<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/NCT02251847</url>
  </required_header>
  <id_info>
    <org_study_id>ID-ROEZ-301</org_study_id>
    <nct_id>NCT02251847</nct_id>
  </id_info>
  <brief_title>The Efficacy and Safety of a Combination Therapy of Rosuvastatin and Ezetimibe Versus Monotherapy of Rosuvastatin in Hypercholesterolemia Patients</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>IlDong Pharmaceutical Co Ltd</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>IlDong Pharmaceutical Co Ltd</source>
  <brief_summary>
    <textblock>
      To evaluate efficacy and safety of a combination therapy of rosuvastatin and ezetimibe versus&#xD;
      monotherapy of rosuvastatin in hypercholesterolemia patients&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      To evaluate efficacy and safety of a combination therapy of rosuvastatin and ezetimibe versus&#xD;
      monotherapy of rosuvastatin in hypercholesterolemia patients&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>July 2014</start_date>
  <primary_completion_date type="Anticipated">July 2015</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percent change from baseline to 8 week in LDL-Cholesterol</measure>
    <time_frame>baseline and 8 week</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percent change from baseline to 4 week in LDL-Cholesterol</measure>
    <time_frame>baseline and 4 week</time_frame>
  </secondary_outcome>
  <number_of_arms>6</number_of_arms>
  <enrollment type="Anticipated">400</enrollment>
  <condition>Hypercholesterolemia</condition>
  <arm_group>
    <arm_group_label>R5</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Rosuvastatin 5mg</description>
  </arm_group>
  <arm_group>
    <arm_group_label>R10</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Rosuvastatin 10mg</description>
  </arm_group>
  <arm_group>
    <arm_group_label>R20</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Rosuvastatin 20mg</description>
  </arm_group>
  <arm_group>
    <arm_group_label>R5/E10</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Rosuvastatin 5mg/ezetimibe 10mg</description>
  </arm_group>
  <arm_group>
    <arm_group_label>R10/E10</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Rosuvastatin 10mg/ezetimibe 10mg</description>
  </arm_group>
  <arm_group>
    <arm_group_label>R20/E10</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Rosuvastatin 20mg/ezetimibe 10mg</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Rosuvastatin/Ezetimibe</intervention_name>
    <description>Rosuvastatin 5mg</description>
    <arm_group_label>R10</arm_group_label>
    <arm_group_label>R10/E10</arm_group_label>
    <arm_group_label>R20</arm_group_label>
    <arm_group_label>R20/E10</arm_group_label>
    <arm_group_label>R5</arm_group_label>
    <arm_group_label>R5/E10</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Hypercholesterolemic patient&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Has history of hypersensitivity to HMG-CoA reductase inhibitor and Ezetimibe&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Tae Hoon Ahn</last_name>
    <role>Principal Investigator</role>
    <affiliation>Gachon University Gil Medical Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Min-Hee Kwon</last_name>
    <phone>02-526-3379</phone>
    <email>minhee@ildong.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Gil Medical Center</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Tae Hoon Ahn</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>September 25, 2014</study_first_submitted>
  <study_first_submitted_qc>September 25, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 29, 2014</study_first_posted>
  <last_update_submitted>September 25, 2014</last_update_submitted>
  <last_update_submitted_qc>September 25, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 29, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>cholesterol</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypercholesterolemia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rosuvastatin Calcium</mesh_term>
    <mesh_term>Ezetimibe</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/NCT02251847
org study id: ID-ROEZ-301
nct id: NCT02251847
lead sponsor: 
To evaluate efficacy and safety of a combination therapy of rosuvastatin and ezetimibe versus
      monotherapy of rosuvastatin in hypercholesterolemia patients
To evaluate efficacy and safety of a combination therapy of rosuvastatin and ezetimibe versus
      monotherapy of rosuvastatin in hypercholesterolemia patients
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Percent change from baseline to 8 week in LDL-Cholesterol
time frame: baseline and 8 week
measure: Percent change from baseline to 4 week in LDL-Cholesterol
time frame: baseline and 4 week
arm group label: R5
arm group type: Active Comparator
description: Rosuvastatin 5mg
arm group label: R10
arm group type: Active Comparator
description: Rosuvastatin 10mg
arm group label: R20
arm group type: Active Comparator
description: Rosuvastatin 20mg
arm group label: R5/E10
arm group type: Experimental
description: Rosuvastatin 5mg/ezetimibe 10mg
arm group label: R10/E10
arm group type: Experimental
description: Rosuvastatin 10mg/ezetimibe 10mg
arm group label: R20/E10
arm group type: Experimental
description: Rosuvastatin 20mg/ezetimibe 10mg
intervention type: Drug
intervention name: Rosuvastatin/Ezetimibe
description: Rosuvastatin 5mg
arm group label: R10
arm group label: R10/E10
arm group label: R20
arm group label: R20/E10
arm group label: R5
arm group label: R5/E10
criteria: 
gender: All
minimum age: 19 Years
maximum age: 80 Years
healthy volunteers: No
last name: Tae Hoon Ahn
role: Principal Investigator
affiliation: Gachon University Gil Medical Center
last name: Min-Hee Kwon
phone: 02-526-3379
email: minhee@ildong.com
facility: 
status: Recruiting
contact: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Hypercholesterolemia
mesh term: Rosuvastatin Calcium
mesh term: Ezetimibe