<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/NCT01710007</url>
  </required_header>
  <id_info>
    <org_study_id>QCR10022</org_study_id>
    <nct_id>NCT01710007</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety Study of Pitavastatin for Hypercholesterolemia</brief_title>
  <official_title>A Prospective, Double-blind, Randomized, Parallel, Multiple-center Study to Compare the Efficacy and Safety of 1PC002 and Atorvastatin in Taiwanese Patients With Hypercholesterolemia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Orient Pharma Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Orient Europharma Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Orient Pharma Co., Ltd.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      1PC002 is a newly developed synthetic and highly potent HMG-CoA reductase inhibitor. Its&#xD;
      active compound, pitavastatin has recently been approved by US FDA for indications of primary&#xD;
      hypercholesterolemia and combined dyslipidaemia. It exhibits unique pharmacokinetic&#xD;
      properties. Unlike atorvastatin which is metabolized by CYP3A4, metabolism of 1PC002 does not&#xD;
      depend on CYP3A4. This multi-center study is conducted to confirm the efficacy and safety of&#xD;
      1PC002 administered for 12 weeks is non-inferior to atorvastatin.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective, active-controlled, double-blind, randomized, parallel, and&#xD;
      multi-center study. To target 150 evaluable subjects, approximately 200 Taiwanese patients&#xD;
      with primary hypercholesterolemia or combined dyslipidemia will be enrolled in this study.&#xD;
&#xD;
      After providing the written inform consent, patients will undergo a complete physical&#xD;
      examination, vital sign (brachial BP / HR), medical history, and lab assessment, including&#xD;
      fasting serum LDL-C, TC, HDL-C, TG, and non-HDL. They should not take any hypolipidemic drugs&#xD;
      for at least 4 weeks prior to initiation of study treatment. All eligible subjects will be&#xD;
      randomized into 2 groups in a 1:1 ratio to receive either 2 mg 1PC002 or 10 mg atorvastatin&#xD;
      once daily for 12 weeks.&#xD;
&#xD;
        -  Study Group: 1PC002 1 cap. q.d. p.o.&#xD;
&#xD;
        -  Control Group: Atorvastatin 1 cap. q.d. p.o.&#xD;
&#xD;
      After entering the baseline visit, lipid profiles (including fasting serum LDL-C, TC, HDL-C,&#xD;
      TG, non-HDL, Apo A1, Apo B and Apo B / Apo A1 ratio), hs-CRP, eGFR, spot urinary albumin /&#xD;
      creatinine ratio (ACR) and central BP values will be obtained at baseline, Week 4 and Week 12&#xD;
      for evaluating the effectiveness of study drugs and for any possible changes in laboratory&#xD;
      data. Non-HDL value will be calculated by subtracting HDL-C from TC. Moreover, serum Cystatin&#xD;
      C, another biomarker of renal function, will also be assessed at baseline and Week 12.&#xD;
&#xD;
      For monitoring the safety, biochemical and hematological assessment will be performed at&#xD;
      baseline, Week 4 and 12. Additional liver function and CK test will be conducted at Week 8.&#xD;
      The occurring AE(s) and SAE will be followed until resolution or the event is considered&#xD;
      stable.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2011</start_date>
  <completion_date type="Actual">November 2012</completion_date>
  <primary_completion_date type="Actual">September 2012</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>The Percentage Change From Baseline in LDL-C Level at Week 12.</measure>
    <time_frame>12 weeks</time_frame>
    <description>The study aimed to test that the efficacy of 1PC002 group was non-inferior to Atorvastatin group in percent change from baseline of LDL-C level at Week 12.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>LDL-C</measure>
    <time_frame>week 4</time_frame>
    <description>Percent change from baseline in LDL-C level at Week 4</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HDL-C</measure>
    <time_frame>week 4</time_frame>
    <description>Percent change from baseline in HDL-C level at Week 4</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Triglyceride</measure>
    <time_frame>week 4</time_frame>
    <description>Percent change from baseline in TG level at Week 4</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">202</enrollment>
  <condition>Hypercholesterolemia</condition>
  <arm_group>
    <arm_group_label>1PC002</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>2 mg 1PC002 once daily for 12 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Lipitor</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>10 mg atorvastatin once daily for 12 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>1PC002</intervention_name>
    <description>Subjects should be instructed to take 1 capsule of study drug (1PC002 or atorvastatin) orally once a day, with or without food. Administration before bedtime or at regular time-interval is recommended.</description>
    <arm_group_label>1PC002</arm_group_label>
    <other_name>Pitavastatin</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lipitor</intervention_name>
    <description>Subjects should be instructed to take 1 capsule of study drug (1PC002 or atorvastatin) orally once a day, with or without food. Administration before bedtime or at regular time-interval is recommended.</description>
    <arm_group_label>Lipitor</arm_group_label>
    <other_name>Atorvastatin</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Females or males aged between 20 and 80 years.&#xD;
&#xD;
          2. Subjects who meet All of the following diagnosis at screening visit:&#xD;
&#xD;
               -  Primary hypercholesterolemia or combined dyslipidemia&#xD;
&#xD;
               -  TC ≥ 220 mg/dL or LDL-C ≥ 130 mg/dL&#xD;
&#xD;
               -  TG &lt; 400 mg/dL&#xD;
&#xD;
          3. Subjects who is willing and able to provide ICF.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Females who are pregnant, breast-feeding or intent to be pregnant during study period,&#xD;
             or those of childbearing potential not using effective contraception.&#xD;
&#xD;
          2. Subject with documented homozygous familial hypercholesterolemia.&#xD;
&#xD;
          3. Subject with documented HIV.&#xD;
&#xD;
          4. Subject with documented hypothyroidism and inadequate treatment judged by&#xD;
             investigator.&#xD;
&#xD;
          5. Subjects with unstable cardiovascular disease (CVD) prior to randomization.&#xD;
