<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/NCT03255226</url>
  </required_header>
  <id_info>
    <org_study_id>156-102-00123</org_study_id>
    <secondary_id>JapicCTI-173674</secondary_id>
    <nct_id>NCT03255226</nct_id>
  </id_info>
  <brief_title>Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics Study of Tolvaptan in Pediatric Congestive Heart Failure (CHF) Patients With Volume Overload</brief_title>
  <official_title>A Multicenter, Open-labeled, Dose-defining Trial to Investigate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Tolvaptan in Pediatric Congestive Heart Failure (CHF) Patients With Volume Overload</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Otsuka Pharmaceutical Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Otsuka Pharmaceutical Co., Ltd.</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>
      To determine the efficacy, safety, and dose and regimen of tolvaptan in pediatric CHF&#xD;
      patients with volume overload&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">February 13, 2018</start_date>
  <completion_date type="Anticipated">June 2021</completion_date>
  <primary_completion_date type="Anticipated">June 2021</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>Ratio of subject whom the body weight is decreased from baseline</measure>
    <time_frame>-day1, day4</time_frame>
    <description>Ratio of subject whom the body weight is decreased by 1.7% or more from the baseline.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change the amount of daily urine volume from baseline</measure>
    <time_frame>-day1 to day9</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Pediatric Congestive Heart Failure (CHF) Patients With Volume Overload</condition>
  <arm_group>
    <arm_group_label>Tolvaptan</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Tolvaptan 1% granules or tolvaptan 15 mg tablet with water once daily.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tolvaptan</intervention_name>
    <description>Tolvaptan 1% granules or tolvaptan 15 mg tablet with water once daily.</description>
    <arm_group_label>Tolvaptan</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with volume overload despite having received any of the following diuretic&#xD;
             therapies in whom sufficient effects cannot be expected even if the dose of the&#xD;
             diuretics is increased or in whom the investigator or subinvestigator judges that&#xD;
             increasing the dose of the diuretics is difficult due to concerns regarding&#xD;
             electrolyte abnormalities or other side effects&#xD;
&#xD;
               -  Furosemide (oral administration) ≥0.5 mg/kg/day. Azosemide 30 mg and torasemide 4&#xD;
                  mg will be calculated as equivalent to furosemide 20 mg.&#xD;
&#xD;
               -  Hydrochlorothiazide ≥2 mg/kg/day&#xD;
&#xD;
               -  Trichlormethiazide ≥0.05 mg/kg/day&#xD;
&#xD;
               -  Spironolactone ≥ 1 mg/kg/day&#xD;
&#xD;
          -  Patients capable of complaining of thirst. Patients unable to complain of thirst due&#xD;
             to their young age can also be enrolled in the trial if strict management of fluid&#xD;
             intake and excretion is conducted. However, even if such fluid management is possible,&#xD;
             the patients in whom the investigator or subinvestigator judges that tolvaptan cannot&#xD;
             be safely administered are to be excluded&#xD;
&#xD;
          -  Patients who can be hospitalized from at least 3 days before start of tolvaptan&#xD;
             administration until 2 days after the final administration.&#xD;
&#xD;
        others&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients whose volume overload status shows improvement during the screening period or&#xD;
             pretreatment observation period&#xD;
&#xD;
          -  Patients who are unable to drink fluid (including patients who are unable to sense&#xD;
             thirst)&#xD;
&#xD;
          -  Patients whose circulatory blood flow is suspected to be decreased&#xD;
&#xD;
          -  Patients with an assisted circulation apparatus&#xD;
&#xD;
          -  Patients with hypernatremia (serum or blood sodium concentration exceeding 145 mEq/L)&#xD;
             others&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Months</minimum_age>
    <maximum_age>14 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hiroaki Ono, Mr</last_name>
    <role>Study Director</role>
    <affiliation>Otsuka Pharmaceutical Co., Ltd.</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Drug Information Center</last_name>
    <phone>+81-3-6361-7314</phone>
  </overall_contact>
  <location>
    <facility>
      <address>
        <city>Kanto Region</city>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>August 18, 2017</study_first_submitted>
  <study_first_submitted_qc>August 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 21, 2017</study_first_posted>
  <last_update_submitted>January 11, 2021</last_update_submitted>
  <last_update_submitted_qc>January 11, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 13, 2021</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>Heart Failure</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tolvaptan</mesh_term>
  </intervention_browse>
  <pending_results>
    <submitted>June 27, 2022</submitted>
    <returned>May 9, 2023</returned>
    <submitted>May 12, 2023</submitted>
    <submission_canceled>May 15, 2023</submission_canceled>
    <submitted>May 15, 2023</submitted>
  </pending_results>
  <!-- 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/NCT03255226
org study id: 156-102-00123
secondary id: JapicCTI-173674
nct id: NCT03255226
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To determine the efficacy, safety, and dose and regimen of tolvaptan in pediatric CHF
      patients with volume overload
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Ratio of subject whom the body weight is decreased from baseline
time frame: -day1, day4
description: Ratio of subject whom the body weight is decreased by 1.7% or more from the baseline.
measure: Change the amount of daily urine volume from baseline
time frame: -day1 to day9
arm group label: Tolvaptan
arm group type: Experimental
description: Tolvaptan 1% granules or tolvaptan 15 mg tablet with water once daily.
intervention type: Drug
intervention name: Tolvaptan
description: Tolvaptan 1% granules or tolvaptan 15 mg tablet with water once daily.
arm group label: Tolvaptan
criteria: 
gender: All
minimum age: 6 Months
maximum age: 14 Years
healthy volunteers: No
last name: Hiroaki Ono, Mr
role: Study Director
affiliation: Otsuka Pharmaceutical Co., Ltd.
last name: Drug Information Center
phone: +81-3-6361-7314
facility: 
status: Recruiting
country: Japan
responsible party type: Sponsor
mesh term: Heart Failure
mesh term: Tolvaptan
submitted: June 27, 2022
returned: May 9, 2023
submitted: May 12, 2023
submission canceled: May 15, 2023
submitted: May 15, 2023