<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/NCT03288038</url>
  </required_header>
  <id_info>
    <org_study_id>SP-RE-003</org_study_id>
    <nct_id>NCT03288038</nct_id>
  </id_info>
  <brief_title>The Efficacy and Safety of Combination Therapy of Rosuvastatin and Ezetimibe and Rosuvastatin Monotherapy in Patients With Primary Hypercholesterolemia</brief_title>
  <official_title>A Multi-center, Randomized, Double-blind, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Combination Therapy of Rosuvastatin and Ezetimibe and Rosuvastatin Monotherapy in Patients With Primary Hypercholesterolemia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shin Poong Pharmaceutical Co. Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shin Poong Pharmaceutical Co. Ltd.</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      A Multi-center, Randomized, Double-blind, Phase III Clinical Trial to Evaluate the Efficacy&#xD;
      and Safety of Combination Therapy of Rosuvastatin and Ezetimibe and Rosuvastatin Monotherapy&#xD;
      in Patients with Primary Hypercholesterolemia&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 13, 2014</start_date>
  <completion_date type="Actual">November 19, 2015</completion_date>
  <primary_completion_date type="Actual">November 19, 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>Factorial 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>The change in the LDL-C level from the baseline to Week 4 and Week 8</measure>
    <time_frame>baseline to 4 and 8 week</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The change and percent change in the levels of TC, TG, HDL-C, non-HDL-C, apolipoprotein B, and hs-CRP from the baseline to Week 4 and Week 8</measure>
    <time_frame>baseline to 4 and 8 week</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The change and percent change in the ratios of LDL-C/HDL-C, TC/HDL-C, non-HDL-C/HDL-C, and Apo B/Apo A-I from the baseline to Week 4 and Week 8</measure>
    <time_frame>baseline to 4 and 8 week</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The ratio of the subjects who have reached the target LDL-C level according to the NCEP ATP(National Cholesterol Education Program Adult Treatment Panel) III Guideline at Week 4 and Week 8</measure>
    <time_frame>baseline to 4 and 8 week</time_frame>
  </secondary_outcome>
  <number_of_arms>6</number_of_arms>
  <enrollment type="Actual">382</enrollment>
  <condition>Hypercholesterolemia</condition>
  <arm_group>
    <arm_group_label>RSV5mg + EZE 10mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Rosuvastatin 5mg/Ezetimibe 10mg</description>
  </arm_group>
  <arm_group>
    <arm_group_label>RSV5mg</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Rosuvastatin 5mg</description>
  </arm_group>
  <arm_group>
    <arm_group_label>RSV10mg + EZE10mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Rosuvastatin 10mg/ Ezetimibe 10mg</description>
  </arm_group>
  <arm_group>
    <arm_group_label>RSV10mg</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Rosuvastatin 10mg</description>
  </arm_group>
  <arm_group>
    <arm_group_label>RSV20mg + EZE10mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Rosuvastatin 20mg/Ezetimibe 10mg</description>
  </arm_group>
  <arm_group>
    <arm_group_label>RSV20mg</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Rosuvastatin 20mg</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Rosuvastatin</intervention_name>
    <arm_group_label>RSV10mg</arm_group_label>
    <arm_group_label>RSV10mg + EZE10mg</arm_group_label>
    <arm_group_label>RSV20mg</arm_group_label>
    <arm_group_label>RSV20mg + EZE10mg</arm_group_label>
    <arm_group_label>RSV5mg</arm_group_label>
    <arm_group_label>RSV5mg + EZE 10mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ezetimibe</intervention_name>
    <arm_group_label>RSV10mg + EZE10mg</arm_group_label>
    <arm_group_label>RSV20mg + EZE10mg</arm_group_label>
    <arm_group_label>RSV5mg + EZE 10mg</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Adults aged 19 years or older&#xD;
&#xD;
          2. Patients with primary hypercholesterolemia&#xD;
&#xD;
          3. Patients who were informed about the purpose, method, effects, risks of this clinical&#xD;
             study and have provided a written consent form signed by him/herself or by a&#xD;
             representative&#xD;
&#xD;
          4. those who show an LDL-C level of 250 mg/dL or below and a TG level of less than 350&#xD;
