<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/NCT03768427</url>
  </required_header>
  <id_info>
    <org_study_id>0653C-439</org_study_id>
    <secondary_id>MK-0653C-439</secondary_id>
    <nct_id>NCT03768427</nct_id>
  </id_info>
  <brief_title>Ezetimibe (EZ)/Atorvastatin (Ator) (MK-0653C) vs. Ator in Chinese Hypercholesterolemic Participants (MK-0653C-439)</brief_title>
  <official_title>A Phase 3 Randomized, Active-comparator-controlled Clinical Study to Evaluate the Efficacy and Safety of Ezetimibe/Atorvastatin Combination Tablet (MK-0653C) as Second Line Lipid Lowering Treatment in Chinese Participants</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Organon and Co</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Organon and Co</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will evaluate the EZ/Ator fixed-dose combination (FDC) tablet (MK-0653C) as second&#xD;
      line Low-Density Lipoprotein - Cholesterol (LDL-C) treatment in Chinese participants. The&#xD;
      primary hypothesis is that MK-0653C 10/10 mg is superior to atorvastatin 20 mg in percent&#xD;
      change from baseline in LDL-C to 12 weeks after treatment.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 27, 2019</start_date>
  <completion_date type="Actual">April 1, 2021</completion_date>
  <primary_completion_date type="Actual">March 17, 2021</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 in LDL-C at Week 12</measure>
    <time_frame>Baseline (Day 1) and Week 12</time_frame>
    <description>Participants had LDL-C levels assessed at baseline and after 12 weeks of study drug administration. The change from baseline was calculated.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With An Adverse Event (AE)</measure>
    <time_frame>Up to approximately 17 weeks</time_frame>
    <description>An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Discontinued From Study Treatment</measure>
    <time_frame>Up to approximately 15 weeks</time_frame>
    <description>The number of participants who discontinued treatment over the 12-week treatment period was assessed.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">454</enrollment>
  <condition>Hypercholesterolemia</condition>
  <arm_group>
    <arm_group_label>EZ 10 mg/Ator 10 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single oral dose of EZ10mg/Ator10mg FDC tablet once daily (QD) for 84 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Atorvastatin 20 mg</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>2 atorvastatin 10 mg tablets administered orally, QD for 84 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>EZ 10 mg/Ator 20 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single oral dose of EZ10mg/Ator20mg FDC tablet QD for 84 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Atorvastatin 40 mg</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>2 atorvastatin 20 mg tablets administered orally, QD for 84 days</description>
  </arm_group>
  <intervention>
    <intervention_type>Combination Product</intervention_type>
    <intervention_name>EZ 10 mg/Ator 10 mg</intervention_name>
    <description>FDC of EZ10 mg/Ator 10mg</description>
    <arm_group_label>EZ 10 mg/Ator 10 mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Combination Product</intervention_type>
    <intervention_name>EZ 10 mg/Ator 20 mg</intervention_name>
    <description>FDC of EZ10 mg/Ator 20mg</description>
    <arm_group_label>EZ 10 mg/Ator 20 mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Atorvastatin</intervention_name>
    <description>Atorvastatin administered orally QD, either as two 10 mg tablets or as two 20 mg tablets</description>
    <arm_group_label>Atorvastatin 20 mg</arm_group_label>
    <arm_group_label>Atorvastatin 40 mg</arm_group_label>
    <other_name>Lipitor^®</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo for FDC EZ/Ator</intervention_name>
    <description>A single placebo tablet administered orally QD for 84 days</description>
    <arm_group_label>EZ 10 mg/Ator 10 mg</arm_group_label>
    <arm_group_label>EZ 10 mg/Ator 20 mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo for atorvastatin</intervention_name>
    <description>Two placebo tablets matching atorvastatin administered orally QD for 84 days</description>
    <arm_group_label>Atorvastatin 20 mg</arm_group_label>
    <arm_group_label>Atorvastatin 40 mg</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Has hypercholesterolemia diagnosed by investigator according to Chinese Guidelines on&#xD;
             Prevention and Treatment of Dyslipidemia in Adults (2016 Edition).&#xD;
&#xD;
          -  Has been stabilized on atorvastatin treatment at 10 mg or 20 mg (or other statins with&#xD;
             LDL-C lowering efficacy equivalent to atorvastatin) for at least 4 weeks prior to&#xD;
             Visit 1.&#xD;
&#xD;
          -  If female, is not pregnant or breastfeeding, and is either not a woman of childbearing&#xD;
             potential (WOCBP), or is a WOCBP who has used a contraceptive consistent with local&#xD;
             regulations.&#xD;
&#xD;
          -  If male, has used a contraceptive consistent with local regulations.&#xD;
&#xD;
          -  Agrees to maintain a stable diet and stable exercise during the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Has uncontrolled hypertriglyceridemia which needs drug intervention or a fasting&#xD;
             triglyceride (TG) value ≥500 mg/dL (4.52 mmol/L).&#xD;
&#xD;
          -  Is currently treated with statin at dose of equivalent LDL-C lowering effect &gt;20 mg&#xD;
             atorvastatin.&#xD;
&#xD;
