<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/NCT03814148</url>
  </required_header>
  <id_info>
    <org_study_id>EMS0618-LENINGRADO 5</org_study_id>
    <nct_id>NCT03814148</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety of Leningrado 5 Association in the Treatment of Hypertension</brief_title>
  <official_title>Randomized, Double-blind, Double-dummy, National, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Leningrado 5 Association in the Treatment of Hypertension</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>EMS</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>EMS</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the efficacy and safety of Leningrado 5 association&#xD;
      on the treatment of hypertension.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    The design of this protocol was rewritten due to regulatory recommendations.&#xD;
  </why_stopped>
  <start_date type="Anticipated">June 2019</start_date>
  <completion_date type="Anticipated">September 2020</completion_date>
  <primary_completion_date type="Anticipated">June 2020</primary_completion_date>
  <phase>Phase 3</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in systolic blood pressure levels, as measured by ABPM at the initial visit and final visit.</measure>
    <time_frame>70 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence and severity of adverse events recorded during the study</measure>
    <time_frame>101 days</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Arterial Hypertension</condition>
  <arm_group>
    <arm_group_label>LENINGRADO 5</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The study is double-dummy. Thus, the patient will take 2 tablets, as follow:&#xD;
1 tablet Leningrado 5 association and 1 tablet Natrilix® SR placebo.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Natrilix® SR</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The study is double-dummy. Thus, the patient will take 2 tablets, as follow:&#xD;
1 tablet Natrilix® SR 1,5 mg and 1 tablet Leningrado 5 association placebo.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>LENINGRADO 5 association</intervention_name>
    <description>1 coated sustained-release tablet, oral, once a day.</description>
    <arm_group_label>LENINGRADO 5</arm_group_label>
    <other_name>EMS association</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Natrilix® SR</intervention_name>
    <description>1 coated sustained-release tablet, oral, once a day.</description>
    <arm_group_label>Natrilix® SR</arm_group_label>
    <other_name>Indapamide SR 1,5 mg</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Natrilix SR Placebo</intervention_name>
    <description>1 coated sustained-release tablet, oral, once a day.</description>
    <arm_group_label>LENINGRADO 5</arm_group_label>
    <other_name>Placebo</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Leningrado 5 association Placebo</intervention_name>
    <description>1 coated sustained-release tablet, oral, once a day.</description>
    <arm_group_label>Natrilix® SR</arm_group_label>
    <other_name>Placebo</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants aged 18 years or more;&#xD;
&#xD;
          -  Participants diagnosed with hypertension, not controlled by monotherapy and/ or&#xD;
             lifestyle modification;&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any clinical and laboratory findings that, in the judgment of the investigator, may&#xD;
             interfere with the safety of research participants;&#xD;
&#xD;
          -  BP ≥ 180/110 mmHg;&#xD;
&#xD;
          -  Participants with BMI (body mass index) ≥ 40 Kg/m2;&#xD;
&#xD;
          -  Previous diagnosis of secondary hypertension;&#xD;
&#xD;
          -  History of Target Organ Injury;&#xD;
&#xD;
          -  History of cardiovascular, hepatic and renal disease;&#xD;
&#xD;
          -  History of gout, Diabetes Mellitus and hypokalemia;&#xD;
&#xD;
          -  Current medical history of cancer;&#xD;
&#xD;
          -  Current smoking;&#xD;
&#xD;
          -  History of alcohol abuse or drug use;&#xD;
&#xD;
          -  Pregnancy or risk of pregnancy and lactating patients;&#xD;
&#xD;
          -  Known allergy or hypersensitivity to the medicines components used during the clinical&#xD;
             trial;&#xD;
&#xD;
          -  Participation in clinical trial in the year prior to this study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>January 22, 2019</study_first_submitted>
  <study_first_submitted_qc>January 22, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 23, 2019</study_first_posted>
  <last_update_submitted>February 22, 2021</last_update_submitted>
  <last_update_submitted_qc>February 22, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 24, 2021</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>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Indapamide</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/NCT03814148
org study id: EMS0618-LENINGRADO 5
nct id: NCT03814148
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to evaluate the efficacy and safety of Leningrado 5 association
      on the treatment of hypertension.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Change in systolic blood pressure levels, as measured by ABPM at the initial visit and final visit.
time frame: 70 days
measure: Incidence and severity of adverse events recorded during the study
time frame: 101 days
arm group label: LENINGRADO 5
arm group type: Experimental
description: The study is double-dummy. Thus, the patient will take 2 tablets, as follow:
1 tablet Leningrado 5 association and 1 tablet Natrilix® SR placebo.
arm group label: Natrilix® SR
arm group type: Active Comparator
description: The study is double-dummy. Thus, the patient will take 2 tablets, as follow:
1 tablet Natrilix® SR 1,5 mg and 1 tablet Leningrado 5 association placebo.
intervention type: Drug
intervention name: LENINGRADO 5 association
description: 1 coated sustained-release tablet, oral, once a day.
arm group label: LENINGRADO 5
other name: EMS association
intervention type: Drug
intervention name: Natrilix® SR
description: 1 coated sustained-release tablet, oral, once a day.
arm group label: Natrilix® SR
other name: Indapamide SR 1,5 mg
intervention type: Other
intervention name: Natrilix SR Placebo
description: 1 coated sustained-release tablet, oral, once a day.
arm group label: LENINGRADO 5
other name: Placebo
intervention type: Other
intervention name: Leningrado 5 association Placebo
description: 1 coated sustained-release tablet, oral, once a day.
arm group label: Natrilix® SR
other name: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
responsible party type: Sponsor
mesh term: Hypertension
mesh term: Indapamide