<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/NCT03026933</url>
  </required_header>
  <id_info>
    <org_study_id>13-OR-8301</org_study_id>
    <nct_id>NCT03026933</nct_id>
  </id_info>
  <brief_title>Evaluate the Efficacy and Safety of KI1107 in Patients Whose TG Level is Not Adequately Controlled With Rosuvastatin Calcium Monotherapy While LDL-C is Properly Controlled</brief_title>
  <acronym>ROMANTIC</acronym>
  <official_title>A Multi-center, Randomized, Double Blind, Parallel Phase III Study to Evaluate the Efficacy and Safety of KI1107 in Patients Whose TG Level is Not Adequately Controlled With Rosuvastatin Calcium Monotherapy While LDL-C is Properly Controlled</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kuhnil Pharmaceutical Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kuhnil Pharmaceutical Co., Ltd.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To examine variation rate of Non-HDL with KI1107 comparison Rosuvastatin monotherapy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study design:&#xD;
&#xD;
      Randomly assigned to two groups(KI1107 or Rosuvastatin monotherpy) after 4 weeks run-in&#xD;
      period and prescribed KI1107 or Rosuvastatin for 8 weeks.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>May 2014</start_date>
  <completion_date type="Actual">March 2016</completion_date>
  <primary_completion_date type="Actual">March 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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Variation rate of Non HDL-C</measure>
    <time_frame>8 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Variation rate of TG</measure>
    <time_frame>4 weeks, 8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Variation rate of Non HDL-C</measure>
    <time_frame>4 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Variation rate of TC</measure>
    <time_frame>4 weeks, 8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Variation rate of LDL-C</measure>
    <time_frame>4 weeks, 8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Variation rate of VLDL-C</measure>
    <time_frame>4 weeks, 8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Variation rate of Apo A-I</measure>
    <time_frame>4 weeks, 8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Variation rate of Apo B</measure>
    <time_frame>4 weeks, 8 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">215</enrollment>
  <condition>Dyslipidemias</condition>
  <arm_group>
    <arm_group_label>Treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>KI1107</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Rosuvastatin calcium</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>KI1107 4 Capsules, QD</intervention_name>
    <description>KI1107 4 Capsules</description>
    <arm_group_label>Treatment</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Rosuvastatin Calcium 20 MG, QD</intervention_name>
    <description>Rosuvastatin Calcium 20mg, QD</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  Screening Visit&#xD;
&#xD;
               -  Age: 19-80&#xD;
&#xD;
               -  High risk for cardiovascular disease according to NCEP APT III&#xD;
&#xD;
               -  TG≥130mg/dL and 160mg/dL&gt;LDL-C≥100mg/dL for subjects who were not taking statins&#xD;
                  for 4 weeks&#xD;
&#xD;
               -  500mg/dL&gt;TG≥200mg/dL and LDL-C&lt;110mg/dL for subjects who were taking statins for&#xD;
                  4 weeks&#xD;
&#xD;
          -  Baseline Visit&#xD;
&#xD;
               -  500mg/dL&gt;TG≥200mg/dL&#xD;
&#xD;
               -  LDL-C&lt;110mg/dL&#xD;
&#xD;
               -  Reduction of LDL-C dompairng screening visit&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  The patient has histories of acute artery disease within 3 months&#xD;
&#xD;
          -  The patient has histories of operation revasculatiation or aneurysm within 6 months&#xD;
&#xD;
          -  The patient has histories of Unexplained myaliga or diagnosed myalgia or&#xD;
             rhabdomyolysis&#xD;
&#xD;
          -  The patient has histories of Effectable disease to the procedrue and clinical trial&#xD;
             result&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 16, 2017</study_first_submitted>
  <study_first_submitted_qc>January 19, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 20, 2017</study_first_posted>
  <last_update_submitted>January 19, 2017</last_update_submitted>
  <last_update_submitted_qc>January 19, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 20, 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>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>Calcium</mesh_term>
  </intervention_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/NCT03026933
org study id: 13-OR-8301
nct id: NCT03026933
lead sponsor: 
has dmc: No
To examine variation rate of Non-HDL with KI1107 comparison Rosuvastatin monotherapy.
Study design:

      Randomly assigned to two groups(KI1107 or Rosuvastatin monotherpy) after 4 weeks run-in
      period and prescribed KI1107 or Rosuvastatin for 8 weeks.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Variation rate of Non HDL-C
time frame: 8 weeks
measure: Variation rate of TG
time frame: 4 weeks, 8 weeks
measure: Variation rate of Non HDL-C
time frame: 4 weeks
measure: Variation rate of TC
time frame: 4 weeks, 8 weeks
measure: Variation rate of LDL-C
time frame: 4 weeks, 8 weeks
measure: Variation rate of VLDL-C
time frame: 4 weeks, 8 weeks
measure: Variation rate of Apo A-I
time frame: 4 weeks, 8 weeks
measure: Variation rate of Apo B
time frame: 4 weeks, 8 weeks
arm group label: Treatment
arm group type: Experimental
description: KI1107
arm group label: Control
arm group type: Active Comparator
description: Rosuvastatin calcium
intervention type: Drug
intervention name: KI1107 4 Capsules, QD
description: KI1107 4 Capsules
arm group label: Treatment
intervention type: Drug
intervention name: Rosuvastatin Calcium 20 MG, QD
description: Rosuvastatin Calcium 20mg, QD
arm group label: Control
criteria: 
gender: All
minimum age: 19 Years
maximum age: 80 Years
healthy volunteers: No
responsible party type: Sponsor
mesh term: Dyslipidemias
mesh term: Rosuvastatin Calcium
mesh term: Calcium
sharing ipd: No