<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/NCT02248961</url>
  </required_header>
  <id_info>
    <org_study_id>CC09042014</org_study_id>
    <nct_id>NCT02248961</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety Evaluating Study to Compare Kanarb (Fimasartan) and Cozaar® (Losartan) in Adult Patients With Grade I-II Arterial Hypertension</brief_title>
  <official_title>Open-label, Randomized, Multicenter, Efficacy and Safety Evaluating Study to Compare Kanarb (Fimasartan), Manufactured by Boryung Pharmaceutical Co., Ltd, Republic of Korea, Tablets 60/120 mg and Cozaar® (Losartan), Manufactured by MERCK SHARP &amp; DOHME B.V., Netherlands, Tablet 50/100 mg in Adult Patients With Grade I-II Arterial Hypertension</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>R-Pharm</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Covance</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Boryung Pharmaceutical Co., Ltd</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>R-Pharm</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Assess and compare the efficacy and safety of Kanarb (Fimasartan), manufactured by Boryung&#xD;
      Pharmaceutical Co., Ltd, Republic of Korea, tablets 60/120 mg and Cozaar® (Losartan),&#xD;
      manufactured by MERCK SHARP &amp; DOHME B.V., Netherlands, tablet 50/100 mg in adult patients&#xD;
      with Grade I-II arterial hypertension in 12 weeks of therapy&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      1. To evaluate efficacy of 12-week Kanarb (Fimasartan), manufactured by Boryung&#xD;
           Pharmaceutical Co., Ltd, Republic of Korea, tablets 60/120 mg and Cozaar® (Losartan),&#xD;
           manufactured by MERCK SHARP &amp; DOHME B.V., Netherlands, tablet 50/100 mg in adult&#xD;
           patients with Grade I-II arterial hypertension.&#xD;
&#xD;
        2. To evaluate safety of 12-week Kanarb (Fimasartan), manufactured by Boryung&#xD;
           Pharmaceutical Co., Ltd, Republic of Korea, tablets 60/120 mg and Cozaar® (Losartan),&#xD;
           manufactured by MERCK SHARP &amp; DOHME B.V., Netherlands, tablet 50/100 mg in adult&#xD;
           patients with Grade I-II arterial hypertension.&#xD;
&#xD;
        3. Assess the pharmacokinetics parameters of Kanarb (Fimasartan), manufactured by Boryung&#xD;
           Pharmaceutical Co., Ltd, Republic of Korea in adult patients with arterial hypertension&#xD;
           I-II stage after a single dose.&#xD;
&#xD;
      Starting dose of Kanarb (Fimasartan), manufactured by Boryung Pharmaceutical Co., Ltd,&#xD;
      Republic of Korea is 60 mg, orally, once a day in the morning.&#xD;
&#xD;
      The planned study duration for each subject is 18 weeks maximum:&#xD;
&#xD;
      The screening period could takes up to 2 weeks (including the 1-week &quot;wash-out&quot; period ) -&#xD;
      the screening period duration depends on the prior anti-hypertensive therapy:&#xD;
&#xD;
        -  &quot;naive&quot; subjects who never received therapy (which must be reflected in the source&#xD;
           documents), may be randomized after completion of all screening procedures;&#xD;
&#xD;
        -  Subjects receiving anti-hypertensive therapy which may be discontinued without prior&#xD;
           dose reduction must undergo a 7 days &quot;wash-out&quot; period, so the screening period will&#xD;
           take at least 7 days;&#xD;
&#xD;
        -  Subjects, receiving anti-hypertensive therapy which requires dose reduction before&#xD;
           discontinuation must undergo the 7 days &quot;wash-out&quot; period after the last dose&#xD;
           administration, so the screening period will consist of dose reduction period and a&#xD;
           &quot;wash-out&quot; period.&#xD;
&#xD;
      Treatment period - 12 weeks. Follow-up period - 4 weeks. The subjects will visit the clinical&#xD;
      site every 4 weeks to measure ABP. The dose will be doubled in case if SBP ≥140 mmHg or DBP&#xD;
      ≥90 mmHg at Visit 3 (Day 28) or at Visit 4 (Day 56).&#xD;
&#xD;
      If necessary, the dose of the study drug may be increased based on the assessment of&#xD;
      patient's condition performed at the phone contact (Day14±3). Patient may be called for an&#xD;
      unscheduled visit for treatment adjustment (decided individually, with possibility of dose&#xD;
      titration as per investigator's judgment, indicated in source documents).&#xD;
&#xD;
      When possibilities are, the patient should be administrated by the study medication at the&#xD;
      same time in the morning. Governing conditions for defining the time of the drug&#xD;
      administration is the subject comfort and the time of its visits the research center.&#xD;
&#xD;
      If laboratory tests are scheduled, a patient should come to the research center fasting (food&#xD;
      is prohibited for 8 hours before the visit).&#xD;
&#xD;
      All of the clinical evaluations are conducted on the next morning after taking the&#xD;
      medication. On the visit day a patient comes to the research center not taking the drug, and&#xD;
      after all the planned procedures are conducted the patient is administrated by the drug.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>May 2014</start_date>
