<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/NCT01660191</url>
  </required_header>
  <id_info>
    <org_study_id>12943</org_study_id>
    <nct_id>NCT01660191</nct_id>
  </id_info>
  <brief_title>A Study Comparing CoQ10 Levels While Taking 3 Different Statins</brief_title>
  <acronym>SPARQ</acronym>
  <official_title>A Study Comparing the Effects of Pitavastatin, Atorvastatin, and Rosuvastatin on Plasma Levels of CoQ10 (SPARQ)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Kansas Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Kowa Pharmaceuticals America, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Eli Lilly and Company</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Kansas Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine if Pitavastatin lowers CoQ10 less than Atorvastatin&#xD;
      or Rosuvastatin.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Statins are known effectively treat high cholesterol and heart disease. However, statins may&#xD;
      lower endogenous levels of Coenzyme10 (CoQ10). This decrease in CoQ10 levels may be&#xD;
      responsible for side effects such as myalgia.&#xD;
&#xD;
      Previous studies have shown that Pitavastatin may not affect CoQ10 levels as other statins&#xD;
      do, while still lowering cholesterol.&#xD;
&#xD;
      In this study, investigators intend to compare the plasma levels of CoQ10 in patients taking&#xD;
      3 different FDA-approved statins, in equipotent doses.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2011</start_date>
  <completion_date type="Actual">October 2013</completion_date>
  <primary_completion_date type="Actual">August 2013</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in Plasma CoQ10 Levels</measure>
    <time_frame>Change from Baseline to 12 Weeks</time_frame>
    <description>Change in levels will be measured by taking difference between Baseline and Week 12 measures.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in Major Lipid Parameters - VLDL Size</measure>
    <time_frame>Change from Baseline to 12 Weeks</time_frame>
    <description>Change in levels will be measured by difference in levels at 12 weeks. Measure based on VLDL size.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes to Glucose Metabolism - HbA1c and Insulin</measure>
    <time_frame>Change from Baseline to 12 weeks</time_frame>
    <description>Change in levels will be measured by levels at 12 weeks minus levels at baseline. Changes measured based in HbA1c, and insulin.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in HDL and LDL Size</measure>
    <time_frame>Change from Baseline to 12 Weeks</time_frame>
    <description>Change in levels will be measured by difference in levels at 12 weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes to Glucose Metabolism - Fructosamine</measure>
    <time_frame>Change from Baseline to 12 weeks</time_frame>
    <description>Change in levels will be measured by levels at 12 weeks minus levels at baseline. Changes measured based in fructosamine.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes HDL Particle Number and LDL Particle Number</measure>
    <time_frame>Change from Baseline to 12 Weeks</time_frame>
    <description>Change in levels will be measured by difference in levels at 12 weeks.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">134</enrollment>
  <condition>Hypercholesterolemia</condition>
  <arm_group>
    <arm_group_label>Pitavastatin 4mg</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Pitavastatin 4mg tablet by mouth once daily for 12 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Atorvastatin 20mg</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Atorvastatin 20mg tablet by mouth once daily for 12 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>rosuvastatin 5 mg</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>rosuvastatin 5 mg tablet by mouth once daily for 12 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Pitavastin 4mg</intervention_name>
    <arm_group_label>Atorvastatin 20mg</arm_group_label>
    <arm_group_label>rosuvastatin 5 mg</arm_group_label>
    <other_name>Livalo</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Atorvastatin 20mg</intervention_name>
    <arm_group_label>Pitavastatin 4mg</arm_group_label>
    <arm_group_label>rosuvastatin 5 mg</arm_group_label>
    <other_name>Lipitor</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Rosuvastatin 5mg</intervention_name>
    <arm_group_label>Atorvastatin 20mg</arm_group_label>
    <arm_group_label>Pitavastatin 4mg</arm_group_label>
    <other_name>Crestor</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  LDL-C levels of 100-200mg/dl; triglycerides &lt;/=200mg/dl at screening visit&#xD;
&#xD;
          -  Willing to discontinue use of all lipid-altering doses fo medication or supplements&#xD;
             for the duration of the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  LDL-C &lt;100mg/dl or &gt;200mg/dl, Triglycerides &gt;200mg/dl&#xD;
&#xD;
          -  History of diabetes mellitus or documented fasting blood glucose &gt;125mg/dl or HbA1c&#xD;
             &gt;6.4%&#xD;
&#xD;
          -  History of coronary artery disease&#xD;
&#xD;
          -  history of chronic renal or hepatic disease&#xD;
&#xD;
          -  known sensitivity of intolerance to a statin&#xD;
&#xD;
          -  persistent elevated liver enzymes or CPK (&gt;3 x upper normal limit)&#xD;
&#xD;