          -  Has active liver disease&#xD;
&#xD;
          -  Has New York Heart Association (NYHA) Class III or IV symptomatic congestive heart&#xD;
             failure at Visit 1.&#xD;
&#xD;
          -  Has had uncontrolled cardiac arrhythmias, myocardial infarction, percutaneous coronary&#xD;
             intervention, coronary artery bypass graft, unstable angina, or stroke within 3 months&#xD;
             (12 weeks) prior to Visit 1.&#xD;
&#xD;
          -  Has homozygous familial hypercholesterolemia or has undergone LDL apheresis.&#xD;
&#xD;
          -  Has endocrine or metabolic disease known to influence serum lipids or lipoproteins&#xD;
             (i.e., secondary causes of hyperlipidemia, e.g., hyper or hypothyroidism, Cushing's&#xD;
             syndrome).&#xD;
&#xD;
          -  Has had a gastrointestinal tract bypass, or other significant intestinal&#xD;
             malabsorption.&#xD;
&#xD;
          -  Has a history of cancer within the past 5 years from Visit 1 (except for successfully&#xD;
             treated dermatological basal cell or squamous cell carcinoma or in situ cervical&#xD;
             cancer).&#xD;
&#xD;
          -  Is known to be human immunodeficiency virus (HIV) positive.&#xD;
&#xD;
          -  Has hypersensitivity or intolerance to ezetimibe, atorvastatin, the&#xD;
             ezetimibe/atorvastatin combination tablet, or any component of these medications or&#xD;
             has a condition or situation, which is described as a contraindication in labeling of&#xD;
             EZETROL or Lipitor or may interfere with participation in the study.&#xD;
&#xD;
          -  Has disorders of the hematologic, digestive, or central nervous systems including&#xD;
             cerebrovascular disease and degenerative disease that would limit study evaluation or&#xD;
             participation.&#xD;
&#xD;
          -  Has a history of mental instability, drug/alcohol abuse within the past 5 years, or&#xD;
             major psychiatric illness not adequately controlled and stable on pharmacotherapy.&#xD;
&#xD;
          -  Has a history of myopathy or rhabdomyolysis with ezetimibe or any statin.&#xD;
&#xD;
          -  Is a WOCBP who has had a positive urine pregnancy test within 24 hours before the&#xD;
             first dose of study intervention. If the urine test is positive or cannot be confirmed&#xD;
             as negative, a serum pregnancy test will be required.&#xD;
&#xD;
          -  Is currently taking medications that are potent modulators of cytochrome P-450 3A4&#xD;
             (CYP3A4) including: cyclosporine, systemically administered azole antifungals (e.g.,&#xD;
             ketoconazole, fluconazole, and itraconazole), macrolide antibiotics (e.g.,&#xD;
             clarithromycin, and erythromycin), protease inhibitors (e.g., ritonavir, saquinavir,&#xD;
             and lopinavir), grapefruit or juice of grapefruit (200 ml/day for &gt;3 times per week)&#xD;
&#xD;
          -  Is taking any cyclical hormones (e.g., cyclical oral contraceptives, cyclical hormone&#xD;
             replacement), including the combination of ethinyl estradiol and norethisterone, or&#xD;
             non-cyclical hormones, including non-cyclical hormone replacement therapy (HRT) or any&#xD;
             estrogen antagonist/agonist within 8 weeks.&#xD;
&#xD;
          -  Note: If participant has been treated with a stable regimen of non-cyclical HRT for &gt;&#xD;
             8 weeks and agree to continue this regimen for the duration of the trial, concomitant&#xD;
             therapy is acceptable.&#xD;
&#xD;
          -  Is receiving treatment with systemic corticosteroids (intravenous, intramuscular and&#xD;
             oral steroids).&#xD;
&#xD;
          -  Is treated with psyllium, other fiber-based laxatives, phytosterol margarine, and&#xD;
             herbal medicine and/or over the counter (OTC) therapies that are known to affect serum&#xD;
             lipids.&#xD;
&#xD;
          -  Note: If participant has been treated with a stable regimen for &gt; 8 weeks and agrees&#xD;
             to continue this regimen for the duration of the trial, concomitant therapy is&#xD;
             acceptable.&#xD;
&#xD;
          -  Is treated with an anti-obesity drug (e.g. mazindol) within 12 weeks prior to Visit 1.&#xD;
&#xD;
          -  Is treated with warfarin or warfarin-like anticoagulants and has not been on a stable&#xD;
             dose with a stable International Normalized Ratio (INR) for at least 6 weeks.&#xD;
&#xD;
        weeks.&#xD;
&#xD;
          -  Has taken lipid-lowering agents (except probucol) including, Cholestin, bile acid&#xD;
             sequestrants, ezetimibe, fibrates or niacin (&gt;200 mg/day), proprotein convertases&#xD;
             subtilisin/kexin type 9 (PCSK9) inhibitors within 6 weeks prior to Visit 1.&#xD;
&#xD;
          -  Has taken probucol within 10 weeks prior to Visit 1.&#xD;
&#xD;
          -  Has been treated with any other investigational drug within 30 days.&#xD;
&#xD;
          -  Currently follows an excessive weight reduction diet.&#xD;
&#xD;
          -  Currently engages in a vigorous exercise regimen (e.g., marathon training, body&#xD;
             building training) or intends to start training during the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Medical Director</last_name>
    <role>Study Director</role>
    <affiliation>Merck Sharp &amp; Dohme LLC</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Baotou Medical College ( Site 0025)</name>
      <address>
        <city>Baotou</city>
        <state>Anhui</state>