  <completion_date type="Actual">August 2015</completion_date>
  <primary_completion_date type="Actual">August 2015</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Systolic Blood Pressure (SBP) After 12 Weeks of Treatment</measure>
    <time_frame>Baseline and week 12 of treatment</time_frame>
    <description>The value of SBP (seated) to be registered was mean of the 3 measurements performed with interval no less than 1 minute using the manual (mercury or mechanic) tonometer after 5 minutes rest.&#xD;
&quot;Change&quot; was calculated as (Value of SBP at week 12 minus Value of SBP at baseline).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Diastolic Blood Pressure (DBP) After 4 Weeks of Treatment</measure>
    <time_frame>Baseline and week 4 of treatment</time_frame>
    <description>The value of DBP (seated) to be registered was mean of the 3 measurements performed with interval no less than 1 minute using the manual (mercury or mechanic) tonometer after 5 minutes rest.&#xD;
&quot;Change&quot; was calculated as (Value of DBP at week 4 minus Value of SBP at baseline).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in DBP After 8 Weeks of Treatment</measure>
    <time_frame>Baseline and week 8 of treatment</time_frame>
    <description>The value of DBP (seated) to be registered was mean of the 3 measurements performed with interval no less than 1 minute using the manual (mercury or mechanic) tonometer after 5 minutes rest.&#xD;
&quot;Change&quot; was calculated as (Value of DBP at week 8 minus Value of SBP at baseline).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in DBP After 12 Weeks of Treatment</measure>
    <time_frame>Baseline and week 12 of treatment</time_frame>
    <description>The value of DBP (seated) to be registered was mean of the 3 measurements performed with interval no less than 1 minute using the manual (mercury or mechanic) tonometer after 5 minutes rest.&#xD;
&quot;Change&quot; was calculated as (Value of DBP at week 12 minus Value of SBP at baseline).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in SBP After 4 Weeks of Treatment</measure>
    <time_frame>Baseline and week 4 of treatment</time_frame>
    <description>The value of SBP (seated) to be registered was mean of the 3 measurements performed with interval no less than 1 minute using the manual (mercury or mechanic) tonometer after 5 minutes rest.&#xD;
&quot;Change&quot; was calculated as (Value of SBP at week 4 minus Value of SBP at baseline).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in SBP After 8 Weeks of Treatment</measure>
    <time_frame>Baseline and week 8 of treatment</time_frame>
    <description>The value of SBP( seated) to be registered was mean of the 3 measurements performed with interval no less than 1 minute using the manual (mercury or mechanic) tonometer after 5 minutes rest.&#xD;
&quot;Change&quot; was calculated as (Value of SBP at week 8 minus Value of SBP at baseline).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects Who Responded on Therapy</measure>
    <time_frame>Week 12 of treatment</time_frame>
    <description>The subject will be considered a responder if SBP (when seated) &lt;140 mmHg or SBP decrease is &gt;10% from baseline.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">179</enrollment>
  <condition>Arterial Hypertension</condition>
  <arm_group>
    <arm_group_label>Kanarb (Fimasartan)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>88 subjects will receive Kanarb (Fimasartan), manufactured by Boryung Pharmaceutical Co., Ltd, Republic of Korea, tablets 60/120 mg for 12 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cozaar® (Losartan)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>88 subjects will receive Cozaar® (Losartan), manufactured by MERCK SHARP &amp; DOHME B.V., Netherlands, tablets 50/100 mg for 12 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fimasartan</intervention_name>
    <description>Starting dose of Kanarb (Fimasartan) is 60 mg, orally, once a day in the morning. The subjects will visit the clinical site every 4 weeks to measure Arterial blood pressure (ABP). The dose will be doubled in case if SBP ≥140 mmHg or DBP ≥90 mmHg at Visit 3 (Day 28) or at Visit 4 (Day 56).&#xD;
If necessary, the dose of the study drug may be increased based on the assessment of patient's condition performed at the phone contact (Day14±3). Patient may be called for an unscheduled visit for treatment adjustment (decided individually, with possibility of dose titration as per investigator's judgment, indicated in source documents).&#xD;
When possibilities are, the patient should be administrated by the study medication at the same time in the morning.</description>
    <arm_group_label>Kanarb (Fimasartan)</arm_group_label>
    <other_name>Kanarb</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Losartan</intervention_name>
    <description>Cozaar® (Losartan), manufactured by MERCK SHARP &amp; DOHME B.V., Netherlands, tablets 50/100 mg</description>
    <arm_group_label>Cozaar® (Losartan)</arm_group_label>
