<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/NCT02262143</url>
  </required_header>
  <id_info>
    <org_study_id>ID-ROFE-301</org_study_id>
    <nct_id>NCT02262143</nct_id>
  </id_info>
  <brief_title>Phase III Study of Rosuvastatin and Fenofibrate Versus Rosuvastatin in Mixed Dyslipidemia</brief_title>
  <official_title>Efficacy and Safety of Combination Therapy of Rosuvastatin and Fenofibrate Versus Rosuvastatin Monotherapy in Mixed Dyslipidemia Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>IlDong Pharmaceutical Co Ltd</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>IlDong Pharmaceutical Co Ltd</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Efficacy and safety of combination therapy of rosuvastatin and fenofibrate versus&#xD;
      rosuvastatin monotherapy in mixed dyslipidemia patients: A randomized, multi-center,&#xD;
      double-blind, phase 3 study&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2014</start_date>
  <completion_date type="Actual">June 2017</completion_date>
  <primary_completion_date type="Actual">October 2016</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The mean percent change of Non-HDL Cholesterol</measure>
    <time_frame>from baseline at week 8</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>The mean change, percent change of Non-LDL-C</measure>
    <time_frame>from baseline at week 4</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The mean change of Non-LDL-C</measure>
    <time_frame>from baseline at week 8</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The mean percent change of LDL-C, HDL-C, VLDL-C, TG, TC, Apo-AI, Apo-B</measure>
    <time_frame>from baseline at week 4, 8</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The achievement rate of Non-HDL-C&lt;130mg/dl</measure>
    <time_frame>from baseline at week 4, 8</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">362</enrollment>
  <condition>Mixed Dyslipidemias</condition>
  <arm_group>
    <arm_group_label>Experimental</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Rosuvastatin 10 mg, Fenofibrate 160 mg</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Comparator</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Rosuvastatin 10 mg</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Rosuvastatin</intervention_name>
    <description>Rosuvastatin 10 mg, qd, po</description>
    <arm_group_label>Comparator</arm_group_label>
    <arm_group_label>Experimental</arm_group_label>
    <other_name>Crestor Tab.</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fenofibrate</intervention_name>
    <description>Fenofibrate 160mg, qd, po</description>
    <arm_group_label>Experimental</arm_group_label>
    <other_name>Lipidil supra Tab.</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  19 ~ 80 years old&#xD;
&#xD;
          -  High risk patient to Coronary Heart Disease&#xD;
&#xD;
          -  At Visit 1(Screening)&#xD;
&#xD;
               1. Treated with Rosuvastatin 10mg monotherapy 4weeks prior to this study&#xD;
&#xD;
               2. 110 mg/dl ≥ LDL-C, 200 mg/dl ≤ TG ≤ 500 mg/dl&#xD;
&#xD;
          -  At Visit 2 (Baseline), 110 mg/dl ≥ LDL-C, 200 mg/dl ≤ TG ≤ 500 mg/dl&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  AST or ALT &gt; 2X ULN&#xD;
&#xD;
          -  Patients with uncontrolled hyperthyroidism (TSH&gt;1.5X ULN)&#xD;
&#xD;
          -  Patients with uncontrolled diabetes (HbA1c ≥ 9%)&#xD;
&#xD;
          -  Patients with uncontrolled hypertension(SBP&gt;160mmHg or DBP&gt;95mmHg)&#xD;
&#xD;
          -  Patients with congestive heart failure(NYHA class III~IV) or uncontrolled arrhythmia&#xD;
             within 6 months&#xD;
&#xD;
          -  Patients treated with any investigational drugs within 3 months at the time consents&#xD;
             are obtained&#xD;
&#xD;
          -  Not eligible to participate for the study at the discretion of investigator&#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>Jeongtaeck Woo, M.D., Ph.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Kyunghee University Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ildong Pharm.</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>October 7, 2014</study_first_submitted>
  <study_first_submitted_qc>October 7, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 10, 2014</study_first_posted>
  <last_update_submitted>August 23, 2018</last_update_submitted>
  <last_update_submitted_qc>August 23, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 24, 2018</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>Dyslipidemias</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>Fenofibrate</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/NCT02262143
org study id: ID-ROFE-301
nct id: NCT02262143
lead sponsor: 
has dmc: No
Efficacy and safety of combination therapy of rosuvastatin and fenofibrate versus
      rosuvastatin monotherapy in mixed dyslipidemia patients: A randomized, multi-center,
      double-blind, phase 3 study
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: The mean percent change of Non-HDL Cholesterol
time frame: from baseline at week 8
measure: The mean change, percent change of Non-LDL-C
time frame: from baseline at week 4
measure: The mean change of Non-LDL-C
time frame: from baseline at week 8
measure: The mean percent change of LDL-C, HDL-C, VLDL-C, TG, TC, Apo-AI, Apo-B
time frame: from baseline at week 4, 8
measure: The achievement rate of Non-HDL-C<130mg/dl
time frame: from baseline at week 4, 8
arm group label: Experimental
arm group type: Experimental
description: Rosuvastatin 10 mg, Fenofibrate 160 mg
arm group label: Comparator
arm group type: Active Comparator
description: Rosuvastatin 10 mg
intervention type: Drug
intervention name: Rosuvastatin
description: Rosuvastatin 10 mg, qd, po
arm group label: Comparator
arm group label: Experimental
other name: Crestor Tab.
intervention type: Drug
intervention name: Fenofibrate
description: Fenofibrate 160mg, qd, po
arm group label: Experimental
other name: Lipidil supra Tab.
criteria: 
gender: All
minimum age: 19 Years
maximum age: 80 Years
healthy volunteers: No
last name: Jeongtaeck Woo, M.D., Ph.D
role: Principal Investigator
affiliation: Kyunghee University Medical Center
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Dyslipidemias
mesh term: Rosuvastatin Calcium
mesh term: Fenofibrate