          -  currently taking CoQ10 supplements and unable discontinue for duration of study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Patrick M Moriarty, MD, FACC</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Kansas Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Kansas Medical Center</name>
      <address>
        <city>Kansas City</city>
        <state>Kansas</state>
        <zip>66160</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>May 21, 2012</study_first_submitted>
  <study_first_submitted_qc>August 3, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 8, 2012</study_first_posted>
  <results_first_submitted>February 15, 2016</results_first_submitted>
  <results_first_submitted_qc>November 22, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">January 18, 2017</results_first_posted>
  <last_update_submitted>November 22, 2016</last_update_submitted>
  <last_update_submitted_qc>November 22, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 18, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Kansas Medical Center</investigator_affiliation>
    <investigator_full_name>Patrick Moriarty, MD, FACP, FACC</investigator_full_name>
    <investigator_title>Director, Atherosclerosis &amp; LDL-Apheresis Center</investigator_title>
  </responsible_party>
  <keyword>LDL, HDL</keyword>
  <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>Atorvastatin</mesh_term>
    <mesh_term>Rosuvastatin Calcium</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Atorvastatin 20mg</title>
          <description>Atorvastatin 20mg, once daily by mouth for 12 weeks</description>
        </group>
        <group group_id="P2">
          <title>Pitavastatin 4mg</title>
          <description>Pitavastatin 4mg, once daily by mouth for 12 weeks</description>
        </group>
        <group group_id="P3">
          <title>Rosuvastatin 5 mg</title>
          <description>Rosuvastatin 5mg, once daily by mouth for 12 weeks</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Enrollment and Washout</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="45"/>
                <participants group_id="P2" count="45"/>
                <participants group_id="P3" count="44"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="45"/>
                <participants group_id="P2" count="45"/>
                <participants group_id="P3" count="44"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Randomization</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="45"/>
                <participants group_id="P2" count="45"/>
                <participants group_id="P3" count="44"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="45"/>
                <participants group_id="P2" count="45"/>
                <participants group_id="P3" count="44"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>End of Treatment</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="45"/>
                <participants group_id="P2" count="45"/>
                <participants group_id="P3" count="44"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="44"/>
                <participants group_id="P2" count="39"/>
                <participants group_id="P3" count="43"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Atorvastatin 20mg</title>
          <description>Atorvastatin 20mg, once daily by mouth for 12 weeks</description>
        </group>
        <group group_id="B2">
          <title>Pitavastatin 4mg</title>
          <description>Pitavastatin 4mg, once daily by mouth for 12 weeks</description>
        </group>
        <group group_id="B3">
          <title>Rosuvastatin 5 mg</title>
          <description>Rosuvastatin 5mg, once daily by mouth for 12 weeks</description>
        </group>
        <group group_id="B4">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="45"/>
            <count group_id="B2" value="45"/>
            <count group_id="B3" value="44"/>
            <count group_id="B4" value="134"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="54.68" spread="12.52"/>
                    <measurement group_id="B2" value="56.66" spread="9.93"/>
                    <measurement group_id="B3" value="56.08" spread="12.28"/>
                    <measurement group_id="B4" value="55.80" spread="11.57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Gender</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="28"/>
                    <measurement group_id="B2" value="30"/>
                    <measurement group_id="B3" value="36"/>
                    <measurement group_id="B4" value="94"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="8"/>
                    <measurement group_id="B4" value="40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="45"/>
                    <measurement group_id="B2" value="45"/>
                    <measurement group_id="B3" value="44"/>
                    <measurement group_id="B4" value="134"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Waist Size</title>
          <units>inches</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="36.41" spread="5.76"/>
                    <measurement group_id="B2" value="37.45" spread="4.20"/>
                    <measurement group_id="B3" value="34.54" spread="5.60"/>
                    <measurement group_id="B4" value="36.12" spread="5.33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Changes in Plasma CoQ10 Levels</title>
        <description>Change in levels will be measured by taking difference between Baseline and Week 12 measures.</description>
        <time_frame>Change from Baseline to 12 Weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Atorvastatin 20mg</title>
            <description>Atorvastatin 20mg, once daily by mouth for 12 weeks</description>
