<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/NCT02977065</url>
  </required_header>
  <id_info>
    <org_study_id>148HL16011</org_study_id>
    <nct_id>NCT02977065</nct_id>
  </id_info>
  <brief_title>To Assess the Safety, Efficacy and Tolerability of CKD-519, Administered With HMG-CoA Reductase Inhibitors</brief_title>
  <official_title>Multicenter, Parallel-group, Double-blind, Randomized, Active-controlled, Dose-ranging Study to Assess the Safety, Efficacy, and Tolerability of CKD-519, Administered With HMG-CoA Reductase Inhibitors, in Subjects With Dyslipidemia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chong Kun Dang Pharmaceutical</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chong Kun Dang Pharmaceutical</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      A multicenter, double-blind, parallel-group, active-controlled, dose-ranging study to assess&#xD;
      the safety and efficacy of the novel cholesteryl ester transfer protein (CETP) inhibitor&#xD;
      CKD-519 in combination with atorvastatin or rosuvastatin in subjects with dyslipidemia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this study is to assess the safety, efficacy, and tolerability of CKD-519,&#xD;
      administered with HMG-CoA reductase inhibitors in subjects with dyslipidemia&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 23, 2017</start_date>
  <completion_date type="Actual">January 30, 2018</completion_date>
  <primary_completion_date type="Actual">December 30, 2017</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Factorial Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage change from baseline (Visit 3) in LDL-C</measure>
    <time_frame>at Week 4</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage change from baseline in HDL-C</measure>
    <time_frame>at Weeks 2 and Week 4</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage change from baseline in concentration of HDL particles (HDL-P)</measure>
    <time_frame>at Weeks 2 and 4</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in size of HDL particles (HDL-P)</measure>
    <time_frame>at Weeks 2 and 4</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage change from baseline in LDL-C</measure>
    <time_frame>at Week 2</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in concentration from baseline in LDL-C</measure>
    <time_frame>at Weeks 2 and 4</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in concentration from baseline in HDL-C</measure>
    <time_frame>at Weeks 2 and 4</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage change from baseline in total cholesterol, TG, and non-HDL-C</measure>
    <time_frame>at Weeks 2 and 4</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in concentration from baseline in total cholesterol, TG, and non-HDL-C</measure>
    <time_frame>at Weeks 2 and 4</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage change from baseline in apolipoprotein B (Apo B), apolipoprotein A1 (Apo A1), and apolipoprotein E (Apo E)</measure>
    <time_frame>at Weeks 2 and 4</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in concentration from baseline in Apo B, Apo A1, and Apo E</measure>
    <time_frame>at Weeks 2 and 4</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage change from baseline in lipoprotein(a) (Lp-a)</measure>
    <time_frame>at Weeks 2 and 4</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in concentration from baseline in Lp-a</measure>
    <time_frame>at Weeks 2 and 4</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in concentration from baseline in high-sensitivity C-reactive protein at</measure>
    <time_frame>at Weeks 2 and 4</time_frame>
  </secondary_outcome>
  <number_of_arms>6</number_of_arms>
  <enrollment type="Actual">62</enrollment>
  <condition>Dyslipidemias</condition>
  <arm_group>
    <arm_group_label>Atorvastatin 20 mg</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>To administrate Atorvastatin 20 mg and 4 Placebos, PO, QD for 4weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Atorvastatin 20 mg + CKD-519 50 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>To administrate Atorvastatin 20 mg, CKD-519 50 mg and 3 Placebos, PO, QD for 4weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Atorvastatin 20 mg + CKD-519 100 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>To administrate Atorvastatin 20 mg, CKD-519 100 mg and 3 Placebos, PO, QD for 4weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Atorvastatin 20 mg + CKD-519 200 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>To administrate Atorvastatin 20 mg, CKD-519 200 mg and 2 Placebos, PO, QD for 4weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Rosuvastatin 10 mg</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>To administrate Rosuvastatin 10 mg and 4 Placebos, PO, QD for 4weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Rosuvastatin 10 mg + CKD-519 100 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>To administrate Rosuvastatin 10 mg, CKD-519 100 mg and 3 Placebos, PO, QD for 4weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Atorvastatin 20mg</intervention_name>
    <description>PO daily for 4weeks</description>
    <arm_group_label>Atorvastatin 20 mg</arm_group_label>
    <other_name>Lipitor 20mg</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Atorvastatin 20 mg + CKD-519 50 mg</intervention_name>
