<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/NCT02242344</url>
  </required_header>
  <id_info>
    <org_study_id>502.403</org_study_id>
    <nct_id>NCT02242344</nct_id>
  </id_info>
  <brief_title>Evaluation of the Safety, Efficacy and Pharmacokinetics of MICARDIS® (Telmisartan) in Children and Adolescents With Hypertension</brief_title>
  <official_title>A Prospective, Randomized, Double-blind, Placebo-controlled, Evaluation of the Safety, Efficacy and Pharmacokinetics of MICARDIS® (Telmisartan) in Children and Adolescents With Hypertension After Four Weeks of Treatment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boehringer Ingelheim</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boehringer Ingelheim</source>
  <brief_summary>
    <textblock>
      Study to assess the blood pressure lowering effects of two doses of telmisartan over a&#xD;
      four-week treatment period; to determine potentially effective doses for pediatric patients&#xD;
      for future studies; to assess the safety and tolerability of two doses of telmisartan.&#xD;
&#xD;
      Pharmacokinetic objectives included the determination of the steady-state pharmacokinetics of&#xD;
      telmisartan in children and adolescents aged 6 to &lt;18 years, and to determine if age-related&#xD;
      differences exist&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>April 2006</start_date>
  <primary_completion_date type="Actual">September 2007</primary_completion_date>
  <phase>Phase 2</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</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline in seated systolic blood pressure (SBP)</measure>
    <time_frame>Baseline, after 4 weeks of treatment</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in seated diastolic blood pressure (DBP)</measure>
    <time_frame>Baseline, after 4 weeks of treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Response rate of blood pressure</measure>
    <time_frame>after 4 weeks</time_frame>
    <description>defined as both SBP and DBP &lt; 95th percentile at the patient's final visit based on age, height, and gender</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cmax,ss (maximum concentration of the analyte in plasma at steady state over a uniform dosing interval)</measure>
    <time_frame>72 hours after last study drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cmin,ss (minimum measured concentration of the analyte in plasma at steady state over a uniform dosing interval)</measure>
    <time_frame>72 hours after last study drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cpre,ss (predose concentration of the analyte in plasma at steady state immediately before administration of the next dose)</measure>
    <time_frame>72 hours after last study drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cavg (Average concentration of the analyte in plasma at steady state)</measure>
    <time_frame>72 hours after last study drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>tmax,ss (time from dosing to maximum concentration at steady state)</measure>
    <time_frame>72 hours after last study drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUCτ,ss (area under the concentration time curve of the analyte in plasma at steady state over a uniform dosing interval)</measure>
    <time_frame>72 hours after last study drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>t1/2,ss (terminal half-life of the analyte in plasma at steady state)</measure>
    <time_frame>72 hours after last study drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MRTpo,ss (mean residence time of the analyte in the body at steady state)</measure>
    <time_frame>72 hours after last study drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CL/F,ss (apparent clearance of the analyte in the plasma after extravascular administration at steady state)</measure>
    <time_frame>72 hours after last study drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vz/F,ss (apparent volume of distribution during the terminal phase λz following an extravascular dose at steady state)</measure>
    <time_frame>72 hours after last study drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PTF (peak trough fluctuation)</measure>
    <time_frame>72 hours after last study drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with adverse events</measure>
    <time_frame>up to 45 days</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">77</enrollment>
  <condition>Hypertension</condition>
  <arm_group>
    <arm_group_label>telmisartan - low dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>telmisartan - high dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Telmisartan</intervention_name>
    <arm_group_label>telmisartan - high dose</arm_group_label>
    <arm_group_label>telmisartan - low dose</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male or female children and adolescents 6 to &lt;18 years of age at time of informed&#xD;