    <other_name>Cozaar®</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subjects of both sex aged 18-75 inclusively.&#xD;
&#xD;
          2. Subjects who signed their written Informed Consent for participation in the study and&#xD;
             willing to adhere to all Protocol procedures.&#xD;
&#xD;
          3. Subjects with documented diagnosis of grade I-II primary arterial hypertension within&#xD;
             at least 3 months before screening.&#xD;
&#xD;
          4. Systolic blood pressure (SBP) (when seated) at Screening (Day -14)&#xD;
&#xD;
               -  For subjects administered with anti-hypertensive therapy: SBP ≤ 179 Hg&#xD;
&#xD;
               -  For subjects receiving no anti-hypertensive therapy (so called 'naïve' patients):&#xD;
                  140≥SBP ≤179.&#xD;
&#xD;
          5. As per investigator's judgment, subjects with controlled arterial hypertension must&#xD;
             benefit from the therapy switch to Kanarb (Fimasartan), manufactured by Boryung&#xD;
             Pharmaceutical Co., Ltd, Republic of Korea, tablets 60/120 mg and Cozaar® (Losartan),&#xD;
             manufactured by MERCK SHARP &amp; DOHME B.V., Netherlands, .&#xD;
&#xD;
          6. For subjects administered with anti-hypertensive drugs: the anti-hypertensive drug may&#xD;
             be safely cancelled during the &quot;wash-out&quot; period according to the investigator's&#xD;
             judgment.&#xD;
&#xD;
          7. For women of child-bearing potential: negative urine pregnancy test at screening (Day&#xD;
             -14). 8. Systolic blood pressure (SBP) (when seated) at Randomization (Day 0) ≥140&#xD;
             mmHg and ≤179 mmHg.&#xD;
&#xD;
        9. For women of child-bearing potential: negative urine pregnancy test at Randomization&#xD;
        (Day 0)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Grade III Arterial Hypertension.&#xD;
&#xD;
          2. Arterial hypotension (SPB ≤100 mm Hg) at Screening (Day -14) and/or Randomization (Day&#xD;
             0).&#xD;
&#xD;
          3. Subjects needing treatment with more than one anti-hypertensive drug (more than one&#xD;
             active substance, including complex drugs).&#xD;
&#xD;
          4. Secondary (symptomatic) arterial hypertension.&#xD;
&#xD;
          5. Known bilateral renal arterial stenosis or unilateral renal arterial stenosis.&#xD;
&#xD;
          6. Hyperpotassemia &gt;5,0 mmol/l (as per blood biochemistry results at Screening).&#xD;
&#xD;
          7. Primary hyperaldosteronism.&#xD;
&#xD;
          8. Known hypersensitivity to angiotensin-II receptors antagonists or any other study drug&#xD;
             or comparator component.&#xD;
&#xD;
          9. Contraindications for use of angiotensin-II receptors antagonists.&#xD;
&#xD;
         10. Myocardial infarction and or unstable angina, and/or acute cerebrovascular&#xD;
             accident/transient ischemic attack, and/or percutaneous coronary intervention, and/or&#xD;
             coronary arterial bypass graft, acute coronary arteries involvement, and/or&#xD;
             obliterative vascular atherosclerosis of low extremities, and/or grade III and IV&#xD;
             retinopathy in anamnesis.&#xD;
&#xD;
         11. Clinically significant cardiac valves damage.&#xD;
&#xD;
         12. Cardiomyopathies&#xD;
&#xD;
         13. Chronic Heart failure (CHF) (except for CHF FC I NYHA).&#xD;
&#xD;
         14. Creatinine clearance less than 60 ml/min/1.73m2 calculated by Cockroft-Gault formula.&#xD;
&#xD;
         15. Known moderate to severe hepatic insufficiency and/or transaminase increase: AST&#xD;
             and/or ALT ≥2*ULN.&#xD;
&#xD;
         16. History of infections (HIV, hepatitis B or C, syphilis).&#xD;
&#xD;
         17. Uncontrolled Diabetes mellitus, Glycosylated hemoglobin level (HbA1c) &gt;7%.&#xD;
&#xD;
         18. Severe systemic diseases, such as gastro-intestinal tract diseases, autoimmune&#xD;
             disorders, blood disorders and other conditions which may affect on the study drugs'&#xD;
             absorption, distribution and and excretion.&#xD;
&#xD;
         19. Clinically significant abnormalities of laboratory parameters.&#xD;
&#xD;
         20. Drug or alcohol addiction, psychiatric disorders.&#xD;
&#xD;
         21. Medical history of oncological disease within 5 years before screening.&#xD;
&#xD;
         22. Subjects with biliary tracts obstruction.&#xD;
&#xD;
         23. Subjects with genetic disorders, such as galactose intolerance, congenital lactase&#xD;
             insufficiency and glucose-galaclose malabsorption syndrome.&#xD;
&#xD;
         24. Any other acute disease or progression and/or decompensation at the moment of&#xD;
             enrollment&#xD;
&#xD;
         25. Necessity to administer or administration of prohibited concomitant drugs from the&#xD;
             &quot;List of Prohibited Drugs&quot; within 14 days before enrollment&#xD;
&#xD;
         26. Pregnancy or breast-feeding period; fertile women not using adequate contraception&#xD;
             methods&#xD;
&#xD;
         27. Participation in another clinical trial within 3 months before Screening.&#xD;
&#xD;
