<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/NCT02206165</url>
  </required_header>
  <id_info>
    <org_study_id>144HT13021</org_study_id>
    <nct_id>NCT02206165</nct_id>
  </id_info>
  <brief_title>A Dose Selection Trial of CKD-330 in Patients With Essential Hypertension</brief_title>
  <official_title>A Randomized, Double-blind, Multi-center, Phase 2 Trial to Evaluate the Efficacy and Safety of Candesartan/Amlodipine Combined or Alone and Select Better Dose of CKD-330 in Patients With Essential Hypertension</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>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the efficacy and safety of Candesartan/Amlodipine&#xD;
      combined or alone and select better dose of CKD-330 in essential hypertension patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>March 2014</start_date>
  <completion_date type="Anticipated">June 2015</completion_date>
  <primary_completion_date type="Anticipated">April 2015</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The mean change of sitDBP (sitting diastolic blood pressure)</measure>
    <time_frame>From baseline at week 8</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>The mean change of sitDBP</measure>
    <time_frame>From baseline at week 4 and week 8</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The mean change of sitSBP</measure>
    <time_frame>From baseline at week 4 and 8</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Responder rate: The change of sitDBP &gt; 10mmHg, sitSBP &gt; 20mmHg</measure>
    <time_frame>From baseline at week 4 and 8</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Control rate: Patient achieving sitDBP &lt; 90mmHg and sitSBP &lt; 140mmHg</measure>
    <time_frame>At week 4 and 8</time_frame>
  </secondary_outcome>
  <number_of_arms>8</number_of_arms>
  <enrollment type="Anticipated">456</enrollment>
  <condition>Essential Hypertension</condition>
  <arm_group>
    <arm_group_label>Candesartan 8mg + Amlodipine 5mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Candesartan 8mg + Amlodipine 5mg, po, q.d.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Candesartan 8mg + Amlodipine 10mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Candesartan 8mg + Amlodipine 10mg, po, q.d.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Candesartan 16mg + Amlodipine 5mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Candesartan 16mg + Amlodipine 5mg, po, q.d.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Candesartan 16mg + Amlodipine 10mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Candesartan 16mg + Amlodipine 10mg, po, q.d.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Candesartan 8mg</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Candesartan 8mg, po, q.d.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Candesartan 16mg</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Candesartan 16mg, po, q.d.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Amlodipine 5mg</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Amlodipine 5mg, po, q.d.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Amlodipine 10mg</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Amlodipine 10mg, po, q.d.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Candesartan 8mg</intervention_name>
    <description>Once a day, 8 weeks</description>
    <arm_group_label>Candesartan 8mg</arm_group_label>
    <arm_group_label>Candesartan 8mg + Amlodipine 10mg</arm_group_label>
    <arm_group_label>Candesartan 8mg + Amlodipine 5mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Candesartan 16mg</intervention_name>
    <description>Once a day, 8 weeks</description>
    <arm_group_label>Candesartan 16mg</arm_group_label>
    <arm_group_label>Candesartan 16mg + Amlodipine 10mg</arm_group_label>
    <arm_group_label>Candesartan 16mg + Amlodipine 5mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Amlodipine 5mg</intervention_name>
    <description>Once a day, 8 weeks</description>
    <arm_group_label>Amlodipine 5mg</arm_group_label>
    <arm_group_label>Candesartan 16mg + Amlodipine 5mg</arm_group_label>
    <arm_group_label>Candesartan 8mg + Amlodipine 5mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Amlodipine 10mg</intervention_name>
    <description>Once a day, 8 weeks</description>
    <arm_group_label>Amlodipine 10mg</arm_group_label>
    <arm_group_label>Candesartan 16mg + Amlodipine 10mg</arm_group_label>
    <arm_group_label>Candesartan 8mg + Amlodipine 10mg</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age of 18 or above&#xD;
&#xD;
          -  Essential hypertension with 90mmHg ≤ mean sitDBP ≤ 115mmHg on target arm at Visit 3&#xD;
&#xD;
          -  Ability to provide written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  nean sitDBP ≥ 116mmHg or mean sitSBP ≥ 200mmHg at Visit 1, Visit 2, Visit 3&#xD;
&#xD;
          -  The change of mean sitDBP ≥ 10mmHg or mean sitSBP ≥ 20mmHg on target arm at Visit 1&#xD;
&#xD;
          -  Known or suspected Stage 2 Hypertension (aortic coarctation, Primary&#xD;
             hyperaldosteronism, renal artery stenosis, pheochromocytoma)&#xD;
&#xD;
          -  Patients with congestive heart failure(NYHA class III~IV), ischemic heart disease,&#xD;
             cardiomyopathy, heart valve disorder, arrhythmia, coronary artery bypass graft&#xD;
&#xD;
          -  History of cerebrovascular disease as cerebral infarction, cerebral hemorrhage within&#xD;
             6 months&#xD;
&#xD;
          -  Type I Diabets Mellitus, Type II Diabetes Mellitus with HbA1c &gt; 8%&#xD;
&#xD;
          -  History of severe or malignant retinopathy&#xD;