             consent/assent&#xD;
&#xD;
          2. Ability to provide written informed consent in accordance with Good Clinical Practice&#xD;
             (GCP) and local Institutional Review Boards (IRBs), and/or patient assent, when&#xD;
             appropriate&#xD;
&#xD;
          3. Ability to stop any current antihypertensive therapy without unacceptable risk to the&#xD;
             patient (Investigator's discretion)&#xD;
&#xD;
          4. Weight ≥20 kg and ≤120 kg&#xD;
&#xD;
          5. Hypertensive patients: in-clinic seated SBP ≥ 95th percentile based on age, height,&#xD;
             and gender as defined in The Fourth Report on the Diagnosis, Evaluation and Treatment&#xD;
             of High Blood Pressure in Children and Adolescents&#xD;
&#xD;
          6. Ability to swallow whole tablets&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Hypertension accompanied by symptoms or signs of central nervous system injury,&#xD;
             including stroke, seizures, or encephalopathy, within 6 months prior to enrollment in&#xD;
             the study&#xD;
&#xD;
          2. Children whose in-clinic seated BP measurements are 20 mmHg SBP or 10 mmHg DBP above&#xD;
             the 95th percentile based on The Fourth Report on the Diagnosis, Evaluation and&#xD;
             Treatment of High Blood Pressure in Children and Adolescents&#xD;
&#xD;
          3. Bilateral renal artery stenosis, unilateral renal artery stenosis in a solitary&#xD;
             kidney, or uncorrected coarctation of the aorta&#xD;
&#xD;
          4. Congestive heart failure, valvular disease, or clinically significant cardiac rhythm&#xD;
             disturbances&#xD;
&#xD;
          5. Bone marrow transplantation&#xD;
&#xD;
          6. Solid organ transplantation&#xD;
&#xD;
          7. Stroke&#xD;
&#xD;
          8. Chronic Kidney Disease with Glomerular Filtration Rate (GFR) to &lt; 40 ml/min/1.73m2 by&#xD;
             the Schwartz formula:&#xD;
&#xD;
             Estimated GFR = (k x Height [cm]/ Serum Creatinine (mg/dL). k = 0.55 for all females&#xD;
             and boys &lt;13 years old; k = 0.7 in adolescent males ≥13 years old)&#xD;
&#xD;
          9. Clinically significant hepatic disease or abnormal liver function tests:&#xD;
&#xD;
               1. Serum Glutamate-Oxaloacetate-Transaminase (Aspartate Aminotransferase) (SGOT),&#xD;
                  Serum Glutamate-Pyruvate-Transaminase (Alanine Aminotransferase) (SGPT), or&#xD;
                  Gamma-Glutamyl-Transferase (GGT) more than 2x upper limit of normal&#xD;
&#xD;
               2. Total or direct bilirubin more than 1.5x upper limit of normal&#xD;
&#xD;
         10. Clinically significant gastrointestinal disease that may affect drug absorption or&#xD;
             excretion (including gastroesophageal reflux, malabsorption, biliary disease,&#xD;
             pancreatic disease)&#xD;
&#xD;
         11. Hyponatremia (serum sodium ≤130 mEq/L), hyperkalemia (Serum potassium ≥ 5.5 mEq/L), or&#xD;
             other clinically significant electrolyte disorders&#xD;
&#xD;
         12. Significant hypoalbuminemia (serum albumin ≤2.5 g/dL)&#xD;
&#xD;
         13. Clinically significant neurological, psychiatric, pulmonary, hematological, or other&#xD;
             condition that, in the opinion of the Investigator, will interfere with the safe and&#xD;
             successful completion of the study&#xD;
&#xD;
         14. Hypersensitivity to angiotensin II receptor antagonists&#xD;
&#xD;
         15. Females who are of childbearing potential who:&#xD;
&#xD;
               1. are pregnant/have a positive urine pregnancy test (UPT) prior to randomization&#xD;
                  (Visit 2), or&#xD;
&#xD;
               2. are nursing, or lactating, or&#xD;
&#xD;
               3. would not confirm abstinence (patients must be abstinent throughout the duration&#xD;
                  of the trial), or&#xD;
&#xD;
               4. are not currently practicing one of the acceptable methods of birth control.&#xD;
                  Acceptable methods of birth control are limited to: Intra-Uterine Device (IUD),&#xD;
                  oral, implantable or injectable contraceptives and estrogen patch.&#xD;
&#xD;
         16. Concomitant therapy with any of the following agents:&#xD;
&#xD;
               -  Any angiotensin II receptor antagonist within four (4) weeks prior to&#xD;
                  randomization into the study&#xD;
&#xD;
               -  Any medication that could affect BP&#xD;
&#xD;
               -  Angiotensin Converting Enzyme (ACE) inhibitors within four (4) weeks prior to&#xD;
                  randomization into the study&#xD;
&#xD;
               -  Intravenous pulse steroid therapy within one month, daily treatment with oral&#xD;
                  corticosteroids ≥1 mg/kg/day)&#xD;
&#xD;
               -  Anticonvulsant medications&#xD;
&#xD;
               -  Bile acid binding agents&#xD;
&#xD;
               -  Any drug that may interfere with absorption of the study medication&#xD;