&#xD;
          6. Subjects with hepatic or biliary disorders, such as acute hepatitis, acute&#xD;
             exacerbation of chronic hepatitis, liver cirrhosis, liver cancer and jaundice.&#xD;
&#xD;
          7. Any condition which might significantly alter the absorption, distribution,&#xD;
             metabolism, or excretion of study drugs.&#xD;
&#xD;
          8. Subjects with the following lab data at screening visit:&#xD;
&#xD;
               -  serum creatine kinase (CK) &gt; 5 x upper limit of normal (ULN)&#xD;
&#xD;
               -  ALT or AST of &gt; 3 x ULN&#xD;
&#xD;
               -  serum creatinine ≥ 1.5 mg/dL&#xD;
&#xD;
               -  HbA1c &gt; 8.0%&#xD;
&#xD;
          9. Subject with the following past histories:&#xD;
&#xD;
               -  hypersensitivity to statins or any other ingredients of study drugs&#xD;
&#xD;
               -  resistant to statins treatment&#xD;
&#xD;
         10. Use of any lipid-lowering agents within 4 weeks prior to the initiation of study&#xD;
             treatment.&#xD;
&#xD;
         11. Use of any investigational product within 4 weeks prior to screening.&#xD;
&#xD;
         12. Any unstable concomitant disease or clinical condition, including the presence of&#xD;
             laboratory abnormalities, which places the subject at unacceptable risk to participate&#xD;
             in the study or confounds the ability to interpret data from the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Chiau-Suong Liau</last_name>
    <role>Principal Investigator</role>
    <affiliation>Buddhist Taipei TzuChi General Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ming-Shien Wen</last_name>
    <role>Principal Investigator</role>
    <affiliation>Chang Gung Medical Foundation- LinKuo Branch</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Wen-Pin Huang</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cheng-Hsin General Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Dee Pei</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cardinal Tien Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Wei-Shiang Lin</last_name>
    <role>Principal Investigator</role>
    <affiliation>Tri-Service General Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Huey-Herng Sheu</last_name>
    <role>Principal Investigator</role>
    <affiliation>Taichung Veterans General Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Chen-Huan Chen</last_name>
    <role>Principal Investigator</role>
    <affiliation>Taipei Veterans General Hospital, Taiwan</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ju-Chi Liu</last_name>
    <role>Principal Investigator</role>
    <affiliation>Taipei Medical University Shuang Ho Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Buddhist Taipei TzuChi General Hospital</name>
      <address>
        <city>New Taipei City</city>
        <zip>23142</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cardinal Tien Hospital</name>
      <address>
        <city>New Taipei City</city>
        <zip>231</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Taipei Medical University - Shuang Ho Hospital</name>
      <address>
        <city>New Taipei City</city>
        <zip>23561</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Taichung Veterans General Hospital</name>
      <address>
        <city>Taichung City</city>
        <zip>40705</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Taipei Veterans General Hospital</name>
      <address>
        <city>Taipei City</city>
        <zip>11217</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cheng Hsin General Hospital</name>
      <address>
        <city>Taipei City</city>
        <zip>112</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tri-Service General Hospital</name>
      <address>
        <city>Taipei City</city>
        <zip>114</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chang Gung Medical Foundation- LinKuo Branch</name>
      <address>
        <city>Taoyuan City</city>
        <zip>333</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>October 16, 2012</study_first_submitted>
  <study_first_submitted_qc>October 16, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 18, 2012</study_first_posted>
  <results_first_submitted>November 30, 2021</results_first_submitted>
  <results_first_submitted_qc>August 26, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">July 17, 2023</results_first_posted>
  <last_update_submitted>August 26, 2022</last_update_submitted>
  <last_update_submitted_qc>August 26, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 17, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>HMG-CoA reductase inhibitors</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypercholesterolemia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Atorvastatin</mesh_term>
    <mesh_term>Pitavastatin</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>1PC002</title>
          <description>2 mg 1PC002 once daily for 12 weeks.&#xD;
1PC002: Subjects should be instructed to take 1 capsule of study drug (1PC002 or atorvastatin) orally once a day, with or without food. Administration before bedtime or at regular time-interval is recommended.</description>
        </group>
        <group group_id="P2">
          <title>Lipitor</title>
          <description>10 mg atorvastatin once daily for 12 weeks.&#xD;
Lipitor: Subjects should be instructed to take 1 capsule of study drug (1PC002 or atorvastatin) orally once a day, with or without food. Administration before bedtime or at regular time-interval is recommended.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="103"/>
                <participants group_id="P2" count="99"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="87"/>
                <participants group_id="P2" count="81"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="16"/>
                <participants group_id="P2" count="18"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>1PC002</title>
          <description>2 mg 1PC002 once daily for 12 weeks.&#xD;
1PC002: Subjects should be instructed to take 1 capsule of study drug (1PC002 or atorvastatin) orally once a day, with or without food. Administration before bedtime or at regular time-interval is recommended.</description>
        </group>
        <group group_id="B2">
          <title>Lipitor</title>
          <description>10 mg atorvastatin once daily for 12 weeks.&#xD;
Lipitor: Subjects should be instructed to take 1 capsule of study drug (1PC002 or atorvastatin) orally once a day, with or without food. Administration before bedtime or at regular time-interval is recommended.</description>