          </group>
          <group group_id="O2">
            <title>Pitavastatin 4mg</title>
            <description>Pitavastatin 4mg, once daily by mouth for 12 weeks</description>
          </group>
          <group group_id="O3">
            <title>Rosuvastatin 5 mg</title>
            <description>Rosuvastatin 5mg, once daily by mouth for 12 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Changes in Plasma CoQ10 Levels</title>
          <description>Change in levels will be measured by taking difference between Baseline and Week 12 measures.</description>
          <units>μg/g</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="42"/>
                <count group_id="O2" value="40"/>
                <count group_id="O3" value="36"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Ubiquinone</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-96.70" spread="224.24"/>
                    <measurement group_id="O2" value="-110.42" spread="136.29"/>
                    <measurement group_id="O3" value="-103.91" spread="237.27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total CoQ10</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-721.09" spread="830.47"/>
                    <measurement group_id="O2" value="-464.85" spread="571.37"/>
                    <measurement group_id="O3" value="-642.43" spread="874.99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Upiquinol</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-624.39" spread="669.45"/>
                    <measurement group_id="O2" value="-354.43" spread="544.42"/>
                    <measurement group_id="O3" value="-538.52" spread="709.53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes in Major Lipid Parameters - VLDL Size</title>
        <description>Change in levels will be measured by difference in levels at 12 weeks. Measure based on VLDL size.</description>
        <time_frame>Change from Baseline to 12 Weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Atorvastatin 20mg</title>
            <description>Atorvastatin 20mg, once daily by mouth for 12 weeks</description>
          </group>
          <group group_id="O2">
            <title>Pitavastatin 4mg</title>
            <description>Pitavastatin 4mg, once daily by mouth for 12 weeks</description>
          </group>
          <group group_id="O3">
            <title>Rosuvastatin 5 mg</title>
            <description>Rosuvastatin 5mg, once daily by mouth for 12 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Changes in Major Lipid Parameters - VLDL Size</title>
          <description>Change in levels will be measured by difference in levels at 12 weeks. Measure based on VLDL size.</description>
          <units>nanometre (nm)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="44"/>
                <count group_id="O2" value="43"/>
                <count group_id="O3" value="37"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.68" spread="5.63"/>
                    <measurement group_id="O2" value="0.81" spread="5.84"/>
                    <measurement group_id="O3" value="3.17" spread="6.25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes to Glucose Metabolism - HbA1c and Insulin</title>
        <description>Change in levels will be measured by levels at 12 weeks minus levels at baseline. Changes measured based in HbA1c, and insulin.</description>
        <time_frame>Change from Baseline to 12 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Atorvastatin 20mg</title>
            <description>Atorvastatin 20mg, once daily by mouth for 12 weeks</description>
          </group>
          <group group_id="O2">
            <title>Pitavastatin 4mg</title>
            <description>Pitavastatin 4mg, once daily by mouth for 12 weeks</description>
          </group>
          <group group_id="O3">
            <title>Rosuvastatin 5 mg</title>
            <description>Rosuvastatin 5mg, once daily by mouth for 12 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Changes to Glucose Metabolism - HbA1c and Insulin</title>
          <description>Change in levels will be measured by levels at 12 weeks minus levels at baseline. Changes measured based in HbA1c, and insulin.</description>
          <units>percentage change from baseline measure</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="44"/>
                <count group_id="O2" value="42"/>
                <count group_id="O3" value="37"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>HbA1c</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.00" spread="0.03"/>
                    <measurement group_id="O2" value="0.00" spread="0.04"/>
                    <measurement group_id="O3" value="0.00" spread="0.04"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Insulin</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.16" spread="0.47"/>
                    <measurement group_id="O2" value="0.01" spread="0.43"/>
                    <measurement group_id="O3" value="0.17" spread="0.38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes in HDL and LDL Size</title>
        <description>Change in levels will be measured by difference in levels at 12 weeks</description>
        <time_frame>Change from Baseline to 12 Weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Atorvastatin 20mg</title>
            <description>Atorvastatin 20mg, once daily by mouth for 12 weeks</description>
          </group>
          <group group_id="O2">
            <title>Pitavastatin 4mg</title>
            <description>Pitavastatin 4mg, once daily by mouth for 12 weeks</description>