&#xD;
          -  AST/ALT &gt; UNL * 2, Serum Creatinine &gt; UNL * 1.5, K &gt; 5.5mEq/L&#xD;
&#xD;
          -  Patients with acute or chronic inflammatory status, autoimmune disease&#xD;
&#xD;
          -  Patients who need to take antihypertensive drug besides Investigational products&#xD;
&#xD;
          -  Patients must be treated with medications prohibited for concomitant use during study&#xD;
             period&#xD;
&#xD;
          -  Hypersensitive to Candesartan/Amlodipine or other dihydropyridine drugs&#xD;
&#xD;
          -  Hereditary angioedema or history of angioedema related to ACE inhibitor or angiotensin&#xD;
             II receptor blockers&#xD;
&#xD;
          -  History of malignant tumor within 5 years&#xD;
&#xD;
          -  Patients who are dependent on drugs or alcohol&#xD;
&#xD;
          -  History of disability to drug absorption, active inflammatory bowel syndrome with&#xD;
             12months, impaired pancreatic function, GI bleeding, obstructions of urinary tract&#xD;
&#xD;
          -  Patients treated with other investigational product within 4 weeks at the time&#xD;
             concents are obtained&#xD;
&#xD;
          -  Women with pregnant, breast-feeding&#xD;
&#xD;
          -  Not eligible to participate for study at the discretion of investigator&#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>Cheol-Ho Kim, M.D., Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Seoul National University Bundang Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>HyunKyung Oh</last_name>
    <phone>82-2-2194-0469</phone>
    <email>hkoh@ckdpharm.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Seoul National University Bundang Hospital</name>
      <address>
        <city>Seongnam</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Cheol-Ho Kim, M.D., Ph.D.</last_name>
    </contact>
    <investigator>
      <last_name>Cheol-Ho Kim, M.D., Ph.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>March 2015</verification_date>
  <study_first_submitted>June 16, 2014</study_first_submitted>
  <study_first_submitted_qc>July 31, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 1, 2014</study_first_posted>
  <last_update_submitted>March 27, 2015</last_update_submitted>
  <last_update_submitted_qc>March 27, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 30, 2015</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>Candesartan</mesh_term>
    <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/NCT02206165
org study id: 144HT13021
nct id: NCT02206165
lead sponsor: 
The purpose of this study is to evaluate the efficacy and safety of Candesartan/Amlodipine
      combined or alone and select better dose of CKD-330 in essential hypertension patients.
allocation: Randomized
intervention model: Factorial Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: The mean change of sitDBP (sitting diastolic blood pressure)
time frame: From baseline at week 8
measure: The mean change of sitDBP
time frame: From baseline at week 4 and week 8
measure: The mean change of sitSBP
time frame: From baseline at week 4 and 8
measure: Responder rate: The change of sitDBP > 10mmHg, sitSBP > 20mmHg
time frame: From baseline at week 4 and 8
measure: Control rate: Patient achieving sitDBP < 90mmHg and sitSBP < 140mmHg
time frame: At week 4 and 8
arm group label: Candesartan 8mg + Amlodipine 5mg
arm group type: Experimental
description: Candesartan 8mg + Amlodipine 5mg, po, q.d.
arm group label: Candesartan 8mg + Amlodipine 10mg
arm group type: Experimental
description: Candesartan 8mg + Amlodipine 10mg, po, q.d.
arm group label: Candesartan 16mg + Amlodipine 5mg
arm group type: Experimental
description: Candesartan 16mg + Amlodipine 5mg, po, q.d.
arm group label: Candesartan 16mg + Amlodipine 10mg
arm group type: Experimental
description: Candesartan 16mg + Amlodipine 10mg, po, q.d.
arm group label: Candesartan 8mg
arm group type: Active Comparator
description: Candesartan 8mg, po, q.d.
arm group label: Candesartan 16mg
arm group type: Active Comparator
description: Candesartan 16mg, po, q.d.
arm group label: Amlodipine 5mg
arm group type: Active Comparator
description: Amlodipine 5mg, po, q.d.
arm group label: Amlodipine 10mg
arm group type: Active Comparator
description: Amlodipine 10mg, po, q.d.
intervention type: Drug
intervention name: Candesartan 8mg
description: Once a day, 8 weeks
arm group label: Candesartan 8mg
arm group label: Candesartan 8mg + Amlodipine 10mg
arm group label: Candesartan 8mg + Amlodipine 5mg
intervention type: Drug
intervention name: Candesartan 16mg
description: Once a day, 8 weeks
arm group label: Candesartan 16mg
arm group label: Candesartan 16mg + Amlodipine 10mg
arm group label: Candesartan 16mg + Amlodipine 5mg
intervention type: Drug
intervention name: Amlodipine 5mg
description: Once a day, 8 weeks
arm group label: Amlodipine 5mg
arm group label: Candesartan 16mg + Amlodipine 5mg
arm group label: Candesartan 8mg + Amlodipine 5mg
intervention type: Drug
intervention name: Amlodipine 10mg
description: Once a day, 8 weeks
arm group label: Amlodipine 10mg
arm group label: Candesartan 16mg + Amlodipine 10mg
arm group label: Candesartan 8mg + Amlodipine 10mg
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Cheol-Ho Kim, M.D., Ph.D.
role: Principal Investigator
affiliation: Seoul National University Bundang Hospital
last name: HyunKyung Oh
phone: 82-2-2194-0469
email: hkoh@ckdpharm.com
facility: 
status: Recruiting
contact: 
investigator: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Hypertension
mesh term: Essential Hypertension
mesh term: Amlodipine
mesh term: Candesartan
mesh term: Candesartan cilexetil