<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/NCT02227784</url>
  </required_header>
  <id_info>
    <org_study_id>14502</org_study_id>
    <secondary_id>I1V-MC-EIBH</secondary_id>
    <nct_id>NCT02227784</nct_id>
  </id_info>
  <brief_title>A Study of Evacetrapib (LY2484595) in Participants With High Cholesterol</brief_title>
  <acronym>ACCENTUATE</acronym>
  <official_title>The Addition of Evacetrapib to Atorvastatin Compared to Placebo, High Intensity Atorvastatin, and Atorvastatin With Ezetimibe to Evaluate LDL-C Lowering in Patients With Primary Hyperlipidemia - The ACCENTUATE Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Eli Lilly and Company</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Eli Lilly and Company</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the ACCENTUATE study is to evaluate whether the study drug known as&#xD;
      evacetrapib is effective in treating participants with high cholesterol and atherosclerotic&#xD;
      cardiovascular disease (ASCVD) and/or diabetes.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Study termination due to program termination.&#xD;
  </why_stopped>
  <start_date>October 2014</start_date>
  <completion_date type="Actual">December 2015</completion_date>
  <primary_completion_date type="Actual">December 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 3 Months in Low-Density Lipoprotein Cholesterol (LDL-C)</measure>
    <time_frame>Baseline, 3 Months</time_frame>
    <description>Change in LDL-C levels from baseline to the 3-month visit expressed as a percentage of the baseline levels. LDL-C was measured by beta quantification. Statistics are from analysis of covariance with log baseline measurement and treatment is included in the model. Least Square Means (LS means) and median differences were analyzed in log units and converted to standard units. Log Percent change from baseline response is the dependent variable.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline to 3 Months in High-Density Lipoprotein Cholesterol (HDL-C)</measure>
    <time_frame>Baseline, 3 Months</time_frame>
    <description>Change in HDL-C levels from baseline to the 3-month visit expressed as a percentage of the baseline levels. LS medians and median differences were analyzed in log units and converted to standard units. Statistics are from mixed model repeated measures analysis with log baseline measurement, treatment, visit, and treatment by visit interaction included in the model. Log percent change from baseline response is the dependent variable. Within-participant repeated measures at multiple visits are modeled by a compound symmetry covariance structure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline to 3 Months in Apolipoprotein AI (apoAI)</measure>
    <time_frame>Baseline, 3 Months</time_frame>
    <description>Change in apoAI levels from baseline to the 3-month visit expressed as a percentage of the baseline levels. Statistics are from analysis of covariance with log baseline measurement and treatment is included in the model. LS means and median differences were analyzed in log units and converted to standard units. Log Percent change from baseline response is the dependent variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline to 3 Months in Non-HDL-C</measure>
    <time_frame>Baseline, 3 Months</time_frame>
    <description>Change in Non-HDL-C levels from baseline to the 3-month visit expressed as a percentage of the baseline levels. LS medians and median differences were analyzed in log units and converted to standard units. Statistics are from mixed model repeated measures analysis with log baseline measurement, treatment, visit, and treatment by visit interaction included in the model. Log percent change from baseline response is the dependent variable. Within-participant repeated measures at multiple visits are modeled by a compound symmetry covariance structure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline to 3 Months in Apolipoprotein B (apoB)</measure>
    <time_frame>Baseline, 3 Months</time_frame>
    <description>Change in apoB levels from baseline to the 3-month visit expressed as a percentage of the baseline levels. Statistics are from analysis of covariance with log baseline measurement and treatment is included in the model. LS means and median differences were analyzed in log units and converted to standard units. Log Percent change from baseline response is the dependent variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline to 3 Months in Cholesterol Efflux Capacity</measure>
    <time_frame>Baseline, 3 Months</time_frame>
    <description>Change in cholesterol efflux capacity from baseline to the 3-month visit expressed as a percentage of the baseline levels. Statistics are from analysis of covariance with log baseline measurement and treatment is included in the model. LS means and median differences were analyzed in log units and converted to standard units. Log Percent change from baseline response is the dependent variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline to 3 Months in Lipoprotein(a) (Lp[a])</measure>
    <time_frame>Baseline, 3 Months</time_frame>
    <description>Change in Lp(a) levels from baseline to the 3-month visit expressed as a percentage of the baseline levels. Statistics are from analysis of covariance with log baseline measurement and treatment is included in the model. LS means and median differences were analyzed in log units and converted to standard units. Log Percent change from baseline response is the dependent variable.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">366</enrollment>
  <condition>Hyperlipidemia</condition>
  <arm_group>
    <arm_group_label>Atorvastatin + Evacetrapib</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Atorvastatin 40 milligrams (mg) orally once daily for 28 days during lead in period. Atorvastatin 40 mg plus evacetrapib 130 mg with placebo for blinding orally once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Atorvastatin 80 mg</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 80 mg orally with placebo for blinding once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Atorvastatin + Ezetimibe</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 40 mg plus ezetimibe 10 mg with placebo for blinding orally once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Atorvastatin 40 mg</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 40 mg with placebo for blinding orally once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Evacetrapib</intervention_name>
    <description>Administered orally</description>
    <arm_group_label>Atorvastatin + Evacetrapib</arm_group_label>
    <other_name>LY2484595</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Atorvastatin</intervention_name>
    <description>Administered orally</description>
    <arm_group_label>Atorvastatin + Evacetrapib</arm_group_label>
    <arm_group_label>Atorvastatin + Ezetimibe</arm_group_label>
    <arm_group_label>Atorvastatin 40 mg</arm_group_label>
    <arm_group_label>Atorvastatin 80 mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ezetimibe</intervention_name>
    <description>Administered orally</description>
    <arm_group_label>Atorvastatin + Ezetimibe</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Administered orally</description>
    <arm_group_label>Atorvastatin + Evacetrapib</arm_group_label>
    <arm_group_label>Atorvastatin + Ezetimibe</arm_group_label>
    <arm_group_label>Atorvastatin 40 mg</arm_group_label>
    <arm_group_label>Atorvastatin 80 mg</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Must be treated with atorvastatin 40 mg/day for at least 30 days prior to screening&#xD;
&#xD;
          -  Have an LDL-C &gt;70 mg/deciliter(dL) or non-HDL-C &gt;100 mg/dL&#xD;
&#xD;
          -  Have screening triglycerides ≤400 mg/dL (≤4.5 millimoles/Liter)&#xD;
&#xD;
          -  Individuals with ASCVD and/or individuals with type 1 or type 2 diabetes&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Have a hemoglobin A1c (HbA1c) &gt;9.5%&#xD;
&#xD;
          -  New York Heart Association (NYHA) class III or IV congestive heart failure&#xD;
&#xD;
          -  History of either a transient ischemic stroke or ischemic stroke &lt;30 days&#xD;
&#xD;
          -  History of acute coronary syndrome (ACS) &lt;30 days&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)</last_name>
    <role>Study Director</role>
    <affiliation>Eli Lilly and Company</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Heart Center Research, LLC</name>
      <address>
        <city>Huntsville</city>
        <state>Alabama</state>
        <zip>35801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Desert Clinical Research</name>
      <address>
        <city>Mesa</city>
        <state>Arizona</state>
        <zip>85213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Central Phoenix Med Clinic LLC</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85020</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Advanced Clinical Research</name>
      <address>
        <city>Carmichael</city>
        <state>California</state>
        <zip>95608</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tooraj Joseph Raoof M.D., Inc.</name>
      <address>
        <city>Encino</city>
        <state>California</state>
        <zip>91436</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Irvine Clinical Research Center</name>
      <address>
        <city>Irvine</city>
        <state>California</state>