        </group>
        <group group_id="B3">
          <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="103"/>
            <count group_id="B2" value="99"/>
            <count group_id="B3" value="202"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="87"/>
                    <measurement group_id="B2" value="93"/>
                    <measurement group_id="B3" value="180"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <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="55.36" spread="10.50"/>
                    <measurement group_id="B2" value="57.90" spread="8.80"/>
                    <measurement group_id="B3" value="56.60" spread="9.76"/>
                  </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="60"/>
                    <measurement group_id="B2" value="57"/>
                    <measurement group_id="B3" value="117"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="43"/>
                    <measurement group_id="B2" value="42"/>
                    <measurement group_id="B3" value="85"/>
                  </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_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="103"/>
                    <measurement group_id="B2" value="99"/>
                    <measurement group_id="B3" value="202"/>
                  </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_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Taiwan</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="103."/>
                    <measurement group_id="B2" value="99"/>
                    <measurement group_id="B3" value="202"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>The Percentage Change From Baseline in LDL-C Level at Week 12.</title>
        <description>The study aimed to test that the efficacy of 1PC002 group was non-inferior to Atorvastatin group in percent change from baseline of LDL-C level at Week 12.</description>
        <time_frame>12 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Lipitor</title>
            <description>10 mg atorvastatin once daily for 12 weeks.&#xD;
Lipitor: Subjects should be instructed to take 1 capsule of study drug (1PC002 or atorvastatin) orally once a day, with or without food. Administration before bedtime or at regular time-interval is recommended.</description>
          </group>
          <group group_id="O2">
            <title>1PC002</title>
            <description>2 mg 1PC002 once daily for 12 weeks.&#xD;
1PC002: Subjects should be instructed to take 1 capsule of study drug (1PC002 or atorvastatin) orally once a day, with or without food. Administration before bedtime or at regular time-interval is recommended.</description>
          </group>
        </group_list>
        <measure>
          <title>The Percentage Change From Baseline in LDL-C Level at Week 12.</title>
          <description>The study aimed to test that the efficacy of 1PC002 group was non-inferior to Atorvastatin group in percent change from baseline of LDL-C level at Week 12.</description>
          <units>Percent change from baseline</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="94"/>
                <count group_id="O2" value="100"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-42.89" spread="12.80"/>
                    <measurement group_id="O2" value="-37.43" spread="17.97"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>LDL-C</title>
        <description>Percent change from baseline in LDL-C level at Week 4</description>
        <time_frame>week 4</time_frame>
        <population>ITT population had been analysis</population>
        <group_list>
          <group group_id="O1">
            <title>1PC002</title>
            <description>2 mg 1PC002 once daily for 12 weeks.&#xD;
1PC002: Subjects should be instructed to take 1 capsule of study drug (1PC002 or atorvastatin) orally once a day, with or without food. Administration before bedtime or at regular time-interval is recommended.</description>
          </group>
          <group group_id="O2">
            <title>Lipitor</title>
            <description>10 mg atorvastatin once daily for 12 weeks.&#xD;
Lipitor: Subjects should be instructed to take 1 capsule of study drug (1PC002 or atorvastatin) orally once a day, with or without food. Administration before bedtime or at regular time-interval is recommended.</description>
          </group>
        </group_list>
        <measure>
          <title>LDL-C</title>
          <description>Percent change from baseline in LDL-C level at Week 4</description>
          <population>ITT population had been analysis</population>
          <units>Percent change from baseline</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="96"/>
                <count group_id="O2" value="90"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-39.01" spread="13.04"/>
                    <measurement group_id="O2" value="-40.07" spread="12.18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>HDL-C</title>
        <description>Percent change from baseline in HDL-C level at Week 4</description>
        <time_frame>week 4</time_frame>
        <population>ITT</population>
        <group_list>
          <group group_id="O1">
            <title>1PC002</title>
            <description>2 mg 1PC002 once daily for 12 weeks.&#xD;
1PC002: Subjects should be instructed to take 1 capsule of study drug (1PC002 or atorvastatin) orally once a day, with or without food. Administration before bedtime or at regular time-interval is recommended.</description>
          </group>
          <group group_id="O2">
            <title>Lipitor</title>
            <description>10 mg atorvastatin once daily for 12 weeks.&#xD;
Lipitor: Subjects should be instructed to take 1 capsule of study drug (1PC002 or atorvastatin) orally once a day, with or without food. Administration before bedtime or at regular time-interval is recommended.</description>
          </group>
        </group_list>
        <measure>
          <title>HDL-C</title>
          <description>Percent change from baseline in HDL-C level at Week 4</description>
          <population>ITT</population>
          <units>Percent change from baseline</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="96"/>
                <count group_id="O2" value="90"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.06" spread="10.49"/>
                    <measurement group_id="O2" value="-1.64" spread="11.01"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Triglyceride</title>
