<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/NCT02254824</url>
  </required_header>
  <id_info>
    <org_study_id>SF2011-4003-04</org_study_id>
    <nct_id>NCT02254824</nct_id>
  </id_info>
  <brief_title>Effects and Underlying Mechanism of Lipid Lowering Intervention on Vascular Protection in Hypertensive Patients</brief_title>
  <official_title>Effects and Underlying Mechanism of Lipid Lowering Intervention on Vascular Protection in Hypertensive Patients (EMINENT Study)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chinese Academy of Medical Sciences, Fuwai Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Peking University First Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Peking Union Medical College Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Beijing Hospital of Traditional Chinese Medicine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Chinese Academy of Medical Sciences, Fuwai Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of EMINENT study is to evaluate the efficacy of Xuezhikang or atorvastatin in&#xD;
      hypertensive patients at low/moderate cardiovascular risk.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      EMINENT study is to evaluate the efficacy of Xuezhikang or atorvastatin on vascular function&#xD;
      protection in hypertensive patients at low/moderate cardiovascular risk.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>October 2013</start_date>
  <completion_date type="Anticipated">October 2016</completion_date>
  <primary_completion_date type="Anticipated">October 2015</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>The primary endpoint is the Flow Mediated Dilatation (FMD)</measure>
    <time_frame>1 year</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>the carotid - femoral Pulse Wave Velocity (cf-PWV),</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>inflammatory markers</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>lipid profiles</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Hypertension</condition>
  <arm_group>
    <arm_group_label>Normal-dose statin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Lifestyle modification with Normal-dose statin</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Lifestyle modification + Xuezhikang</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Lifestyle changes with Xuezhikang</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Lifestyle modification</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Lifestyle modification</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Xuezhikang</intervention_name>
    <description>Xuezhikang</description>
    <arm_group_label>Lifestyle modification + Xuezhikang</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Atorvastatin</intervention_name>
    <description>Atorvastatin</description>
    <arm_group_label>Normal-dose statin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Lifestyle modification</intervention_name>
    <description>Lifestyle modification</description>
    <arm_group_label>Lifestyle modification</arm_group_label>
    <arm_group_label>Lifestyle modification + Xuezhikang</arm_group_label>
    <arm_group_label>Normal-dose statin</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients must meet the hypertension with low or moderate cardiovascular risk&#xD;
             following 2010 Guidelines for prevention and treatment of hypertension in China&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Secondary Hypertension&#xD;
&#xD;
          -  Women who are pregnant or lactating&#xD;
&#xD;
          -  History of mental instability, or major psychiatric illness not adequately controlled&#xD;
             and stable on therapy&#xD;
&#xD;
          -  Type 2 Diabetes&#xD;
&#xD;
          -  Active liver disease or impaired liver function tests&#xD;
&#xD;
          -  Impaired renal function&#xD;
&#xD;
          -  Uncontrolled cardiac arrhythmia&#xD;
&#xD;
          -  Patient who is unable to give informed consent&#xD;
&#xD;
          -  Any condition or situation, which in the opinion of the investigator, might pose a&#xD;
             risk to the patient or confound the results of the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Aimin Dang, Doctor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fuwai Hospital &amp; Cardiovascular Institute</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Aimin - Dang, Doctor</last_name>
    <phone>0086-10-88398155</phone>
    <email>amdang@fuwaihospital.org</email>
  </overall_contact>
  <location>
    <facility>
      <name>Fuwai Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100037</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Naqiang Lv, Doctor</last_name>
      <phone>0086-10-13466500331</phone>
      <email>lvnaqiang@gmail.com</email>
    </contact>
    <investigator>
      <last_name>Aimin Dang, Doctor</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>April 17, 2014</study_first_submitted>
  <study_first_submitted_qc>September 29, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 2, 2014</study_first_posted>
  <last_update_submitted>September 29, 2014</last_update_submitted>
  <last_update_submitted_qc>September 29, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 2, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chinese Academy of Medical Sciences, Fuwai Hospital</investigator_affiliation>
    <investigator_full_name>Aimin Dang</investigator_full_name>
    <investigator_title>Cardiovascular Institute &amp; Fuwai Hospital</investigator_title>
  </responsible_party>
  <keyword>Xuezhikang</keyword>
  <keyword>atorvastatin</keyword>
  <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>Atorvastatin</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/NCT02254824
org study id: SF2011-4003-04
nct id: NCT02254824
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
The purpose of EMINENT study is to evaluate the efficacy of Xuezhikang or atorvastatin in
      hypertensive patients at low/moderate cardiovascular risk.
EMINENT study is to evaluate the efficacy of Xuezhikang or atorvastatin on vascular function
      protection in hypertensive patients at low/moderate cardiovascular risk.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: The primary endpoint is the Flow Mediated Dilatation (FMD)
time frame: 1 year
measure: the carotid - femoral Pulse Wave Velocity (cf-PWV),
time frame: 1 year
measure: inflammatory markers
time frame: 1 year
measure: lipid profiles
time frame: 1 year
arm group label: Normal-dose statin
arm group type: Active Comparator
description: Lifestyle modification with Normal-dose statin
arm group label: Lifestyle modification + Xuezhikang
arm group type: Active Comparator
description: Lifestyle changes with Xuezhikang
arm group label: Lifestyle modification
arm group type: Active Comparator
description: Lifestyle modification
intervention type: Drug
intervention name: Xuezhikang
description: Xuezhikang
arm group label: Lifestyle modification + Xuezhikang
intervention type: Drug
intervention name: Atorvastatin
description: Atorvastatin
arm group label: Normal-dose statin
intervention type: Behavioral
intervention name: Lifestyle modification
description: Lifestyle modification
arm group label: Lifestyle modification
arm group label: Lifestyle modification + Xuezhikang
arm group label: Normal-dose statin
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Aimin Dang, Doctor
role: Principal Investigator
affiliation: Fuwai Hospital & Cardiovascular Institute
last name: Aimin - Dang, Doctor
phone: 0086-10-88398155
email: amdang@fuwaihospital.org
facility: 
status: Recruiting
contact: 
investigator: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Chinese Academy of Medical Sciences, Fuwai Hospital
investigator full name: Aimin Dang
investigator title: Cardiovascular Institute & Fuwai Hospital
mesh term: Hypertension
mesh term: Atorvastatin