<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/NCT03246555</url>
  </required_header>
  <id_info>
    <org_study_id>BR-FMS-CT-304</org_study_id>
    <nct_id>NCT03246555</nct_id>
  </id_info>
  <brief_title>Fimasartan in the Senior Subjects</brief_title>
  <acronym>FITNESS</acronym>
  <official_title>A Randomized, Double-blind, Active-controlled, 2-parallel Group, Optional Titration, Multicenter, Phase 3b Study to Evaluate the Efficacy and Safety of Fimasartan Versus Perindopril Monotherapy With and Without Diuretics Combination in Elderly Patients With Essential Hypertension</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boryung Pharmaceutical Co., Ltd</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boryung Pharmaceutical Co., Ltd</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this study is to confirm the noninferiority of the blood pressure lowering&#xD;
      effect of fimasartan and evaluate its safety compared to perindopril in the elderly with&#xD;
      essential hypertension.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 15, 2016</start_date>
  <completion_date type="Actual">December 9, 2019</completion_date>
  <primary_completion_date type="Actual">August 19, 2019</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>
    <intervention_model_description>Parallel Assignment</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in siSBP</measure>
    <time_frame>8 weeks</time_frame>
    <description>Change in siSBP from baseline after the administration of the investigational product for 8 weeks</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in siSBP</measure>
    <time_frame>Weeks 4, 16 and 24</time_frame>
    <description>Change in siSBP from baseline at Weeks 4, 16 and 24</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in siDBP</measure>
    <time_frame>Weeks 4, 8, 16 and 24</time_frame>
    <description>Change in siDBP from baseline at Weeks 4, 8, 16 and 24</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood pressure response rate</measure>
    <time_frame>4, 8 and 16 weeks</time_frame>
    <description>Blood pressure response rate (siSBP &lt; 140 mmHg, or decrease of △siSBP ≥ 20 mmHg after the administration for 4, 8 and 16 weeks compared to baseline) and blood pressure normalization rate after the administration of the investigational products for 4, 8 and 16 weeks(siSBP&lt;140mmHg and siDBP&lt;90mmHg)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in the differences in standing SBP and DBP compared to their sitting measurements</measure>
    <time_frame>4, 8, 16 and 24 weeks</time_frame>
    <description>Change from baseline in the differences in standing SBP and DBP compared to their sitting measurements after the administration of the investigational product for 4, 8, 16 and 24 weeks</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">241</enrollment>
  <condition>The Elderly (≥ 70 Years) With Essential Hypertension</condition>
  <arm_group>
    <arm_group_label>Fimasartan or Fimasartan/Hydrochlorothiazide</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Perindopril or Perindopril/Indapamide</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fimasartan or Fimasartan/Hydrochlorothiazide</intervention_name>
    <description>The treatment in this clinical study starts with fimasartan 30 mg; if blood pressure is not controlled (siSBP ≥ 140 mmHg or siDBP ≥ 90 mmHg), the dose is escalated once gradually, and then a diuretic combination is administered. The escalation of dose and administration of diuretic combination are decided after checking blood pressure 4 weeks after the administration of each investigational product.</description>
    <arm_group_label>Fimasartan or Fimasartan/Hydrochlorothiazide</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Perindopril or Perindopril/Indapamide</intervention_name>
    <description>The treatment in this clinical study starts with penrindopril 2.5 mg; if blood pressure is not controlled (siSBP ≥ 140 mmHg or siDBP ≥ 90 mmHg), the dose is escalated once gradually, and then a diuretic combination is administered. The escalation of dose and administration of diuretic combination are decided after checking blood pressure 4 weeks after the administration of each investigational product.</description>
    <arm_group_label>Perindopril or Perindopril/Indapamide</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Voluntarily provided a written consent to participate in this clinical study after&#xD;
             receiving an explanation of this study&#xD;
&#xD;
          2. Elderly aged 70 years or older&#xD;
&#xD;
          3. At the screening visit (Visit 1), Blood pressure: Mean blood pressure measured 3 times&#xD;
             on the selected arm is as below.&#xD;
&#xD;
               -  For treatment-naïve patients who have not taken drugs for hypertension within the&#xD;
                  last 3 months from the screening visit: Mean siSBP ≥ 140mmHg&#xD;
&#xD;
               -  For patients with essential hypertension who are taking drugs for hypertension:&#xD;
                  Mean siSBP ≥ 130mmHg&#xD;
&#xD;
          4. At the baseline visit (Visit 2), Blood pressure: Patients with mild to moderate&#xD;
             essential hypertension whose mean siSBP measured 3 times on the selected arm is ≥140&#xD;
             mmHg Patients with treatment compliance of ≥70% during the placebo run-in period&#xD;
&#xD;
          5. Capable of understanding written instructions, cooperative, able to participate until&#xD;
             the end of the clinical study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Severe hypertension patients with mean siSBP ≥ 180 mmHg or siDBP ≥ 110 mmHg (office&#xD;
             BP) at the screening visit (Visit 1) and the baseline visit (Visit 2) (However, at&#xD;