        <zip>92618</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>VA Long Beach Healthcare System</name>
      <address>
        <city>Long Beach</city>
        <state>California</state>
        <zip>90822</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rancho Cucamonga Clinical</name>
      <address>
        <city>Rancho Cucamonga</city>
        <state>California</state>
        <zip>91730</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Encompass Clinical Research</name>
      <address>
        <city>Spring Valley</city>
        <state>California</state>
        <zip>91978</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Clinical Investigators, Inc.</name>
      <address>
        <city>Tustin</city>
        <state>California</state>
        <zip>92780</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Diablo Clinical Research</name>
      <address>
        <city>Walnut Creek</city>
        <state>California</state>
        <zip>94598</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Colorado Health Sciences Center</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045-2517</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cardiac Research</name>
      <address>
        <city>Colorado Springs</city>
        <state>Colorado</state>
        <zip>80909</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ZASA Clinical Research</name>
      <address>
        <city>Boynton Beach</city>
        <state>Florida</state>
        <zip>33472</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cardiology Research Assoc.</name>
      <address>
        <city>Daytona Beach</city>
        <state>Florida</state>
        <zip>32117</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Avail Clinical Research LLC</name>
      <address>
        <city>DeLand</city>
        <state>Florida</state>
        <zip>32720</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alan Graff, MD, PA</name>
      <address>
        <city>Fort Lauderdale</city>
        <state>Florida</state>
        <zip>33308</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nature Coast Clinical Research, LLC</name>
      <address>
        <city>Inverness</city>
        <state>Florida</state>
        <zip>34452</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Suncoast Research Group, LLC</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33135</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Progressive Medical Research</name>
      <address>
        <city>Port Orange</city>
        <state>Florida</state>
        <zip>32127</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cardiology Partners Clinical Research Institute, LLC</name>
      <address>
        <city>Wellington</city>
        <state>Florida</state>
        <zip>33449</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Georgia Heart Specialists</name>
      <address>
        <city>Covington</city>
        <state>Georgia</state>
        <zip>30014</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>United Osteoporosis Center</name>
      <address>
        <city>Gainesville</city>
        <state>Georgia</state>
        <zip>30501</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>East West Medical Institute</name>
      <address>
        <city>Honolulu</city>
        <state>Hawaii</state>
        <zip>96814</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Solaris Clinical Research</name>
      <address>
        <city>Meridian</city>
        <state>Idaho</state>
        <zip>83646</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northwest Heart Clinical Research, LLC</name>
      <address>
        <city>Arlington Heights</city>
        <state>Illinois</state>
        <zip>60005</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cedar-Crosse Research Center</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60607</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Midwest CRC</name>
      <address>
        <city>Crystal Lake</city>
        <state>Illinois</state>
        <zip>60012</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Indiana Heart Physicians Inc</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46237</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Midwest Institute for Clinical Research</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46260</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hutchinson Clinic</name>
      <address>
        <city>Hutchinson</city>
        <state>Kansas</state>
        <zip>67502</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Community Medical Associates</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Grace Research</name>
      <address>
        <city>Bossier City</city>
        <state>Louisiana</state>
        <zip>71111</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Maryland Cardiovascular Specialists</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Overlea Personal Physicians</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21236</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cape Cod Research Institute</name>
      <address>
        <city>Hyannis</city>
        <state>Massachusetts</state>
        <zip>02601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ActivMed Practices &amp; Research, Inc</name>
      <address>
        <city>Methuen</city>
        <state>Massachusetts</state>
        <zip>01844</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medex Healthcare Research, Inc.</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63117</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Palm Research Center</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89128</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Heart and Vascular Center of New Brunswick LLC</name>
      <address>
        <city>Somerset</city>
        <state>New Jersey</state>
        <zip>08873</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medex Healthcare Research, Inc.</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10036</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saratoga Clinical Research LLC</name>
      <address>
        <city>Saratoga Springs</city>
        <state>New York</state>
        <zip>12866</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Buffalo Cardiology and Pulmonary Associates, P.C.</name>
      <address>
        <city>Williamsville</city>
        <state>New York</state>
        <zip>14221</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Asheville Cardiology Associates</name>
      <address>
        <city>Asheville</city>
        <state>North Carolina</state>
        <zip>28803</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Metrolina Internal Medicine, P.A.</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>High Point Clinical Trials Center</name>
      <address>
        <city>High Point</city>
        <state>North Carolina</state>
        <zip>27265</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Boice Willis Clinic, PA</name>
      <address>
        <city>Rocky Mount</city>
        <state>North Carolina</state>
        <zip>27804</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PMG Research of Wilmington, LLC</name>
      <address>
        <city>Wilmington</city>
        <state>North Carolina</state>
        <zip>28401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lillestol Research LLC</name>
      <address>
        <city>Fargo</city>
        <state>North Dakota</state>
        <zip>58103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aventiv Research</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>South Oklahoma Heart Research, LLC</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73135</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Portland Preventive Cardiology, LLC</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97225</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Partners in Clinical Research</name>
      <address>
        <city>Cumberland</city>
        <state>Rhode Island</state>
        <zip>02864</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PMG Research of Charleston, LLC</name>
      <address>
        <city>Mount Pleasant</city>
        <state>South Carolina</state>
        <zip>29464</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Black Hills Cardiovascular Research Group</name>
      <address>
        <city>Rapid City</city>
        <state>South Dakota</state>
        <zip>57701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Holston Medical Group Clinical Research</name>
      <address>
        <city>Kingsport</city>
        <state>Tennessee</state>
        <zip>37660</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northwest Houston Heart Center</name>
      <address>
        <city>Tomball</city>
        <state>Texas</state>
        <zip>77375-4536</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Clinical Research - Richmond</name>
      <address>
        <city>Richmond</city>
        <state>Virginia</state>
        <zip>23294</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northwest Clinical Research Center</name>
      <address>
        <city>Bellevue</city>
        <state>Washington</state>
        <zip>98007-4209</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kootenai Heart Clinics, LLC</name>
      <address>
        <city>Spokane</city>
        <state>Washington</state>
        <zip>99204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Investigation Specialists Inc</name>
      <address>
        <city>Kenosha</city>
        <state>Wisconsin</state>
        <zip>53142</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research and Cardiovascular Corp.</name>
