<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/NCT02250495</url>
  </required_header>
  <id_info>
    <org_study_id>STS1402</org_study_id>
    <nct_id>NCT02250495</nct_id>
  </id_info>
  <brief_title>The Sympara VIBE Study for Hypertension</brief_title>
  <acronym>VIBE</acronym>
  <official_title>VIBE: A Clinical Study to Evaluate the Sympara Therapeutic System for the Treatment of Hypertension</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sympara Medical, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sympara Medical, Inc.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the VIBE study is to evaluate the efficacy and safety of the Sympara&#xD;
      Therapeutic System in the treatment of hypertension&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Company closed&#xD;
  </why_stopped>
  <start_date>October 2014</start_date>
  <completion_date type="Anticipated">January 2016</completion_date>
  <primary_completion_date type="Anticipated">December 2015</primary_completion_date>
  <phase>Phase 1/Phase 2</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>Number of subjects with serious, device-related adverse events as a measure of safety and tolerability</measure>
    <time_frame>30 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of subjects with a reduction in baseline blood pressure following 30 days of Sympara device use as a measure of efficacy</measure>
    <time_frame>30 days</time_frame>
    <description>Evaluating change in office, home and ambulatory blood pressure measurements at 30 days compared to baseline</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">8</enrollment>
  <condition>Hypertension</condition>
  <arm_group>
    <arm_group_label>Sympara Therapeutic System</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All subjects will wear for the Sympara device for 30 days</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Sympara Therapeutic System</intervention_name>
    <description>Sympara Therapeutic System as a non-invasive, fully reversible alternative for the treatment of hypertension</description>
    <arm_group_label>Sympara Therapeutic System</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Office systolic blood pressure of ≥150mmHg based on an average of three (3) blood&#xD;
             pressure reading measured at both the initial screening visit and a confirmatory&#xD;
             screening visit OR a mean daytime systolic blood pressure ≥135mm Hg on 24-hour&#xD;
             Ambulatory Blood Pressure Measurement&#xD;
&#xD;
          -  Receiving and adhering to an appropriate anti-hypertensive treatment regimen, as&#xD;
             prescribed by physician&#xD;
&#xD;
          -  Minimum six- (6) month history of diagnosis and treatment of hypertension&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous renal denervation or carotid barostimulation implant&#xD;
&#xD;
          -  Secondary causes of hypertension or primary pulmonary hypertension&#xD;
&#xD;
          -  Prior surgery or radiation to the area of the carotid sinus, or presence of a stent or&#xD;
             other implant in the carotid artery&#xD;
&#xD;
          -  Known or suspected baroreflex failure or significant orthostatic hypotension&#xD;
&#xD;
          -  One or more hospital admissions for a hypertensive crisis within the past year&#xD;
&#xD;
          -  History of myocardial infarction, fibrillation event, unstable angina pectoris,&#xD;
             syncope, transient ischemic attach (TIA) or a cerebrovascular accident within six (6)&#xD;
             months of the screening period, or has widespread atherosclerosis with documented&#xD;
             intrasvascular thrombosis or unstable plaques&#xD;
&#xD;
          -  Diabetes mellitus (Type 1)&#xD;
&#xD;
          -  Chronic renal disease requiring dialysis&#xD;
&#xD;
          -  Kidney or liver transplant&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ian Meredith, AM, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Monash Health</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Princess Alexandra Hospital</name>
      <address>
        <city>Woolloongabba</city>
        <state>Queensland</state>
        <zip>4102</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Monash Health</name>
      <address>
        <city>Clayton</city>
        <state>Victoria</state>
        <zip>3168</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Barwon Health</name>
      <address>
        <city>Geelong</city>
        <state>Victoria</state>
        <zip>3220</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
  </location_countries>
  <verification_date>September 2015</verification_date>
  <study_first_submitted>September 20, 2014</study_first_submitted>
  <study_first_submitted_qc>September 23, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 26, 2014</study_first_posted>
  <last_update_submitted>September 11, 2015</last_update_submitted>
  <last_update_submitted_qc>September 11, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 14, 2015</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>
  <!-- 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/NCT02250495
org study id: STS1402
nct id: NCT02250495
lead sponsor: 
has dmc: Yes
The purpose of the VIBE study is to evaluate the efficacy and safety of the Sympara
      Therapeutic System in the treatment of hypertension
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of subjects with serious, device-related adverse events as a measure of safety and tolerability
time frame: 30 days
measure: Number of subjects with a reduction in baseline blood pressure following 30 days of Sympara device use as a measure of efficacy
time frame: 30 days
description: Evaluating change in office, home and ambulatory blood pressure measurements at 30 days compared to baseline
arm group label: Sympara Therapeutic System
arm group type: Experimental
description: All subjects will wear for the Sympara device for 30 days
intervention type: Device
intervention name: Sympara Therapeutic System
description: Sympara Therapeutic System as a non-invasive, fully reversible alternative for the treatment of hypertension
arm group label: Sympara Therapeutic System
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Ian Meredith, AM, PhD
role: Principal Investigator
affiliation: Monash Health
facility: 
facility: 
facility: 
country: Australia
responsible party type: Sponsor
mesh term: Hypertension