id: AI-C201
nct id: NCT04488978
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
A Randomized, Double-blind, Multicenter, Factorial Design, Phase II Study to Evaluate the
      Efficacy and Safety of Irbesartan and Amlodipine Combined or Alone in Patients With Essential
      Hypertension
allocation: Randomized
intervention model: Factorial Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: The change in MSSBP between baseline and Week8.
time frame: Baseline and Week8
description: The primary efficacy variable was the change in Mean Sitting Systolic Blood Pressure between baseline and Week8.
measure: The change in MSSBP between baseline and Week4.
time frame: Baseline and Week4
measure: The change in Mean Sitting Diastolic Blood Pressure between baseline and Week4 / Week8.
time frame: Baseline and Week4/8
measure: The proportion of patients having reached MSSBP < 140 mmHg and MSDBP < 90 mmHg at W4 and at W8.
time frame: Baseline and Week4/8
arm group label: Irbesartan low/Amlodipine low
arm group type: Experimental
description: Irbesartan low & Amlodipine low, once daily for 8 weeks
arm group label: Irbesartan low/Amlodipine high
arm group type: Experimental
description: Irbesartan low & Amlodipine high, once daily for 8 weeks
arm group label: Irbesartan high/Amlodipine low
arm group type: Experimental
description: Irbesartan high & Amlodipine low, once daily for 8 weeks
arm group label: Irbesartan high/Amlodipine high
arm group type: Experimental
description: Irbesartan high & Amlodipine high, once daily for 8 weeks
arm group label: Amlodipine low
arm group type: Active Comparator
description: Amlodipine low, once daily for 8 weeks
arm group label: Amlodipine high
arm group type: Active Comparator
description: Amlodipine high, once daily for 8 weeks
arm group label: Irbesartan low
arm group type: Active Comparator
description: Irbesartan low, once daily for 8 weeks
arm group label: Irbesartan high
arm group type: Active Comparator
description: Irbesartan high, once daily for 8 weeks
intervention type: Drug
intervention name: Irbesartan/Amlodipine
description: QID
arm group label: Amlodipine high
arm group label: Amlodipine low
arm group label: Irbesartan high
arm group label: Irbesartan high/Amlodipine high
arm group label: Irbesartan high/Amlodipine low
arm group label: Irbesartan low
arm group label: Irbesartan low/Amlodipine high
arm group label: Irbesartan low/Amlodipine low
criteria: 
gender: All
minimum age: 19 Years
maximum age: 75 Years
healthy volunteers: No
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Hypertension
mesh term: Essential Hypertension
mesh term: Amlodipine
mesh term: Irbesartan