<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/NCT04474899</url>
  </required_header>
  <id_info>
    <org_study_id>RA-4-1-7565</org_study_id>
    <nct_id>NCT04474899</nct_id>
  </id_info>
  <brief_title>Sympathoinhibition as a Preferred Second Line Treatment of Obesity Related Hypertension</brief_title>
  <acronym>OHT</acronym>
  <official_title>Sympathoinhibition as a Preferred Second Line Treatment of Obesity Related Hypertension</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Royal Perth Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The University of Western Australia</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Royal Perth Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is designed to investigate whether sympathoinhibition with moxonidine could&#xD;
      provide added metabolic benefit compared to the second line therapy in the current&#xD;
      guidelines.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a randomised, double-blind, cross-over study. Participants will be randomly assigned&#xD;
      to receive either moxonidine 0.4mg daily or amlodipine 5mg and will later receive the&#xD;
      alternate treatment.&#xD;
&#xD;
      Comprehensive testing will occur after each 12 week treatment phase and will include&#xD;
      assessment of muscle sympathetic nerve activity, gut microbiome analysis and metabolic&#xD;
      markers.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">June 24, 2015</start_date>
  <completion_date type="Anticipated">June 24, 2024</completion_date>
  <primary_completion_date type="Anticipated">February 24, 2024</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>Crossover Assignment</intervention_model>
    <intervention_model_description>Randomized, double blind cross over study</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>Double (Participant, Investigator)</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Blood Pressure</measure>
    <time_frame>30 weeks</time_frame>
    <description>Both Systolic and diastolic blood pressure assessed by office and ambulatory blood pressure monitoring</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>blood glucose levels</measure>
    <time_frame>30 weeks</time_frame>
    <description>Changes in glycemic control through oral glucose tolerance test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gut microbiota profile</measure>
    <time_frame>30 weeks</time_frame>
    <description>Change in gut microbiota assessed by short chain fatty acid</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lipid levels in blood</measure>
    <time_frame>30 weeks</time_frame>
    <description>change in triglyceride, HDL and LDL levels in blood</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">120</enrollment>
  <condition>Obesity</condition>
  <condition>Hypertension</condition>
  <arm_group>
    <arm_group_label>Phase 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Moxonidine 0.4mg/daily</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Phase 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Amlodipine 5mg</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Moxonidine 0.4 MG</intervention_name>
    <description>Participants will be randomly assigned to receive moxonidine 0.4mg/daily and will later receive the alternate treatment. As the study is double blind neither the participant nor the study personnel will be aware of which treatment is currently being tested to avoid any effect this may have on the results. The two 12-week treatment phases will be separated by a 6-week wash out (drug-free) period.</description>
    <arm_group_label>Phase 1</arm_group_label>
    <arm_group_label>Phase 2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Amlodipine 5mg</intervention_name>
    <description>Participants will be randomly assigned to receive amlodipine 5mg and will later receive the alternate treatment. As the study is double blind neither the participant nor the study personnel will be aware of which treatment is currently being tested to avoid any effect this may have on the results. The two 12-week treatment phases will be separated by a 6-week wash out (drug-free) period.</description>
    <arm_group_label>Phase 1</arm_group_label>
    <arm_group_label>Phase 2</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age: 25 -70 years&#xD;
&#xD;
          -  (Body Mass Index) BMI≥30kg/m2&#xD;
&#xD;
          -  Currently weight stable (+/- 3% in previous 6-12 months and not on any specific&#xD;
             exercise or dietary program)&#xD;
&#xD;
          -  Elevated clinic systolic (Blood Pressure) BP ≥135 or diastolic BP ≥85mmHg,&#xD;
&#xD;
          -  on ACE inhibitor for at least 6 weeks prior to baseline assessment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Grade 2-3 hypertension (systolic office BP &gt;160, diastolic office BP &gt;100 mmHg)&#xD;
&#xD;
          -  Secondary causes of hypertension&#xD;
&#xD;
          -  CKD (Chronic kidney disease) stage 4-5 {(estimated glomerular filtration)&#xD;
             eGFR&lt;30ml/min}&#xD;
&#xD;
          -  Heart failure NYHA (New York Heart Association) class II-IV&#xD;
&#xD;
          -  Recent CV (cardiovascular) event (acute myocardial infarction, acute coronary&#xD;
             syndrome, stroke or transient ischaemic attack within the previous six months)&#xD;
             unstable psychiatric condition&#xD;
&#xD;
          -  medication such as corticosteroids, several antidepressants and antipsychotics&#xD;
&#xD;
          -  Female participants of childbearing potential must have a negative pregnancy test&#xD;
             prior to treatment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Markus Schlaich, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Western Australia and Royal Perth Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Revathy Carnagarin, MD</last_name>
    <phone>+61 8 92240316</phone>
    <email>revathy.carnagarin@uwa.edu.au</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Anu Joyson, MSN</last_name>