             screening, it is based on the blood pressures measured from both arms, and the patient&#xD;
             is excluded if the result from any of the arms falls within the criteria.)&#xD;
&#xD;
          2. Patients with siSBP ≥ 20 mmHg and siDBP ≥ 10 mmHg in the difference between blood&#xD;
             pressures in the selected arm at the screening visit (Visit 1)&#xD;
&#xD;
          3. Patients with a history of secondary hypertension and any history suspected of&#xD;
             secondary hypertension (but not limited to the following: coarctation of the aorta,&#xD;
             primary hyperaldosteronism, renal artery stenosis, Cushing's syndrome,&#xD;
             pheochromocytoma, polycystic kidney disease, etc.)&#xD;
&#xD;
          4. Orthostatic hypotension with symptoms&#xD;
&#xD;
          5. Patients with insulin-dependent diabetes mellitus or uncontrolled diabetes mellitus&#xD;
             (HbA1c &gt; 9.0% at the screening visit (Visit 1))&#xD;
&#xD;
          6. Patients with a history of malignant tumor, including leukemia and lymphoma, within&#xD;
             the past 5 years (however, participation is allowed if it has not recurred for at&#xD;
             least 5 years after a tumor surgery)&#xD;
&#xD;
          7. Patients with any chronic inflammatory disease requiring chronic anti-inflammatory&#xD;
             treatment, consumption disease, autoimmune disease like rheumatoid arthritis and&#xD;
             systemic lupus erythematosus, etc., or connective tissue disease at present or in the&#xD;
             past&#xD;
&#xD;
          8. Patients with a history of hypersensitivity reaction to any component of the&#xD;
             investigational product and its similar compound Renin-angiotensin system inhibitors,&#xD;
             ACE inhibitors, thiazide diuretics and sulfonamides, Yellow 5 (Sunset Yellow FCF),&#xD;
             etc.&#xD;
&#xD;
          9. Patients with hyperlipidemia undergoing LDL (low density lipoprotein) apheresis&#xD;
             (patients undergoing LDL hemapheresis using a dextran sulfate cellulose)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>70 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Seoul National University Bundang</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>July 25, 2017</study_first_submitted>
  <study_first_submitted_qc>August 7, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 11, 2017</study_first_posted>
  <last_update_submitted>March 19, 2020</last_update_submitted>
  <last_update_submitted_qc>March 19, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 23, 2020</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>Hydrochlorothiazide</mesh_term>
    <mesh_term>Perindopril</mesh_term>
    <mesh_term>Indapamide</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/NCT03246555
org study id: BR-FMS-CT-304
nct id: NCT03246555
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The objective of this study is to confirm the noninferiority of the blood pressure lowering
      effect of fimasartan and evaluate its safety compared to perindopril in the elderly with
      essential hypertension.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Change in siSBP
time frame: 8 weeks
description: Change in siSBP from baseline after the administration of the investigational product for 8 weeks
measure: Change in siSBP
time frame: Weeks 4, 16 and 24
description: Change in siSBP from baseline at Weeks 4, 16 and 24
measure: Change in siDBP
time frame: Weeks 4, 8, 16 and 24
description: Change in siDBP from baseline at Weeks 4, 8, 16 and 24
measure: Blood pressure response rate
time frame: 4, 8 and 16 weeks
description: Blood pressure response rate (siSBP < 140 mmHg, or decrease of △siSBP ≥ 20 mmHg after the administration for 4, 8 and 16 weeks compared to baseline) and blood pressure normalization rate after the administration of the investigational products for 4, 8 and 16 weeks(siSBP<140mmHg and siDBP<90mmHg)
measure: Change from baseline in the differences in standing SBP and DBP compared to their sitting measurements
time frame: 4, 8, 16 and 24 weeks
description: Change from baseline in the differences in standing SBP and DBP compared to their sitting measurements after the administration of the investigational product for 4, 8, 16 and 24 weeks
arm group label: Fimasartan or Fimasartan/Hydrochlorothiazide
arm group type: Experimental
arm group label: Perindopril or Perindopril/Indapamide
arm group type: Active Comparator
intervention type: Drug
intervention name: Fimasartan or Fimasartan/Hydrochlorothiazide
description: The treatment in this clinical study starts with fimasartan 30 mg; if blood pressure is not controlled (siSBP ≥ 140 mmHg or siDBP ≥ 90 mmHg), the dose is escalated once gradually, and then a diuretic combination is administered. The escalation of dose and administration of diuretic combination are decided after checking blood pressure 4 weeks after the administration of each investigational product.
arm group label: Fimasartan or Fimasartan/Hydrochlorothiazide
intervention type: Drug
intervention name: Perindopril or Perindopril/Indapamide
description: The treatment in this clinical study starts with penrindopril 2.5 mg; if blood pressure is not controlled (siSBP ≥ 140 mmHg or siDBP ≥ 90 mmHg), the dose is escalated once gradually, and then a diuretic combination is administered. The escalation of dose and administration of diuretic combination are decided after checking blood pressure 4 weeks after the administration of each investigational product.
arm group label: Perindopril or Perindopril/Indapamide
criteria: 
gender: All
minimum age: 70 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Hypertension
mesh term: Essential Hypertension
mesh term: Hydrochlorothiazide
mesh term: Perindopril
mesh term: Indapamide