                  (e.g.antacids)&#xD;
&#xD;
               -  Drugs that may affect gastrointestinal motility (e.g. metoclopramide)&#xD;
&#xD;
               -  Cytotoxic agents within 12 months prior to enrollment into the study&#xD;
&#xD;
         17. Other investigational drugs or treatments within 30 days prior to enrollment&#xD;
&#xD;
         18. Patients who require two or more anti-hypertensive medications&#xD;
&#xD;
         19. Hereditary fructose intolerance&#xD;
&#xD;
         20. Patients who have previously experienced symptoms characteristic of angioedema during&#xD;
             treatment with ACE inhibitors or angiotensin II receptor antagonists&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <link>
    <url>http://trials.boehringer-ingelheim.com</url>
    <description>Related Info</description>
  </link>
  <verification_date>December 2017</verification_date>
  <study_first_submitted>September 16, 2014</study_first_submitted>
  <study_first_submitted_qc>September 16, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 17, 2014</study_first_posted>
  <last_update_submitted>December 27, 2017</last_update_submitted>
  <last_update_submitted_qc>December 27, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">December 28, 2017</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>Hypertension</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Telmisartan</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/NCT02242344
org study id: 502.403
nct id: NCT02242344
lead sponsor: 
Study to assess the blood pressure lowering effects of two doses of telmisartan over a
      four-week treatment period; to determine potentially effective doses for pediatric patients
      for future studies; to assess the safety and tolerability of two doses of telmisartan.

      Pharmacokinetic objectives included the determination of the steady-state pharmacokinetics of
      telmisartan in children and adolescents aged 6 to <18 years, and to determine if age-related
      differences exist
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double
measure: Change from baseline in seated systolic blood pressure (SBP)
time frame: Baseline, after 4 weeks of treatment
measure: Change from baseline in seated diastolic blood pressure (DBP)
time frame: Baseline, after 4 weeks of treatment
measure: Response rate of blood pressure
time frame: after 4 weeks
description: defined as both SBP and DBP < 95th percentile at the patient's final visit based on age, height, and gender
measure: Cmax,ss (maximum concentration of the analyte in plasma at steady state over a uniform dosing interval)
time frame: 72 hours after last study drug administration
measure: Cmin,ss (minimum measured concentration of the analyte in plasma at steady state over a uniform dosing interval)
time frame: 72 hours after last study drug administration
measure: Cpre,ss (predose concentration of the analyte in plasma at steady state immediately before administration of the next dose)
time frame: 72 hours after last study drug administration
measure: Cavg (Average concentration of the analyte in plasma at steady state)
time frame: 72 hours after last study drug administration
measure: tmax,ss (time from dosing to maximum concentration at steady state)
time frame: 72 hours after last study drug administration
measure: AUCτ,ss (area under the concentration time curve of the analyte in plasma at steady state over a uniform dosing interval)
time frame: 72 hours after last study drug administration
measure: t1/2,ss (terminal half-life of the analyte in plasma at steady state)
time frame: 72 hours after last study drug administration
measure: MRTpo,ss (mean residence time of the analyte in the body at steady state)
time frame: 72 hours after last study drug administration
measure: CL/F,ss (apparent clearance of the analyte in the plasma after extravascular administration at steady state)
time frame: 72 hours after last study drug administration
measure: Vz/F,ss (apparent volume of distribution during the terminal phase λz following an extravascular dose at steady state)
time frame: 72 hours after last study drug administration
measure: PTF (peak trough fluctuation)
time frame: 72 hours after last study drug administration
measure: Number of patients with adverse events
time frame: up to 45 days
arm group label: telmisartan - low dose
arm group type: Experimental
arm group label: telmisartan - high dose
arm group type: Experimental
arm group label: Placebo
arm group type: Placebo Comparator
intervention type: Drug
intervention name: Telmisartan
arm group label: telmisartan - high dose
arm group label: telmisartan - low dose
intervention type: Drug
intervention name: Placebo
arm group label: Placebo
criteria: 
gender: All
minimum age: 6 Years
maximum age: 17 Years
healthy volunteers: No
url: http://trials.boehringer-ingelheim.com
description: Related Info
responsible party type: Sponsor
mesh term: Hypertension
mesh term: Telmisartan