      <address>
        <city>Ponce</city>
        <zip>00717-1322</zip>
        <country>Puerto Rico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research Puerto Rico, Inc.</name>
      <address>
        <city>San Juan</city>
        <zip>00909</zip>
        <country>Puerto Rico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GCM Medical Group PSC</name>
      <address>
        <city>San Juan</city>
        <zip>00909</zip>
        <country>Puerto Rico</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Puerto Rico</country>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>August 26, 2014</study_first_submitted>
  <study_first_submitted_qc>August 26, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 28, 2014</study_first_posted>
  <results_first_submitted>February 18, 2018</results_first_submitted>
  <results_first_submitted_qc>February 18, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">March 22, 2018</results_first_posted>
  <disposition_first_submitted>December 23, 2015</disposition_first_submitted>
  <disposition_first_submitted_qc>December 23, 2015</disposition_first_submitted_qc>
  <disposition_first_posted type="Estimate">January 29, 2016</disposition_first_posted>
  <last_update_submitted>September 25, 2019</last_update_submitted>
  <last_update_submitted_qc>September 25, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 8, 2019</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>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>Atorvastatin</mesh_term>
    <mesh_term>Ezetimibe</mesh_term>
    <mesh_term>Evacetrapib</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.</ipd_time_frame>
    <ipd_access_criteria>A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.</ipd_access_criteria>
    <ipd_url>https://vivli.org/</ipd_url>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Atorvastatin + Evacetrapib</title>
          <description>Atorvastatin 40 milligrams (mg) orally once daily for 28 days during lead in period. Atorvastatin 40 mg plus evacetrapib 130 mg with placebo for blinding orally once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.</description>
        </group>
        <group group_id="P2">
          <title>Atorvastatin 40 mg</title>
          <description>Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 40 mg with placebo for blinding orally once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.</description>
        </group>
        <group group_id="P3">
          <title>Atorvastatin 80 mg</title>
          <description>Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 80 mg orally with placebo for blinding once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.</description>
        </group>
        <group group_id="P4">
          <title>Atorvastatin + Ezetimibe</title>
          <description>Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 40 mg plus ezetimibe 10 mg with placebo for blinding orally once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.</description>
        </group>
        <group group_id="P5">
          <title>Atorvastatin + Evacetrapib Open-Label (OLE)</title>
          <description>Open label extension (OLE) (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Double-Blind Phase</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="123"/>
                <participants group_id="P2" count="54"/>
                <participants group_id="P3" count="62"/>
                <participants group_id="P4" count="127"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="83"/>
                <participants group_id="P2" count="36"/>
                <participants group_id="P3" count="41"/>
                <participants group_id="P4" count="88"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="40"/>
                <participants group_id="P2" count="18"/>
                <participants group_id="P3" count="21"/>
                <participants group_id="P4" count="39"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="3"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Sponsor Decision</title>
              <participants_list>
                <participants group_id="P1" count="34"/>
                <participants group_id="P2" count="15"/>
                <participants group_id="P3" count="14"/>
                <participants group_id="P4" count="32"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="5"/>
                <participants group_id="P4" count="2"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Open-Label Extension Phase (OLE)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="0">After the double-blind treatment phase, participants entered an OLE phase.</participants>
                <participants group_id="P2" count="0">After the double-blind treatment phase, participants entered an OLE phase.</participants>
                <participants group_id="P3" count="0">After the double-blind treatment phase, participants entered an OLE phase.</participants>
                <participants group_id="P4" count="0">After the double-blind treatment phase, participants entered an OLE phase.</participants>
                <participants group_id="P5" count="248">After the double-blind treatment phase, participants entered an OLE phase.</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>Received at Least 1 Dose of Study Drug</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="247"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </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 group_id="P4" count="0"/>
                <participants group_id="P5" count="248"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Sponsor Decision</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="243"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Atorvastatin + Evacetrapib</title>
          <description>Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 40 mg plus evacetrapib 130 mg with placebo for blinding orally once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.</description>
        </group>
        <group group_id="B2">
          <title>Atorvastatin 40 mg</title>
          <description>Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 40 mg with placebo for blinding orally once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.</description>
        </group>
        <group group_id="B3">
          <title>Atorvastatin 80 mg</title>
          <description>Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 80 mg orally with placebo for blinding once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.</description>
        </group>
        <group group_id="B4">
          <title>Atorvastatin + Ezetimibe</title>
          <description>Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 40 mg plus ezetimibe 10 mg with placebo for blinding orally once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.</description>
        </group>
        <group group_id="B5">
          <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="123"/>
            <count group_id="B2" value="54"/>
            <count group_id="B3" value="62"/>
            <count group_id="B4" value="127"/>
            <count group_id="B5" value="366"/>
          </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="63.2" spread="8.7"/>
                    <measurement group_id="B2" value="62.7" spread="9.3"/>
                    <measurement group_id="B3" value="61.7" spread="10.2"/>
                    <measurement group_id="B4" value="64.7" spread="8.9"/>
                    <measurement group_id="B5" value="63.4" spread="9.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</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="38"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="18"/>
                    <measurement group_id="B4" value="53"/>
                    <measurement group_id="B5" value="124"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="85"/>
                    <measurement group_id="B2" value="39"/>
                    <measurement group_id="B3" value="44"/>
                    <measurement group_id="B4" value="74"/>
                    <measurement group_id="B5" value="242"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="9"/>
                    <measurement group_id="B4" value="13"/>
                    <measurement group_id="B5" value="38"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="110"/>
                    <measurement group_id="B2" value="51"/>
                    <measurement group_id="B3" value="53"/>
                    <measurement group_id="B4" value="114"/>
                    <measurement group_id="B5" value="328"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="15"/>
                    <measurement group_id="B4" value="14"/>
                    <measurement group_id="B5" value="56"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="97"/>
                    <measurement group_id="B2" value="44"/>
                    <measurement group_id="B3" value="46"/>
                    <measurement group_id="B4" value="110"/>
                    <measurement group_id="B5" value="297"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="123"/>
                    <measurement group_id="B2" value="54"/>
                    <measurement group_id="B3" value="62"/>
                    <measurement group_id="B4" value="127"/>
                    <measurement group_id="B5" value="366"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percent Change From Baseline to 3 Months in Low-Density Lipoprotein Cholesterol (LDL-C)</title>
