<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/NCT02184858</url>
  </required_header>
  <id_info>
    <org_study_id>EC project number: 2012/498</org_study_id>
    <secondary_id>2012-002927-14</secondary_id>
    <nct_id>NCT02184858</nct_id>
  </id_info>
  <brief_title>Dose Titration of Lisinopril in Children Aged 1 to 18 Years With Primary or Secondary Hypertension</brief_title>
  <acronym>Lisi-ped</acronym>
  <official_title>Dose Titration Study to Test Efficacy and Safety of Lisinopril in Children Aged 1 to 18 Years With Primary or Secondary Hypertension.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Ghent</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Ghent</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This open label 4 month study will evaluate efficacy (blood pressure lowering effects) and&#xD;
      safety of lisinopril in children 1-18y whose parents grant permission to participate. This&#xD;
      dose titration study is being conducted to support the statement that personalized titration&#xD;
      of lisinopril (based on blood pressure and renin-aldosterone ratio) can increase patient&#xD;
      response.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 25, 2014</start_date>
  <completion_date type="Actual">September 17, 2018</completion_date>
  <primary_completion_date type="Actual">May 8, 2017</primary_completion_date>
  <phase>Phase 4</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>blood pressure</measure>
    <time_frame>4 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Serum concentrations will be assessed after every dose titration</measure>
    <time_frame>trough and 4 hours post dosing</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse events with assessment of specific blood parameters</measure>
    <time_frame>up to 4 months</time_frame>
    <description>sodium, potassium, creatinine, bilirubin, aspartate transaminase/alanine transaminase (AST/ALT) and blood count</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">13</enrollment>
  <condition>Primary Hypertension</condition>
  <condition>Secondary Hypertension</condition>
  <arm_group>
    <arm_group_label>lisinopril</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>dose titration of investigational product (lisinopril) dependant on blood pressure, levels of renin and aldosterone and on adverse events.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>lisinopril, ACE-inhibitor</intervention_name>
    <description>Lisinopril 0.1mg/kg/d, titration with + 0.1mg/kg/d. Max; daily dose: 0.4mg/kg. CAVE: dose reduction in case of renal impairment</description>
    <arm_group_label>lisinopril</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Parental consent must be granted&#xD;
&#xD;
          -  Patient age: 1y - 18 y&#xD;
&#xD;
          -  Documented diagnosis of hypertension as defined in the National Heart, Lung and Blood&#xD;
             Institute (NHBLI) 4th report, 2004&#xD;
&#xD;
          -  No reversible cause found on diagnostic work-up for hypertension&#xD;
&#xD;
          -  Children older than 6y: 24h blood pressure monitoring confirms the diagnosis of&#xD;
             hypertension&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Sexually active girls can only be included in the trial if they use an adequate form&#xD;
             of birth control; during and until 30 days after ending the trial&#xD;
&#xD;
          -  Following abnormal laboratory values: Hyperkaliemia (serum potassium &gt; 5.3mmol/L);&#xD;
             Anemia (hemoglobin &lt; 8g/dL); AST or ALT &gt; 3 times the upper limit of reference range;&#xD;
             Total bilirubin &gt; 3 times the upper limit of reference range&#xD;
&#xD;
          -  Abnormalities of the oral cavity that can influence intake of medication&#xD;
&#xD;
          -  Known sensitivity to ACE-inhibitors&#xD;
&#xD;
          -  Known lactose intolerance&#xD;
&#xD;
          -  History of angioedema&#xD;
&#xD;
          -  Unilateral or bilateral stenosis of the renal artery&#xD;
&#xD;
          -  Diagnosis of heart failure (NYHA Class II-IV)&#xD;
&#xD;
          -  History of coarctation of the aorta&#xD;
&#xD;
          -  Current treatment with: other drugs influencing the renin-angiotensin-aldosterone&#xD;
             system; lithium; potassium sparing diuretics; non-steroidal anti-inflammatory drugs;&#xD;
             aspirin; oral antidiabetic medication&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Year</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Johan Vande Walle, PhD MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ghent University, Department of Pediatrics and Medical Genetics</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Pediatrics and Medical Genetics</name>
      <address>
        <city>Ghent</city>
        <zip>9000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>September 2018</verification_date>
  <study_first_submitted>June 10, 2014</study_first_submitted>
  <study_first_submitted_qc>July 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 9, 2014</study_first_posted>
  <last_update_submitted>September 18, 2018</last_update_submitted>
  <last_update_submitted_qc>September 18, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">September 20, 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>Neoplasm Metastasis</mesh_term>
    <mesh_term>Hypertension</mesh_term>
    <mesh_term>Essential Hypertension</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lisinopril</mesh_term>
    <mesh_term>Angiotensin-Converting Enzyme Inhibitors</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/NCT02184858
org study id: EC project number: 2012/498
secondary id: 2012-002927-14
nct id: NCT02184858
lead sponsor: 
has dmc: Yes
This open label 4 month study will evaluate efficacy (blood pressure lowering effects) and
      safety of lisinopril in children 1-18y whose parents grant permission to participate. This
      dose titration study is being conducted to support the statement that personalized titration
      of lisinopril (based on blood pressure and renin-aldosterone ratio) can increase patient
      response.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: blood pressure
time frame: 4 months
measure: Serum concentrations will be assessed after every dose titration
time frame: trough and 4 hours post dosing
measure: Adverse events with assessment of specific blood parameters
time frame: up to 4 months
description: sodium, potassium, creatinine, bilirubin, aspartate transaminase/alanine transaminase (AST/ALT) and blood count
arm group label: lisinopril
arm group type: Experimental
description: dose titration of investigational product (lisinopril) dependant on blood pressure, levels of renin and aldosterone and on adverse events.
intervention type: Drug
intervention name: lisinopril, ACE-inhibitor
description: Lisinopril 0.1mg/kg/d, titration with + 0.1mg/kg/d. Max; daily dose: 0.4mg/kg. CAVE: dose reduction in case of renal impairment
arm group label: lisinopril
criteria: 
gender: All
minimum age: 1 Year
maximum age: 18 Years
healthy volunteers: No
last name: Johan Vande Walle, PhD MD
role: Principal Investigator
affiliation: Ghent University, Department of Pediatrics and Medical Genetics
facility: 
country: Belgium
responsible party type: Sponsor
mesh term: Neoplasm Metastasis
mesh term: Hypertension
mesh term: Essential Hypertension
mesh term: Lisinopril
mesh term: Angiotensin-Converting Enzyme Inhibitors