<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/NCT03009721</url>
  </required_header>
  <id_info>
    <org_study_id>DW_DOLO003</org_study_id>
    <nct_id>NCT03009721</nct_id>
  </id_info>
  <brief_title>Observational Study to Investigate the Effectiveness and Safety of Olostar Tab in Patients With Essential Hypertension and Dyslipidemia</brief_title>
  <official_title>A Non-interventional, Multi-center, Retrospective Observational Study to Investigate the Effectiveness and Safety of Olostar Tab in Patients With Essential Hypertension and Dyslipidemia (ROSE Study)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Daewoong Pharmaceutical Co. LTD.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Daewoong Pharmaceutical Co. LTD.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to investigate the effectiveness and safety of Olostar Tab in&#xD;
      patients with essential hypertension and dyslipidemia&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>August 2016</start_date>
  <completion_date type="Anticipated">June 2018</completion_date>
  <primary_completion_date type="Anticipated">June 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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Percent change from baseline in blood pressure (SBP/DBP)</measure>
    <time_frame>At 8 Weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Percent change from baseline in LDL-Cholesterol (LDL-C)</measure>
    <time_frame>At 8 Weeks</time_frame>
  </primary_outcome>
  <enrollment type="Anticipated">9707</enrollment>
  <condition>Hypertension</condition>
  <condition>Dyslipidemias</condition>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Other: Not applicable-observational study</intervention_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with essential hypertension and dyslipidemia&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female ≥ 19&#xD;
&#xD;
          -  Patients have record of blood pressure (SBP/DBP) and LDL-C after prescription of&#xD;
             Olostar Tab.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients that have participated clinical trials or PMS with Olostar Tab.&#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>Daewoong Clinical</last_name>
    <phone>+82-2-550-8800</phone>
    <phone_ext>8800</phone_ext>
  </overall_contact>
  <location>
    <facility>
      <name>Dongguk Ilsan University Hospital</name>
      <address>
        <city>Ilsan</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Daewoong Clinical</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 2, 2017</study_first_submitted>
  <study_first_submitted_qc>January 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 4, 2017</study_first_posted>
  <last_update_submitted>January 3, 2017</last_update_submitted>
  <last_update_submitted_qc>January 3, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 4, 2017</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>
    <mesh_term>Dyslipidemias</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/NCT03009721
org study id: DW_DOLO003
nct id: NCT03009721
lead sponsor: 
has dmc: No
The purpose of this study is to investigate the effectiveness and safety of Olostar Tab in
      patients with essential hypertension and dyslipidemia
observational model: Case-Only
time perspective: Retrospective
measure: Percent change from baseline in blood pressure (SBP/DBP)
time frame: At 8 Weeks
measure: Percent change from baseline in LDL-Cholesterol (LDL-C)
time frame: At 8 Weeks
intervention type: Drug
intervention name: Other: Not applicable-observational study
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
healthy volunteers: No
last name: Daewoong Clinical
phone: +82-2-550-8800
phone ext: 8800
facility: 
status: Recruiting
contact: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Hypertension
mesh term: Essential Hypertension
mesh term: Dyslipidemias
sharing ipd: No