    <phone>+61 8 92240390</phone>
    <email>anu.joyson@uwa.edu.au</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Dobney Hypertension Centre</name>
      <address>
        <city>Perth</city>
        <state>Western Australia</state>
        <zip>6155</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Markus Schlaich</last_name>
      <phone>+61 8 92240390</phone>
      <email>markus.schlaich@uwa.edu.au</email>
    </contact>
    <contact_backup>
      <last_name>Revathy Carnagarin</last_name>
      <phone>+61 8 92240316</phone>
      <email>revathy.carnagarin@uwa.edu.au</email>
    </contact_backup>
    <investigator>
      <last_name>Markus Schlaich</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Revathy Carnagarin</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Australia</country>
  </location_countries>
  <reference>
    <citation>Carnagarin R, Gregory C, Azzam O, Hillis GS, Schultz C, Watts GF, Bell D, Matthews V, Schlaich MP. The Role of Sympatho-Inhibition in Combination Treatment of Obesity-Related Hypertension. Curr Hypertens Rep. 2017 Oct 28;19(12):99. doi: 10.1007/s11906-017-0795-1.</citation>
    <PMID>29080925</PMID>
  </reference>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>June 3, 2020</study_first_submitted>
  <study_first_submitted_qc>July 15, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 17, 2020</study_first_posted>
  <last_update_submitted>September 28, 2022</last_update_submitted>
  <last_update_submitted_qc>September 28, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 29, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Royal Perth Hospital</investigator_affiliation>
    <investigator_full_name>Dr Markus Schlaich</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertension</mesh_term>
    <mesh_term>Obesity</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Amlodipine</mesh_term>
    <mesh_term>Moxonidine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Individual Participant Data will not be shared to maintain anonymity and confidentiality of the participants</ipd_description>
  </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/NCT04474899
org study id: RA-4-1-7565
nct id: NCT04474899
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
This study is designed to investigate whether sympathoinhibition with moxonidine could
      provide added metabolic benefit compared to the second line therapy in the current
      guidelines.
This is a randomised, double-blind, cross-over study. Participants will be randomly assigned
      to receive either moxonidine 0.4mg daily or amlodipine 5mg and will later receive the
      alternate treatment.

      Comprehensive testing will occur after each 12 week treatment phase and will include
      assessment of muscle sympathetic nerve activity, gut microbiome analysis and metabolic
      markers.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: Randomized, double blind cross over study
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: Double (Participant, Investigator)
measure: Blood Pressure
time frame: 30 weeks
description: Both Systolic and diastolic blood pressure assessed by office and ambulatory blood pressure monitoring
measure: blood glucose levels
time frame: 30 weeks
description: Changes in glycemic control through oral glucose tolerance test
measure: Gut microbiota profile
time frame: 30 weeks
description: Change in gut microbiota assessed by short chain fatty acid
measure: Lipid levels in blood
time frame: 30 weeks
description: change in triglyceride, HDL and LDL levels in blood
arm group label: Phase 1
arm group type: Experimental
description: Moxonidine 0.4mg/daily
arm group label: Phase 2
arm group type: Experimental
description: Amlodipine 5mg
intervention type: Drug
intervention name: Moxonidine 0.4 MG
description: Participants will be randomly assigned to receive moxonidine 0.4mg/daily and will later receive the alternate treatment. As the study is double blind neither the participant nor the study personnel will be aware of which treatment is currently being tested to avoid any effect this may have on the results. The two 12-week treatment phases will be separated by a 6-week wash out (drug-free) period.
arm group label: Phase 1
arm group label: Phase 2
intervention type: Drug
intervention name: Amlodipine 5mg
description: Participants will be randomly assigned to receive amlodipine 5mg and will later receive the alternate treatment. As the study is double blind neither the participant nor the study personnel will be aware of which treatment is currently being tested to avoid any effect this may have on the results. The two 12-week treatment phases will be separated by a 6-week wash out (drug-free) period.
arm group label: Phase 1
arm group label: Phase 2
criteria: 
gender: All
minimum age: 25 Years
maximum age: 70 Years
healthy volunteers: No
last name: Markus Schlaich, MD
role: Principal Investigator
affiliation: University of Western Australia and Royal Perth Hospital
last name: Revathy Carnagarin, MD
phone: +61 8 92240316
email: revathy.carnagarin@uwa.edu.au
last name: Anu Joyson, MSN
phone: +61 8 92240390
email: anu.joyson@uwa.edu.au
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
country: Australia
citation: Carnagarin R, Gregory C, Azzam O, Hillis GS, Schultz C, Watts GF, Bell D, Matthews V, Schlaich MP. The Role of Sympatho-Inhibition in Combination Treatment of Obesity-Related Hypertension. Curr Hypertens Rep. 2017 Oct 28;19(12):99. doi: 10.1007/s11906-017-0795-1.
PMID: 29080925
responsible party type: Principal Investigator
investigator affiliation: Royal Perth Hospital
investigator full name: Dr Markus Schlaich
investigator title: Principal Investigator
mesh term: Hypertension
mesh term: Obesity
mesh term: Amlodipine
mesh term: Moxonidine
sharing ipd: No
ipd description: Individual Participant Data will not be shared to maintain anonymity and confidentiality of the participants