<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/NCT02213224</url>
  </required_header>
  <id_info>
    <org_study_id>NAFLD20140805</org_study_id>
    <nct_id>NCT02213224</nct_id>
  </id_info>
  <brief_title>Perindopril and Telmisartan for the Treatment of Nonalcoholic Fatty Liver Disease</brief_title>
  <acronym>NF-NAFLD</acronym>
  <official_title>Evaluation of Perindopril and Telmisartan for the Treatment of Nonalcoholic Fatty Liver Disease: A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nanfang Hospital, Southern Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Nanfang Hospital, Southern Medical University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this current study was to assess the therapeutic effects of perindopril and&#xD;
      telmisartan for hypertensive patients with NAFLD and make comparison between the therapeutic&#xD;
      effects of these two kind of drugs.&#xD;
&#xD;
      This study is a randomized parallel control clinical trial which would be carried out in&#xD;
      Nanfang Hospital, Southern Medical University.&#xD;
&#xD;
      About one hundred and eighty patients would be randomly assigned to perindopril,telmisartan&#xD;
      and amlodipine three groups.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Inclusion criteria:&#xD;
&#xD;
      18-70 years old patients who were diagnosed with mild-moderate hypertension and NAFLD; The&#xD;
      patients did not take ACEIs or ARBs drugs six weeks before the inclusion; Patients agreed to&#xD;
      participate in the trial and signed the informed consent.&#xD;
&#xD;
      Exclusion criteria:&#xD;
&#xD;
      There are no coexisting causes for chronic liver disease, such as viral,&#xD;
      alcoholic,drug-induced and autoimmune liver diseases; Patients with diabetes mellitus;&#xD;
      Patients with serious primary diseases; Patients with mental disorder or can not take the&#xD;
      medicine regularly; Pregnancy and nursing mothers; Allergic constitution or intolerance to&#xD;
      ACEIs or ARBs drugs. Outcome measures include Cap value of FibroScan,angiotensin&#xD;
      II,IL-18，IL-1β,aminotransferase,lipids and HOMA-IR.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>August 2014</start_date>
  <completion_date type="Anticipated">September 2017</completion_date>
  <primary_completion_date type="Anticipated">September 2016</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cap value of FibroScan （dB/m）</measure>
    <time_frame>48 weeks after the treatment</time_frame>
    <description>FibroScan examination would be performed in all patients 48 weeks after administration of the drugs, and Cap value of FirbroScan will be recorded.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Angiotensin II</measure>
    <time_frame>12, 24, 48 weeks after the treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>IL-18，IL-1β</measure>
    <time_frame>12, 24, 48 weeks after the treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>aminotransferase</measure>
    <time_frame>12, 24, 48 weeks after the treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>lipids</measure>
    <time_frame>12, 24, 48 weeks after the treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HOMA-IR</measure>
    <time_frame>12, 24, 48 weeks after the treatment</time_frame>
    <description>homeostasis model assessment of insulin resistance (HOMA-IR)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>computed tomography value of liver</measure>
    <time_frame>48 weeks after the treatment</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">180</enrollment>
  <condition>Nonalcoholic Fatty Liver Disease (NAFLD)</condition>
  <arm_group>
    <arm_group_label>Perindopril</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Perindopril 4mg qd taken in the morning;</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Telmisartan</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Telmisartan 80mg qd taken in the morning;</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Amlodipine</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Amlodipine；5mg qd taken in the morning.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Perindopril</intervention_name>
    <description>Perindopril is a kind of angiotensin converting enzyme inhibitors (ACEIs) which has been considered as the first-line drugs for the treatment of hypertension and has been proved safe during the widespread use.</description>
    <arm_group_label>Perindopril</arm_group_label>
    <other_name>Perindopril; brand name: Acertil, serial number:H20034053</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Telmisartan</intervention_name>
    <description>Telmisartan is a kind of angiotensin receptor blockers (ARBs) which has also been considered as the first-line drugs for the treatment of hypertension and has been proved safe during the widespread use.</description>
    <arm_group_label>Telmisartan</arm_group_label>
    <other_name>Telmisartan; brand name: Micardis, serial number:J20090089</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Amlodipine</intervention_name>
    <description>Amlodipine is also a kind of widely used first-line drugs for the treatment of hypertension, and there is no evidence showing that it is effective for NAFLD.</description>
    <arm_group_label>Amlodipine</arm_group_label>
    <other_name>Amlodipine；5mg qd taken in the morning.</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18-70 years old patients who were diagnosed with mild-moderate hypertension and NAFLD;&#xD;
&#xD;
          -  The patients did not take ACEIs or ARBs drugs six weeks before the inclusion; Patients&#xD;
             agreed to participate in the trial and signed the informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  There are no coexisting causes for chronic liver disease, such as viral,&#xD;
             alcoholic,drug-induced and autoimmune liver diseases;&#xD;
&#xD;
          -  Patients with diabetes mellitus; Patients with serious primary diseases; Patients with&#xD;
             mental disorder or can not take the medicine regularly;&#xD;
&#xD;
          -  Pregnancy and nursing mothers;&#xD;
&#xD;
          -  Allergic constitution or intolerance to ACEIs or ARBs drugs.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Side Liu, MD,PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Gastroenterology, Nanfang Hospital, Southern Medical University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Side Liu, MD,PhD</last_name>
    <phone>+86 020 61641537</phone>
    <email>liuside2011@163.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Nanfang Hospital, Southern Medical University</name>
      <address>
        <city>GuangZhou</city>
        <state>Guangdong</state>
        <zip>510515</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yue Li, MD</last_name>
      <phone>+86-15975537291</phone>
      <email>liyue_1989919@126.com</email>
    </contact>
    <investigator>
      <last_name>Side Liu, MD.PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Yue Li, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Xu Li, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Zelong Han, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Wen Xu, MM</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Yubin Guo, MM</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Feng Xiong, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>August 6, 2014</study_first_submitted>
  <study_first_submitted_qc>August 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 11, 2014</study_first_posted>
  <last_update_submitted>August 8, 2014</last_update_submitted>
  <last_update_submitted_qc>August 8, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 11, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Perindopril,Telmisartan, Efficacy, NAFLD</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Liver Diseases</mesh_term>
    <mesh_term>Fatty Liver</mesh_term>
    <mesh_term>Non-alcoholic Fatty Liver Disease</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Amlodipine</mesh_term>
    <mesh_term>Telmisartan</mesh_term>
    <mesh_term>Perindopril</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/NCT02213224
org study id: NAFLD20140805
nct id: NCT02213224
lead sponsor: 
has dmc: Yes
The aim of this current study was to assess the therapeutic effects of perindopril and
      telmisartan for hypertensive patients with NAFLD and make comparison between the therapeutic
      effects of these two kind of drugs.