        <description>Percent change from baseline in TG level at Week 4</description>
        <time_frame>week 4</time_frame>
        <population>ITT</population>
        <group_list>
          <group group_id="O1">
            <title>1PC002</title>
            <description>2 mg 1PC002 once daily for 12 weeks.&#xD;
1PC002: Subjects should be instructed to take 1 capsule of study drug (1PC002 or atorvastatin) orally once a day, with or without food. Administration before bedtime or at regular time-interval is recommended.</description>
          </group>
          <group group_id="O2">
            <title>Lipitor</title>
            <description>10 mg atorvastatin once daily for 12 weeks.&#xD;
Lipitor: Subjects should be instructed to take 1 capsule of study drug (1PC002 or atorvastatin) orally once a day, with or without food. Administration before bedtime or at regular time-interval is recommended.</description>
          </group>
        </group_list>
        <measure>
          <title>Triglyceride</title>
          <description>Percent change from baseline in TG level at Week 4</description>
          <population>ITT</population>
          <units>Percent change from baseline</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="96"/>
                <count group_id="O2" value="90"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-18.75" spread="26.9"/>
                    <measurement group_id="O2" value="-19.5" spread="25.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>12-16 weeks</time_frame>
      <group_list>
        <group group_id="E1">
          <title>1PC002</title>
          <description>To summary the total adverse event of 1PC002.</description>
        </group>
        <group group_id="E2">
          <title>Lipitor</title>
          <description>To summary the total adverse event of Lipitor.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA (Version14.1)</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="3" subjects_at_risk="103"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="99"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Congestive heart failure</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="103"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="99"/>
              </event>
              <event>
                <sub_title>Rheumatic heart disease with Moderate Calcified Mitral stenosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="103"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="99"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Cellulitis,right hand</sub_title>
                <assessment>Non-systematic Assessment</assessment>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="103"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="99"/>
              </event>
              <event>
                <sub_title>Urinary tract infections</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="103"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="99"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA (Version14.1)</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="58" subjects_at_risk="103"/>
                <counts group_id="E2" subjects_affected="55" subjects_at_risk="99"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Iron deficiency anaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="103"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="99"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Arrhythmia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="103"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="99"/>
              </event>
              <event>
                <sub_title>Cardiac failure acute</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="103"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="99"/>
              </event>
              <event>
                <sub_title>Cardiac failure congestive</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="103"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="99"/>
              </event>
              <event>
                <sub_title>Mitral valve stenosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="103"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="99"/>
              </event>
              <event>
                <sub_title>Palpitations</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="103"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="99"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Congenital, familial and genetic disorders</title>
            <event_list>
              <event>
                <sub_title>Acute pulmonary oedema</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="103"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="99"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Vertigo</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="103"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="99"/>
              </event>
              <event>
                <sub_title>Lacrimation decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="103"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="99"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="103"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="99"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="103"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="99"/>
              </event>
              <event>
                <sub_title>Dental caries</sub_title>
                <assessment>Non-systematic Assessment</assessment>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="103"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="99"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="103"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="99"/>
              </event>
              <event>
                <sub_title>Gastrooesophageal reflux disease</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="103"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="99"/>
              </event>
              <event>
                <sub_title>Haemorrhoids</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="103"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="99"/>
              </event>
              <event>
                <sub_title>Mouth ulceration</sub_title>
                <assessment>Non-systematic Assessment</assessment>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="103"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="99"/>
              </event>
              <event>
