<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/NCT03006445</url>
  </required_header>
  <id_info>
    <org_study_id>FYU-981-010</org_study_id>
    <nct_id>NCT03006445</nct_id>
  </id_info>
  <brief_title>Study of FYU-981 in Hyperuricemia With or Without Gout</brief_title>
  <official_title>Official Title: Safety and Efficacy Evaluation Study of FYU-981 Long-term Administration for Hyperuricemia With or Without Gout (Phase III Study)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fuji Yakuhin Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Mochida Pharmaceutical Company, Ltd.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Fuji Yakuhin Co., Ltd.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is confirmatory investigation of safety and efficacy of FYU-981&#xD;
      administered orally to hyperuricemic patients with and without gout for 34 or 58 weeks by the&#xD;
      method of multicenter, open label and ascending dose regimen.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 2016</start_date>
  <completion_date type="Actual">October 24, 2018</completion_date>
  <primary_completion_date type="Actual">August 23, 2018</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percent reduction from baseline in serum urate level at the final visit</measure>
    <time_frame>34 or 58 weeks</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">330</enrollment>
  <condition>Hyperuricemia With or Without Gout</condition>
  <arm_group>
    <arm_group_label>FYU-981</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>FYU-981</intervention_name>
    <arm_group_label>FYU-981</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Hyperuricemic or gout patients&#xD;
&#xD;
          -  Serum urate level:&#xD;
&#xD;
        &gt;= 7.0mg/dL in patients with history of gout, or &gt;= 8.0mg/dL in patients with hypertension,&#xD;
        diabetes or metabolic syndrome, or &gt;= 9.0mg/dL&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Gouty arthritis within two weeks before start of study treatment&#xD;
&#xD;
          -  Secondary hyperuricemia&#xD;
&#xD;
          -  HbA1c: &gt;= 8.4%&#xD;
&#xD;
          -  Uric acid-overproduction type in the classification of hyperuricemia&#xD;
&#xD;
          -  History of, clinically significant cardiac, hematologic and hepatic disease&#xD;
&#xD;
          -  Kidney calculi or clinically significant urinary calculi&#xD;
&#xD;
          -  eGFR: &lt; 30mL/min/1.73m^2&#xD;
&#xD;
          -  Systolic blood pressure: &gt;= 180 mmHg&#xD;
&#xD;
          -  Diastolic blood pressure: &gt;= 110 mmHg&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <address>
        <city>Tokyo</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>December 28, 2016</study_first_submitted>
  <study_first_submitted_qc>December 29, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 30, 2016</study_first_posted>
  <last_update_submitted>December 4, 2018</last_update_submitted>
  <last_update_submitted_qc>December 4, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 6, 2018</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>Gout</mesh_term>
    <mesh_term>Hyperuricemia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dotinurad</mesh_term>
  </intervention_browse>
  <!-- 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/NCT03006445
org study id: FYU-981-010
nct id: NCT03006445
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this study is confirmatory investigation of safety and efficacy of FYU-981
      administered orally to hyperuricemic patients with and without gout for 34 or 58 weeks by the
      method of multicenter, open label and ascending dose regimen.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Percent reduction from baseline in serum urate level at the final visit
time frame: 34 or 58 weeks
arm group label: FYU-981
arm group type: Experimental
intervention type: Drug
intervention name: FYU-981
arm group label: FYU-981
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Japan
responsible party type: Sponsor
mesh term: Gout
mesh term: Hyperuricemia
mesh term: Dotinurad