        <zip>014010</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beijing Anzhen Hospital. Capital Medical University ( Site 0001)</name>
      <address>
        <city>Beijing</city>
        <state>Anhui</state>
        <zip>100024</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aero Space center hospital ( Site 0003)</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100049</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beijing Friendship Hospital ( Site 0005)</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100050</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chongqing General Hospital ( Site 0037)</name>
      <address>
        <city>Chongqing</city>
        <state>Chongqing</state>
        <zip>400013</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lanzhou University Second Hospital ( Site 0041)</name>
      <address>
        <city>Lanzhou</city>
        <state>Gansu</state>
        <zip>730030</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Guangdong General Hospital ( Site 0006)</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510080</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital.Sun Yat-sen University ( Site 0007)</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510080</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sun Yat-sen Memorial Hospital of Sun Yat-sen University ( Site 0008)</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510210</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Daqing Oilfield General Hospital ( Site 0010)</name>
      <address>
        <city>Daqing</city>
        <state>Heilongjiang</state>
        <zip>163001</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The first affiliated Hospital of Harbin Medical University ( Site 0009)</name>
      <address>
        <city>Haerbin</city>
        <state>Heilongjiang</state>
        <zip>150001</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Third Xiangya Hospital of Central South University ( Site 0013)</name>
      <address>
        <city>Changsha</city>
        <state>Hunan</state>
        <zip>410000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hunan Provincial People's Hospital ( Site 0011)</name>
      <address>
        <city>Changsha</city>
        <state>Hunan</state>
        <zip>410005</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Zhongda Hospital Southeast University ( Site 0045)</name>
      <address>
        <city>Nanjing</city>
        <state>Jiangsu</state>
        <zip>210009</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Second Affiliated Hospital of Nanjing Medical University ( Site 0020)</name>
      <address>
        <city>Nanjing</city>
        <state>Jiangsu</state>
        <zip>210011</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>First Affiliated Hospital of Soochow University ( Site 0048)</name>
      <address>
        <city>Suzhou</city>
        <state>Jiangsu</state>
        <zip>215006</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Affiliated Hospital of Xuzhou Medical University ( Site 0017)</name>
      <address>
        <city>Xuzhou</city>
        <state>Jiangsu</state>
        <zip>221000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Subei People's Hospital ( Site 0040)</name>
      <address>
        <city>Yangzhou</city>
        <state>Jiangsu</state>
        <zip>225001</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Second Affiliated Hospital of Nanchang University ( Site 0038)</name>
      <address>
        <city>Nanchang</city>
        <state>Jiangxi</state>
        <zip>330006</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ji Lin Province People Hospital ( Site 0016)</name>
      <address>
        <city>Changchun</city>
        <state>Jilin</state>
        <zip>130021</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>China-Japan Union Hospital of Jilin University ( Site 0015)</name>
      <address>
        <city>Changchun</city>
        <state>Jilin</state>
        <zip>130033</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Central People s Hospital of Siping ( Site 0046)</name>
      <address>
        <city>Siping</city>
        <state>Jilin</state>
        <zip>136000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The People's Hospital of Liaoning Province-Cardiovascular ( Site 0022)</name>
      <address>
        <city>Shenyang</city>
        <state>Liaoning</state>
        <zip>110016</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Zhongshan Hospital Fudan University ( Site 0049)</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200032</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shanghai Tongji Hospital ( Site 0031)</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200065</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tianjin Union Medicine Centre ( Site 0032)</name>
      <address>
        <city>Tianjin</city>
        <state>Tianjin</state>
        <zip>300121</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>People s Hospital of Lishui City ( Site 0036)</name>
      <address>
        <city>Lishui</city>
        <state>Zhejiang</state>
        <zip>323000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ningbo First Hospital ( Site 0042)</name>
      <address>
        <city>Ningbo</city>
        <state>Zhejiang</state>
        <zip>315010</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Taizhou Hospital of Zhejiang Province ( Site 0035)</name>
      <address>
        <city>Taizhou</city>
        <state>Zhejiang</state>
        <zip>317000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Wenzhou Medical University ( Site 0034)</name>
      <address>
        <city>Wenzhou</city>