                <sub_title>Rectal ulcer</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="103"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="99"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="103"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="99"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="103"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="99"/>
              </event>
              <event>
                <sub_title>Malaise</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="103"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="99"/>
              </event>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="103"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="99"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Hepatitis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="103"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="99"/>
              </event>
              <event>
                <sub_title>Hepatic function abnormal</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="103"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="99"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Acute sinusitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="103"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="99"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="103"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="99"/>
              </event>
              <event>
                <sub_title>Bronchopneumonia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="103"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="99"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="103"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="99"/>
              </event>
              <event>
                <sub_title>Cystitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="103"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="99"/>
              </event>
              <event>
                <sub_title>Hepatitis C</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="103"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="99"/>
              </event>
              <event>
                <sub_title>Hordeolum</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="103"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="99"/>
              </event>
              <event>
                <sub_title>Subcutaneous abscess</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="103"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="99"/>
              </event>
              <event>
                <sub_title>Tinea pedis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="103"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="99"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="103"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="99"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="103"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="99"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="103"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="99"/>
              </event>
              <event>
                <sub_title>Muscle strain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="103"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="99"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="103"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="99"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="103"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="99"/>
              </event>
              <event>
                <sub_title>Blood bilirubin increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="103"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="99"/>
              </event>
              <event>
                <sub_title>Blood creatine phosphokinase</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="103"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="99"/>
              </event>
              <event>
                <sub_title>Blood pressure increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="103"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="99"/>
              </event>
              <event>
                <sub_title>Blood urea increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="103"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="99"/>
              </event>
              <event>
                <sub_title>C-reactive protein abnormal</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="103"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="99"/>
              </event>
              <event>
                <sub_title>C-reactive protein increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="103"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="99"/>
              </event>
              <event>
                <sub_title>Gamma-glutamyltransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="103"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="99"/>
              </event>
              <event>
                <sub_title>Glycosylated haemoglobin increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="103"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="99"/>
              </event>
              <event>
                <sub_title>Hepatic enzyme increased</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="103"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="99"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="103"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="99"/>
              </event>
              <event>
                <sub_title>Liver function test abnormal</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="103"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="99"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Diabetes mellitus</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="103"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="99"/>
              </event>
              <event>
                <sub_title>Glucose tolerance impaired</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="103"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="99"/>
              </event>
              <event>
                <sub_title>Gout</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="103"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="99"/>
