<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/NCT01672476</url>
  </required_header>
  <id_info>
    <org_study_id>A657-BR-CT-L301</org_study_id>
    <nct_id>NCT01672476</nct_id>
  </id_info>
  <brief_title>A Multicenter, Phase 3 Study to Evaluate the Antihypertensive Efficacy and Safety of Fimasartan(BR-A-657∙K) 30mg Compared to Placebo in Patients With Mild to Moderate Essential Hypertension</brief_title>
  <acronym>fimasartan</acronym>
  <official_title>A Randomized, Double-Blind, Multicenter, Phase 3 Study to Evaluate the Antihypertensive Efficacy and Safety of Fimasartan(BR-A-657∙K) 30mg Compared to Placebo in Patients With Mild to Moderate Essential Hypertension</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boryung Pharmaceutical Co., Ltd</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Bucheon St. Mary's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Konyang University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Korea University Anam Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Health Insurance Service Ilsan Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Daegu Fatima Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Dong-A University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Soon Chun Hyang University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Asan Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Gangnam Severance Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Severance Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Ulsan University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Kangbuk Samsung Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Sejong General Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Ewha Womans University Mokdong Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Jeju National University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hallym University Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hanyang University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Boryung Pharmaceutical Co., Ltd</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A Randomized, Double-Blind, Multicenter, phase III Study to Evaluate the Antihypertensive&#xD;
      Efficacy and Safety of Fimasartan (BR-A-657·K) 30mg Compared to Placebo in Patients with Mild&#xD;
      to Moderate Essential Hypertension&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      After subjects have signed informed consent voluntarily, when they are taking hypertension&#xD;
      medication, they go through screening period for 7 days including wash-out period.&#xD;
&#xD;
      After screening and wash-out period, subjects take the placebo for 14 days (Maximum 21 days),&#xD;
      and evaluate their suitability to Inclusion and Exclusion criteria.&#xD;
&#xD;
      Patients, who evaluated the proper subject for this clinical trial, are allocated to&#xD;
      experimental group (Fimasartan 30mg) or Control group (Placebo group) or Reference group&#xD;
      (Valsartan 80mg) randomly at a ratio 2:2:1 and their investigational drugs will be&#xD;
      administered daily for the study period (8 weeks). Subjects visit their investigators twice&#xD;
      during treatment period, when they take their investigational drugs for 4 weeks, and 8 weeks.&#xD;
&#xD;
      The placebo period will be single-blinded and the treatment allocation in this study will be&#xD;
      double-blinded.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>April 2012</start_date>
  <completion_date type="Actual">April 2013</completion_date>
  <primary_completion_date type="Actual">March 2013</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>the difference of sitting DBP</measure>
    <time_frame>After 8 weeks from baseline visit</time_frame>
    <description>To compare the difference of sitting DBP between fimasartan 30mg group and placebo group</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>the difference of sitting DBP</measure>
    <time_frame>After 8 weeks from baseline visit</time_frame>
    <description>To compare the difference of sitting DBP between fimasartan 30mg group and valsartan 80mg group</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the difference of SiDBP</measure>
    <time_frame>After 4 weeks from baseline visit</time_frame>
    <description>To compare the difference of SiDBP among fimasartan 30mg group, valsartan 80mg and placebo group</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the difference of SiSBP</measure>
    <time_frame>After 4 weeks and 8 weeks from baseline visit</time_frame>
    <description>To compare the difference of SiSBP among fimasartan 30mg group, valsartan 80mg and placebo group</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the ratio of responder(SiDBP&lt;90mmHg or ΔSiDBP≥10mmHg)</measure>
    <time_frame>After 8 weeks from baseline visit</time_frame>
    <description>To compare the ratio of responder(SiDBP&lt;90mmHg or ΔSiDBP≥10mmHg) among fimasartan 30mg group, valsartan 80mg and placebo group</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the ratio of subjects who get normalized blood pressure(SiDBP&lt;90mmHg &amp; SiSBP&lt;140mmHg)</measure>
    <time_frame>After 8 weeks from baseline visit</time_frame>
    <description>To compare the ratio of subjects who get normalized blood pressure(SiDBP&lt;90mmHg &amp; SiSBP&lt;140mmHg) among fimasartan 30mg group, valsartan 80mg and placebo group</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">293</enrollment>
  <condition>Hypertension</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>1 capsule/day of placebo will be orally administered for the study period (8 weeks)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Valsartan 80mg</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>(As reference group) 80mg/day of Valsartan will be orally administered for the study period (8 weeks)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Fimasartan 30mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>30mg/day of Fimasartan will be orally administered for the study period (8 weeks)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Valsartan</intervention_name>
    <description>Valsartan 80mg</description>
