xml: <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/NCT05970679</url>
    </required_header>
    <id_info>
      <org_study_id>DW1125-301</org_study_id>
      <nct_id>NCT05970679</nct_id>
    </id_info>
    <brief_title>Clinical Trial to Evaluate the Efficacy and Safety of DW1125 and DW1125A</brief_title>
    <official_title>A Randomized, Double Blind, Parallel, Multi-center, Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of DW1125 and DW1125A in Patient With Primary Hypercholesterolemia or Mixed Dyslipidemia</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Daewon Pharmaceutical Co., Ltd.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Daewon Pharmaceutical Co., Ltd.</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 Randomized, Double blind, Parallel, Multi-center, Phase 3 Clinical Trial to Evaluate the&#xD;
        Efficacy and Safety of DW1125 and DW1125A in Patient with primary Hypercholesterolemia or&#xD;
        Mixed Dyslipidemia&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">August 17, 2022</start_date>
    <completion_date type="Actual">April 13, 2023</completion_date>
    <primary_completion_date type="Actual">April 13, 2023</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>% Change of LDL-C</measure>
      <time_frame>8 weeks</time_frame>
      <description>% Change of LDL-C in week 8 from baseline</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>% Change of LDL-C</measure>
      <time_frame>4 weeks</time_frame>
      <description>% Change of LDL-C in week 4 from baseline</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>% Change of Lipid parameters</measure>
      <time_frame>4 weeks and 8 weeks</time_frame>
      <description>% Change of Lipid parameters(TC, TG, HDL-C, Non-HDL-C, Apo A1, Apo B) in week 4 and week 8 respectively after administrating the treatment drugs</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>LDL-C goal achievement rates</measure>
      <time_frame>4 weeks and 8 weeks</time_frame>
      <description>LDL-C goal achievement rates in week 4 and week 8 respectively after administrating the treatment drugs (goal achievement for LDL-C: low risk group: &lt; 160 mg/dL, intermediate risk group: &lt;130 mg/dL, high risk group: &lt; 100 mg/dL, extreme risk group: &lt; 70 mg/dL)</description>
    </secondary_outcome>
    <number_of_arms>4</number_of_arms>
    <enrollment type="Actual">252</enrollment>
    <condition>Hypercholesterolemia, Dyslipidemia</condition>
    <arm_group>
      <arm_group_label>DW1125</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>1 Ezetimibe/Atorvastatin 10/5 mg tablet orally once daily</description>
    </arm_group>
    <arm_group>
      <arm_group_label>DW1125A</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>1 Atorvastatin 5 mg tablet orally once daily</description>
    </arm_group>
    <arm_group>
      <arm_group_label>DW1125E</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>1 Ezetimibe 10mg tablet orally once daily</description>
    </arm_group>
    <arm_group>
      <arm_group_label>DW1125A-1</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>1 Atorvastatin 10mg tablet orally once daily</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Ezetimibe/Atorvastatin 10/5 mg</intervention_name>
      <description>DW1125</description>
      <arm_group_label>DW1125</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Atorvastatin 5mg</intervention_name>
      <description>DW1125A</description>
      <arm_group_label>DW1125A</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Ezetimibe 10mg</intervention_name>
      <description>DW1125E</description>
      <arm_group_label>DW1125E</arm_group_label>
      <other_name>Ezetrol Tab. 10mg</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Atorvastatin 10mg</intervention_name>
      <description>DW1125A-1</description>
      <arm_group_label>DW1125A-1</arm_group_label>
      <other_name>Lipiwon Tab. 10mg</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>DW1125 placebo</intervention_name>
      <description>Ezetimibe/Atorvastatin 10/5 mg placebo</description>
      <arm_group_label>DW1125A</arm_group_label>
      <arm_group_label>DW1125A-1</arm_group_label>
      <arm_group_label>DW1125E</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>DW1125A placebo</intervention_name>
      <description>Atorvastatin 5mg placebo</description>
      <arm_group_label>DW1125</arm_group_label>
      <arm_group_label>DW1125A-1</arm_group_label>
      <arm_group_label>DW1125E</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>DW1125E placebo</intervention_name>
      <description>Ezetimibe 10mg placebo</description>
      <arm_group_label>DW1125</arm_group_label>
      <arm_group_label>DW1125A</arm_group_label>
      <arm_group_label>DW1125A-1</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>DW1125A-1 placebo</intervention_name>
      <description>Atorvastatin 10mg placebo</description>
      <arm_group_label>DW1125</arm_group_label>
      <arm_group_label>DW1125A</arm_group_label>