        <description>Change in LDL-C levels from baseline to the 3-month visit expressed as a percentage of the baseline levels. LDL-C was measured by beta quantification. Statistics are from analysis of covariance with log baseline measurement and treatment is included in the model. Least Square Means (LS means) and median differences were analyzed in log units and converted to standard units. Log Percent change from baseline response is the dependent variable.</description>
        <time_frame>Baseline, 3 Months</time_frame>
        <population>All randomized participants who had evaluable LDL-C data</population>
        <group_list>
          <group group_id="O1">
            <title>Atorvastatin + Evacetrapib</title>
            <description>Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 40 mg plus evacetrapib 130 mg with placebo for blinding orally once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.</description>
          </group>
          <group group_id="O2">
            <title>Atorvastatin 40 mg</title>
            <description>Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 40 mg with placebo for blinding orally once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.</description>
          </group>
          <group group_id="O3">
            <title>Atorvastatin 80 mg</title>
            <description>Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 80 mg orally with placebo for blinding once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.</description>
          </group>
          <group group_id="O4">
            <title>Atorvastatin + Ezetimibe</title>
            <description>Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 40 mg plus ezetimibe 10 mg with placebo for blinding orally once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline to 3 Months in Low-Density Lipoprotein Cholesterol (LDL-C)</title>
          <description>Change in LDL-C levels from baseline to the 3-month visit expressed as a percentage of the baseline levels. LDL-C was measured by beta quantification. Statistics are from analysis of covariance with log baseline measurement and treatment is included in the model. Least Square Means (LS means) and median differences were analyzed in log units and converted to standard units. Log Percent change from baseline response is the dependent variable.</description>
          <population>All randomized participants who had evaluable LDL-C data</population>
          <units>percent</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="86"/>
                <count group_id="O2" value="40"/>
                <count group_id="O3" value="44"/>
                <count group_id="O4" value="91"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-33.44" lower_limit="-34.47" upper_limit="-32.41"/>
                    <measurement group_id="O2" value="0.04" lower_limit="-1.01" upper_limit="1.09"/>
                    <measurement group_id="O3" value="-6.19" lower_limit="-7.24" upper_limit="-5.15"/>
                    <measurement group_id="O4" value="-27.30" lower_limit="-28.33" upper_limit="-26.27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANCOVA</method>
            <param_type>Median Difference (Final Values)</param_type>
            <param_value>-33.48</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-44.4</ci_lower_limit>
            <ci_upper_limit>-23.3</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANCOVA</method>
            <param_type>Median Difference (Final Values)</param_type>
            <param_value>-27.24</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-36.6</ci_lower_limit>
            <ci_upper_limit>-18.5</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>0.045</p_value>
            <method>ANCOVA</method>
            <param_type>Median Difference (Final Values)</param_type>
            <param_value>-6.14</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-12.2</ci_lower_limit>
            <ci_upper_limit>-0.22</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline to 3 Months in High-Density Lipoprotein Cholesterol (HDL-C)</title>
        <description>Change in HDL-C levels from baseline to the 3-month visit expressed as a percentage of the baseline levels. LS medians and median differences were analyzed in log units and converted to standard units. Statistics are from mixed model repeated measures analysis with log baseline measurement, treatment, visit, and treatment by visit interaction included in the model. Log percent change from baseline response is the dependent variable. Within-participant repeated measures at multiple visits are modeled by a compound symmetry covariance structure.</description>
        <time_frame>Baseline, 3 Months</time_frame>
        <population>All randomized participants who had evaluable HDL-C data.</population>
        <group_list>
          <group group_id="O1">
            <title>Atorvastatin + Evacetrapib</title>
            <description>Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 40 mg plus evacetrapib 130 mg with placebo for blinding orally once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.</description>
          </group>
          <group group_id="O2">
            <title>Atorvastatin 40 mg</title>
            <description>Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 40 mg with placebo for blinding orally once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.</description>
          </group>
          <group group_id="O3">
            <title>Atorvastatin 80 mg</title>
            <description>Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 80 mg orally with placebo for blinding once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.</description>
          </group>
          <group group_id="O4">
            <title>Atorvastatin + Ezetimibe</title>
            <description>Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 40 mg plus ezetimibe 10 mg with placebo for blinding orally once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline to 3 Months in High-Density Lipoprotein Cholesterol (HDL-C)</title>
          <description>Change in HDL-C levels from baseline to the 3-month visit expressed as a percentage of the baseline levels. LS medians and median differences were analyzed in log units and converted to standard units. Statistics are from mixed model repeated measures analysis with log baseline measurement, treatment, visit, and treatment by visit interaction included in the model. Log percent change from baseline response is the dependent variable. Within-participant repeated measures at multiple visits are modeled by a compound symmetry covariance structure.</description>
          <population>All randomized participants who had evaluable HDL-C data.</population>
          <units>percent</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="86"/>
                <count group_id="O2" value="40"/>
                <count group_id="O3" value="44"/>
                <count group_id="O4" value="91"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="125.39" lower_limit="124.37" upper_limit="126.40"/>
                    <measurement group_id="O2" value="0.11" lower_limit="-0.92" upper_limit="1.13"/>
                    <measurement group_id="O3" value="-6.10" lower_limit="-7.12" upper_limit="-5.07"/>
                    <measurement group_id="O4" value="-2.18" lower_limit="-3.20" upper_limit="-1.17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Median Difference (Final Values)</param_type>
            <param_value>125.28</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>117.1</ci_lower_limit>
            <ci_upper_limit>133.6</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Median Difference (Final Values)</param_type>
            <param_value>131.48</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>123.5</ci_lower_limit>
            <ci_upper_limit>139.5</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Median Difference (Final Values)</param_type>
            <param_value>127.57</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>120.1</ci_lower_limit>
            <ci_upper_limit>135.0</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline to 3 Months in Apolipoprotein AI (apoAI)</title>
        <description>Change in apoAI levels from baseline to the 3-month visit expressed as a percentage of the baseline levels. Statistics are from analysis of covariance with log baseline measurement and treatment is included in the model. LS means and median differences were analyzed in log units and converted to standard units. Log Percent change from baseline response is the dependent variable.</description>
        <time_frame>Baseline, 3 Months</time_frame>
        <population>All randomized participants with evaluable apoAI data.</population>
        <group_list>
          <group group_id="O1">
            <title>Atorvastatin + Evacetrapib</title>
            <description>Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 40 mg plus evacetrapib 130 mg with placebo for blinding orally once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.</description>
          </group>
          <group group_id="O2">
            <title>Atorvastatin 40 mg</title>
            <description>Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 40 mg with placebo for blinding orally once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.</description>
          </group>
          <group group_id="O3">
            <title>Atorvastatin 80 mg</title>
            <description>Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 80 mg orally with placebo for blinding once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.</description>
