<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/NCT01682564</url>
  </required_header>
  <id_info>
    <org_study_id>m106CHF11E</org_study_id>
    <nct_id>NCT01682564</nct_id>
  </id_info>
  <brief_title>To Evaluate the Efficacy and Safety on Blood Pressure In Patients With Hypertension Diagnosed Congestive Heart Failure</brief_title>
  <acronym>CANTABILE</acronym>
  <official_title>Open Label, Randomized, Active Drug Comparative, Parallel Group, Multi-center, Phase IV Study to Compare and Evaluate the Efficacy and Safety of Candemore Tab and Atacand Tab.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chong Kun Dang Pharmaceutical</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chong Kun Dang Pharmaceutical</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To compare and evaluate the efficacy and safety of Candemore tab. versus Atacand tab. on&#xD;
      blood pressure in patients with hypertension diagnosed congestive heart failure&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is an open label, randomized, active drug comparative, Parallel group, Multi-center,&#xD;
      phase IV study. Patients receive candemore tablet or atacand tablet. Initial dose is 4mg/day&#xD;
      or 8mg/day. Every 2 weeks, patients take double dose if patients blood pressure is measured&#xD;
      SBP ≥ 100mmHg and DBP &gt; 60mmHg. Maximum dose is 16mg/day.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2012</start_date>
  <completion_date type="Actual">October 2014</completion_date>
  <primary_completion_date type="Actual">October 2014</primary_completion_date>
  <phase>Phase 4</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mean sitting Systolic Blood Pressure</measure>
    <time_frame>After 12 weeks of treatment</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mean Sitting Diastolic Blood Pressure</measure>
    <time_frame>After 12 weeks of treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>echocardiography</measure>
    <time_frame>After 12 weeks of treatment</time_frame>
    <description>Left Ventricle Volume, Left Ventricle Ejection Fraction, E/E' ration, Peak TR velocity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood Creatinine and Potssium level</measure>
    <time_frame>After 4 and 12 weeks of treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>NYHA class</measure>
    <time_frame>After 12 weeks of treatment</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">169</enrollment>
  <condition>Hypertension</condition>
  <condition>Congestive Heart Failure</condition>
  <arm_group>
    <arm_group_label>Candemore tablet</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Candemore tablet&#xD;
Initial dose : 4mg/day if SBP&lt;140mmHg and/or DBP&lt;90mmHg, 8mg/day if SBP≥140mmHg and DBP≥90mmHg&#xD;
dose escalation : double dose if SBP≥100mmHg and DBP&gt;60mmHg (maximum dose 16mg/day)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Atacand tablet</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Atacand tablet&#xD;
Initial dose : 4mg/day if SBP&lt;140mmHg and/or DBP&lt;90mmHg, 8mg/day if SBP≥140mmHg and DBP≥90mmHg&#xD;
dose escalation : double dose if SBP≥100mmHg and DBP&gt;60mmHg (maximum dose 16mg/day)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Candemore tablet</intervention_name>
    <description>Initial dose : 4mg/day if SBP&lt;140mmHg and/or DBP&lt;90mmHg, 8mg/day if SBP≥140mmHg and DBP≥90mmHg&#xD;
dose escalation : double dose if SBP≥100mmHg and DBP&gt;60mmHg (maximum dose 16mg/day)</description>
    <arm_group_label>Candemore tablet</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Atacand tablet</intervention_name>
    <description>Initial dose : 4mg/day if SBP&lt;140mmHg and/or DBP&lt;90mmHg, 8mg/day if SBP≥140mmHg and DBP≥90mmHg&#xD;
dose escalation : double dose if SBP≥100mmHg and DBP&gt;60mmHg (maximum dose 16mg/day)</description>
    <arm_group_label>Atacand tablet</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  willing and able to provide written informed consent&#xD;
&#xD;
          -  age 20 years or older&#xD;
&#xD;
          -  patient with congestive heart failure, taking treatment medicine and NYHA grade II~III&#xD;
&#xD;
          -  patient with hypertension, taking treatment medicine or SBP ≥ 140mmHg or DBP ≥ 90mmHg&#xD;
             at the screening visit&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known or suspected secondary hypertension(ex. aortic coactation, primary&#xD;
             hyperaldosteronism, renal artery stenosis, pheochromocytoma, cushing syndrome,&#xD;
             polycystic renal disease)&#xD;
&#xD;
          -  blood creatinine level ≥ 2.5mg/dl&#xD;
&#xD;
          -  blood potassium level &gt; 5.5mEq/L&#xD;
&#xD;
          -  blood SGOT, SGPT level ≥ maximum normal range X3 or patient with sever hepatic&#xD;
             dysfunction, cholestasis&#xD;
&#xD;
          -  pregnant or breast-feeding&#xD;
&#xD;
          -  premenopausal women not using adequate contraception&#xD;
&#xD;
          -  patient has history about hypersensitivity or taboo of investigational product&#xD;
&#xD;
          -  patient with lactose intolerance or Lapp lactase deficiency or glucode-galactose&#xD;
             malabsorption&#xD;
&#xD;
          -  administration of other study drugs within 1 month prior to screening&#xD;
&#xD;
          -  history of ischemic heart disease(ex. angina pectoris, myocardial infarction) within&#xD;
             the last 3 months&#xD;
&#xD;
          -  in investigator's judgement&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>KeeSik Kim, M.D Ph.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Daegu Catholic University Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Inje university pusan hospital</name>
      <address>
        <city>Busan</city>
        <state>Busanjin-gu Gaegum-dong</state>
        <zip>614-735</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gyeongsang national university hospital</name>
      <address>
        <city>Jinju</city>