             mg/dL at the run-in period (Week -1), and fall under the criterion of requiring the&#xD;
             administration of antidyslipidemic drug of NCEP ATP III&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients with hypersensitivity to the investigational product or its ingredients&#xD;
&#xD;
          2. Those with an uncontrolled hypertension (SBP ≧ 180 mmHg or DBP ≧ 100 mmHg)&#xD;
&#xD;
          3. Those with a history of unstable angina, myocardial infarction, transient ischemic&#xD;
             attack, cerebral vascular disease, coronary artery bypass or coronary intervention&#xD;
             within 3 months of screening date&#xD;
&#xD;
          4. Those with a history of malignant tumor within 5 years&#xD;
&#xD;
          5. Those with a history of myopathy or rhabdomyolysis&#xD;
&#xD;
          6. Those who show clinically significant confirmed laboratory test results (1) Patients&#xD;
             showing AST or ALT level of greater than 2 times the institutional upper limit of&#xD;
             normal or those with active liver disease or chronic hepatitis (2) A serum creatinine&#xD;
             level greater than 2 times the institutional upper limit of normal (3) HbA1c &gt; 9% (4)&#xD;
             Those with TSH level of greater than 1.5 times the institutional upper limit of normal&#xD;
             (5) Those with CK level greater than 2 times the institutional upper limit of normal&#xD;
             (However, except for an increase caused by a recent trauma, intramuscular injection or&#xD;
             strenuous exercise)&#xD;
&#xD;
          7. Those who were given, within 4 weeks prior to the baseline (8 weeks in case of&#xD;
             fibrate) or are expected to be given during the study period, a drug that can have an&#xD;
             effect on the efficacy assessment of the clinical study (eg: antidyslipidemic drug&#xD;
             (statins, ezetimibe, fibrates, BAS, nicotinic acid and derivative, etc.), systemic&#xD;
             glucocorticosteroids, steatolytic enzyme inhibitor, cyclosporine, HIV proteinase&#xD;
             inhibitor, macrolide class antibiotics, etc.)&#xD;
&#xD;
          8. Patients who were given estrogen within 3 months from the screening or those who are&#xD;
             expected to be given an administration during the study period. (However, a patient&#xD;
             who is under a hormone replacement therapy (HRT) will be allowed if no dose change is&#xD;
             expected in the course of the clinical study.)&#xD;
&#xD;
          9. Those with a history of alcohol or drug abuse&#xD;
&#xD;
         10. Patients with a hereditary disorder of galactose intolerance, Lapp lactase deficiency&#xD;
             or glucose-galactose malabsorption&#xD;
&#xD;
         11. Pregnant or breast-feeding women&#xD;
&#xD;
         12. Women of childbearing potential or men who do not intend to use an adequate&#xD;
             contraceptive measure during the study period and for 4 weeks after the end of the&#xD;
             study(Adequate contraception: Administration and transplantation of a progestin-only&#xD;
             contraceptive pill, intrauterine device, condom, spermicidal agent, etc.)&#xD;
&#xD;
         13. Patients who participated in another clinical study within 3 months from the screening&#xD;
             date or have not had a washout period of at least 5 times the half-life of the active&#xD;
             ingredient of the previously administered investigational product, whichever is longer&#xD;
&#xD;
         14. Those with drug malabsorption&#xD;
&#xD;
         15. Patients who has been judged by the investigator to be ineligible to participate in&#xD;
             the clinical study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Chungbuk National University Hospital</name>
      <address>
        <city>Cheongju-si</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yeungnam University Medical Center</name>
      <address>
        <city>Daegu</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chungnam National University Hospital</name>
      <address>
        <city>Daejeon</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dongguk University Ilsan Hospital</name>
      <address>
        <city>Goyang-si</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hallym University Dongtan Sacred Heart Hospital</name>
      <address>
        <city>Hwaseong-si</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gachon University Gil Medical Center</name>
