<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/NCT02996916</url>
  </required_header>
  <id_info>
    <org_study_id>Olme-brain</org_study_id>
    <nct_id>NCT02996916</nct_id>
  </id_info>
  <brief_title>Efficacy of Olmesartan on Cerebral Glucose Metabolism, Vascular Inflammation and Adipose Tissue</brief_title>
  <official_title>Efficacy of Olmesartan on Cerebral Glucose Metabolism, Vascular Inflammation and Adipose Tissue</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kurume University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kurume University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Hypertension is a leading risk factor for morbidity and mortality worldwide. The brain is a&#xD;
      major target of the damaging effects of hypertension. Hypertension has been recognized as the&#xD;
      leading cause of dementia as well as the most important risk factor for stroke and vascular&#xD;
      cognitive impairment. Although glucose is the principal cerebral energy source, impact of&#xD;
      hypertensive treatment on cerebral glucose metabolism is poorly understood.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>December 2015</start_date>
  <completion_date type="Anticipated">December 2020</completion_date>
  <primary_completion_date type="Anticipated">December 2018</primary_completion_date>
  <phase>Phase 4</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Effects of treatment on the nominal change in cerebral glucose metabolism from baseline after 6 months of treatment as measured by FDG-PET/CT</measure>
    <time_frame>6 months of treatment</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in vascular inflammation measured by blood-normalized standardized uptake value, known as a target-to-background ratio (TBR) by FDG-PET/CT</measure>
    <time_frame>6 months of treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in abdominal and muscle fat volume as measured by CT</measure>
    <time_frame>6 months of treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in circulating inflammatory markers including hsCRP (mg/L), adiponectin (µg/mL), ADMA (nmoL/mL), DPP-4 (ng/mL), advanced glycation end products (AGEs, µg/mL) and angiotensin-(1-7) (ng/mL)</measure>
    <time_frame>6 months of treatment</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Efficacy of Olmesartan on Cerebral Glucose Metabolism in Essential Hypertension</condition>
  <arm_group>
    <arm_group_label>Olmesartan</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Olmesartan 10-40mg daily</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Amlodipine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Amlodipine 2.5-10mg daily</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Olmesartan</intervention_name>
    <description>10-40mg daily</description>
    <arm_group_label>Olmesartan</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Amlodipine</intervention_name>
    <description>2.5-10mg daily</description>
    <arm_group_label>Amlodipine</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Written informed consent obtained&#xD;
&#xD;
          -  Male and female subjects aged 20 years or older at informed consent&#xD;
&#xD;
          -  Essential hypertension who had never received angiotensin II receptor antagonists and&#xD;
             calcium channel blockers&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Secondary hypertension or malignant hypertension&#xD;
&#xD;
          -  Diabetes mellitus&#xD;
&#xD;
          -  History or evidence of a stroke&#xD;
&#xD;
          -  Hepatic or hematologic abnormality&#xD;
&#xD;
          -  Mild Cognitive Impairment or Dementia&#xD;
&#xD;
          -  Serum potassium level ≥ 5.5 mEq/L&#xD;
&#xD;
          -  Serum creatinine level ≥ 3.0 mg/dL&#xD;
&#xD;
          -  Acute or chronic disease&#xD;
&#xD;
          -  Allergy to any drugs&#xD;
&#xD;
          -  Pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nobuhiro Tahara, MD, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Department of Medicine, Division of Cardiovascular Medicine, Kurume University School of Medicine</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Nobuhiro Tahara, MD, PhD</last_name>
    <phone>+81-942-31-7580</phone>
    <email>ntahara@med.kurume-u.ac.jp</email>
  </overall_contact>
  <location>
    <facility>
      <name>Kurume University Hospital</name>
      <address>
        <city>Kurume</city>
        <zip>830-0011</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Nobuhiro Tahara, MD, PhD</last_name>
      <phone>+81-942-31-7580</phone>
      <email>ntahara@med.kurume-u.ac.jp</email>
    </contact>
    <contact_backup>
      <last_name>Akihiro Honda, MD, PhD</last_name>
      <phone>+81-942-31-7580</phone>
      <email>honda_akihiro@med.kurume-u.ac.jp</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 13, 2016</study_first_submitted>
  <study_first_submitted_qc>December 14, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 19, 2016</study_first_posted>
  <last_update_submitted>December 16, 2016</last_update_submitted>
  <last_update_submitted_qc>December 16, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 20, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Kurume University</investigator_affiliation>
    <investigator_full_name>Nobuhiro Tahara</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Essential Hypertension</mesh_term>
    <mesh_term>Inflammation</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Amlodipine</mesh_term>
    <mesh_term>Olmesartan</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT02996916
org study id: Olme-brain
nct id: NCT02996916
lead sponsor: 
has dmc: Yes
Hypertension is a leading risk factor for morbidity and mortality worldwide. The brain is a
      major target of the damaging effects of hypertension. Hypertension has been recognized as the
      leading cause of dementia as well as the most important risk factor for stroke and vascular
      cognitive impairment. Although glucose is the principal cerebral energy source, impact of
      hypertensive treatment on cerebral glucose metabolism is poorly understood.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Effects of treatment on the nominal change in cerebral glucose metabolism from baseline after 6 months of treatment as measured by FDG-PET/CT
time frame: 6 months of treatment
measure: Change from baseline in vascular inflammation measured by blood-normalized standardized uptake value, known as a target-to-background ratio (TBR) by FDG-PET/CT
time frame: 6 months of treatment
measure: Change from baseline in abdominal and muscle fat volume as measured by CT
time frame: 6 months of treatment
measure: Change from baseline in circulating inflammatory markers including hsCRP (mg/L), adiponectin (µg/mL), ADMA (nmoL/mL), DPP-4 (ng/mL), advanced glycation end products (AGEs, µg/mL) and angiotensin-(1-7) (ng/mL)
time frame: 6 months of treatment
arm group label: Olmesartan
arm group type: Active Comparator
description: Olmesartan 10-40mg daily
arm group label: Amlodipine
arm group type: Active Comparator
description: Amlodipine 2.5-10mg daily
intervention type: Drug
intervention name: Olmesartan
description: 10-40mg daily
arm group label: Olmesartan
intervention type: Drug
intervention name: Amlodipine
description: 2.5-10mg daily
arm group label: Amlodipine
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Nobuhiro Tahara, MD, PhD
role: Study Chair
affiliation: Department of Medicine, Division of Cardiovascular Medicine, Kurume University School of Medicine
last name: Nobuhiro Tahara, MD, PhD
phone: +81-942-31-7580
email: ntahara@med.kurume-u.ac.jp
facility: 
status: Recruiting
contact: 
contact backup: 
country: Japan
responsible party type: Principal Investigator
investigator affiliation: Kurume University
investigator full name: Nobuhiro Tahara
investigator title: Associate Professor
mesh term: Essential Hypertension
mesh term: Inflammation
mesh term: Amlodipine
mesh term: Olmesartan
sharing ipd: Undecided