      This study is a randomized parallel control clinical trial which would be carried out in
      Nanfang Hospital, Southern Medical University.

      About one hundred and eighty patients would be randomly assigned to perindopril,telmisartan
      and amlodipine three groups.
Inclusion criteria:

      18-70 years old patients who were diagnosed with mild-moderate hypertension and NAFLD; The
      patients did not take ACEIs or ARBs drugs six weeks before the inclusion; Patients agreed to
      participate in the trial and signed the informed consent.

      Exclusion criteria:

      There are no coexisting causes for chronic liver disease, such as viral,
      alcoholic,drug-induced and autoimmune liver diseases; Patients with diabetes mellitus;
      Patients with serious primary diseases; Patients with mental disorder or can not take the
      medicine regularly; Pregnancy and nursing mothers; Allergic constitution or intolerance to
      ACEIs or ARBs drugs. Outcome measures include Cap value of FibroScan,angiotensin
      II,IL-18，IL-1β,aminotransferase,lipids and HOMA-IR.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Cap value of FibroScan （dB/m）
time frame: 48 weeks after the treatment
description: FibroScan examination would be performed in all patients 48 weeks after administration of the drugs, and Cap value of FirbroScan will be recorded.
measure: Angiotensin II
time frame: 12, 24, 48 weeks after the treatment
measure: IL-18，IL-1β
time frame: 12, 24, 48 weeks after the treatment
measure: aminotransferase
time frame: 12, 24, 48 weeks after the treatment
measure: lipids
time frame: 12, 24, 48 weeks after the treatment
measure: HOMA-IR
time frame: 12, 24, 48 weeks after the treatment
description: homeostasis model assessment of insulin resistance (HOMA-IR)
measure: computed tomography value of liver
time frame: 48 weeks after the treatment
arm group label: Perindopril
arm group type: Experimental
description: Perindopril 4mg qd taken in the morning;
arm group label: Telmisartan
arm group type: Experimental
description: Telmisartan 80mg qd taken in the morning;
arm group label: Amlodipine
arm group type: Placebo Comparator
description: Amlodipine；5mg qd taken in the morning.
intervention type: Drug
intervention name: Perindopril
description: Perindopril is a kind of angiotensin converting enzyme inhibitors (ACEIs) which has been considered as the first-line drugs for the treatment of hypertension and has been proved safe during the widespread use.
arm group label: Perindopril
other name: Perindopril; brand name: Acertil, serial number:H20034053
intervention type: Drug
intervention name: Telmisartan
description: Telmisartan is a kind of angiotensin receptor blockers (ARBs) which has also been considered as the first-line drugs for the treatment of hypertension and has been proved safe during the widespread use.
arm group label: Telmisartan
other name: Telmisartan; brand name: Micardis, serial number:J20090089
intervention type: Drug
intervention name: Amlodipine
description: Amlodipine is also a kind of widely used first-line drugs for the treatment of hypertension, and there is no evidence showing that it is effective for NAFLD.
arm group label: Amlodipine
other name: Amlodipine；5mg qd taken in the morning.
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Side Liu, MD,PhD
role: Principal Investigator
affiliation: Department of Gastroenterology, Nanfang Hospital, Southern Medical University
last name: Side Liu, MD,PhD
phone: +86 020 61641537
email: liuside2011@163.com
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
country: China
responsible party type: Sponsor
mesh term: Liver Diseases
mesh term: Fatty Liver
mesh term: Non-alcoholic Fatty Liver Disease
mesh term: Amlodipine
mesh term: Telmisartan
mesh term: Perindopril