              </event>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="103"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="99"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="103"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="99"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="103"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="99"/>
              </event>
              <event>
                <sub_title>Fasciitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="103"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="99"/>
              </event>
              <event>
                <sub_title>Flank pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="103"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="99"/>
              </event>
              <event>
                <sub_title>Muscle twitching</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="103"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="99"/>
              </event>
              <event>
                <sub_title>Musculoskeletal stiffness</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="103"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="99"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="103"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="99"/>
              </event>
              <event>
                <sub_title>Myositis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="103"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="99"/>
              </event>
              <event>
                <sub_title>Spinal osteoarthritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="103"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="99"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Carpal tunnel syndrome</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="103"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="99"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="103"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="99"/>
              </event>
              <event>
                <sub_title>Dizziness postural</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="103"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="99"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="103"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="99"/>
              </event>
              <event>
                <sub_title>Hypoaesthesia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="103"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="99"/>
              </event>
              <event>
                <sub_title>Lacunar infarction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="103"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="99"/>
              </event>
              <event>
                <sub_title>Post herpetic neuralgia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="103"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="99"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="103"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="99"/>
              </event>
              <event>
                <sub_title>Sleep disorder</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="103"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="99"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Microalbuminuria</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="103"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="99"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="103"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="99"/>
              </event>
              <event>
                <sub_title>Rhinitis allergic</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="103"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="99"/>
              </event>
              <event>
                <sub_title>Rhinorrhoea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="103"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="99"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Dermatitis allergic</sub_title>
                <assessment>Non-systematic Assessment</assessment>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="103"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="99"/>
              </event>
              <event>
                <sub_title>Eczema</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="103"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="99"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="103"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="99"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="103"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="99"/>
              </event>
              <event>
                <sub_title>Skin exfoliation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="103"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="99"/>
              </event>
              <event>
                <sub_title>Swelling face</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="103"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="99"/>
              </event>
              <event>
                <sub_title>Urticaria</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="103"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="99"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="103"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="99"/>
              </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 less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Vivian Lu</name_or_title>
      <organization>Orient Europharma Co., Ltd.</organization>
      <phone>+886-2-2755-4881 ext 2958</phone>
      <email>Vivian.Lu@oppharma.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/NCT01710007
org study id: QCR10022
nct id: NCT01710007
lead sponsor: 
collaborator: 
has dmc: No
1PC002 is a newly developed synthetic and highly potent HMG-CoA reductase inhibitor. Its
      active compound, pitavastatin has recently been approved by US FDA for indications of primary
      hypercholesterolemia and combined dyslipidaemia. It exhibits unique pharmacokinetic
      properties. Unlike atorvastatin which is metabolized by CYP3A4, metabolism of 1PC002 does not
      depend on CYP3A4. This multi-center study is conducted to confirm the efficacy and safety of
      1PC002 administered for 12 weeks is non-inferior to atorvastatin.
This is a prospective, active-controlled, double-blind, randomized, parallel, and
      multi-center study. To target 150 evaluable subjects, approximately 200 Taiwanese patients
      with primary hypercholesterolemia or combined dyslipidemia will be enrolled in this study.