         28. Other medical or psychiatric conditions or lab abnormalities that may increase&#xD;
             potential risk associated with study participation and IP administration, or that may&#xD;
             affect study results interpretation and as per investigator's judgment, make the&#xD;
             subject ineligible.&#xD;
&#xD;
         29. Study site personnel or Sponsor's representatives immediately involved in the study.&#xD;
&#xD;
         30. Subjects, excluded from the study may not be included in it again.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Federal State Institution &quot;Russian Cardiology Research and Production Complex&quot; of the Ministry of Health and Social Development of the Russian Federation (FSI &quot;Cardiology&quot; Russian Healthcare Ministry)</name>
      <address>
        <city>Moscow</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Moscow Health Department &quot;City Clinical Hospital № 81&quot;</name>
      <address>
        <city>Moscow</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>State Research Center for Preventive Medicine of Ministry of Health of the Russian gederation</name>
      <address>
        <city>Moscow</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Petersburg State health agency &quot;City Hospital number 38 it. NA Semashko &quot;</name>
      <address>
        <city>Pushkin</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Petersburg State healthcare Institution &quot;City Hospital number 28&quot; &quot;Maximilianovskaya&quot;</name>
      <address>
        <city>St. Petersburg</city>
        <zip>190000</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Hospital n. a. St. Luka</name>
      <address>
        <city>St. Petersburg</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Federal Almazov Medical Research Centre</name>
      <address>
        <city>St. Petersburg</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Petersburg State Healthcare Institution 'Diagnostic Centre #85'</name>
      <address>
        <city>St. Petersburg</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Petersburg State Institution of Health &quot;City Hospital № 15&quot;</name>
      <address>
        <city>St. Petersburg</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Petersburg State Institution of Healthcare &quot;Pokrovskaya City Hospital&quot;</name>
      <address>
        <city>St. Petersburg</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>State Budget Education Institution of Higher Professional Education &quot;North-Western State Medical University named after I.I. Mechnikov&quot; on base St. Petersburg State Institution of Healthcare &quot;Pokrovskaya City Hospital&quot;</name>
      <address>
        <city>St. Petersburg</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>State Budget Education Institution of Higher Professional Education &quot;North-Western State Medical University named after I.I. Mechnikov&quot;, the department faculty and hospital care, court number 5</name>
      <address>
        <city>St. Petersburg</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Troitsk City Hospital</name>
      <address>
        <city>Troitsk</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Russian Federation</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>September 22, 2014</study_first_submitted>
  <study_first_submitted_qc>September 22, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2014</study_first_posted>
  <results_first_submitted>July 30, 2018</results_first_submitted>
  <results_first_submitted_qc>February 5, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">May 6, 2019</results_first_posted>
  <last_update_submitted>February 5, 2019</last_update_submitted>
  <last_update_submitted_qc>February 5, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 6, 2019</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>Losartan</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Participants recruitment was conducted in 13 clinical sites of Moscow and Saint-Petersburg between May and October of 2014</recruitment_details>
      <pre_assignment_details>Duration of screening period was up to 14 days depended on prior antihypertensive treatment. 184 patients were screened, 179 randomized.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Kanarb (Fimasartan)</title>
          <description>60/120 mg Kanarb (Fimasartan) administered orally once a day in the morning for 12 weeks period</description>
        </group>
        <group group_id="P2">
          <title>Cozaar® (Losartan)</title>
          <description>50/100 mg Cozaar® (Losartan) administered orally once a day for 12 week period</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="89"/>
                <participants group_id="P2" count="90"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="86"/>
                <participants group_id="P2" count="88"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Unmet inclusion/exclusion criteria</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Full Analysis Set Population (FAS) - those subjects from Intent-to-treat population (ITT, all randomized patients), who had at least one assessment for efficacy analysis after the start of therapy.</population>