    <description>PO daily for 4weeks</description>
    <arm_group_label>Atorvastatin 20 mg + CKD-519 50 mg</arm_group_label>
    <other_name>Lipitor 20mg</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Atorvastatin 20 mg + CKD-519 100 mg</intervention_name>
    <description>PO daily for 4weeks</description>
    <arm_group_label>Atorvastatin 20 mg + CKD-519 100 mg</arm_group_label>
    <other_name>Lipitor 20mg</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Atorvastatin 20 mg + CKD-519 200 mg</intervention_name>
    <description>PO daily for 4weeks</description>
    <arm_group_label>Atorvastatin 20 mg + CKD-519 200 mg</arm_group_label>
    <other_name>Lipitor 20mg</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Rosuvastatin 10 mg</intervention_name>
    <description>PO daily for 4weeks</description>
    <arm_group_label>Rosuvastatin 10 mg</arm_group_label>
    <other_name>Crestor 10mg</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Rosuvastatin 10 mg + CKD-519 100 mg</intervention_name>
    <description>PO daily for 4weeks</description>
    <arm_group_label>Rosuvastatin 10 mg + CKD-519 100 mg</arm_group_label>
    <other_name>Crestor 10mg</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age 18 to 80 years.&#xD;
&#xD;
          2. Dyslipidemia with LDL-C&#xD;
&#xD;
               -  At screening if untreated: 100 to 190 mg/dL&#xD;
&#xD;
               -  At screening if treated with statins or other lipid-lowering drugs: 100 to 170&#xD;
                  mg/dL&#xD;
&#xD;
               -  At start of double-blind treatment: 100 to 190 mg/dL.&#xD;
&#xD;
          3. HDL-C &lt;45 mg/dL (males) or &lt;50 mg/dL (females).&#xD;
&#xD;
          4. Fasting TG &lt;400 mg/dL.&#xD;
&#xD;
          5. Presence of the following conditions is permitted but not mandatory, at the discretion&#xD;
             of the investigator:&#xD;
&#xD;
               -  Treated and stable coronary heart disease without acute events in the past 3&#xD;
                  months and stable, state-of-the-art medication.&#xD;
&#xD;
               -  Treated and stable carotid artery disease or peripheral arterial disease on&#xD;
                  stable, standard medication for the past 3 months&#xD;
&#xD;
               -  Treated and stable Type 2 diabetes mellitus with glycosylated hemoglobin (HbA1c)&#xD;
                  ≤9.5%.&#xD;
&#xD;
          6. Willing and able to sign the informed consent form (ICF).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Chronic heart failure as defined by New York Heart Association classes III and IV.&#xD;
&#xD;
          2. Uncontrolled cardiac arrhythmias.&#xD;
&#xD;
          3. Myocardial infarction, percutaneous coronary intervention, coronary artery bypass&#xD;
             graft, or unstable angina in past 3 months before Visit 1.&#xD;
&#xD;
          4. Stroke or transient ischemic attack within 3 months before Visit 1.&#xD;
&#xD;
          5. Uncontrolled hypertension.&#xD;
&#xD;
          6. Clinically significant laboratory abnormalities&#xD;
&#xD;
               -  Aspartate aminotransferase or alanine aminotransferase &gt;2 times upper limit of&#xD;
                  normal range&#xD;
&#xD;
               -  Bilirubin &gt;1.5 times upper limit of normal range&#xD;
&#xD;
               -  Creatine kinase &gt;2 times upper limit of normal range.&#xD;
&#xD;
          7. Any active nephropathy or estimated glomerular filtration rate &lt;60 mL/min/1.73m2 or on&#xD;
             kidney dialysis.&#xD;
&#xD;
          8. Poorly controlled (thyroid-stimulating hormone [TSH] &gt;2 times upper limit of normal)&#xD;
             hyperthyroidism.&#xD;
&#xD;
          9. Homozygous familial hypercholesterolemia.&#xD;
&#xD;
         10. Intolerance or hypersensitivity to atorvastatin or rosuvastatin.&#xD;
&#xD;
         11. Prior treatment with any CETP inhibitor.&#xD;
&#xD;
         12. Positive for human immunodeficiency virus (HIV) positive, hepatitis B or hepatitis C.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kyung-Mi Park, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Chong Kun Dang Pharm.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Not provided</name>
      <address>
        <city>Adelaide</city>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>November 27, 2016</study_first_submitted>
  <study_first_submitted_qc>November 29, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 30, 2016</study_first_posted>
  <last_update_submitted>November 5, 2018</last_update_submitted>
  <last_update_submitted_qc>November 5, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 6, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Dyslipidemia</keyword>
  <keyword>CETP Inhibitors</keyword>
  <keyword>Hyperlipidemia</keyword>
  <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>Atorvastatin</mesh_term>
    <mesh_term>Rosuvastatin 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/NCT02977065
org study id: 148HL16011
nct id: NCT02977065
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
A multicenter, double-blind, parallel-group, active-controlled, dose-ranging study to assess
      the safety and efficacy of the novel cholesteryl ester transfer protein (CETP) inhibitor
      CKD-519 in combination with atorvastatin or rosuvastatin in subjects with dyslipidemia.
