<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/NCT03006796</url>
  </required_header>
  <id_info>
    <org_study_id>IISR-2015-101477</org_study_id>
    <nct_id>NCT03006796</nct_id>
  </id_info>
  <brief_title>Observational Study of Azilsartan/Chlorthalidone and Irbesartan/Hydrochlorothiazide in Hypertension and Obesity.</brief_title>
  <acronym>PUZZLE</acronym>
  <official_title>Observational Prospective stUdy of aZilsartan Medoxomil/ Chlorthalidone Compared With Irbesartan/hydrochlorothiaZide Combination Therapy in Patients With arteriaL Hypertension and obEsity in Routine Clinical Practice (PUZZLE).</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Russian Heart Failure Society</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Russian Heart Failure Society</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is an observational prospective study of azilsartan medoxomil / chlorthalidone compared&#xD;
      with irbesartan / hydrochlorothiazide in routine therapy of patients with arterial&#xD;
      hypertension and obesity.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Observational Prospective stUdy of aZilsartan medoxomil/ chlorthalidone compared with&#xD;
      irbesartan/hydrochlorothiaZide combination therapy in patients with arteriaL hypertension and&#xD;
      obEsity in routine clinical practice (PUZZLE).&#xD;
&#xD;
      The study population is 94 patients with untreated or poorly controlled arterial hypertension&#xD;
      and obesity.&#xD;
&#xD;
      The main inclusion criteria are:&#xD;
&#xD;
        1. Male and female 35-55 year old.&#xD;
&#xD;
        2. Diagnosis of essential arterial hypertension I-II grade.&#xD;
&#xD;
        3. Patients with obesity (BMI ≥ 30 kg/m²)&#xD;
&#xD;
        4. Patients with untreated arterial hypertension (clinic SBP ≥ 140 mmHg, DBP ≥ 90 mmHg and&#xD;
           no previous antihypertensive treatment.&#xD;
&#xD;
        5. Patients with poorly controlled arterial hypertension (clinic SBP ≥ 140 mmHg, DBP ≥ 90&#xD;
           mmHg on previous antihypertensive treatment.&#xD;
&#xD;
        6. Written informed consent.&#xD;
&#xD;
      The main exclusion criteria are:&#xD;
&#xD;
        1. Patients with symptomatic organ damage (myocardial infarction, stroke, angina pectoris,&#xD;
           chronic kidney disease ≥ 4 grade, diabetes).&#xD;
&#xD;
        2. Patients with secondary arterial hypertension.&#xD;
&#xD;
        3. Patients with intolerance of angiotensin II receptor blockers, thiazide diuretic.&#xD;
&#xD;
        4. Patients with contraindication to study drugs in accordance with Russian instruction.&#xD;
&#xD;
        5. Patients currently enrolled in other clinical trials. The treatment period is 6 months.&#xD;
           The study plan includes 4 basic and 1 additional visits are planned: initial visit, 3&#xD;
           follow-ups (including additional) and study-end visit.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 16, 2017</start_date>
  <completion_date type="Actual">March 31, 2020</completion_date>
  <primary_completion_date type="Actual">February 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Clinic systolic blood pressure lowering.</measure>
    <time_frame>From baseline (Month 0) to the study-end visit (Month 6)</time_frame>
    <description>Lowering of clinic systolic blood pressure.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>24-hour systolic brachial and central blood pressure lowering.</measure>
    <time_frame>From baseline (Month 0) to the study-end visit (Month 6).</time_frame>
    <description>Lowering of ambulatory brachial and central blood pressure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>24-hour aortic pulse wave velocity reduction.</measure>
    <time_frame>From baseline (Month 0) to the study-end visit (Month 6).</time_frame>
    <description>Lowering of ambulatory aortic pulse wave velocity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change in proportion of patients with normal and abnormal LV geometry with assessment of LV mass index and relative wall thickness.</measure>
    <time_frame>From baseline (Month 0) to the study-end visit (Month 6).</time_frame>
    <description>Normalization of abnormal left ventricle geometry assessed by left ventricle mass index and relative wall thickness.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">94</enrollment>
  <condition>Arterial Hypertension</condition>
  <arm_group>
    <arm_group_label>group 1 (AZL/C)</arm_group_label>
    <description>Group 1 - patients receiving azilsartan medoxomil/chlorthalidone 40/12.5 mg or 40/25 mg per os once a day for 6 months.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>group 2 (IRB/H)</arm_group_label>
    <description>Group 2 - patients receiving irbesartan/hydrochlorothiazide 150/12.5 mg or 300/25 mg per once a day for 6 months.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        The study population is 94 patients with untreated or poorly controlled arterial&#xD;
        hypertension and obesity 35-55 years old.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. male and female 35-55 year old,&#xD;
&#xD;
          2. diagnosis of I-II grade essential AH,&#xD;
&#xD;
          3. patients with obesity (BMI ≥ 30 kg/m²),&#xD;
&#xD;
          4. patients with untreated AH (office SBP ≥ 140 mmHg, DBP ≥ 90 mmHg, no previous&#xD;
             antihypertensive therapy),&#xD;
&#xD;
          5. patients with poorly controlled AH (office SBP ≥ 140 mmHg, DBP ≥ 90 mmHg on previous&#xD;
             antihypertensive therapy),&#xD;
&#xD;
          6. written informed consent form (ICF).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. patients with symptomatic organ damage (myocardial infarction, stroke, angina&#xD;
             pectoris, chronic kidney disease stage ≥ 4, diabetes),&#xD;
&#xD;
          2. patients with intolerance of ARB, thiazide diuretics,&#xD;
&#xD;
          3. secondary AH,&#xD;
&#xD;
          4. patients with contraindication to study drugs in accordance with Russian instruction,&#xD;
&#xD;
          5. patients currently enrolled in other clinical trials.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>35 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yury A Vasyuk, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Russian HFS</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>City Hospital №5</name>
      <address>
        <city>Moscow</city>
        <zip>107015</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Russian Federation</country>
  </location_countries>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>December 27, 2016</study_first_submitted>
  <study_first_submitted_qc>December 27, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 30, 2016</study_first_posted>
  <last_update_submitted>October 14, 2020</last_update_submitted>
  <last_update_submitted_qc>October 14, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 19, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Russian Heart Failure Society</investigator_affiliation>
    <investigator_full_name>Yury Vasyuk</investigator_full_name>
    <investigator_title>professor</investigator_title>
  </responsible_party>
  <keyword>Obesity</keyword>
  <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>
  <patient_data>
    <sharing_ipd>No</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/NCT03006796
org study id: IISR-2015-101477
nct id: NCT03006796
lead sponsor: 
has dmc: Yes
This is an observational prospective study of azilsartan medoxomil / chlorthalidone compared
      with irbesartan / hydrochlorothiazide in routine therapy of patients with arterial
      hypertension and obesity.
Observational Prospective stUdy of aZilsartan medoxomil/ chlorthalidone compared with
      irbesartan/hydrochlorothiaZide combination therapy in patients with arteriaL hypertension and
      obEsity in routine clinical practice (PUZZLE).