        <state>Zhejiang</state>
        <zip>325000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>November 29, 2018</study_first_submitted>
  <study_first_submitted_qc>December 6, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 7, 2018</study_first_posted>
  <results_first_submitted>March 1, 2022</results_first_submitted>
  <results_first_submitted_qc>May 11, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">February 8, 2023</results_first_posted>
  <last_update_submitted>April 12, 2023</last_update_submitted>
  <last_update_submitted_qc>April 12, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 14, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypercholesterolemia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Atorvastatin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf</ipd_description>
    <ipd_url>http://engagezone.msd.com/ds_documentation.php</ipd_url>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>November 5, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/27/NCT03768427/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Chinese participants with Hypercholesterolemia inadequately controlled with 10 mg or 20 mg atorvastatin (Ator) monotherapy were enrolled.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Atorvastatin 10 mg - Ezetimibe 10 mg/Ator 10 mg</title>
          <description>Participants had a 5-week run-in of atorvastatin 10 mg once daily (QD). They then received a single oral dose of ezetimibe (EZ) 10 mg/Ator 10 mg fixed dose combination (FDC) tablet QD, and 1 placebo tablet matched to active atorvastatin tablet QD for 84 days.</description>
        </group>
        <group group_id="P2">
          <title>Atorvastatin 10mg - Atorvastatin 20 mg</title>
          <description>Participants had a 5-week run-in of atorvastatin 10 mg QD. They then received 2 atorvastatin 20 mg tablets QD, and 1 placebo tablet matched to active atorvastatin tablet QD for 84 days.</description>
        </group>
        <group group_id="P3">
          <title>Atorvastatin 20 mg - EZ 10 mg/Ator 20 mg</title>
          <description>Participants had a 5-week run-in of atorvastatin 20 mg QD. They then received a single oral dose of EZ 10 mg/Ator 20 mg FDC tablet QD, and 1 placebo tablet matched to active atorvastatin tablet QD for 84 days.</description>
        </group>
        <group group_id="P4">
          <title>Atorvastatin 20 mg - Atorvastatin 40 mg</title>
          <description>Participants had a 5-week run-in of atorvastatin 20 mg QD. They then received 2 atorvastatin 20 mg tablets administered orally, QD, and 1 placebo tablet matched to active atorvastatin tablet QD for 84 days.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="88"/>
                <participants group_id="P2" count="89"/>
                <participants group_id="P3" count="137"/>
                <participants group_id="P4" count="140"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="76"/>
                <participants group_id="P2" count="85"/>
                <participants group_id="P3" count="126"/>
                <participants group_id="P4" count="129"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="11"/>
                <participants group_id="P4" count="11"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <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="1"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="4"/>
                <participants group_id="P4" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="6"/>
                <participants group_id="P4" count="7"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Atorvastatin 10 mg - Ezetimibe 10 mg/Ator 10 mg</title>
          <description>Participants had a 5-week run-in of atorvastatin 10 mg once daily (QD). They then received a single oral dose of ezetimibe (EZ) 10 mg/Ator 10 mg fixed dose combination (FDC) tablet QD, and 1 placebo tablet matched to active atorvastatin tablet QD for 84 days.</description>
        </group>
        <group group_id="B2">
          <title>Atorvastatin 10mg - Atorvastatin 20 mg</title>
          <description>Participants had a 5-week run-in of atorvastatin 10 mg QD. They then received 2 atorvastatin 20 mg tablets QD, and 1 placebo tablet matched to active atorvastatin tablet QD for 84 days.</description>
        </group>
        <group group_id="B3">
          <title>Atorvastatin 20 mg - EZ 10 mg/Ator 20 mg</title>
          <description>Participants had a 5-week run-in of atorvastatin 20 mg QD. They then received a single oral dose of EZ 10 mg/Ator 20 mg FDC tablet QD, and 1 placebo tablet matched to active atorvastatin tablet QD for 84 days.</description>
        </group>
        <group group_id="B4">
          <title>Atorvastatin 20 mg - Atorvastatin 40 mg</title>
          <description>Participants had a 5-week run-in of atorvastatin 20 mg QD. They then received 2 atorvastatin 20 mg tablets administered orally, QD, and 1 placebo tablet matched to active atorvastatin tablet QD for 84 days.</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="88"/>
            <count group_id="B2" value="89"/>
            <count group_id="B3" value="137"/>
            <count group_id="B4" value="140"/>
            <count group_id="B5" value="454"/>
          </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="62.4" spread="7.4"/>
                    <measurement group_id="B2" value="62.4" spread="8.5"/>
                    <measurement group_id="B3" value="59.4" spread="9.3"/>
                    <measurement group_id="B4" value="60.6" spread="10.3"/>
                    <measurement group_id="B5" value="60.9" 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="43"/>
