<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/NCT04433533</url>
  </required_header>
  <id_info>
    <org_study_id>4-2019-1125</org_study_id>
    <nct_id>NCT04433533</nct_id>
  </id_info>
  <brief_title>Compare the Efficacy and Safety of Rosuvastatin/Ezetimibe Combination Therapy Versus Rosuvastatin Monotherapy in Korean Patients With Left Ventricular Diastolic Dysfunction and Hyperlipidemia</brief_title>
  <official_title>A Randomized, Single-center, Open, Parallel, Phase 4 Study to Compare the Efficacy and Safety of Rosuvastatin/Ezetimibe Combination Therapy Versus Rosuvastatin Monotherapy in Korean Patients With Left Ventricular Diastolic Dysfunction and Hyperlipidemia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yonsei University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Yonsei University</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>
      preserved left ventricular ejection fraction (LVEF ≥ 50%) and are accompanied by dyslipidemia&#xD;
      (LDL ≥ 100 mg / dl) will be enrolled.&#xD;
&#xD;
      Only patients who do not meet the exclusion criteria should be enrolled in the study.&#xD;
&#xD;
      Once the patient is selected, the patient is informed of the study and receives the consent&#xD;
      form.&#xD;
&#xD;
      Patients who are eligible for all of the criteria and who do not qualify as exclusion&#xD;
      criteria should be enrolled in the study and randomly assigned in a 1: 1 dose of&#xD;
      rosuvastatin/ezetimibe 10/10mg once daily or rosuvastatin 20 mg once daily. Patients who&#xD;
      previously used statins have a wash-out period of 4 weeks or more.&#xD;
&#xD;
      Patients will visit outpatient clinic at 12 weeks and 24 weeks after initiation of treatment.&#xD;
      Physical examination, blood test, and 6 minute working test will be performed. For fasting&#xD;
      blood tests, patients visit on an empty stomach. Drug adverse events and changes in vital&#xD;
      signs or body weight will be checked.&#xD;
&#xD;
      After 48 weeks of treatment, the patients will visit outpatient clinic for efficacy&#xD;
      evaluation; physical examination, blood test, transthoracic echocardiography, cardiopulmonary&#xD;
      exercise test, central blood pressure, and pulse wave velocity. Drug adverse events and&#xD;
      medication compliance will be checked.&#xD;
&#xD;
      The primary endpoint is change of low-density lipoprotein cholesterol and secondary endpoint&#xD;
      is improvement of diastolic dysfunction, VAC index, peak VO2, distance of 6 minute working&#xD;
      test, and clinical outcomes including death, readmission rate.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 6, 2021</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Anticipated">June 2023</primary_completion_date>
  <phase>Phase 4</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in serum level of low-density lipoprotein cholesterol</measure>
    <time_frame>24 weeks</time_frame>
    <description>Compare the evaluation low-density lipoprotein cholesterol changes in Rosuvastatin/Ezetimibe Combination Therapy versus Rosuvastatin Monotherapy</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in serum level of low-density lipoprotein cholesterol</measure>
    <time_frame>48 weeks</time_frame>
    <description>Compare the evaluation low-density lipoprotein cholesterol changes in Rosuvastatin/Ezetimibe Combination Therapy versus Rosuvastatin Monotherapy</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Improvement of diastolic dysfunction</measure>
    <time_frame>48 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improvement of ventriculoarterial coupling index</measure>
    <time_frame>48 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improvement of peak VO2</measure>
    <time_frame>48 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improvement of 6 minute walking test combination therapy and monotherapy</measure>
    <time_frame>48 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical outcomes including death rate</measure>
    <time_frame>48 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical outcomes including readmission rate</measure>
    <time_frame>48 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Left Ventricular Diastolic Dysfunction</condition>
  <condition>Hyperlipidemias</condition>
  <arm_group>
    <arm_group_label>Rosuvastatin 20mg (Group 1)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Rosuvamibe 10/10mg (Group 2)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Rosuvastatin 20</intervention_name>
    <description>Patients who are eligible for all of the criteria and who do not qualify as exclusion criteria should be enrolled in the study and randomly enrolled in a 1: 1 dose of Rosuvastatin 20mg Monotherapy.</description>
    <arm_group_label>Rosuvastatin 20mg (Group 1)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Rosuvamibe 10/10</intervention_name>
    <description>Patients who are eligible for all of the criteria and who do not qualify as exclusion criteria should be enrolled in the study and randomly enrolled in a 1: 1 dose of rosuvastatin10mg/ezetimibe 10mg combination Therapy</description>
    <arm_group_label>Rosuvamibe 10/10mg (Group 2)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Participants who have left ventricular diastolic dysfunction (relaxation abnormality,&#xD;
             pseudonormalization, restrictive pattern) with preserved left ventricular systolic&#xD;
             function (left ventricular ejection fraction ≥ 50%)&#xD;
&#xD;
          2. Adult participants (≥ 20 years old) who have dyslipidemia and need treatment&#xD;
&#xD;
          3. Patients who understand the information about the trial and voluntarily agree to&#xD;
             participate in the trial&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Baseline fasting low-density lipoprotein cholesterol ≤ 70 mg/dL&#xD;
&#xD;
          2. Baseline fasting triglyceride ≥ 400 mg/dL&#xD;
&#xD;
          3. Baseline fasting total cholesterol ≥ 300 mg/dL&#xD;
&#xD;
          4. Participants who have structural heart disease&#xD;
&#xD;
          5. Participants who have prior acute coronary syndrome or cerebrovascular attack within 3&#xD;
             months.&#xD;
&#xD;
          6. Renal dysfunction (estimated glomerular filtration rate &lt; 30mL/min/1.73m2)&#xD;
&#xD;
          7. Creatinine phosphokinase elevations greater than three times the upper limit of normal&#xD;
&#xD;
          8. Aspartate or alanine aminotransferase elevations greater than three times the upper&#xD;
             limit of normal&#xD;
&#xD;
          9. Previous history of rhabdomyolysis&#xD;
&#xD;
         10. Females who are pregnant or breastfeeding or have a plan for pregnancy&#xD;
&#xD;
         11. Life expectancy less than a year.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Geu-Ru Hong</last_name>
    <phone>82-2-2228-8443</phone>
    <email>grhong@yuhs.ac</email>
  </overall_contact>
  <location>
    <facility>
      <name>Yonsei Severance Hospital</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Geu-Ru Hong</last_name>
      <phone>82-2-2228-8443</phone>
      <email>grhong@yuhs.ac</email>
    </contact>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>June 12, 2020</study_first_submitted>
  <study_first_submitted_qc>June 15, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 16, 2020</study_first_posted>
  <last_update_submitted>January 13, 2021</last_update_submitted>
  <last_update_submitted_qc>January 13, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 15, 2021</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>Ventricular Dysfunction, Left</mesh_term>
    <mesh_term>Hyperlipidemias</mesh_term>
    <mesh_term>Hyperlipoproteinemias</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <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/NCT04433533
org study id: 4-2019-1125
nct id: NCT04433533
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
preserved left ventricular ejection fraction (LVEF ≥ 50%) and are accompanied by dyslipidemia
      (LDL ≥ 100 mg / dl) will be enrolled.