      <address>
        <city>Incheon</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Inha University Hospital</name>
      <address>
        <city>Incheon</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seoul National University Bundang Hospital</name>
      <address>
        <city>Seongnam-si</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Boramae Hospital</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chung-Ang University Hospital</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gangnam Severance Hospital</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hanyang University Hospital</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kangbuk Samsung Hospital</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Korea University Anam Hospital</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Korea University Guro Hospital</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>KyungHee University Hospital</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seoul National University Hospital</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Soon Chun Hyang University Hospital Seoul</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ajou University Hospital</name>
      <address>
        <city>Suwon-si</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wonju Severance Christian Hospital</name>
      <address>
        <city>Wŏnju</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 18, 2017</study_first_submitted>
  <study_first_submitted_qc>September 15, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 19, 2017</study_first_posted>
  <last_update_submitted>September 15, 2017</last_update_submitted>
  <last_update_submitted_qc>September 15, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 19, 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>Hypercholesterolemia</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>Ezetimibe</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/NCT03288038
org study id: SP-RE-003
nct id: NCT03288038
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
A Multi-center, Randomized, Double-blind, Phase III Clinical Trial to Evaluate the Efficacy
      and Safety of Combination Therapy of Rosuvastatin and Ezetimibe and Rosuvastatin Monotherapy
      in Patients with Primary Hypercholesterolemia
allocation: Randomized
intervention model: Factorial 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: The change in the LDL-C level from the baseline to Week 4 and Week 8
time frame: baseline to 4 and 8 week
measure: The change and percent change in the levels of TC, TG, HDL-C, non-HDL-C, apolipoprotein B, and hs-CRP from the baseline to Week 4 and Week 8
time frame: baseline to 4 and 8 week
measure: The change and percent change in the ratios of LDL-C/HDL-C, TC/HDL-C, non-HDL-C/HDL-C, and Apo B/Apo A-I from the baseline to Week 4 and Week 8
time frame: baseline to 4 and 8 week
measure: The ratio of the subjects who have reached the target LDL-C level according to the NCEP ATP(National Cholesterol Education Program Adult Treatment Panel) III Guideline at Week 4 and Week 8
time frame: baseline to 4 and 8 week
arm group label: RSV5mg + EZE 10mg
arm group type: Experimental
description: Rosuvastatin 5mg/Ezetimibe 10mg
arm group label: RSV5mg
arm group type: Active Comparator
description: Rosuvastatin 5mg
arm group label: RSV10mg + EZE10mg
arm group type: Experimental
description: Rosuvastatin 10mg/ Ezetimibe 10mg
arm group label: RSV10mg
arm group type: Active Comparator
description: Rosuvastatin 10mg
arm group label: RSV20mg + EZE10mg
arm group type: Experimental
description: Rosuvastatin 20mg/Ezetimibe 10mg
arm group label: RSV20mg
arm group type: Active Comparator
description: Rosuvastatin 20mg
intervention type: Drug
intervention name: Rosuvastatin
arm group label: RSV10mg
arm group label: RSV10mg + EZE10mg
arm group label: RSV20mg
arm group label: RSV20mg + EZE10mg
arm group label: RSV5mg
arm group label: RSV5mg + EZE 10mg
intervention type: Drug
intervention name: Ezetimibe
arm group label: RSV10mg + EZE10mg
arm group label: RSV20mg + EZE10mg
arm group label: RSV5mg + EZE 10mg
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
healthy volunteers: No
facility: 
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country: Korea, Republic of
responsible party type: Sponsor
mesh term: Hypercholesterolemia
mesh term: Rosuvastatin Calcium
mesh term: Ezetimibe
sharing ipd: No