                    <measurement group_id="B2" value="38"/>
                    <measurement group_id="B3" value="34"/>
                    <measurement group_id="B4" value="46"/>
                    <measurement group_id="B5" value="161"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="45"/>
                    <measurement group_id="B2" value="51"/>
                    <measurement group_id="B3" value="103"/>
                    <measurement group_id="B4" value="94"/>
                    <measurement group_id="B5" value="293"/>
                  </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="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>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="88"/>
                    <measurement group_id="B2" value="89"/>
                    <measurement group_id="B3" value="137"/>
                    <measurement group_id="B4" value="140"/>
                    <measurement group_id="B5" value="454"/>
                  </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="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="88"/>
                    <measurement group_id="B2" value="89"/>
                    <measurement group_id="B3" value="137"/>
                    <measurement group_id="B4" value="140"/>
                    <measurement group_id="B5" value="454"/>
                  </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="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>White</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>More than one race</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>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>Baseline Low-Density Lipoprotein Cholesterol (LDL-C)</title>
          <units>mg/dL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="95.5" spread="24.6"/>
                    <measurement group_id="B2" value="96.8" spread="25.9"/>
                    <measurement group_id="B3" value="96.2" spread="25.2"/>
                    <measurement group_id="B4" value="88.4" spread="21.9"/>
                    <measurement group_id="B5" value="91.9" spread="24.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percent Change From Baseline in LDL-C at Week 12</title>
        <description>Participants had LDL-C levels assessed at baseline and after 12 weeks of study drug administration. The change from baseline was calculated.</description>
        <time_frame>Baseline (Day 1) and Week 12</time_frame>
        <population>All randomized participants who took at least one dose of study treatment, and have at least one post treatment observation of the respective endpoint (Baseline and Week 12) during the treatment period.</population>
        <group_list>
          <group group_id="O1">
            <title>Atorvastatin 10 mg - Ezetimibe 10 mg/Ator 10 mg</title>
            <description>Participants had a 5-week run-in of atorvastatin 10 mg once daily (QD). They then received a single oral dose of ezetimibe (EZ) 10 mg/Ator 10 mg fixed dose combination (FDC) tablet QD, and 1 placebo tablet matched to active atorvastatin tablet QD for 84 days.</description>
          </group>
          <group group_id="O2">
            <title>Atorvastatin 10mg - Atorvastatin 20 mg</title>
            <description>Participants had a 5-week run-in of atorvastatin 10 mg QD. They then received 2 atorvastatin 20 mg tablets QD, and 1 placebo tablet matched to active atorvastatin tablet QD for 84 days.</description>
          </group>
          <group group_id="O3">
            <title>Atorvastatin 20 mg - EZ 10 mg/Ator 20 mg</title>
            <description>Participants had a 5-week run-in of atorvastatin 20 mg QD. They then received a single oral dose of EZ 10 mg/Ator 20 mg FDC tablet QD, and 1 placebo tablet matched to active atorvastatin tablet QD for 84 days.</description>
          </group>
          <group group_id="O4">
            <title>Atorvastatin 20 mg - Atorvastatin 40 mg</title>
            <description>Participants had a 5-week run-in of atorvastatin 20 mg QD. They then received 2 atorvastatin 20 mg tablets administered orally, QD, and 1 placebo tablet matched to active atorvastatin tablet QD for 84 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline in LDL-C at Week 12</title>
          <description>Participants had LDL-C levels assessed at baseline and after 12 weeks of study drug administration. The change from baseline was calculated.</description>
          <population>All randomized participants who took at least one dose of study treatment, and have at least one post treatment observation of the respective endpoint (Baseline and Week 12) during the treatment period.</population>
          <units>Percent change</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="67"/>
                <count group_id="O2" value="77"/>
                <count group_id="O3" value="114"/>
                <count group_id="O4" value="116"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-24.7" spread="24.9"/>
                    <measurement group_id="O2" value="-5.3" spread="22.5"/>
                    <measurement group_id="O3" value="-23.3" spread="23.1"/>
                    <measurement group_id="O4" value="-9.1" spread="18.2"/>
                  </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>
            <groups_desc>This statistical analysis was performed by fitting a constrained longitudinal model adjusting for time and the interaction of time by treatment, and time by baseline disease risk category, including all participants with baseline data (88 participants in arm &quot;Atorvastatin 10 mg - ezetimibe 10 mg/Ator 10 mg&quot; and 89 participants in arm &quot;Atorvastatin 10mg - Atorvastatin 20 mg&quot;).</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Difference in least squares mean</non_inferiority_desc>