          </group>
          <group group_id="O3">
            <title>Rosuvastatin 5 mg</title>
            <description>Rosuvastatin 5mg, once daily by mouth for 12 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Changes in HDL and LDL Size</title>
          <description>Change in levels will be measured by difference in levels at 12 weeks</description>
          <units>nanometre (nm)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="42"/>
                <count group_id="O2" value="43"/>
                <count group_id="O3" value="36"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>HDL Size</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.23" spread="0.27"/>
                    <measurement group_id="O2" value="0.23" spread="0.26"/>
                    <measurement group_id="O3" value="0.12" spread="0.32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>LDL Size</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.02" spread="0.44"/>
                    <measurement group_id="O2" value="-0.11" spread="0.43"/>
                    <measurement group_id="O3" value="-0.09" spread="0.41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes to Glucose Metabolism - Fructosamine</title>
        <description>Change in levels will be measured by levels at 12 weeks minus levels at baseline. Changes measured based in fructosamine.</description>
        <time_frame>Change from Baseline to 12 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Atorvastatin 20mg</title>
            <description>Atorvastatin 20mg, once daily by mouth for 12 weeks</description>
          </group>
          <group group_id="O2">
            <title>Pitavastatin 4mg</title>
            <description>Pitavastatin 4mg, once daily by mouth for 12 weeks</description>
          </group>
          <group group_id="O3">
            <title>Rosuvastatin 5 mg</title>
            <description>Rosuvastatin 5mg, once daily by mouth for 12 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Changes to Glucose Metabolism - Fructosamine</title>
          <description>Change in levels will be measured by levels at 12 weeks minus levels at baseline. Changes measured based in fructosamine.</description>
          <units>µmol</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="33"/>
                <count group_id="O2" value="30"/>
                <count group_id="O3" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.91" spread="17.16"/>
                    <measurement group_id="O2" value="-1.17" spread="13.74"/>
                    <measurement group_id="O3" value="-3.07" spread="14.77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes HDL Particle Number and LDL Particle Number</title>
        <description>Change in levels will be measured by difference in levels at 12 weeks.</description>
        <time_frame>Change from Baseline to 12 Weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Atorvastatin 20mg</title>
            <description>Atorvastatin 20mg, once daily by mouth for 12 weeks</description>
          </group>
          <group group_id="O2">
            <title>Pitavastatin 4mg</title>
            <description>Pitavastatin 4mg, once daily by mouth for 12 weeks</description>
          </group>
          <group group_id="O3">
            <title>Rosuvastatin 5 mg</title>
            <description>Rosuvastatin 5mg, once daily by mouth for 12 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Changes HDL Particle Number and LDL Particle Number</title>
          <description>Change in levels will be measured by difference in levels at 12 weeks.</description>
          <units>particle number</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="42"/>
                <count group_id="O2" value="43"/>
                <count group_id="O3" value="36"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>HDL Particle Number</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.64" spread="5.24"/>
                    <measurement group_id="O2" value="2.55" spread="4.19"/>
                    <measurement group_id="O3" value="2.05" spread="5.17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>LDL Particle Number</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-873.48" spread="353.76"/>
                    <measurement group_id="O2" value="-768.26" spread="334.01"/>
                    <measurement group_id="O3" value="-626.61" spread="341.28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Atorvastatin 20mg</title>
          <description>Atorvastatin 20mg, once daily by mouth for 12 weeks</description>
        </group>
        <group group_id="E2">
          <title>Pitavastatin 4mg</title>
          <description>Pitavastatin 4mg, once daily by mouth for 12 weeks</description>
        </group>
        <group group_id="E3">
          <title>Rosuvastatin 5 mg</title>
          <description>Rosuvastatin 5mg, once daily by mouth for 12 weeks</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="44"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="44"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="44"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Julie-Ann Dutton</name_or_title>
      <organization>University of Kansas Medical Center</organization>
      <phone>913-588-4064</phone>
      <email>JDUTTON@kumc.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT01660191
org study id: 12943
nct id: NCT01660191
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
The purpose of this study is to determine if Pitavastatin lowers CoQ10 less than Atorvastatin
      or Rosuvastatin.
