<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/NCT03254914</url>
  </required_header>
  <id_info>
    <org_study_id>BR-FMS-OS-403</org_study_id>
    <nct_id>NCT03254914</nct_id>
  </id_info>
  <brief_title>Fimasartan Optimal Reduction Targeting Elevated Blood Pressure: the FORTE Study</brief_title>
  <official_title>A Multi-center, Cluster-randomized, Prospective, Observational Study</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 purpose of this study is to evaluate the effect of home blood pressure monitoring on&#xD;
      controlling blood pressure and correlation between home blood pressure and clinic blood&#xD;
      pressure in hypertensive patients receiving two or more concomitant antihypertensive agents&#xD;
      including fimasartan&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A multi-center, cluster-randomized, prospective, observational study&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">August 9, 2017</start_date>
  <completion_date type="Anticipated">September 30, 2019</completion_date>
  <primary_completion_date type="Anticipated">February 28, 2019</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>12 Weeks</target_duration>
  <primary_outcome>
    <measure>Rate of reaching target blood pressure</measure>
    <time_frame>12 weeks after treatment</time_frame>
    <description>Rate of reaching target blood pressure after treatment for 12 weeks</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">4320</enrollment>
  <condition>Hypertension</condition>
  <arm_group>
    <arm_group_label>Control Site</arm_group_label>
    <description>Measure Clinic Blood Pressure</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Test Site</arm_group_label>
    <description>Measure Clinic Blood Pressure and Home Blood Pressure</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Home Blood Pressure</intervention_name>
    <description>Measure Home Blood Pressure</description>
    <arm_group_label>Test Site</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Hypertensive patients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects who voluntarily signed informed consent for participating in this clinical&#xD;
             study&#xD;
&#xD;
          -  Male and female over the age of 19&#xD;
&#xD;
          -  Hypertensive patients receiving two or more concomitant anti-hypertensive agents&#xD;
             including fimasartan&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Renal dialysis patients.&#xD;
&#xD;
          -  Diabetic nephropathy patients taking angiotensin-converting enzyme inhibitor.&#xD;
&#xD;
          -  Severe renal disorder&#xD;
&#xD;
          -  Subjects with hereditary disorders of galactose intolerance, Lapp lactase deficiency&#xD;
             or glucose-galactose malabsorption.&#xD;
&#xD;
          -  Medical history with hypersensitivity to Fimasartan&#xD;
&#xD;
          -  Pregnant women or lactating female.&#xD;
&#xD;
          -  Participate in another clinical trial.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hae-young Lee, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Seoul National Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Hyung-jin Jung, MD</last_name>
    <phone>82-2-708-8233</phone>
    <email>hjjung@boryung.co.kr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Seoul national university hospital</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hae-young Lee, MD</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 17, 2017</study_first_submitted>
  <study_first_submitted_qc>August 17, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 21, 2017</study_first_posted>
  <last_update_submitted>August 17, 2017</last_update_submitted>
  <last_update_submitted_qc>August 17, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 21, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Home Blood Pressure</keyword>
  <keyword>Fimasartan</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertension</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03254914
org study id: BR-FMS-OS-403
nct id: NCT03254914
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to evaluate the effect of home blood pressure monitoring on
      controlling blood pressure and correlation between home blood pressure and clinic blood
      pressure in hypertensive patients receiving two or more concomitant antihypertensive agents
      including fimasartan
A multi-center, cluster-randomized, prospective, observational study
observational model: Cohort
time perspective: Prospective
measure: Rate of reaching target blood pressure
time frame: 12 weeks after treatment
description: Rate of reaching target blood pressure after treatment for 12 weeks
arm group label: Control Site
description: Measure Clinic Blood Pressure
arm group label: Test Site
description: Measure Clinic Blood Pressure and Home Blood Pressure
intervention type: Procedure
intervention name: Home Blood Pressure
description: Measure Home Blood Pressure
arm group label: Test Site
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
healthy volunteers: No
last name: Hae-young Lee, MD
role: Principal Investigator
affiliation: Seoul National Hospital
last name: Hyung-jin Jung, MD
phone: 82-2-708-8233
email: hjjung@boryung.co.kr
facility: 
status: Recruiting
contact: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Hypertension
sharing ipd: No