      Only patients who do not meet the exclusion criteria should be enrolled in the study.

      Once the patient is selected, the patient is informed of the study and receives the consent
      form.

      Patients who are eligible for all of the criteria and who do not qualify as exclusion
      criteria should be enrolled in the study and randomly assigned in a 1: 1 dose of
      rosuvastatin/ezetimibe 10/10mg once daily or rosuvastatin 20 mg once daily. Patients who
      previously used statins have a wash-out period of 4 weeks or more.

      Patients will visit outpatient clinic at 12 weeks and 24 weeks after initiation of treatment.
      Physical examination, blood test, and 6 minute working test will be performed. For fasting
      blood tests, patients visit on an empty stomach. Drug adverse events and changes in vital
      signs or body weight will be checked.

      After 48 weeks of treatment, the patients will visit outpatient clinic for efficacy
      evaluation; physical examination, blood test, transthoracic echocardiography, cardiopulmonary
      exercise test, central blood pressure, and pulse wave velocity. Drug adverse events and
      medication compliance will be checked.

      The primary endpoint is change of low-density lipoprotein cholesterol and secondary endpoint
      is improvement of diastolic dysfunction, VAC index, peak VO2, distance of 6 minute working
      test, and clinical outcomes including death, readmission rate.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in serum level of low-density lipoprotein cholesterol
time frame: 24 weeks
description: Compare the evaluation low-density lipoprotein cholesterol changes in Rosuvastatin/Ezetimibe Combination Therapy versus Rosuvastatin Monotherapy
measure: Change in serum level of low-density lipoprotein cholesterol
time frame: 48 weeks
description: Compare the evaluation low-density lipoprotein cholesterol changes in Rosuvastatin/Ezetimibe Combination Therapy versus Rosuvastatin Monotherapy
measure: Improvement of diastolic dysfunction
time frame: 48 weeks
measure: Improvement of ventriculoarterial coupling index
time frame: 48 weeks
measure: Improvement of peak VO2
time frame: 48 weeks
measure: Improvement of 6 minute walking test combination therapy and monotherapy
time frame: 48 weeks
measure: Clinical outcomes including death rate
time frame: 48 weeks
measure: Clinical outcomes including readmission rate
time frame: 48 weeks
arm group label: Rosuvastatin 20mg (Group 1)
arm group type: Active Comparator
arm group label: Rosuvamibe 10/10mg (Group 2)
arm group type: Experimental
intervention type: Drug
intervention name: Rosuvastatin 20
description: Patients who are eligible for all of the criteria and who do not qualify as exclusion criteria should be enrolled in the study and randomly enrolled in a 1: 1 dose of Rosuvastatin 20mg Monotherapy.
arm group label: Rosuvastatin 20mg (Group 1)
intervention type: Drug
intervention name: Rosuvamibe 10/10
description: Patients who are eligible for all of the criteria and who do not qualify as exclusion criteria should be enrolled in the study and randomly enrolled in a 1: 1 dose of rosuvastatin10mg/ezetimibe 10mg combination Therapy
arm group label: Rosuvamibe 10/10mg (Group 2)
criteria: 
gender: All
minimum age: 20 Years
maximum age: 85 Years
healthy volunteers: No
last name: Geu-Ru Hong
phone: 82-2-2228-8443
email: grhong@yuhs.ac
facility: 
status: Recruiting
contact: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Ventricular Dysfunction, Left
mesh term: Hyperlipidemias
mesh term: Hyperlipoproteinemias
mesh term: Rosuvastatin Calcium
sharing ipd: No