Statins are known effectively treat high cholesterol and heart disease. However, statins may
      lower endogenous levels of Coenzyme10 (CoQ10). This decrease in CoQ10 levels may be
      responsible for side effects such as myalgia.

      Previous studies have shown that Pitavastatin may not affect CoQ10 levels as other statins
      do, while still lowering cholesterol.

      In this study, investigators intend to compare the plasma levels of CoQ10 in patients taking
      3 different FDA-approved statins, in equipotent doses.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Changes in Plasma CoQ10 Levels
time frame: Change from Baseline to 12 Weeks
description: Change in levels will be measured by taking difference between Baseline and Week 12 measures.
measure: Changes in Major Lipid Parameters - VLDL Size
time frame: Change from Baseline to 12 Weeks
description: Change in levels will be measured by difference in levels at 12 weeks. Measure based on VLDL size.
measure: Changes to Glucose Metabolism - HbA1c and Insulin
time frame: Change from Baseline to 12 weeks
description: Change in levels will be measured by levels at 12 weeks minus levels at baseline. Changes measured based in HbA1c, and insulin.
measure: Changes in HDL and LDL Size
time frame: Change from Baseline to 12 Weeks
description: Change in levels will be measured by difference in levels at 12 weeks
measure: Changes to Glucose Metabolism - Fructosamine
time frame: Change from Baseline to 12 weeks
description: Change in levels will be measured by levels at 12 weeks minus levels at baseline. Changes measured based in fructosamine.
measure: Changes HDL Particle Number and LDL Particle Number
time frame: Change from Baseline to 12 Weeks
description: Change in levels will be measured by difference in levels at 12 weeks.
arm group label: Pitavastatin 4mg
arm group type: Active Comparator
description: Pitavastatin 4mg tablet by mouth once daily for 12 weeks
arm group label: Atorvastatin 20mg
arm group type: Active Comparator
description: Atorvastatin 20mg tablet by mouth once daily for 12 weeks
arm group label: rosuvastatin 5 mg
arm group type: Active Comparator
description: rosuvastatin 5 mg tablet by mouth once daily for 12 weeks
intervention type: Drug
intervention name: Pitavastin 4mg
arm group label: Atorvastatin 20mg
arm group label: rosuvastatin 5 mg
other name: Livalo
intervention type: Drug
intervention name: Atorvastatin 20mg
arm group label: Pitavastatin 4mg
arm group label: rosuvastatin 5 mg
other name: Lipitor
intervention type: Drug
intervention name: Rosuvastatin 5mg
arm group label: Atorvastatin 20mg
arm group label: Pitavastatin 4mg
other name: Crestor
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Patrick M Moriarty, MD, FACC
role: Principal Investigator
affiliation: University of Kansas Medical Center
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Kansas Medical Center
investigator full name: Patrick Moriarty, MD, FACP, FACC
investigator title: Director, Atherosclerosis & LDL-Apheresis Center
mesh term: Hypercholesterolemia
mesh term: Atorvastatin
mesh term: Rosuvastatin Calcium
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 