<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/NCT04402112</url>
  </required_header>
  <id_info>
    <org_study_id>JWP-PTV-712</org_study_id>
    <nct_id>NCT04402112</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety of Pitavastatin in a Real-world Setting</brief_title>
  <acronym>PROOF</acronym>
  <official_title>Efficacy and Safety of Pitavastatin in a Real-wOrld Setting: Observational Study Evaluating saFety in Patient With Pitavastatin for Lipid Lowering Therapy in Korea</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>JW Pharmaceutical</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>JW Pharmaceutical</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The prospective, observational, non-comparative trial in South Korea was designed to evaluate&#xD;
      the efficacy and safety of pitavastatin (Livalo) in clinical practice in 28,343 patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study was conducted in 893 facilities in Korea from 2 Apr 2012 to 1 Apr 2017. This study&#xD;
      was designed to administer 1mg, 2mg, or 4mg pitavastatin to patients with hyperlipidemia at&#xD;
      the age of 20 or older for at least 8 weeks.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 2, 2012</start_date>
  <completion_date type="Actual">August 1, 2017</completion_date>
  <primary_completion_date type="Actual">April 1, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Number of participants with adverse events as assessed by CTCAE v4.0</measure>
    <time_frame>At 8 weeks after administration of pitavastatin</time_frame>
    <description>Incidence of musculoskeletal-related adverse events and rhabdomyolysis</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall symptom satisfaction evaluation</measure>
    <time_frame>At 8 weeks after administration of pitavastatin</time_frame>
    <description>The investigating physician selects one of the followings according to medical judgment: Improvement, constant, exacerbation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in serum lipid profile before and after administration of pitavastatin</measure>
    <time_frame>At screening and after 8 weeks</time_frame>
    <description>Total cholesterol, LDL-cholesterol, HDL-cholesterol, Triglyceride</description>
  </secondary_outcome>
  <enrollment type="Actual">28343</enrollment>
  <condition>Hypercholesterolemia</condition>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Pitavastatin</intervention_name>
    <description>1mg, 2mg, or 4mg, Once a day, at least 8 weeks</description>
    <other_name>LIVALO</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients receiving Livalo tablets in clinical practice in South Korea&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients in need of statin treatment who are taking or are planning to take Livalo&#xD;
             tablets, or who are taking other statins or are planning to change to Livalo tablets.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with hypersensitivity to pitavastatin&#xD;
&#xD;
          -  Patients with active liver disease or untranslated transaminase levels Patients with a&#xD;
             constant rise in&#xD;
&#xD;
          -  Patients with severe liver failure or biliary obstruction and patients with&#xD;
             cholestasis&#xD;
&#xD;
          -  Patients who are receiving cyclosporine&#xD;
&#xD;
          -  Myopathy patients&#xD;
&#xD;
          -  Pregnant women or women of childbearing age and lactating women&#xD;
&#xD;
          -  Children&#xD;
&#xD;
          -  Patients with genetic problems, such as galactose intolerance, Lapp lactose deficiency&#xD;
             or glucose-galactose&#xD;
&#xD;
          -  Patients deemed inappropriate by the investigator&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sung-Rae Kim, MD,PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Catholic University of Korea</affiliation>
  </overall_official>
  <results_reference>
    <citation>Jeong IK, Kim SR. Efficacy and Safety of Pitavastatin in a Real-World Setting: Observational Study Evaluating SaFety in Patient Treated with Pitavastatin in Korea (PROOF Study). Endocrinol Metab (Seoul). 2020 Dec;35(4):882-891. doi: 10.3803/EnM.2020.723. Epub 2020 Dec 2.</citation>
    <PMID>33261312</PMID>
  </results_reference>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>April 27, 2020</study_first_submitted>
  <study_first_submitted_qc>May 20, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 26, 2020</study_first_posted>
  <last_update_submitted>April 14, 2021</last_update_submitted>
  <last_update_submitted_qc>April 14, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 19, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Pitavastatin</keyword>
  <keyword>LIVALO</keyword>
  <keyword>Safety data</keyword>
  <keyword>South Korea</keyword>
  <keyword>Large-scale prospective trial</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>Pitavastatin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04402112
org study id: JWP-PTV-712
nct id: NCT04402112
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
The prospective, observational, non-comparative trial in South Korea was designed to evaluate
      the efficacy and safety of pitavastatin (Livalo) in clinical practice in 28,343 patients.
This study was conducted in 893 facilities in Korea from 2 Apr 2012 to 1 Apr 2017. This study
      was designed to administer 1mg, 2mg, or 4mg pitavastatin to patients with hyperlipidemia at
      the age of 20 or older for at least 8 weeks.
observational model: Cohort
time perspective: Prospective
measure: Number of participants with adverse events as assessed by CTCAE v4.0
time frame: At 8 weeks after administration of pitavastatin
description: Incidence of musculoskeletal-related adverse events and rhabdomyolysis
measure: Overall symptom satisfaction evaluation
time frame: At 8 weeks after administration of pitavastatin
description: The investigating physician selects one of the followings according to medical judgment: Improvement, constant, exacerbation
measure: Change in serum lipid profile before and after administration of pitavastatin
time frame: At screening and after 8 weeks
description: Total cholesterol, LDL-cholesterol, HDL-cholesterol, Triglyceride
intervention type: Drug
intervention name: Pitavastatin
description: 1mg, 2mg, or 4mg, Once a day, at least 8 weeks
other name: LIVALO
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Sung-Rae Kim, MD,PhD
role: Principal Investigator
affiliation: The Catholic University of Korea
citation: Jeong IK, Kim SR. Efficacy and Safety of Pitavastatin in a Real-World Setting: Observational Study Evaluating SaFety in Patient Treated with Pitavastatin in Korea (PROOF Study). Endocrinol Metab (Seoul). 2020 Dec;35(4):882-891. doi: 10.3803/EnM.2020.723. Epub 2020 Dec 2.
PMID: 33261312
responsible party type: Sponsor
mesh term: Hypercholesterolemia
mesh term: Pitavastatin
sharing ipd: No