<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/NCT03231293</url>
  </required_header>
  <id_info>
    <org_study_id>BR-FMS-OS-401</org_study_id>
    <nct_id>NCT03231293</nct_id>
  </id_info>
  <brief_title>Fimasartan Blood Pressure Lowering After Acute Stroke</brief_title>
  <acronym>FABULOUS</acronym>
  <official_title>A Multicenter Longitudinal Observational Study to Assess the Effectiveness of Fimasartan-based Antihypertensive Treatment and Prognosis in Post-Acute Phase of Ischemic Stroke or Transient Ischemic Attack</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>
  <brief_summary>
    <textblock>
      This study evaluates the effectiveness of fimasartan-based antihypertensive treatment and&#xD;
      prognosis in post-acute phase of ischemic stroke or transient ischemic attack patients. All&#xD;
      participants will receive fimasartan, and the investigators will follow them up for 6 months.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 28, 2016</start_date>
  <completion_date type="Actual">April 5, 2019</completion_date>
  <primary_completion_date type="Actual">November 2, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>BP</measure>
    <time_frame>24 weeks</time_frame>
    <description>Blood pressure control rate(&lt;140/90 mmHg)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>BP</measure>
    <time_frame>4, 12 weeks</time_frame>
    <description>Blood pressure control rate(&lt;140/90 mmHg)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>BP</measure>
    <time_frame>4, 12, 24 weeks</time_frame>
    <description>Blood pressure changes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>mRS</measure>
    <time_frame>4, 12, 24 weeks</time_frame>
    <description>mRS changes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fimasartan-based treatment</measure>
    <time_frame>24 weeks</time_frame>
    <description>Fimasartan-based treatment modalities</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fimasartan starting point</measure>
    <time_frame>24 weeks</time_frame>
    <description>Fimasartan starting point after stroke</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stroke recurrence</measure>
    <time_frame>24 weeks</time_frame>
    <description>Rate of stroke recurrence</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cardiovascular events</measure>
    <time_frame>24 weeks</time_frame>
    <description>Incidence of cardiovascular events</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mortality rates from cardiovascular disease</measure>
    <time_frame>24 weeks</time_frame>
    <description>Mortality rates from cardiovascular disease</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mortality rates of any cause</measure>
    <time_frame>24 weeks</time_frame>
    <description>Mortality rates of any cause</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse events</measure>
    <time_frame>24 weeks</time_frame>
    <description>Adverse events related to antihypertensive treatments</description>
  </secondary_outcome>
  <enrollment type="Actual">1035</enrollment>
  <condition>Hypertension</condition>
  <condition>Ischemic Stroke</condition>
  <condition>Transient Ischemic Attack</condition>
  <eligibility>
    <study_pop>
      <textblock>
        1,032 subjects of post-acute phase of ischemic stroke or transient ischemic attack patients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Ischemic stroke or transient ischemic attack occurs after 7 days to 3 months.&#xD;
&#xD;
          -  Mean blood pressure measured 3 times at the first visit (Visit 1) should be over 140&#xD;
             mmHg for systolic blood pressure or 90 mmHg for diastolic blood pressure&#xD;
&#xD;
          -  Suitable for administration of fimasartan&#xD;
&#xD;
          -  The life expectancy should be over 6 months.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients already treated with antihypertensive medications&#xD;
&#xD;
          -  Hemorrhagic stroke patients&#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>Myung Sook Hong</last_name>
    <role>Study Director</role>
    <affiliation>Boryung Pharmaceutical Co., Ltd</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Korea University Ansan Hospital</name>
      <address>
        <city>Ansan</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hallym University Medical Center</name>
      <address>
        <city>Anyang</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dong-A University Hospital</name>
      <address>
        <city>Busan</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Inje University Busan Paik Hospital</name>
      <address>
        <city>Busan</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pusan National University Hospital</name>
      <address>
        <city>Busan</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Keimyung University Dongsan Medical Center</name>
      <address>
        <city>Daegu</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kyungpook National University Hospital</name>
      <address>
        <city>Daegu</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Daejeon Eulji Medical Center</name>
      <address>
        <city>Daejeon</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Inje University Ilsan Paik Hospital</name>
      <address>
        <city>Goyang</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Myongji Hospital</name>
      <address>
        <city>Goyang</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chonnam National University Hospital</name>
      <address>
        <city>Gwangju</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chosun University Hospital</name>
      <address>
        <city>Gwangju</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Inha University Hospital</name>
      <address>
        <city>Incheon</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jeju National University Hospital</name>
      <address>
        <city>Jeju</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seoul National University Bundang Hospital</name>
      <address>
        <city>Seongnam</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Asan Medical Center</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ewha Womans University Medical Center</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gangnam Severance Hospital</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Inje University Sanggye Paik Hospital</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kyunghee University Medical Center</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nowon Eulji Medical Center, Eulji University</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Samsung Medical Center</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seoul National University Boramae Medical Center</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seoul St. Mary's Hospital</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Severance Hospital, Yonsei University Health System</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Soonchunhyang University Hospital</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ulsan University Hospital</name>
      <address>
        <city>Ulsan</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>November 2019</verification_date>
  <study_first_submitted>July 25, 2017</study_first_submitted>
  <study_first_submitted_qc>July 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 27, 2017</study_first_posted>
  <last_update_submitted>November 1, 2019</last_update_submitted>
  <last_update_submitted_qc>November 1, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">November 4, 2019</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>Stroke</mesh_term>
    <mesh_term>Ischemic Stroke</mesh_term>
    <mesh_term>Ischemic Attack, Transient</mesh_term>
    <mesh_term>Ischemia</mesh_term>
  </condition_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/NCT03231293
org study id: BR-FMS-OS-401
nct id: NCT03231293
lead sponsor: 
This study evaluates the effectiveness of fimasartan-based antihypertensive treatment and
      prognosis in post-acute phase of ischemic stroke or transient ischemic attack patients. All
      participants will receive fimasartan, and the investigators will follow them up for 6 months.
observational model: Case-Only
time perspective: Prospective
measure: BP
time frame: 24 weeks
description: Blood pressure control rate(<140/90 mmHg)
measure: BP
time frame: 4, 12 weeks
description: Blood pressure control rate(<140/90 mmHg)
measure: BP
time frame: 4, 12, 24 weeks
description: Blood pressure changes
measure: mRS
time frame: 4, 12, 24 weeks
description: mRS changes
measure: Fimasartan-based treatment
time frame: 24 weeks
description: Fimasartan-based treatment modalities
measure: Fimasartan starting point
time frame: 24 weeks
description: Fimasartan starting point after stroke
measure: Stroke recurrence
time frame: 24 weeks
description: Rate of stroke recurrence
measure: Cardiovascular events
time frame: 24 weeks
description: Incidence of cardiovascular events
measure: Mortality rates from cardiovascular disease
time frame: 24 weeks
description: Mortality rates from cardiovascular disease
measure: Mortality rates of any cause
time frame: 24 weeks
description: Mortality rates of any cause
measure: Adverse events
time frame: 24 weeks
description: Adverse events related to antihypertensive treatments
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
healthy volunteers: No
last name: Myung Sook Hong
role: Study Director
affiliation: Boryung Pharmaceutical Co., Ltd
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country: Korea, Republic of
responsible party type: Sponsor
mesh term: Stroke
mesh term: Ischemic Stroke
mesh term: Ischemic Attack, Transient
mesh term: Ischemia