      <group_list>
        <group group_id="B1">
          <title>Kanarb (Fimasartan)</title>
          <description>60/120 mg Kanarb (Fimasartan) administered orally once a day in the morning for 12 weeks period</description>
        </group>
        <group group_id="B2">
          <title>Cozaar® (Losartan)</title>
          <description>50/100 mg Cozaar® (Losartan) administered orally once a day for 12 week period</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="89"/>
            <count group_id="B2" value="90"/>
            <count group_id="B3" value="179"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="53.4" lower_limit="25.6" upper_limit="75.9"/>
                    <measurement group_id="B2" value="53.8" lower_limit="21.9" upper_limit="73.2"/>
                    <measurement group_id="B3" value="53.6" lower_limit="21.9" upper_limit="75.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="30"/>
                    <measurement group_id="B2" value="34"/>
                    <measurement group_id="B3" value="64"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="59"/>
                    <measurement group_id="B2" value="56"/>
                    <measurement group_id="B3" value="115"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>European</title>
                  <measurement_list>
                    <measurement group_id="B1" value="87"/>
                    <measurement group_id="B2" value="90"/>
                    <measurement group_id="B3" value="177"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>BMI</title>
          <description>Body Mass Index calculated as weight(kg)/height(m^2)</description>
          <units>kg/m^2</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="29.4" lower_limit="20.3" upper_limit="50.5"/>
                    <measurement group_id="B2" value="28.9" lower_limit="20.7" upper_limit="41.7"/>
                    <measurement group_id="B3" value="29.1" lower_limit="20.3" upper_limit="50.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Arterial hypertension (AH) duration</title>
          <description>The duration of AH in patients at study inclusion in population of all randomized patients</description>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5.8" lower_limit="0.3" upper_limit="19.2"/>
                    <measurement group_id="B2" value="6.2" lower_limit="0.3" upper_limit="33.1"/>
                    <measurement group_id="B3" value="6.0" lower_limit="0.3" upper_limit="33.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Hypertension grade</title>
          <description>The grade of blood pressure increase was determined in accordance with Russian guidelines (fourth revision) &quot;Diagnosis and treatment of arterial hypertension&quot;.&#xD;
Grade I AH: sistolic blood pressure (SBP) 140-159 mmHg and/or diastolic blood pressure (DBP) 90-99 mmHg&#xD;
Grade II AH: sistolic blood pressure (SBP) 160-179 mmHg and/or diastolic blood pressure (DBP) 100-109 mmHg</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Grade I</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="27"/>
                    <measurement group_id="B3" value="47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade II</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="69"/>
                    <measurement group_id="B2" value="63"/>
                    <measurement group_id="B3" value="132"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Chronic heart failure (CHF) NYHA Class I</title>
          <description>Patients with no limitation of physical activity (ordinary physical activity does not cause undue fatigue, palpitation, dyspnea - shortness of breath) but having symptoms of chronic heart failure could be defined as NYHA (New-York Heart Association) Class I of chronic heart failure</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Prior therapy for arterial hypertension</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="55"/>
                    <measurement group_id="B2" value="46"/>
                    <measurement group_id="B3" value="101"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Smoking history</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Smoker</title>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B2" value="62"/>
                    <measurement group_id="B3" value="81"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Has never smoked</title>
                  <measurement_list>
                    <measurement group_id="B1" value="63"/>
                    <measurement group_id="B2" value="21"/>
                    <measurement group_id="B3" value="84"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Smoker-in-the-past</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Alcohol history</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Drinking</title>
                  <measurement_list>
                    <measurement group_id="B1" value="52"/>
                    <measurement group_id="B2" value="57"/>