          </group>
          <group group_id="O4">
            <title>Atorvastatin + Ezetimibe</title>
            <description>Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 40 mg plus ezetimibe 10 mg with placebo for blinding orally once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline to 3 Months in Apolipoprotein AI (apoAI)</title>
          <description>Change in apoAI levels from baseline to the 3-month visit expressed as a percentage of the baseline levels. Statistics are from analysis of covariance with log baseline measurement and treatment is included in the model. LS means and median differences were analyzed in log units and converted to standard units. Log Percent change from baseline response is the dependent variable.</description>
          <population>All randomized participants with evaluable apoAI data.</population>
          <units>percent</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="86"/>
                <count group_id="O2" value="40"/>
                <count group_id="O3" value="44"/>
                <count group_id="O4" value="91"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="46.08" lower_limit="45.07" upper_limit="47.09"/>
                    <measurement group_id="O2" value="-0.27" lower_limit="-1.29" upper_limit="0.76"/>
                    <measurement group_id="O3" value="-6.14" lower_limit="-7.16" upper_limit="-5.12"/>
                    <measurement group_id="O4" value="-2.36" lower_limit="-3.38" upper_limit="-1.35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANCOVA</method>
            <param_type>Median Difference (Final Values)</param_type>
            <param_value>46.35</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>40.79</ci_lower_limit>
            <ci_upper_limit>51.98</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANCOVA</method>
            <param_type>Median Difference (Final Values)</param_type>
            <param_value>52.22</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>47.12</ci_lower_limit>
            <ci_upper_limit>57.33</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANCOVA</method>
            <param_type>Median Difference (Final Values)</param_type>
            <param_value>48.44</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>43.82</ci_lower_limit>
            <ci_upper_limit>52.86</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline to 3 Months in Non-HDL-C</title>
        <description>Change in Non-HDL-C levels from baseline to the 3-month visit expressed as a percentage of the baseline levels. LS medians and median differences were analyzed in log units and converted to standard units. Statistics are from mixed model repeated measures analysis with log baseline measurement, treatment, visit, and treatment by visit interaction included in the model. Log percent change from baseline response is the dependent variable. Within-participant repeated measures at multiple visits are modeled by a compound symmetry covariance structure.</description>
        <time_frame>Baseline, 3 Months</time_frame>
        <population>All randomized participants who had evaluable non-HDL-C data.</population>
        <group_list>
          <group group_id="O1">
            <title>Atorvastatin + Evacetrapib</title>
            <description>Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 40 mg plus evacetrapib 130 mg with placebo for blinding orally once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.</description>
          </group>
          <group group_id="O2">
            <title>Atorvastatin 40 mg</title>
            <description>Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 40 mg with placebo for blinding orally once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.</description>
          </group>
          <group group_id="O3">
            <title>Atorvastatin 80 mg</title>
            <description>Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 80 mg orally with placebo for blinding once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.</description>
          </group>
          <group group_id="O4">
            <title>Atorvastatin + Ezetimibe</title>
            <description>Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 40 mg plus ezetimibe 10 mg with placebo for blinding orally once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline to 3 Months in Non-HDL-C</title>
          <description>Change in Non-HDL-C levels from baseline to the 3-month visit expressed as a percentage of the baseline levels. LS medians and median differences were analyzed in log units and converted to standard units. Statistics are from mixed model repeated measures analysis with log baseline measurement, treatment, visit, and treatment by visit interaction included in the model. Log percent change from baseline response is the dependent variable. Within-participant repeated measures at multiple visits are modeled by a compound symmetry covariance structure.</description>
          <population>All randomized participants who had evaluable non-HDL-C data.</population>
          <units>percent</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="86"/>
                <count group_id="O2" value="40"/>
                <count group_id="O3" value="44"/>
                <count group_id="O4" value="91"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-31.42" lower_limit="-32.44" upper_limit="-30.40"/>
                    <measurement group_id="O2" value="-4.95" lower_limit="-5.98" upper_limit="-3.92"/>
                    <measurement group_id="O3" value="-9.40" lower_limit="-10.44" upper_limit="-8.37"/>
                    <measurement group_id="O4" value="-24.37" lower_limit="-25.40" upper_limit="-23.35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Median Difference (Final Values)</param_type>
            <param_value>-26.47</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-33.4</ci_lower_limit>
            <ci_upper_limit>-20.0</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Median Difference (Final Values)</param_type>
            <param_value>-22.02</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-28.4</ci_lower_limit>
            <ci_upper_limit>-15.9</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Median Difference (Final Values)</param_type>
            <param_value>-7.05</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-11.5</ci_lower_limit>
            <ci_upper_limit>-2.68</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline to 3 Months in Apolipoprotein B (apoB)</title>
        <description>Change in apoB levels from baseline to the 3-month visit expressed as a percentage of the baseline levels. Statistics are from analysis of covariance with log baseline measurement and treatment is included in the model. LS means and median differences were analyzed in log units and converted to standard units. Log Percent change from baseline response is the dependent variable.</description>
        <time_frame>Baseline, 3 Months</time_frame>
        <population>All randomized participants who had evaluable apoB data.</population>
        <group_list>
          <group group_id="O1">
            <title>Atorvastatin + Evacetrapib</title>
            <description>Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 40 mg plus evacetrapib 130 mg with placebo for blinding orally once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.</description>
          </group>
          <group group_id="O2">
            <title>Atorvastatin 40 mg</title>
            <description>Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 40 mg with placebo for blinding orally once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.</description>
          </group>
          <group group_id="O3">
            <title>Atorvastatin 80 mg</title>
            <description>Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 80 mg orally with placebo for blinding once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.</description>
          </group>
          <group group_id="O4">
            <title>Atorvastatin + Ezetimibe</title>
            <description>Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 40 mg plus ezetimibe 10 mg with placebo for blinding orally once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline to 3 Months in Apolipoprotein B (apoB)</title>
          <description>Change in apoB levels from baseline to the 3-month visit expressed as a percentage of the baseline levels. Statistics are from analysis of covariance with log baseline measurement and treatment is included in the model. LS means and median differences were analyzed in log units and converted to standard units. Log Percent change from baseline response is the dependent variable.</description>
          <population>All randomized participants who had evaluable apoB data.</population>
          <units>percent</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="86"/>
                <count group_id="O2" value="40"/>
                <count group_id="O3" value="44"/>
                <count group_id="O4" value="91"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-22.96" lower_limit="-23.98" upper_limit="-22.96"/>
                    <measurement group_id="O2" value="0.21" lower_limit="-0.82" upper_limit="1.24"/>
                    <measurement group_id="O3" value="-6.54" lower_limit="-7.56" upper_limit="-5.51"/>
                    <measurement group_id="O4" value="-18.84" lower_limit="-19.86" upper_limit="-17.82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANCOVA</method>
