<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/NCT01666067</url>
  </required_header>
  <id_info>
    <org_study_id>GMC-201110</org_study_id>
    <nct_id>NCT01666067</nct_id>
  </id_info>
  <brief_title>Vascular and Metabolic Effects of Vytorin vs Simvastatin</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Gachon University Gil Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Gachon University Gil Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators hypothesize that vytorin will improve insulin resistance compared with&#xD;
      simvastatin&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2011</start_date>
  <completion_date type="Actual">November 2012</completion_date>
  <primary_completion_date type="Actual">October 2012</primary_completion_date>
  <phase>Phase 4</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>flow-mediated dilation</measure>
    <time_frame>8 weeks of treatment</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>insulin resistance</measure>
    <time_frame>8 weeks of treatment</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">204</enrollment>
  <condition>Hypercholesterolemia</condition>
  <arm_group>
    <arm_group_label>placebo</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>placebo</description>
  </arm_group>
  <arm_group>
    <arm_group_label>vytorin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>vytorin</description>
  </arm_group>
  <arm_group>
    <arm_group_label>simvastatin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>simvastatin</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>placebo</intervention_name>
    <arm_group_label>placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>vytorin</intervention_name>
    <arm_group_label>vytorin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>simvastatin</intervention_name>
    <arm_group_label>simvastatin</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  hypercholesterolemic patients (LDL cholesterol levels&gt;100 mg/dl)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  overt liver disease, chronic renal failure, hypothyroidism, myopathy, uncontrolled&#xD;
             diabetes (HbA1c &gt; 9%), severe hypertension, stroke, acute coronary events, coronary&#xD;
             revascularization within the preceding 3 months, or alcohol abuse&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Gil Medical Center</name>
      <address>
        <city>Incheon</city>
        <zip>405-760</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>August 15, 2012</study_first_submitted>
  <study_first_submitted_qc>August 15, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 16, 2012</study_first_posted>
  <last_update_submitted>November 1, 2014</last_update_submitted>
  <last_update_submitted_qc>November 1, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 4, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Gachon University Gil Medical Center</investigator_affiliation>
    <investigator_full_name>Kwang Kon Koh</investigator_full_name>
    <investigator_title>professor</investigator_title>
  </responsible_party>
  <keyword>insulin resistance</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>Simvastatin</mesh_term>
    <mesh_term>Ezetimibe, Simvastatin Drug Combination</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/NCT01666067
org study id: GMC-201110
nct id: NCT01666067
lead sponsor: 
has dmc: Yes
The investigators hypothesize that vytorin will improve insulin resistance compared with
      simvastatin
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: flow-mediated dilation
time frame: 8 weeks of treatment
measure: insulin resistance
time frame: 8 weeks of treatment
arm group label: placebo
arm group type: Active Comparator
description: placebo
arm group label: vytorin
arm group type: Active Comparator
description: vytorin
arm group label: simvastatin
arm group type: Active Comparator
description: simvastatin
intervention type: Drug
intervention name: placebo
arm group label: placebo
intervention type: Drug
intervention name: vytorin
arm group label: vytorin
intervention type: Drug
intervention name: simvastatin
arm group label: simvastatin
criteria: 
gender: All
minimum age: 25 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Gachon University Gil Medical Center
investigator full name: Kwang Kon Koh
investigator title: professor
mesh term: Hypercholesterolemia
mesh term: Simvastatin
mesh term: Ezetimibe, Simvastatin Drug Combination