                    <measurement group_id="B3" value="109"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Never-drinking</title>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                    <measurement group_id="B2" value="23"/>
                    <measurement group_id="B3" value="48"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Drinking-in-the-past</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="21"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change in Systolic Blood Pressure (SBP) After 12 Weeks of Treatment</title>
        <description>The value of SBP (seated) to be registered was mean of the 3 measurements performed with interval no less than 1 minute using the manual (mercury or mechanic) tonometer after 5 minutes rest.&#xD;
&quot;Change&quot; was calculated as (Value of SBP at week 12 minus Value of SBP at baseline).</description>
        <time_frame>Baseline and week 12 of treatment</time_frame>
        <population>Full Analysis Set Population (FAS) - those subjects from Intent-to-treat population (ITT, all randomized patients), who had at least one assessment for efficacy analysis after the start of therapy. Last observation carried forward (LOCF) imputation method.</population>
        <group_list>
          <group group_id="O1">
            <title>Kanarb (Fimasartan)</title>
            <description>60/120 mg Kanarb (Fimasartan) administered orally once a day in the morning for 12 weeks period</description>
          </group>
          <group group_id="O2">
            <title>Cozaar® (Losartan)</title>
            <description>50/100 mg Cozaar® (Losartan) administered orally once a day for 12 week period</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Systolic Blood Pressure (SBP) After 12 Weeks of Treatment</title>
          <description>The value of SBP (seated) to be registered was mean of the 3 measurements performed with interval no less than 1 minute using the manual (mercury or mechanic) tonometer after 5 minutes rest.&#xD;
&quot;Change&quot; was calculated as (Value of SBP at week 12 minus Value of SBP at baseline).</description>
          <population>Full Analysis Set Population (FAS) - those subjects from Intent-to-treat population (ITT, all randomized patients), who had at least one assessment for efficacy analysis after the start of therapy. Last observation carried forward (LOCF) imputation method.</population>
          <units>mm Hg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="89"/>
                <count group_id="O2" value="90"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>SBP at Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="152.9" spread="5.9"/>
                    <measurement group_id="O2" value="151.9" spread="5.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline at Week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-25.2" spread="8.6"/>
                    <measurement group_id="O2" value="-24.3" spread="7.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The null hypothesis (H0) is that there is a decrease in SBP on the background treatment with Kanarb (fimasartan), that is at least 5.5 mmHg lower compared to Cozaar® (losartan).&#xD;
Test of the hypotheses was performed using mixed linear models, where the site effect was considered a random effect, and the treatment group effect was considered a fixed effect. Baseline SBP on the study arm was included into the model as a covariate (a fixed effect) in all cases.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>It was calculated that at least 140 patients (70 patients per group) must be enrolled into the study to achieve 80% power. With regard to 20% of patients withdrawn prematurely or data not suitable for analysis, it was necessary to include at least 176 patients (88 per group) into the study.</non_inferiority_desc>
            <p_value>=0.390</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.18</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.00</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>1-Sided</ci_n_sides>
            <ci_upper_limit>1.47</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Diastolic Blood Pressure (DBP) After 4 Weeks of Treatment</title>
        <description>The value of DBP (seated) to be registered was mean of the 3 measurements performed with interval no less than 1 minute using the manual (mercury or mechanic) tonometer after 5 minutes rest.&#xD;
&quot;Change&quot; was calculated as (Value of DBP at week 4 minus Value of SBP at baseline).</description>
        <time_frame>Baseline and week 4 of treatment</time_frame>
        <population>All randomized patients, who had at least one assessment for efficacy analysis after the start of therapy. One patient (Kanarb (fimasartan) treatment group) was withdrawn from the study by the time of assessment at week 4.</population>
        <group_list>
          <group group_id="O1">
            <title>Kanarb (Fimasartan)</title>
            <description>60/120 mg Kanarb (Fimasartan) administered orally once a day in the morning for 12 weeks period</description>
          </group>
          <group group_id="O2">
            <title>Cozaar® (Losartan)</title>