            <param_type>Median Difference (Final Values)</param_type>
            <param_value>-23.16</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-30.00</ci_lower_limit>
            <ci_upper_limit>-16.5</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANCOVA</method>
            <param_type>Median Difference (Final Values)</param_type>
            <param_value>-16.42</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-22.3</ci_lower_limit>
            <ci_upper_limit>-10.6</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>0.062</p_value>
            <method>ANCOVA</method>
            <param_type>Median Difference (Final Values)</param_type>
            <param_value>-4.11</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-8.47</ci_lower_limit>
            <ci_upper_limit>0.15</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline to 3 Months in Cholesterol Efflux Capacity</title>
        <description>Change in cholesterol efflux capacity from baseline to the 3-month visit expressed as a percentage of the baseline levels. Statistics are from analysis of covariance with log baseline measurement and treatment is included in the model. LS means and median differences were analyzed in log units and converted to standard units. Log Percent change from baseline response is the dependent variable.</description>
        <time_frame>Baseline, 3 Months</time_frame>
        <population>All randomized participants who had evaluable cholesterol efflux capacity</population>
        <group_list>
          <group group_id="O1">
            <title>Atorvastatin + Evacetrapib</title>
            <description>Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 40 mg plus evacetrapib 130 mg with placebo for blinding orally once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.</description>
          </group>
          <group group_id="O2">
            <title>Atorvastatin 40 mg</title>
            <description>Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 40 mg with placebo for blinding orally once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.</description>
          </group>
          <group group_id="O3">
            <title>Atorvastatin + Ezetimibe</title>
            <description>Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 40 mg plus ezetimibe 10 mg with placebo for blinding orally once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.</description>
          </group>
          <group group_id="O4">
            <title>Atorvastatin 80 mg</title>
            <description>Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 80 mg orally with placebo for blinding once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline to 3 Months in Cholesterol Efflux Capacity</title>
          <description>Change in cholesterol efflux capacity from baseline to the 3-month visit expressed as a percentage of the baseline levels. Statistics are from analysis of covariance with log baseline measurement and treatment is included in the model. LS means and median differences were analyzed in log units and converted to standard units. Log Percent change from baseline response is the dependent variable.</description>
          <population>All randomized participants who had evaluable cholesterol efflux capacity</population>
          <units>percent</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="86"/>
                <count group_id="O2" value="40"/>
                <count group_id="O3" value="44"/>
                <count group_id="O4" value="91"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35.09" lower_limit="34.07" upper_limit="36.11"/>
                    <measurement group_id="O2" value="-2.96" lower_limit="-3.99" upper_limit="-1.93"/>
                    <measurement group_id="O3" value="-7.03" lower_limit="-8.06" upper_limit="-6.00"/>
                    <measurement group_id="O4" value="-4.55" lower_limit="-5.57" upper_limit="-3.53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANCOVA</method>
            <param_type>Median Difference (Final Values)</param_type>
            <param_value>38.05</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>30.17</ci_lower_limit>
            <ci_upper_limit>45.88</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANCOVA</method>
            <param_type>Median Difference (Final Values)</param_type>
            <param_value>42.12</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>34.29</ci_lower_limit>
            <ci_upper_limit>49.76</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANCOVA</method>
            <param_type>Median Difference (Final Values)</param_type>
            <param_value>39.64</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>33.20</ci_lower_limit>
            <ci_upper_limit>46.08</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline to 3 Months in Lipoprotein(a) (Lp[a])</title>
        <description>Change in Lp(a) levels from baseline to the 3-month visit expressed as a percentage of the baseline levels. Statistics are from analysis of covariance with log baseline measurement and treatment is included in the model. LS means and median differences were analyzed in log units and converted to standard units. Log Percent change from baseline response is the dependent variable.</description>
        <time_frame>Baseline, 3 Months</time_frame>
        <population>All randomized participants who had evaluable Lp(a) data.</population>
        <group_list>
          <group group_id="O1">
            <title>Atorvastatin + Evacetrapib</title>
            <description>Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 40 mg plus evacetrapib 130 mg with placebo for blinding orally once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.</description>
          </group>
          <group group_id="O2">
            <title>Atorvastatin 40 mg</title>
            <description>Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 40 mg with placebo for blinding orally once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.</description>
          </group>
          <group group_id="O3">
            <title>Atorvastatin 80 mg</title>
            <description>Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 80 mg orally with placebo for blinding once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.</description>
          </group>
          <group group_id="O4">
            <title>Atorvastatin + Ezetimibe</title>
            <description>Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 40 mg plus ezetimibe 10 mg with placebo for blinding orally once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline to 3 Months in Lipoprotein(a) (Lp[a])</title>
          <description>Change in Lp(a) levels from baseline to the 3-month visit expressed as a percentage of the baseline levels. Statistics are from analysis of covariance with log baseline measurement and treatment is included in the model. LS means and median differences were analyzed in log units and converted to standard units. Log Percent change from baseline response is the dependent variable.</description>
          <population>All randomized participants who had evaluable Lp(a) data.</population>
          <units>percent</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="86"/>
                <count group_id="O2" value="44"/>
                <count group_id="O3" value="40"/>
                <count group_id="O4" value="91"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-28.73" lower_limit="-29.77" upper_limit="27.69"/>
                    <measurement group_id="O2" value="4.45" lower_limit="3.40" upper_limit="5.50"/>
                    <measurement group_id="O3" value="3.90" lower_limit="2.86" upper_limit="4.95"/>
                    <measurement group_id="O4" value="13.42" lower_limit="12.39" upper_limit="14.45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANCOVA</method>
            <param_type>Median Difference (Final Values)</param_type>
            <param_value>-33.18</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-44.9</ci_lower_limit>
            <ci_upper_limit>-22.3</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANCOVA</method>
            <param_type>Median Difference (Final Values)</param_type>
            <param_value>-32.63</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-44.0</ci_lower_limit>
            <ci_upper_limit>-21.8</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANCOVA</method>
            <param_type>Median Difference (Final Values)</param_type>
            <param_value>-42.15</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-50.9</ci_lower_limit>
            <ci_upper_limit>-33.4</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <desc>248 randomized participants from the double-blind phase moved to open-label phase but 1 participant did not receive drug. 247 randomized participants who moved to open-label phase that received drug are part of the safety population.</desc>
      <group_list>
        <group group_id="E1">
          <title>Atorvastatin + Evacetrapib Double-Blind (DB)</title>
          <description>Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 40 mg plus evacetrapib 130 mg with placebo for blinding orally once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.</description>
        </group>
        <group group_id="E2">
          <title>Atorvastatin 40 mg DB</title>
          <description>Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 40 mg with placebo for blinding orally once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.</description>