            <p_value>&lt;0.001</p_value>
            <method>Constrained longitudinal model</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-19.5</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-26.7</ci_lower_limit>
            <ci_upper_limit>-12.3</ci_upper_limit>
            <other_analysis_desc>Difference in least squares mean is Atorvastatin 10 mg - EZ 10 mg/Ator 10 mg minus Atorvastatin 10mg - Atorvastatin 20 mg.</other_analysis_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>This statistical analysis was performed by fitting a constrained longitudinal model adjusting for time and the interaction of time by treatment, and time by baseline disease risk category, including all participants with baseline data (137 participants in arm &quot;Atorvastatin 20 mg - EZ 10 mg/Ator 20 mg&quot; and 140 participants in arm &quot;Atorvastatin 20 mg - Atorvastatin 40 mg&quot;).</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Difference in least squares mean</non_inferiority_desc>
            <p_value>&lt;0.001</p_value>
            <method>Constrained longitudinal model</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-15.9</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-21.0</ci_lower_limit>
            <ci_upper_limit>-10.7</ci_upper_limit>
            <other_analysis_desc>Atorvastatin 20 mg - EZ 10 mg/Ator 20 mg minus Atorvastatin 20 mg - Atorvastatin 40 mg.</other_analysis_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With An Adverse Event (AE)</title>
        <description>An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.</description>
        <time_frame>Up to approximately 17 weeks</time_frame>
        <population>All randomized participants who received at least one dose of study treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Atorvastatin 10 mg - Ezetimibe 10 mg/Ator 10 mg</title>
            <description>Participants had a 5-week run-in of atorvastatin 10 mg once daily (QD). They then received a single oral dose of ezetimibe (EZ) 10 mg/Ator 10 mg fixed dose combination (FDC) tablet QD, and 1 placebo tablet matched to active atorvastatin tablet QD for 84 days.</description>
          </group>
          <group group_id="O2">
            <title>Atorvastatin 10mg - Atorvastatin 20 mg</title>
            <description>Participants had a 5-week run-in of atorvastatin 10 mg QD. They then received 2 atorvastatin 20 mg tablets QD, and 1 placebo tablet matched to active atorvastatin tablet QD for 84 days.</description>
          </group>
          <group group_id="O3">
            <title>Atorvastatin 20 mg - EZ 10 mg/Ator 20 mg</title>
            <description>Participants had a 5-week run-in of atorvastatin 20 mg QD. They then received a single oral dose of EZ 10 mg/Ator 20 mg FDC tablet QD, and 1 placebo tablet matched to active atorvastatin tablet QD for 84 days.</description>
          </group>
          <group group_id="O4">
            <title>Atorvastatin 20 mg - Atorvastatin 40 mg</title>
            <description>Participants had a 5-week run-in of atorvastatin 20 mg QD. They then received 2 atorvastatin 20 mg tablets administered orally, QD, and 1 placebo tablet matched to active atorvastatin tablet QD for 84 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With An Adverse Event (AE)</title>
          <description>An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.</description>
          <population>All randomized participants who received at least one dose of study treatment.</population>
          <units>Percentage of Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="88"/>
                <count group_id="O2" value="89"/>
                <count group_id="O3" value="137"/>
                <count group_id="O4" value="140"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31.8"/>
                    <measurement group_id="O2" value="34.8"/>
                    <measurement group_id="O3" value="55.5"/>
                    <measurement group_id="O4" value="47.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Who Discontinued From Study Treatment</title>
        <description>The number of participants who discontinued treatment over the 12-week treatment period was assessed.</description>
        <time_frame>Up to approximately 15 weeks</time_frame>
        <population>All randomized participants who received at least one dose of study treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Atorvastatin 10 mg - Ezetimibe 10 mg/Ator 10 mg</title>
            <description>Participants had a 5-week run-in of atorvastatin 10 mg once daily (QD). They then received a single oral dose of ezetimibe (EZ) 10 mg/Ator 10 mg fixed dose combination (FDC) tablet QD, and 1 placebo tablet matched to active atorvastatin tablet QD for 84 days.</description>
          </group>
          <group group_id="O2">
            <title>Atorvastatin 10mg - Atorvastatin 20 mg</title>
            <description>Participants had a 5-week run-in of atorvastatin 10 mg QD. They then received 2 atorvastatin 20 mg tablets QD, and 1 placebo tablet matched to active atorvastatin tablet QD for 84 days.</description>
          </group>
          <group group_id="O3">
            <title>Atorvastatin 20 mg - EZ 10 mg/Ator 20 mg</title>
            <description>Participants had a 5-week run-in of atorvastatin 20 mg QD. They then received a single oral dose of EZ 10 mg/Ator 20 mg FDC tablet QD, and 1 placebo tablet matched to active atorvastatin tablet QD for 84 days.</description>