        <state>Chiram-dong</state>
        <zip>660-702</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Daegu fatima hospital</name>
      <address>
        <city>Daegu</city>
        <state>Dong-gu Sinam-dong</state>
        <zip>701-724</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Daedong hospital</name>
      <address>
        <city>Busan</city>
        <state>Dongnae-gu Myeongnyun-dong</state>
        <zip>607-711</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Inje university haeundae paik hospital</name>
      <address>
        <city>Busan</city>
        <state>Haeundae-gu Heaundae-ro 875</state>
        <zip>612-030</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Maryknoll medical center</name>
      <address>
        <city>Busan</city>
        <state>Jung-gu Daecheong-dong</state>
        <zip>600-730</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Keimyung university dongsan medical center</name>
      <address>
        <city>Daegu</city>
        <state>Jung-gu Dongsan-dong</state>
        <zip>700-712</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kyungpook national university hospital</name>
      <address>
        <city>Daegu</city>
        <state>Jung-gu Samdeok-dong</state>
        <zip>700-721</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Samsung changwon hospital</name>
      <address>
        <city>Changwon</city>
        <state>Masanhoiwon-gu Hapseong-dong 50</state>
        <zip>630-723</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yeungnam university medical center</name>
      <address>
        <city>Daegu</city>
        <state>Nam-gu Daemyeong-dong</state>
        <zip>705-717</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Daegu catholic univ. medical center</name>
      <address>
        <city>Daegu</city>
        <state>Nam-gu Daemyung-dong</state>
        <zip>705-718</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kosin university gospel hospital</name>
      <address>
        <city>Busan</city>
        <state>Seo-gu Amnam-dong</state>
        <zip>602-702</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dong-A university medical center</name>
      <address>
        <city>Busan</city>
        <state>Seo-gu Dongdaesin-dong</state>
        <zip>602-715</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dongguk university gyeongju hospital</name>
      <address>
        <city>Gyeongju</city>
        <state>Seokjang-dong</state>
        <zip>780-350</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>September 2015</verification_date>
  <study_first_submitted>September 4, 2012</study_first_submitted>
  <study_first_submitted_qc>September 6, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 11, 2012</study_first_posted>
  <last_update_submitted>September 22, 2015</last_update_submitted>
  <last_update_submitted_qc>September 22, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 24, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Candemore</keyword>
  <keyword>Atacand</keyword>
  <keyword>Candesartan cilexetil</keyword>
  <keyword>Primary Hypertension</keyword>
  <keyword>Congestive Hypertension</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertension</mesh_term>
    <mesh_term>Heart Failure</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Candesartan cilexetil</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/NCT01682564
org study id: m106CHF11E
nct id: NCT01682564
lead sponsor: 
has dmc: No
To compare and evaluate the efficacy and safety of Candemore tab. versus Atacand tab. on
      blood pressure in patients with hypertension diagnosed congestive heart failure
This is an open label, randomized, active drug comparative, Parallel group, Multi-center,
      phase IV study. Patients receive candemore tablet or atacand tablet. Initial dose is 4mg/day
      or 8mg/day. Every 2 weeks, patients take double dose if patients blood pressure is measured
      SBP ≥ 100mmHg and DBP > 60mmHg. Maximum dose is 16mg/day.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Mean sitting Systolic Blood Pressure
time frame: After 12 weeks of treatment
measure: Mean Sitting Diastolic Blood Pressure
time frame: After 12 weeks of treatment
measure: echocardiography
time frame: After 12 weeks of treatment
description: Left Ventricle Volume, Left Ventricle Ejection Fraction, E/E' ration, Peak TR velocity
measure: Blood Creatinine and Potssium level
time frame: After 4 and 12 weeks of treatment
measure: NYHA class
time frame: After 12 weeks of treatment
arm group label: Candemore tablet
arm group type: Experimental
description: Candemore tablet
Initial dose : 4mg/day if SBP<140mmHg and/or DBP<90mmHg, 8mg/day if SBP≥140mmHg and DBP≥90mmHg
dose escalation : double dose if SBP≥100mmHg and DBP>60mmHg (maximum dose 16mg/day)
arm group label: Atacand tablet
arm group type: Active Comparator
description: Atacand tablet
Initial dose : 4mg/day if SBP<140mmHg and/or DBP<90mmHg, 8mg/day if SBP≥140mmHg and DBP≥90mmHg
dose escalation : double dose if SBP≥100mmHg and DBP>60mmHg (maximum dose 16mg/day)
intervention type: Drug
intervention name: Candemore tablet
description: Initial dose : 4mg/day if SBP<140mmHg and/or DBP<90mmHg, 8mg/day if SBP≥140mmHg and DBP≥90mmHg
dose escalation : double dose if SBP≥100mmHg and DBP>60mmHg (maximum dose 16mg/day)
arm group label: Candemore tablet
intervention type: Drug
intervention name: Atacand tablet
description: Initial dose : 4mg/day if SBP<140mmHg and/or DBP<90mmHg, 8mg/day if SBP≥140mmHg and DBP≥90mmHg
dose escalation : double dose if SBP≥100mmHg and DBP>60mmHg (maximum dose 16mg/day)
arm group label: Atacand tablet
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: KeeSik Kim, M.D Ph.D
role: Principal Investigator
affiliation: Daegu Catholic University Medical Center
facility: 
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country: Korea, Republic of
responsible party type: Sponsor
mesh term: Hypertension
mesh term: Heart Failure
mesh term: Candesartan cilexetil