        </group>
        <group group_id="E3">
          <title>Atorvastatin 80 mg DB</title>
          <description>Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 80 mg orally with placebo for blinding once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.</description>
        </group>
        <group group_id="E4">
          <title>Atorvastatin + Ezetimibe DB</title>
          <description>Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 40 mg plus ezetimibe 10 mg with placebo for blinding orally once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.</description>
        </group>
        <group group_id="E5">
          <title>Atorvastatin + Evacetrapib Open-Label (OLE)</title>
          <description>Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 18.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="123"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="54"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="62"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="127"/>
                <counts group_id="E5" subjects_affected="11" subjects_at_risk="247"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Coronary artery disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="123"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="247"/>
              </event>
              <event>
                <sub_title>Myocardial infarction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="123"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="247"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="123"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="247"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Chest discomfort</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="123"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="247"/>
              </event>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="123"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="62"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="247"/>
              </event>
              <event>
                <sub_title>Non-cardiac chest pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="123"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="62"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="247"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Chronic sinusitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="123"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="54"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="247"/>
              </event>
              <event>
                <sub_title>Pyelonephritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="123"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="127"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="247"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="123"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="247"/>
              </event>
              <event>
                <sub_title>Urosepsis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="123"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="247"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Accidental overdose</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="123"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="54"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="247"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Benign neoplasm of spinal cord</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="123"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="247"/>
              </event>
              <event>
                <sub_title>Ductal adenocarcinoma of pancreas</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="123"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="127"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="247"/>
              </event>
              <event>
                <sub_title>Lung adenocarcinoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="123"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="247"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Balance disorder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="123"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="247"/>
              </event>
              <event>
                <sub_title>Carotid artery stenosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="123"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="247"/>
              </event>
              <event>
                <sub_title>Cerebrovascular accident</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="123"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="62"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="247"/>
              </event>
              <event>
                <sub_title>Cervical myelopathy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="123"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="247"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="123"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="247"/>
              </event>
              <event>
                <sub_title>Hypoaesthesia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="123"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="247"/>
              </event>
              <event>
                <sub_title>Ischaemic stroke</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="123"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="247"/>
              </event>
              <event>
                <sub_title>Transient ischaemic attack</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="123"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="62"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="247"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Suicidal ideation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="123"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="54"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="247"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Acute respiratory failure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="123"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="54"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="247"/>
              </event>
              <event>
                <sub_title>Chronic obstructive pulmonary disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="123"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="54"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="247"/>
              </event>
              <event>
                <sub_title>Pulmonary embolism</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="123"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="54"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="247"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Implantable defibrillator replacement</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="123"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="247"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="123"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="127"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="247"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 18.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="123"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="54"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="62"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="127"/>
                <counts group_id="E5" subjects_affected="9" subjects_at_risk="247"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="123"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="54"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="62"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="127"/>
                <counts group_id="E5" events="4" subjects_affected="4" subjects_at_risk="247"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="123"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="54"/>
                <counts group_id="E3" events="5" subjects_affected="4" subjects_at_risk="62"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="127"/>
                <counts group_id="E5" events="5" subjects_affected="5" subjects_at_risk="247"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>Early termination was due to program termination.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Chief Medical Officer</name_or_title>
      <organization>Eli Lilly and Company</organization>
      <phone>800-545-5979</phone>
    </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/NCT02227784
org study id: 14502
secondary id: I1V-MC-EIBH
nct id: NCT02227784
lead sponsor: 
has dmc: No
The purpose of the ACCENTUATE study is to evaluate whether the study drug known as
      evacetrapib is effective in treating participants with high cholesterol and atherosclerotic
      cardiovascular disease (ASCVD) and/or diabetes.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Percent Change From Baseline to 3 Months in Low-Density Lipoprotein Cholesterol (LDL-C)
time frame: Baseline, 3 Months
description: Change in LDL-C levels from baseline to the 3-month visit expressed as a percentage of the baseline levels. LDL-C was measured by beta quantification. Statistics are from analysis of covariance with log baseline measurement and treatment is included in the model. Least Square Means (LS means) and median differences were analyzed in log units and converted to standard units. Log Percent change from baseline response is the dependent variable.
