<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/NCT02222480</url>
  </required_header>
  <id_info>
    <org_study_id>BR-FHC-CT-201-BZ</org_study_id>
    <nct_id>NCT02222480</nct_id>
  </id_info>
  <brief_title>A Clinical Trial to Evaluate Efficacy, Tolerability, and Pharmacokinetic-Pharmacodynamic Relationship of Fimasartan/Hydrochlorothiazide</brief_title>
  <official_title>A 2-Week, Randomized, Double-Blind, Parallel, Placebo-Controlled Study to Evaluate the Efficacy, Tolerability, and Pharmacokinetic-Pharmacodynamic Relationship of Fimasartan in Combination With Hydrochlorothiazide in Patients With Mild to Moderate Hypertension</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boryung Pharmaceutical Co., Ltd</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Seoul National University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Boryung Pharmaceutical Co., Ltd</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A 2-Week, Randomized, Double-Blind, Parallel, Placebo-Controlled Study to Evaluate the&#xD;
      Efficacy, Tolerability, and Pharmacokinetic-Pharmacodynamic Relationship of Fimasartan in&#xD;
      Combination with Hydrochlorothiazide in Patients with Mild to Moderate Hypertension&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2014</start_date>
  <completion_date type="Actual">June 2015</completion_date>
  <primary_completion_date type="Actual">May 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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change of treatment in 24-hour mean systolic blood pressure (SBP) using ambulatory blood pressure monitoring (ABPM)</measure>
    <time_frame>from baseline to 2 weeks</time_frame>
  </primary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Actual">103</enrollment>
  <condition>Hypertension</condition>
  <arm_group>
    <arm_group_label>Fimasartan 60 mg, Hydrochlorothiazide 12.5 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Combination of Fimasartan/Hydrochlorothiazide 60/12.5mg</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Fimasartan 60 mg, Hydrochlorothiazide 25 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Combination of Fimasartan/Hydrochlorothiazide 60/25mg</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Fimasartan 120 mg, Hydrochlorothiazide 12.5 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Combination of Fimasartan/Hydrochlorothiazide 120/12.5mg</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Fimasartan 120 mg, Hydrochlorothiazide 25 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Combination of Fimasartan/Hydrochlorothiazide 120/25mg</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>placebo</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fimasartan</intervention_name>
    <arm_group_label>Fimasartan 120 mg, Hydrochlorothiazide 12.5 mg</arm_group_label>
    <arm_group_label>Fimasartan 120 mg, Hydrochlorothiazide 25 mg</arm_group_label>
    <arm_group_label>Fimasartan 60 mg, Hydrochlorothiazide 12.5 mg</arm_group_label>
    <arm_group_label>Fimasartan 60 mg, Hydrochlorothiazide 25 mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Hydrochlorothiazide</intervention_name>
    <arm_group_label>Fimasartan 120 mg, Hydrochlorothiazide 12.5 mg</arm_group_label>
    <arm_group_label>Fimasartan 120 mg, Hydrochlorothiazide 25 mg</arm_group_label>
    <arm_group_label>Fimasartan 60 mg, Hydrochlorothiazide 12.5 mg</arm_group_label>
    <arm_group_label>Fimasartan 60 mg, Hydrochlorothiazide 25 mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male or female subjects of no childbearing potential 19-70 years of age&#xD;
&#xD;
          2. Mean clinic-measured sitting DBP (siDBP) of 90-109 mmHg and mean clinic-measured&#xD;
             sitting SBP (siSBP) of 140-179 mmHg after a ≥1-week washout of prior antihypertensive&#xD;
             medications (no wash-out is needed for those not on any antihypertensive medications)&#xD;
             with a difference of ≤10 mmHg in sitting DBP between before and after run-in&#xD;
&#xD;
          3. Subjects who agree to participate in this study and give written informed consent&#xD;
&#xD;
          4. Subjects considered to understand the study, be cooperative, and able to be&#xD;
             followed-up until the end of the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Severe hypertension, i.e., mean siDBP ≥110 mmHg or mean siSBP ≥180 mmHg&#xD;
&#xD;
          2. Orthostatic hypotension with clinically significant signs or symptoms&#xD;
&#xD;
          3. Secondary hypertension&#xD;
&#xD;
          4. Not able to stop administration other antihypertensive medications than the study&#xD;
             drugs (i.e., fimasartan and hydrochlorothiazide) throughout the entire study period&#xD;
&#xD;
          5. Clinically significant abnormal laboratory test results, e.g., serum creatinine &gt;1.5&#xD;
             times upper limit of normal, AST, ALT &gt; 2 times upper limit of normal&#xD;
&#xD;
          6. Conditions that may affect to absorption, distribution, metabolism, and excretion for&#xD;
             the study drugs&#xD;
&#xD;
