<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/NCT02205606</url>
  </required_header>
  <id_info>
    <org_study_id>HM-ROZE-301</org_study_id>
    <nct_id>NCT02205606</nct_id>
  </id_info>
  <brief_title>Efficacy/Safety of HCP1306 Tablet Versus HGP0816 Tablet in Patients With Primary Hypercholesterolemia</brief_title>
  <official_title>A Randomized, Double-Blind, Multicenter, Phase 3 Study to Evaluate Efficacy and Safety of HCP1306 Tablet in Patients With Primary Hypercholesterolemia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hanmi Pharmaceutical Company Limited</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hanmi Pharmaceutical Company Limited</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate efficacy and safety of HCP1306 in patients with&#xD;
      primary hypercholesterolemia.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>June 2014</start_date>
  <completion_date type="Actual">April 2015</completion_date>
  <primary_completion_date type="Actual">February 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>
  <secondary_outcome>
    <measure>Percentage of patients reaching treatment goals according to NCEP ATP III Guideline</measure>
    <time_frame>week 4, week 8</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent change from baseline to 4 week and 8 week in TC</measure>
    <time_frame>week 4, week 8</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent change from baseline to 4 week and 8 week in HDL-C</measure>
    <time_frame>week 4, week 8</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent change from baseline to 4 week and 8 week in TG</measure>
    <time_frame>week 4, week 8</time_frame>
  </secondary_outcome>
  <number_of_arms>6</number_of_arms>
  <enrollment type="Actual">412</enrollment>
  <condition>Primary Hypercholesterolemia</condition>
  <arm_group>
    <arm_group_label>HGP0816 5mg</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>HGP0816 10mg</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>HGP0816 20mg</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>HCP1306 5/10mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>HCP1306 10/10mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>HCP1306 20/10mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>HGP0816 5mg</intervention_name>
    <description>P.O.</description>
    <arm_group_label>HGP0816 5mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>HGP0816 10mg</intervention_name>
    <description>P.O.</description>
    <arm_group_label>HGP0816 10mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>HGP0816 20mg</intervention_name>
    <description>P.O.</description>
    <arm_group_label>HGP0816 20mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>HCP1306 5/10mg</intervention_name>
    <description>P.O.</description>
    <arm_group_label>HCP1306 5/10mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>HCP1306 10/10mg</intervention_name>
    <description>P.O.</description>
    <arm_group_label>HCP1306 10/10mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>HCP1306 20/10mg</intervention_name>
    <description>P.O.</description>
    <arm_group_label>HCP1306 20/10mg</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Aged over 19 years&#xD;
&#xD;
          -  Signed informed consent&#xD;
&#xD;
          -  At visit 1, LDL-C ≤ 250mg/dL and Triglyceride &lt; 400 mg/dL&#xD;
&#xD;
          -  After 4 weeks more TLC, At visit2, LDL-C ≤ 250mg/dL, Triglyceride &lt; 400 mg/dL and&#xD;
             satisfied criteria according to Risk of cardiovascular disease&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Current or past history of hypersensitivity to HMG-CoA reductase inhibitors and&#xD;
             component of Ezetimibe&#xD;
&#xD;
          -  Has an active liver disease and severe liver disorder (continous elevation of AST, ALT&#xD;
             level or exceeds more than 3 times of normal upper limit)&#xD;
&#xD;
          -  Has a severe renal failure and kidney injury (Creatinine level exceeds more than 2&#xD;
             times of normal upper limit)&#xD;
&#xD;
          -  CK level exceeds more than 5 times of normal upper limit&#xD;
&#xD;
          -  Uncontrolled hypertension patient (SBP≥ 180 mmHg or DBP ≥ 110 mmHg)&#xD;
&#xD;
          -  Uncontrolled diabetes mellitus patient (HbA1c ≥ 9%)&#xD;
&#xD;
          -  Uncontrolled malfunctional thyroidism (or at pre-visit 2, TSH level exceeds more than&#xD;
             1.5 times of normal upper limit)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hyo-soo Kim, MD, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Seoul National University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>19 institutions including Seoul National University Hospital</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 30, 2014</study_first_submitted>
  <study_first_submitted_qc>July 30, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 31, 2014</study_first_posted>
  <last_update_submitted>September 21, 2015</last_update_submitted>
  <last_update_submitted_qc>September 21, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 22, 2015</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>Hypercholesterolemia</mesh_term>
  </condition_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/NCT02205606
org study id: HM-ROZE-301
nct id: NCT02205606
lead sponsor: 
has dmc: No
The purpose of this study is to evaluate efficacy and safety of HCP1306 in patients with
      primary hypercholesterolemia.
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
measure: Percentage of patients reaching treatment goals according to NCEP ATP III Guideline
time frame: week 4, week 8
measure: Percent change from baseline to 4 week and 8 week in TC
time frame: week 4, week 8
measure: Percent change from baseline to 4 week and 8 week in HDL-C
time frame: week 4, week 8
measure: Percent change from baseline to 4 week and 8 week in TG
time frame: week 4, week 8
arm group label: HGP0816 5mg
arm group type: Active Comparator
arm group label: HGP0816 10mg
arm group type: Active Comparator
arm group label: HGP0816 20mg
arm group type: Active Comparator
arm group label: HCP1306 5/10mg
arm group type: Experimental
arm group label: HCP1306 10/10mg
arm group type: Experimental
arm group label: HCP1306 20/10mg
arm group type: Experimental
intervention type: Drug
intervention name: HGP0816 5mg
description: P.O.
arm group label: HGP0816 5mg
intervention type: Drug
intervention name: HGP0816 10mg
description: P.O.
arm group label: HGP0816 10mg
intervention type: Drug
intervention name: HGP0816 20mg
description: P.O.
arm group label: HGP0816 20mg
intervention type: Drug
intervention name: HCP1306 5/10mg
description: P.O.
arm group label: HCP1306 5/10mg
intervention type: Drug
intervention name: HCP1306 10/10mg
description: P.O.
arm group label: HCP1306 10/10mg
intervention type: Drug
intervention name: HCP1306 20/10mg
description: P.O.
arm group label: HCP1306 20/10mg
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
healthy volunteers: No
last name: Hyo-soo Kim, MD, Ph.D.
role: Principal Investigator
affiliation: Seoul National University Hospital
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Hypercholesterolemia