The purpose of this study is to assess the safety, efficacy, and tolerability of CKD-519,
      administered with HMG-CoA reductase inhibitors in subjects with dyslipidemia
allocation: Randomized
intervention model: Factorial Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Percentage change from baseline (Visit 3) in LDL-C
time frame: at Week 4
measure: Percentage change from baseline in HDL-C
time frame: at Weeks 2 and Week 4
measure: Percentage change from baseline in concentration of HDL particles (HDL-P)
time frame: at Weeks 2 and 4
measure: Change from baseline in size of HDL particles (HDL-P)
time frame: at Weeks 2 and 4
measure: Percentage change from baseline in LDL-C
time frame: at Week 2
measure: Change in concentration from baseline in LDL-C
time frame: at Weeks 2 and 4
measure: Change in concentration from baseline in HDL-C
time frame: at Weeks 2 and 4
measure: Percentage change from baseline in total cholesterol, TG, and non-HDL-C
time frame: at Weeks 2 and 4
measure: Change in concentration from baseline in total cholesterol, TG, and non-HDL-C
time frame: at Weeks 2 and 4
measure: Percentage change from baseline in apolipoprotein B (Apo B), apolipoprotein A1 (Apo A1), and apolipoprotein E (Apo E)
time frame: at Weeks 2 and 4
measure: Change in concentration from baseline in Apo B, Apo A1, and Apo E
time frame: at Weeks 2 and 4
measure: Percentage change from baseline in lipoprotein(a) (Lp-a)
time frame: at Weeks 2 and 4
measure: Change in concentration from baseline in Lp-a
time frame: at Weeks 2 and 4
measure: Change in concentration from baseline in high-sensitivity C-reactive protein at
time frame: at Weeks 2 and 4
arm group label: Atorvastatin 20 mg
arm group type: Active Comparator
description: To administrate Atorvastatin 20 mg and 4 Placebos, PO, QD for 4weeks
arm group label: Atorvastatin 20 mg + CKD-519 50 mg
arm group type: Experimental
description: To administrate Atorvastatin 20 mg, CKD-519 50 mg and 3 Placebos, PO, QD for 4weeks
arm group label: Atorvastatin 20 mg + CKD-519 100 mg
arm group type: Experimental
description: To administrate Atorvastatin 20 mg, CKD-519 100 mg and 3 Placebos, PO, QD for 4weeks
arm group label: Atorvastatin 20 mg + CKD-519 200 mg
arm group type: Experimental
description: To administrate Atorvastatin 20 mg, CKD-519 200 mg and 2 Placebos, PO, QD for 4weeks
arm group label: Rosuvastatin 10 mg
arm group type: Active Comparator
description: To administrate Rosuvastatin 10 mg and 4 Placebos, PO, QD for 4weeks
arm group label: Rosuvastatin 10 mg + CKD-519 100 mg
arm group type: Experimental
description: To administrate Rosuvastatin 10 mg, CKD-519 100 mg and 3 Placebos, PO, QD for 4weeks
intervention type: Drug
intervention name: Atorvastatin 20mg
description: PO daily for 4weeks
arm group label: Atorvastatin 20 mg
other name: Lipitor 20mg
intervention type: Drug
intervention name: Atorvastatin 20 mg + CKD-519 50 mg
description: PO daily for 4weeks
arm group label: Atorvastatin 20 mg + CKD-519 50 mg
other name: Lipitor 20mg
intervention type: Drug
intervention name: Atorvastatin 20 mg + CKD-519 100 mg
description: PO daily for 4weeks
arm group label: Atorvastatin 20 mg + CKD-519 100 mg
other name: Lipitor 20mg
intervention type: Drug
intervention name: Atorvastatin 20 mg + CKD-519 200 mg
description: PO daily for 4weeks
arm group label: Atorvastatin 20 mg + CKD-519 200 mg
other name: Lipitor 20mg
intervention type: Drug
intervention name: Rosuvastatin 10 mg
description: PO daily for 4weeks
arm group label: Rosuvastatin 10 mg
other name: Crestor 10mg
intervention type: Drug
intervention name: Rosuvastatin 10 mg + CKD-519 100 mg
description: PO daily for 4weeks
arm group label: Rosuvastatin 10 mg + CKD-519 100 mg
other name: Crestor 10mg
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Kyung-Mi Park, PhD
role: Study Director
affiliation: Chong Kun Dang Pharm.
facility: 
country: Australia
responsible party type: Sponsor
mesh term: Dyslipidemias
mesh term: Atorvastatin
mesh term: Rosuvastatin Calcium
sharing ipd: No