      After providing the written inform consent, patients will undergo a complete physical
      examination, vital sign (brachial BP / HR), medical history, and lab assessment, including
      fasting serum LDL-C, TC, HDL-C, TG, and non-HDL. They should not take any hypolipidemic drugs
      for at least 4 weeks prior to initiation of study treatment. All eligible subjects will be
      randomized into 2 groups in a 1:1 ratio to receive either 2 mg 1PC002 or 10 mg atorvastatin
      once daily for 12 weeks.

        -  Study Group: 1PC002 1 cap. q.d. p.o.

        -  Control Group: Atorvastatin 1 cap. q.d. p.o.

      After entering the baseline visit, lipid profiles (including fasting serum LDL-C, TC, HDL-C,
      TG, non-HDL, Apo A1, Apo B and Apo B / Apo A1 ratio), hs-CRP, eGFR, spot urinary albumin /
      creatinine ratio (ACR) and central BP values will be obtained at baseline, Week 4 and Week 12
      for evaluating the effectiveness of study drugs and for any possible changes in laboratory
      data. Non-HDL value will be calculated by subtracting HDL-C from TC. Moreover, serum Cystatin
      C, another biomarker of renal function, will also be assessed at baseline and Week 12.

      For monitoring the safety, biochemical and hematological assessment will be performed at
      baseline, Week 4 and 12. Additional liver function and CK test will be conducted at Week 8.
      The occurring AE(s) and SAE will be followed until resolution or the event is considered
      stable.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: The Percentage Change From Baseline in LDL-C Level at Week 12.
time frame: 12 weeks
description: The study aimed to test that the efficacy of 1PC002 group was non-inferior to Atorvastatin group in percent change from baseline of LDL-C level at Week 12.
measure: LDL-C
time frame: week 4
description: Percent change from baseline in LDL-C level at Week 4
measure: HDL-C
time frame: week 4
description: Percent change from baseline in HDL-C level at Week 4
measure: Triglyceride
time frame: week 4
description: Percent change from baseline in TG level at Week 4
arm group label: 1PC002
arm group type: Experimental
description: 2 mg 1PC002 once daily for 12 weeks.
arm group label: Lipitor
arm group type: Active Comparator
description: 10 mg atorvastatin once daily for 12 weeks.
intervention type: Drug
intervention name: 1PC002
description: Subjects should be instructed to take 1 capsule of study drug (1PC002 or atorvastatin) orally once a day, with or without food. Administration before bedtime or at regular time-interval is recommended.
arm group label: 1PC002
other name: Pitavastatin
intervention type: Drug
intervention name: Lipitor
description: Subjects should be instructed to take 1 capsule of study drug (1PC002 or atorvastatin) orally once a day, with or without food. Administration before bedtime or at regular time-interval is recommended.
arm group label: Lipitor
other name: Atorvastatin
criteria: 
gender: All
minimum age: 20 Years
maximum age: 80 Years
healthy volunteers: No
last name: Chiau-Suong Liau
role: Principal Investigator
affiliation: Buddhist Taipei TzuChi General Hospital
last name: Ming-Shien Wen
role: Principal Investigator
affiliation: Chang Gung Medical Foundation- LinKuo Branch
last name: Wen-Pin Huang
role: Principal Investigator
affiliation: Cheng-Hsin General Hospital
last name: Dee Pei
role: Principal Investigator
affiliation: Cardinal Tien Hospital
last name: Wei-Shiang Lin
role: Principal Investigator
affiliation: Tri-Service General Hospital
last name: Huey-Herng Sheu
role: Principal Investigator
affiliation: Taichung Veterans General Hospital
last name: Chen-Huan Chen
role: Principal Investigator
affiliation: Taipei Veterans General Hospital, Taiwan
last name: Ju-Chi Liu
role: Principal Investigator
affiliation: Taipei Medical University Shuang Ho Hospital
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Taiwan
responsible party type: Sponsor
mesh term: Hypercholesterolemia
mesh term: Atorvastatin
mesh term: Pitavastatin
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 