          </group>
          <group group_id="O4">
            <title>Atorvastatin 20 mg - Atorvastatin 40 mg</title>
            <description>Participants had a 5-week run-in of atorvastatin 20 mg QD. They then received 2 atorvastatin 20 mg tablets administered orally, QD, and 1 placebo tablet matched to active atorvastatin tablet QD for 84 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Discontinued From Study Treatment</title>
          <description>The number of participants who discontinued treatment over the 12-week treatment period was assessed.</description>
          <population>All randomized participants who received at least one dose of study treatment.</population>
          <units>Number of Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="88"/>
                <count group_id="O2" value="89"/>
                <count group_id="O3" value="137"/>
                <count group_id="O4" value="140"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="5"/>
                    <measurement group_id="O3" value="13"/>
                    <measurement group_id="O4" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Up to 17 weeks</time_frame>
      <desc>Serious AEs and Other AEs are presented for all participants who received ≥1 dose of study medication. All-Cause Mortality is presented for all participants randomized.</desc>
      <group_list>
        <group group_id="E1">
          <title>Atorvastatin 10 mg - Ezetimibe 10 mg/Ator 10 mg</title>
          <description>Participants had a 5-week run-in of atorvastatin 10 mg once daily (QD). They then received a single oral dose of ezetimibe (EZ) 10 mg/Ator 10 mg fixed dose combination (FDC) tablet QD, and 1 placebo tablet matched to active atorvastatin tablet QD for 84 days.</description>
        </group>
        <group group_id="E2">
          <title>Atorvastatin 10mg - Atorvastatin 20 mg</title>
          <description>Participants had a 5-week run-in of atorvastatin 10 mg QD. They then received 2 atorvastatin 20 mg tablets QD, and 1 placebo tablet matched to active atorvastatin tablet QD for 84 days.</description>
        </group>
        <group group_id="E3">
          <title>Atorvastatin 20 mg - EZ 10 mg/Ator 20 mg</title>
          <description>Participants had a 5-week run-in of atorvastatin 20 mg QD. They then received a single oral dose of EZ 10 mg/Ator 20 mg FDC tablet QD, and 1 placebo tablet matched to active atorvastatin tablet QD for 84 days.</description>
        </group>
        <group group_id="E4">
          <title>Atorvastatin 20 mg - Atorvastatin 40 mg</title>
          <description>Participants had a 5-week run-in of atorvastatin 20 mg QD. They then received 2 atorvastatin 20 mg tablets administered orally, QD, and 1 placebo tablet matched to active atorvastatin tablet QD for 84 days.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 23.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="137"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="140"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="88"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="89"/>
                <counts group_id="E3" subjects_affected="10" subjects_at_risk="137"/>
                <counts group_id="E4" subjects_affected="6" subjects_at_risk="140"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Angina unstable</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="137"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="140"/>
              </event>
              <event>
                <sub_title>Atrioventricular block</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="137"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="140"/>
              </event>
              <event>
                <sub_title>Cardiac failure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="137"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="140"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Vertigo</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="89"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="137"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="140"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Cataract</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="137"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="140"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="89"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="137"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="140"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Femur fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="137"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="140"/>
              </event>
              <event>
                <sub_title>Subdural haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="137"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="140"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Type 2 diabetes mellitus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="137"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="140"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Intervertebral disc protrusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="137"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="140"/>
              </event>
              <event>
                <sub_title>Lumbar spinal stenosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="137"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="140"/>
              </event>
              <event>