          7. Severe insulin-dependent or uncontrolled diabetes mellitus (HbA1c &gt;9%, increased dose&#xD;
             of an oral hypoglycemic agent within 12 weeks before screening, or active insulin&#xD;
             treatment at screening)&#xD;
&#xD;
          8. Severe cardiovascular diseases within 6 months of screening including ischemic heart&#xD;
             disease, peripheral vascular disease, significant ventricular tachycardia, atrial&#xD;
             fibrillation, atrial flutter or other significant arrhythmia, hypertrophic obstructive&#xD;
             cardiomyopathy, severe obstructive coronary artery disease, aortic stenosis,&#xD;
             hemodynamically significant aortic valve or mitral valve disease, severe&#xD;
             cerebrovascular disease&#xD;
&#xD;
          9. History of percutaneous transluminal coronary angiography or coronary artery bypass&#xD;
             graft&#xD;
&#xD;
         10. Chronic debilitating disease, autoimmune disease, connective tissue disease&#xD;
&#xD;
         11. Positive on serum hepatitis B surface antigen, anti-hepatitis C virus antibody, or&#xD;
             anti-HIV antibody&#xD;
&#xD;
         12. History or evidence of alcohol or drug abuse within 2 years&#xD;
&#xD;
         13. Known allergic reaction to any angiotensin receptor blockers&#xD;
&#xD;
         14. Chronic inflammation disease requiring chronic anti-inflammation therapy&#xD;
&#xD;
         15. Women of childbearing potential without any contraceptive measure or breast-feeding&#xD;
             mother&#xD;
&#xD;
         16. Prior participation in a clinical trial of any investigational products within 12&#xD;
             weeks from screening&#xD;
&#xD;
         17. Serum potassium &lt;3.5 mmol/L or &gt;5.5 mmol/L at any time of the study period&#xD;
&#xD;
         18. Depletion of sodium ion or body fluid, which cannot be corrected easily during the&#xD;
             study period&#xD;
&#xD;
         19. Evidence of hereditary disease, including galactose intolerance, Lapp lactase&#xD;
             deficiency, or glucose-galactose malabsorption.&#xD;
&#xD;
         20. Considered unsuitable to participate in the study under the discretion of the&#xD;
             principal investigator&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Seoul National University Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>110-744</zip>
        <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 18, 2014</study_first_submitted>
  <study_first_submitted_qc>August 20, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 21, 2014</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>Patients</keyword>
  <keyword>with mild</keyword>
  <keyword>moderate</keyword>
  <keyword>essential</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertension</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hydrochlorothiazide</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/NCT02222480
org study id: BR-FHC-CT-201-BZ
nct id: NCT02222480
lead sponsor: 
collaborator: 
has dmc: No
A 2-Week, Randomized, Double-Blind, Parallel, Placebo-Controlled Study to Evaluate the
      Efficacy, Tolerability, and Pharmacokinetic-Pharmacodynamic Relationship of Fimasartan in
      Combination with Hydrochlorothiazide in Patients with Mild to Moderate Hypertension
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Change of treatment in 24-hour mean systolic blood pressure (SBP) using ambulatory blood pressure monitoring (ABPM)
time frame: from baseline to 2 weeks
arm group label: Fimasartan 60 mg, Hydrochlorothiazide 12.5 mg
arm group type: Experimental
description: Combination of Fimasartan/Hydrochlorothiazide 60/12.5mg
arm group label: Fimasartan 60 mg, Hydrochlorothiazide 25 mg
arm group type: Experimental
description: Combination of Fimasartan/Hydrochlorothiazide 60/25mg
arm group label: Fimasartan 120 mg, Hydrochlorothiazide 12.5 mg
arm group type: Experimental
description: Combination of Fimasartan/Hydrochlorothiazide 120/12.5mg
arm group label: Fimasartan 120 mg, Hydrochlorothiazide 25 mg
arm group type: Experimental
description: Combination of Fimasartan/Hydrochlorothiazide 120/25mg
arm group label: Placebo
arm group type: Placebo Comparator
description: placebo
intervention type: Drug
intervention name: Fimasartan
arm group label: Fimasartan 120 mg, Hydrochlorothiazide 12.5 mg
arm group label: Fimasartan 120 mg, Hydrochlorothiazide 25 mg
arm group label: Fimasartan 60 mg, Hydrochlorothiazide 12.5 mg
arm group label: Fimasartan 60 mg, Hydrochlorothiazide 25 mg
intervention type: Drug
intervention name: Hydrochlorothiazide
arm group label: Fimasartan 120 mg, Hydrochlorothiazide 12.5 mg
arm group label: Fimasartan 120 mg, Hydrochlorothiazide 25 mg
arm group label: Fimasartan 60 mg, Hydrochlorothiazide 12.5 mg
arm group label: Fimasartan 60 mg, Hydrochlorothiazide 25 mg
intervention type: Drug
intervention name: Placebo
arm group label: Placebo
criteria: 
gender: All
minimum age: 19 Years
maximum age: 70 Years
healthy volunteers: No
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Hypertension
mesh term: Hydrochlorothiazide