      The study population is 94 patients with untreated or poorly controlled arterial hypertension
      and obesity.

      The main inclusion criteria are:

        1. Male and female 35-55 year old.

        2. Diagnosis of essential arterial hypertension I-II grade.

        3. Patients with obesity (BMI ≥ 30 kg/m²)

        4. Patients with untreated arterial hypertension (clinic SBP ≥ 140 mmHg, DBP ≥ 90 mmHg and
           no previous antihypertensive treatment.

        5. Patients with poorly controlled arterial hypertension (clinic SBP ≥ 140 mmHg, DBP ≥ 90
           mmHg on previous antihypertensive treatment.

        6. Written informed consent.

      The main exclusion criteria are:

        1. Patients with symptomatic organ damage (myocardial infarction, stroke, angina pectoris,
           chronic kidney disease ≥ 4 grade, diabetes).

        2. Patients with secondary arterial hypertension.

        3. Patients with intolerance of angiotensin II receptor blockers, thiazide diuretic.

        4. Patients with contraindication to study drugs in accordance with Russian instruction.

        5. Patients currently enrolled in other clinical trials. The treatment period is 6 months.
           The study plan includes 4 basic and 1 additional visits are planned: initial visit, 3
           follow-ups (including additional) and study-end visit.
observational model: Cohort
time perspective: Prospective
measure: Clinic systolic blood pressure lowering.
time frame: From baseline (Month 0) to the study-end visit (Month 6)
description: Lowering of clinic systolic blood pressure.
measure: 24-hour systolic brachial and central blood pressure lowering.
time frame: From baseline (Month 0) to the study-end visit (Month 6).
description: Lowering of ambulatory brachial and central blood pressure.
measure: 24-hour aortic pulse wave velocity reduction.
time frame: From baseline (Month 0) to the study-end visit (Month 6).
description: Lowering of ambulatory aortic pulse wave velocity.
measure: change in proportion of patients with normal and abnormal LV geometry with assessment of LV mass index and relative wall thickness.
time frame: From baseline (Month 0) to the study-end visit (Month 6).
description: Normalization of abnormal left ventricle geometry assessed by left ventricle mass index and relative wall thickness.
arm group label: group 1 (AZL/C)
description: Group 1 - patients receiving azilsartan medoxomil/chlorthalidone 40/12.5 mg or 40/25 mg per os once a day for 6 months.
arm group label: group 2 (IRB/H)
description: Group 2 - patients receiving irbesartan/hydrochlorothiazide 150/12.5 mg or 300/25 mg per once a day for 6 months.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 35 Years
maximum age: 55 Years
healthy volunteers: No
last name: Yury A Vasyuk, MD
role: Principal Investigator
affiliation: Russian HFS
facility: 
country: Russian Federation
responsible party type: Principal Investigator
investigator affiliation: Russian Heart Failure Society
investigator full name: Yury Vasyuk
investigator title: professor
mesh term: Hypertension
mesh term: Obesity
sharing ipd: No