            <description>50/100 mg Cozaar® (Losartan) administered orally once a day for 12 week period</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Diastolic Blood Pressure (DBP) After 4 Weeks of Treatment</title>
          <description>The value of DBP (seated) to be registered was mean of the 3 measurements performed with interval no less than 1 minute using the manual (mercury or mechanic) tonometer after 5 minutes rest.&#xD;
&quot;Change&quot; was calculated as (Value of DBP at week 4 minus Value of SBP at baseline).</description>
          <population>All randomized patients, who had at least one assessment for efficacy analysis after the start of therapy. One patient (Kanarb (fimasartan) treatment group) was withdrawn from the study by the time of assessment at week 4.</population>
          <units>mm Hg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="89"/>
                <count group_id="O2" value="90"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>DBP at Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="89"/>
                    <count group_id="O2" value="90"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="88.7" spread="8.1"/>
                    <measurement group_id="O2" value="89.6" spread="6.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline at Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="88"/>
                    <count group_id="O2" value="90"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-9.5" spread="9.1"/>
                    <measurement group_id="O2" value="-7.4" spread="7.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>=0.018</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>The investigational site was included as random effect. The baseline levels of SBP and the treatment group were included as fixed effects.</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in DBP After 8 Weeks of Treatment</title>
        <description>The value of DBP (seated) to be registered was mean of the 3 measurements performed with interval no less than 1 minute using the manual (mercury or mechanic) tonometer after 5 minutes rest.&#xD;
&quot;Change&quot; was calculated as (Value of DBP at week 8 minus Value of SBP at baseline).</description>
        <time_frame>Baseline and week 8 of treatment</time_frame>
        <population>All randomized patients, who had at least one assessment for efficacy analysis after the start of therapy. One patient (Kanarb (fimasartan) treatment group) was withdrawn from the study by the time of assessment at week 8.</population>
        <group_list>
          <group group_id="O1">
            <title>Kanarb (Fimasartan)</title>
            <description>60/120 mg Kanarb (Fimasartan) administered orally once a day in the morning for 12 weeks period</description>
          </group>
          <group group_id="O2">
            <title>Cozaar® (Losartan)</title>
            <description>50/100 mg Cozaar® (Losartan) administered orally once a day for 12 week period</description>
          </group>
        </group_list>
        <measure>
          <title>Change in DBP After 8 Weeks of Treatment</title>
          <description>The value of DBP (seated) to be registered was mean of the 3 measurements performed with interval no less than 1 minute using the manual (mercury or mechanic) tonometer after 5 minutes rest.&#xD;
&quot;Change&quot; was calculated as (Value of DBP at week 8 minus Value of SBP at baseline).</description>
          <population>All randomized patients, who had at least one assessment for efficacy analysis after the start of therapy. One patient (Kanarb (fimasartan) treatment group) was withdrawn from the study by the time of assessment at week 8.</population>
          <units>mm Hg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="89"/>
                <count group_id="O2" value="90"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>DBP at Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="89"/>
                    <count group_id="O2" value="90"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="88.7" spread="8.1"/>
                    <measurement group_id="O2" value="89.6" spread="6.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline at Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="88"/>
                    <count group_id="O2" value="90"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-10.3" spread="9.5"/>
                    <measurement group_id="O2" value="-10.7" spread="7.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>=0.579</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>The investigational site was included as random effect. The baseline levels of SBP and the treatment group were included as fixed effects.</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in DBP After 12 Weeks of Treatment</title>
        <description>The value of DBP (seated) to be registered was mean of the 3 measurements performed with interval no less than 1 minute using the manual (mercury or mechanic) tonometer after 5 minutes rest.&#xD;
&quot;Change&quot; was calculated as (Value of DBP at week 12 minus Value of SBP at baseline).</description>
        <time_frame>Baseline and week 12 of treatment</time_frame>