      <arm_group_label>DW1125E</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Both gender, the person aged 19 or older&#xD;
  &#xD;
            -  Patients who are diagnosed with primary Hypercholesterolemia or Mixed Dyslipidemia&#xD;
  &#xD;
            -  LDL- C ≤ 250 mg/dL and TG &lt; 500 mg/dL on fasting status&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients with Myopathy, Rhabdomyolysis, Fibromyalgia, hereditary neuromuscular&#xD;
               disorders or family history, or Creatine kinase(CK) ≥ 2 x Upper Limit of Normal(ULN)&#xD;
               on Visit 1&#xD;
  &#xD;
            -  Patients with severe renal disorders, Estimated Flomerular Filtration Rate (eGFR) &lt; 30&#xD;
               mL/min/1.73m^2 on Visit 1&#xD;
  &#xD;
            -  Patients with hepatic failure or active or chronic hepatobiliary diseases or aspartate&#xD;
               transaminase (AST) or alanine aminotransferase (ALT) ≥ 2.0 x ULN on visit 1&#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>Kim</last_name>
      <role>Principal Investigator</role>
      <affiliation>Seoul National University Hospital</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>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 2023</verification_date>
    <study_first_submitted>July 24, 2023</study_first_submitted>
    <study_first_submitted_qc>July 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>July 24, 2023</last_update_submitted>
    <last_update_submitted_qc>July 24, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 1, 2023</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>
      <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>Ezetimibe</mesh_term>
    </intervention_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05970679
  org study id: DW1125-301
  nct id: NCT05970679
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  A Randomized, Double blind, Parallel, Multi-center, Phase 3 Clinical Trial to Evaluate the
        Efficacy and Safety of DW1125 and DW1125A in Patient with primary Hypercholesterolemia or
        Mixed Dyslipidemia
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  measure: % Change of LDL-C
  time frame: 8 weeks
  description: % Change of LDL-C in week 8 from baseline
  measure: % Change of LDL-C
  time frame: 4 weeks
  description: % Change of LDL-C in week 4 from baseline
  measure: % Change of Lipid parameters
  time frame: 4 weeks and 8 weeks
  description: % Change of Lipid parameters(TC, TG, HDL-C, Non-HDL-C, Apo A1, Apo B) in week 4 and week 8 respectively after administrating the treatment drugs
  measure: LDL-C goal achievement rates
  time frame: 4 weeks and 8 weeks
  description: LDL-C goal achievement rates in week 4 and week 8 respectively after administrating the treatment drugs (goal achievement for LDL-C: low risk group: < 160 mg/dL, intermediate risk group: <130 mg/dL, high risk group: < 100 mg/dL, extreme risk group: < 70 mg/dL)
  arm group label: DW1125
  arm group type: Experimental
  description: 1 Ezetimibe/Atorvastatin 10/5 mg tablet orally once daily
  arm group label: DW1125A
  arm group type: Experimental
  description: 1 Atorvastatin 5 mg tablet orally once daily
  arm group label: DW1125E
  arm group type: Placebo Comparator
  description: 1 Ezetimibe 10mg tablet orally once daily
  arm group label: DW1125A-1
  arm group type: Placebo Comparator
  description: 1 Atorvastatin 10mg tablet orally once daily
  intervention type: Drug
  intervention name: Ezetimibe/Atorvastatin 10/5 mg
  description: DW1125
  arm group label: DW1125
  intervention type: Drug
  intervention name: Atorvastatin 5mg
  description: DW1125A
  arm group label: DW1125A
  intervention type: Drug
  intervention name: Ezetimibe 10mg
  description: DW1125E
  arm group label: DW1125E
  other name: Ezetrol Tab. 10mg
  intervention type: Drug
  intervention name: Atorvastatin 10mg
  description: DW1125A-1
  arm group label: DW1125A-1
  other name: Lipiwon Tab. 10mg
  intervention type: Drug
  intervention name: DW1125 placebo
  description: Ezetimibe/Atorvastatin 10/5 mg placebo
  arm group label: DW1125A
  arm group label: DW1125A-1
  arm group label: DW1125E
  intervention type: Drug
  intervention name: DW1125A placebo
  description: Atorvastatin 5mg placebo
  arm group label: DW1125
  arm group label: DW1125A-1
  arm group label: DW1125E
  intervention type: Drug
  intervention name: DW1125E placebo
  description: Ezetimibe 10mg placebo
  arm group label: DW1125
  arm group label: DW1125A
  arm group label: DW1125A-1
  intervention type: Drug
  intervention name: DW1125A-1 placebo
  description: Atorvastatin 10mg placebo
  arm group label: DW1125
  arm group label: DW1125A
  arm group label: DW1125E
  criteria: 
  gender: All
  minimum age: 19 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Kim
  role: Principal Investigator
  affiliation: Seoul National University Hospital
  facility: 
  country: Korea, Republic of
  responsible party type: Sponsor
  mesh term: Hypercholesterolemia
  mesh term: Dyslipidemias
  mesh term: Atorvastatin
  mesh term: Ezetimibe