                <sub_title>Rheumatoid arthritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="137"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="140"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Colon adenoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="137"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="140"/>
              </event>
              <event>
                <sub_title>Ovarian granulosa cell tumour</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="137"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="140"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Cerebral infarction</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="88"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="89"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="137"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="140"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="89"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="137"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="140"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Chronic kidney disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="89"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="137"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="140"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Aortic dissection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="137"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="140"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 23.1</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="0" subjects_at_risk="88"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E3" subjects_affected="7" subjects_at_risk="137"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="140"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E3" events="7" subjects_affected="7" subjects_at_risk="137"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="140"/>
              </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 investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. This allows the Sponsor to protect proprietary information and to provide comments.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Senior Vice President, Global Clinical Development</name_or_title>
      <organization>Merck Sharp &amp; Dohme LLC</organization>
      <phone>1-800-672-6372</phone>
      <email>ClinicalTrialsDisclosure@merck.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03768427
org study id: 0653C-439
secondary id: MK-0653C-439
nct id: NCT03768427
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study will evaluate the EZ/Ator fixed-dose combination (FDC) tablet (MK-0653C) as second
      line Low-Density Lipoprotein - Cholesterol (LDL-C) treatment in Chinese participants. The
      primary hypothesis is that MK-0653C 10/10 mg is superior to atorvastatin 20 mg in percent
      change from baseline in LDL-C to 12 weeks after treatment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Percent Change From Baseline in LDL-C at Week 12
time frame: Baseline (Day 1) and Week 12
description: Participants had LDL-C levels assessed at baseline and after 12 weeks of study drug administration. The change from baseline was calculated.
measure: Percentage of Participants With An Adverse Event (AE)
time frame: Up to approximately 17 weeks
description: An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.
measure: Number of Participants Who Discontinued From Study Treatment
time frame: Up to approximately 15 weeks
description: The number of participants who discontinued treatment over the 12-week treatment period was assessed.
arm group label: EZ 10 mg/Ator 10 mg
arm group type: Experimental
description: Single oral dose of EZ10mg/Ator10mg FDC tablet once daily (QD) for 84 days
arm group label: Atorvastatin 20 mg
arm group type: Active Comparator
description: 2 atorvastatin 10 mg tablets administered orally, QD for 84 days
arm group label: EZ 10 mg/Ator 20 mg
arm group type: Experimental
description: Single oral dose of EZ10mg/Ator20mg FDC tablet QD for 84 days
arm group label: Atorvastatin 40 mg
arm group type: Active Comparator
description: 2 atorvastatin 20 mg tablets administered orally, QD for 84 days
intervention type: Combination Product
intervention name: EZ 10 mg/Ator 10 mg
description: FDC of EZ10 mg/Ator 10mg
arm group label: EZ 10 mg/Ator 10 mg
intervention type: Combination Product
intervention name: EZ 10 mg/Ator 20 mg
description: FDC of EZ10 mg/Ator 20mg
arm group label: EZ 10 mg/Ator 20 mg
intervention type: Drug
intervention name: Atorvastatin
description: Atorvastatin administered orally QD, either as two 10 mg tablets or as two 20 mg tablets
arm group label: Atorvastatin 20 mg
arm group label: Atorvastatin 40 mg
other name: Lipitor^®
intervention type: Drug
intervention name: Placebo for FDC EZ/Ator
description: A single placebo tablet administered orally QD for 84 days
arm group label: EZ 10 mg/Ator 10 mg
arm group label: EZ 10 mg/Ator 20 mg
intervention type: Drug
intervention name: Placebo for atorvastatin
description: Two placebo tablets matching atorvastatin administered orally QD for 84 days
arm group label: Atorvastatin 20 mg
arm group label: Atorvastatin 40 mg
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Medical Director
role: Study Director
affiliation: Merck Sharp & Dohme LLC
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country: China
responsible party type: Sponsor
mesh term: Hypercholesterolemia
mesh term: Atorvastatin
sharing ipd: Yes
ipd description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
ipd url: http://engagezone.msd.com/ds_documentation.php
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 