measure: Percent Change From Baseline to 3 Months in High-Density Lipoprotein Cholesterol (HDL-C)
time frame: Baseline, 3 Months
description: Change in HDL-C levels from baseline to the 3-month visit expressed as a percentage of the baseline levels. LS medians and median differences were analyzed in log units and converted to standard units. Statistics are from mixed model repeated measures analysis with log baseline measurement, treatment, visit, and treatment by visit interaction included in the model. Log percent change from baseline response is the dependent variable. Within-participant repeated measures at multiple visits are modeled by a compound symmetry covariance structure.
measure: Percent Change From Baseline to 3 Months in Apolipoprotein AI (apoAI)
time frame: Baseline, 3 Months
description: Change in apoAI levels from baseline to the 3-month visit expressed as a percentage of the baseline levels. Statistics are from analysis of covariance with log baseline measurement and treatment is included in the model. LS means and median differences were analyzed in log units and converted to standard units. Log Percent change from baseline response is the dependent variable.
measure: Percent Change From Baseline to 3 Months in Non-HDL-C
time frame: Baseline, 3 Months
description: Change in Non-HDL-C levels from baseline to the 3-month visit expressed as a percentage of the baseline levels. LS medians and median differences were analyzed in log units and converted to standard units. Statistics are from mixed model repeated measures analysis with log baseline measurement, treatment, visit, and treatment by visit interaction included in the model. Log percent change from baseline response is the dependent variable. Within-participant repeated measures at multiple visits are modeled by a compound symmetry covariance structure.
measure: Percent Change From Baseline to 3 Months in Apolipoprotein B (apoB)
time frame: Baseline, 3 Months
description: Change in apoB levels from baseline to the 3-month visit expressed as a percentage of the baseline levels. Statistics are from analysis of covariance with log baseline measurement and treatment is included in the model. LS means and median differences were analyzed in log units and converted to standard units. Log Percent change from baseline response is the dependent variable.
measure: Percent Change From Baseline to 3 Months in Cholesterol Efflux Capacity
time frame: Baseline, 3 Months
description: Change in cholesterol efflux capacity from baseline to the 3-month visit expressed as a percentage of the baseline levels. Statistics are from analysis of covariance with log baseline measurement and treatment is included in the model. LS means and median differences were analyzed in log units and converted to standard units. Log Percent change from baseline response is the dependent variable.
measure: Percent Change From Baseline to 3 Months in Lipoprotein(a) (Lp[a])
time frame: Baseline, 3 Months
description: Change in Lp(a) levels from baseline to the 3-month visit expressed as a percentage of the baseline levels. Statistics are from analysis of covariance with log baseline measurement and treatment is included in the model. LS means and median differences were analyzed in log units and converted to standard units. Log Percent change from baseline response is the dependent variable.
arm group label: Atorvastatin + Evacetrapib
arm group type: Experimental
description: Atorvastatin 40 milligrams (mg) orally once daily for 28 days during lead in period. Atorvastatin 40 mg plus evacetrapib 130 mg with placebo for blinding orally once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.
arm group label: Atorvastatin 80 mg
arm group type: Active Comparator
description: Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 80 mg orally with placebo for blinding once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.
arm group label: Atorvastatin + Ezetimibe
arm group type: Active Comparator
description: Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 40 mg plus ezetimibe 10 mg with placebo for blinding orally once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.
arm group label: Atorvastatin 40 mg
arm group type: Active Comparator
description: Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 40 mg with placebo for blinding orally once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.
intervention type: Drug
intervention name: Evacetrapib
description: Administered orally
arm group label: Atorvastatin + Evacetrapib
other name: LY2484595
intervention type: Drug
intervention name: Atorvastatin
description: Administered orally
arm group label: Atorvastatin + Evacetrapib
arm group label: Atorvastatin + Ezetimibe
arm group label: Atorvastatin 40 mg
arm group label: Atorvastatin 80 mg
intervention type: Drug
intervention name: Ezetimibe
description: Administered orally
arm group label: Atorvastatin + Ezetimibe
intervention type: Drug
intervention name: Placebo
description: Administered orally
arm group label: Atorvastatin + Evacetrapib
arm group label: Atorvastatin + Ezetimibe
arm group label: Atorvastatin 40 mg
arm group label: Atorvastatin 80 mg
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: Study Director
affiliation: Eli Lilly and Company
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country: Puerto Rico
country: United States
responsible party type: Sponsor
mesh term: Hyperlipidemias
mesh term: Hyperlipoproteinemias
mesh term: Atorvastatin
mesh term: Ezetimibe
mesh term: Evacetrapib
sharing ipd: Yes
ipd description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Clinical Study Report (CSR)
ipd time frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
ipd access criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
ipd url: https://vivli.org/
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Early termination was due to program termination.
point of contact: 