    <arm_group_label>Valsartan 80mg</arm_group_label>
    <other_name>Diovan</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fimasartan</intervention_name>
    <description>Fimasartan 30mg</description>
    <arm_group_label>Fimasartan 30mg</arm_group_label>
    <other_name>Kanarb</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subjects who agreed to participate in this clinical trial and submitted the written&#xD;
             informed consent&#xD;
&#xD;
          2. Subjects aged 20 to 75 years&#xD;
&#xD;
          3. Essential hypertension patients who are measured more 90mmHg, less than 110mmHg of&#xD;
             sitting diastolic blood pressure(SiDBP) at baseline(Day 0)&#xD;
&#xD;
          4. Subject who considered to understand this clinical trial, be cooperative,and able to&#xD;
             be followed-up whole of the clinical trial period&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Severe hypertension patients: more 110mmHg of mean SiDBP and/or more 185mmHg of mean&#xD;
             Sitting systolic blood pressure(SiSBP)&#xD;
&#xD;
          2. Patients with orthostatic hypotension who has sign and symptom&#xD;
&#xD;
          3. Patients with secondary hypertension&#xD;
&#xD;
          4. Patients who are measured the difference of mean blood pressure of one arm under SiDBP&#xD;
             10mmHg or SiSBP 20mmHg at screening and baseline visit&#xD;
&#xD;
          5. Patients who cannot stop administration of hypertension medication through the&#xD;
             clinical trial period, and can take any other hypertension medication except&#xD;
             investigational drugs&#xD;
&#xD;
          6. Patients with significant investigations-abnormal renal function (Creatinine more 1.5&#xD;
             times than upper limit of normal), abnormal liver function(AST, ALT more 2 times than&#xD;
             upper limit of normal), severe fatty liver disease needed medication&#xD;
&#xD;
          7. Patients with clinically significant investigations in laboratory test of screening&#xD;
             visit&#xD;
&#xD;
          8. Patients with surgical and medical disease that is able to be affect to absorption,&#xD;
             distribution, metabolism and excretion&#xD;
&#xD;
          9. Patients with severe insulin dependent or uncontrolled diabetes mellitus (HbA1c&gt;9,&#xD;
             regimen change of oral hypoglycemic agent, using insulin)&#xD;
&#xD;
         10. Patients with severe heart disease, ischemic heart disease within 6 months, peripheral&#xD;
             vascular disease, Percutaneous transluminal coronary angiography(PTCA), Coronary&#xD;
             artery bypass graft(CABG)&#xD;
&#xD;
         11. Patients with significant ventricular tachycardia, atrial fibrillation, atrial flutter&#xD;
             or other significant arrhythmia&#xD;
&#xD;
         12. Patients with hypertrophic obstructive cardiomyopathy, severe obstructive coronary&#xD;
             artery disease, aortic stenosis, hemodynamically significant aortic valve or mitral&#xD;
             valve disease&#xD;
&#xD;
         13. Patients with severe cerebrovascular disease&#xD;
&#xD;
         14. Patients with wasting disease, autoimmune disease, connective tissue disease at&#xD;
             present and/or previous&#xD;
&#xD;
         15. Patients with known severe or malignancy retinopathy&#xD;
&#xD;
         16. Patients with hepatitis B or C or HIV positive reaction&#xD;
&#xD;
         17. Patients with the medical histories of malignant tumor within 5 years,except local&#xD;
             basal cell carcinoma of the skin&#xD;
&#xD;
         18. Patients who have a story or evidence of alcohol or drug abuse within 2 years&#xD;
&#xD;
         19. Patients with history of allergic reaction to any angiotensin II antagonist&#xD;
&#xD;
         20. Patients with any chronic inflammation disease needed to chronic inflammation therapy&#xD;
&#xD;
         21. Childbearing and breast-feeding women&#xD;
&#xD;
         22. Female who plan to become pregnancy or have a possibility of pregnancy but don't&#xD;
             prevent conception with acknowledged methods&#xD;
&#xD;
         23. Patients who took medicine within 12 weeks from screening visit or is going on the&#xD;
             progress of other clinical trial&#xD;
&#xD;
         24. Patients with significant investigations-Hypokalemia(Less than 3.5 mmol/L),&#xD;
             Hyperkalemia(exceeded 5.5 mmol/L)&#xD;
&#xD;
         25. Patients with sodium ion or body fluid is deplated and not able to correct&#xD;
&#xD;
         26. Subject who are judged unsuitable to participate in this clinical trial by&#xD;
             investigator&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Seok Min Kang, M.D., Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Severance Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Severance Hospital</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>June 2016</verification_date>
  <study_first_submitted>August 20, 2012</study_first_submitted>
  <study_first_submitted_qc>August 22, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 27, 2012</study_first_posted>
  <last_update_submitted>June 30, 2016</last_update_submitted>
  <last_update_submitted_qc>June 30, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 1, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Fimasartan</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>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Valsartan</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/NCT01672476
org study id: A657-BR-CT-L301
nct id: NCT01672476
lead sponsor: 
collaborator: 
collaborator: 
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collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
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collaborator: 
collaborator: 
has dmc: Yes
A Randomized, Double-Blind, Multicenter, phase III Study to Evaluate the Antihypertensive
      Efficacy and Safety of Fimasartan (BR-A-657·K) 30mg Compared to Placebo in Patients with Mild
      to Moderate Essential Hypertension
After subjects have signed informed consent voluntarily, when they are taking hypertension
      medication, they go through screening period for 7 days including wash-out period.

