xml: <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/NCT05970237</url>
    </required_header>
    <id_info>
      <org_study_id>BR-DGF-OS-401</org_study_id>
      <nct_id>NCT05970237</nct_id>
    </id_info>
    <brief_title>A Study to Evaluate the Efficacy and Safety of Dapagliflozin in Patient With Type 2 Diabetes Mellitus and Hypertension</brief_title>
    <official_title>A Multicenter, Prospective, Non-interventional, Observational Study to Evaluate the Efficacy and Safety of Dapagliflozin in Patient With Type 2 Diabetes Mellitus and 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 purpose of this clinical trial is to evaluate the efficacy and safety of dapagliflozin in&#xD;
        patient with type 2 diabetes mellitus and hypertension&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 26, 2023</start_date>
    <completion_date type="Anticipated">December 2024</completion_date>
    <primary_completion_date type="Anticipated">December 2024</primary_completion_date>
    <study_type>Observational</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>
    <primary_outcome>
      <measure>Target blood pressure control rate</measure>
      <time_frame>12weeks after administration</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Target blood glucose achievement rate</measure>
      <time_frame>12weeks after administration</time_frame>
    </primary_outcome>
    <enrollment type="Anticipated">9000</enrollment>
    <condition>Diabetes Mellitus</condition>
    <condition>Hypertension</condition>
    <eligibility>
      <study_pop>
        <textblock>
          Patients with type 2 diabetes mellitus accompanied by hypertension who are scheduled to be&#xD;
          administrated Trudapa Tab. or Trudapa M SR Tab.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Those diagnosed with type 2 diabetes mellitus accompanied by hypertension who are&#xD;
               scheduled to be administrated Trudapa Tab. or Trudapa M SR Tab.&#xD;
  &#xD;
            -  Those who voluntarily signed a written personal information agreement to participate&#xD;
               in this clinical study.&#xD;
  &#xD;
            -  Those able to understand this study, be cooperative in the execution of the study, and&#xD;
               participate in the study until its completion.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients with secondary hypertension: Secondary hypertension is not limited to the&#xD;
               following diseases; (e.g., coarctation of the aorta, hyperaldosteronism, renal artery&#xD;
               stenosis, pheochromocytoma, Cushing's syndrome and polycystic kidney disease, etc.)&#xD;
  &#xD;
            -  Those who have a history of taking dapagliflozin within 4 weeks of baseline (Visit 1)&#xD;
  &#xD;
            -  Those who are expected to need insulin prescription during the study period&#xD;
  &#xD;
            -  Pregnant women, breast-feeding women&#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_contact>
      <last_name>Shinyoung Oh</last_name>
      <phone>+82-2-708-8000</phone>
      <email>syoh@boryung.co.kr</email>
    </overall_contact>
    <location>
      <facility>
        <name>Gachon University Gil Medical Center</name>
        <address>
          <city>Incheon</city>
          <state>Namdong-gu</state>
          <zip>21565</zip>
          <country>Korea, Republic of</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Ki-young Lee</last_name>
      </contact>
    </location>
    <location_countries>
      <country>Korea, Republic of</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 24, 2023</study_first_submitted>
    <study_first_submitted_qc>July 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>August 11, 2023</last_update_submitted>
    <last_update_submitted_qc>August 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</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>Diabetes Mellitus</mesh_term>
      <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05970237
  org study id: BR-DGF-OS-401
  nct id: NCT05970237
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The purpose of this clinical trial is to evaluate the efficacy and safety of dapagliflozin in
        patient with type 2 diabetes mellitus and hypertension
  observational model: Cohort
  time perspective: Prospective
  measure: Target blood pressure control rate
  time frame: 12weeks after administration
  measure: Target blood glucose achievement rate
  time frame: 12weeks after administration
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 19 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Shinyoung Oh
  phone: +82-2-708-8000
  email: syoh@boryung.co.kr
  facility: 
  status: Recruiting
  contact: 
  country: Korea, Republic of
  responsible party type: Sponsor
  mesh term: Hypertension
  mesh term: Diabetes Mellitus
  mesh term: Diabetes Mellitus, Type 2
  sharing ipd: No