      After screening and wash-out period, subjects take the placebo for 14 days (Maximum 21 days),
      and evaluate their suitability to Inclusion and Exclusion criteria.

      Patients, who evaluated the proper subject for this clinical trial, are allocated to
      experimental group (Fimasartan 30mg) or Control group (Placebo group) or Reference group
      (Valsartan 80mg) randomly at a ratio 2:2:1 and their investigational drugs will be
      administered daily for the study period (8 weeks). Subjects visit their investigators twice
      during treatment period, when they take their investigational drugs for 4 weeks, and 8 weeks.

      The placebo period will be single-blinded and the treatment allocation in this study will be
      double-blinded.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: the difference of sitting DBP
time frame: After 8 weeks from baseline visit
description: To compare the difference of sitting DBP between fimasartan 30mg group and placebo group
measure: the difference of sitting DBP
time frame: After 8 weeks from baseline visit
description: To compare the difference of sitting DBP between fimasartan 30mg group and valsartan 80mg group
measure: the difference of SiDBP
time frame: After 4 weeks from baseline visit
description: To compare the difference of SiDBP among fimasartan 30mg group, valsartan 80mg and placebo group
measure: the difference of SiSBP
time frame: After 4 weeks and 8 weeks from baseline visit
description: To compare the difference of SiSBP among fimasartan 30mg group, valsartan 80mg and placebo group
measure: the ratio of responder(SiDBP<90mmHg or ΔSiDBP≥10mmHg)
time frame: After 8 weeks from baseline visit
description: To compare the ratio of responder(SiDBP<90mmHg or ΔSiDBP≥10mmHg) among fimasartan 30mg group, valsartan 80mg and placebo group
measure: the ratio of subjects who get normalized blood pressure(SiDBP<90mmHg & SiSBP<140mmHg)
time frame: After 8 weeks from baseline visit
description: To compare the ratio of subjects who get normalized blood pressure(SiDBP<90mmHg & SiSBP<140mmHg) among fimasartan 30mg group, valsartan 80mg and placebo group
arm group label: Placebo
arm group type: Placebo Comparator
description: 1 capsule/day of placebo will be orally administered for the study period (8 weeks)
arm group label: Valsartan 80mg
arm group type: Active Comparator
description: (As reference group) 80mg/day of Valsartan will be orally administered for the study period (8 weeks)
arm group label: Fimasartan 30mg
arm group type: Experimental
description: 30mg/day of Fimasartan will be orally administered for the study period (8 weeks)
intervention type: Drug
intervention name: Placebo
description: Placebo
arm group label: Placebo
intervention type: Drug
intervention name: Valsartan
description: Valsartan 80mg
arm group label: Valsartan 80mg
other name: Diovan
intervention type: Drug
intervention name: Fimasartan
description: Fimasartan 30mg
arm group label: Fimasartan 30mg
other name: Kanarb
criteria: 
gender: All
minimum age: 20 Years
maximum age: 75 Years
healthy volunteers: No
last name: Seok Min Kang, M.D., Ph.D.
role: Principal Investigator
affiliation: Severance Hospital
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Hypertension
mesh term: Essential Hypertension
mesh term: Valsartan