        <population>One patient (Kanarb (fimasartan) treatment group) was withdrawn from the study by the time of assessment at week 12</population>
        <group_list>
          <group group_id="O1">
            <title>Kanarb (Fimasartan)</title>
            <description>60/120 mg Kanarb (Fimasartan) administered orally once a day in the morning for 12 weeks period</description>
          </group>
          <group group_id="O2">
            <title>Cozaar® (Losartan)</title>
            <description>50/100 mg Cozaar® (Losartan) administered orally once a day for 12 week period</description>
          </group>
        </group_list>
        <measure>
          <title>Change in DBP After 12 Weeks of Treatment</title>
          <description>The value of DBP (seated) to be registered was mean of the 3 measurements performed with interval no less than 1 minute using the manual (mercury or mechanic) tonometer after 5 minutes rest.&#xD;
&quot;Change&quot; was calculated as (Value of DBP at week 12 minus Value of SBP at baseline).</description>
          <population>One patient (Kanarb (fimasartan) treatment group) was withdrawn from the study by the time of assessment at week 12</population>
          <units>mm Hg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="89"/>
                <count group_id="O2" value="88"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>DBP at Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="89"/>
                    <count group_id="O2" value="88"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="88.7" spread="8.1"/>
                    <measurement group_id="O2" value="89.6" spread="6.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline at Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="88"/>
                    <count group_id="O2" value="88"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-10.6" spread="8.8"/>
                    <measurement group_id="O2" value="-11.3" spread="7.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>=0.466</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>The investigational site was included as random effect. The baseline levels of SBP and the treatment group were included as fixed effects.</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in SBP After 4 Weeks of Treatment</title>
        <description>The value of SBP (seated) to be registered was mean of the 3 measurements performed with interval no less than 1 minute using the manual (mercury or mechanic) tonometer after 5 minutes rest.&#xD;
&quot;Change&quot; was calculated as (Value of SBP at week 4 minus Value of SBP at baseline).</description>
        <time_frame>Baseline and week 4 of treatment</time_frame>
        <population>One patient (Kanarb (fimasartan) treatment group) was withdrawn from the study by the time of assessment at week 4</population>
        <group_list>
          <group group_id="O1">
            <title>Kanarb (Fimasartan)</title>
            <description>60/120 mg Kanarb (Fimasartan) administered orally once a day in the morning for 12 weeks period</description>
          </group>
          <group group_id="O2">
            <title>Cozaar® (Losartan)</title>
            <description>50/100 mg Cozaar® (Losartan) administered orally once a day for 12 week period</description>
          </group>
        </group_list>
        <measure>
          <title>Change in SBP After 4 Weeks of Treatment</title>
          <description>The value of SBP (seated) to be registered was mean of the 3 measurements performed with interval no less than 1 minute using the manual (mercury or mechanic) tonometer after 5 minutes rest.&#xD;
&quot;Change&quot; was calculated as (Value of SBP at week 4 minus Value of SBP at baseline).</description>
          <population>One patient (Kanarb (fimasartan) treatment group) was withdrawn from the study by the time of assessment at week 4</population>
          <units>mm Hg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="89"/>
                <count group_id="O2" value="90"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>SBP at Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="89"/>
                    <count group_id="O2" value="90"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="152.9" spread="5.9"/>
                    <measurement group_id="O2" value="151.9" spread="5.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline at Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="88"/>
                    <count group_id="O2" value="90"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-19.7" spread="10.3"/>
                    <measurement group_id="O2" value="-17.6" spread="10.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>=0.118</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>The investigational site was included as random effect. The baseline levels of SBP and the treatment group were included as fixed effects.</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in SBP After 8 Weeks of Treatment</title>
        <description>The value of SBP( seated) to be registered was mean of the 3 measurements performed with interval no less than 1 minute using the manual (mercury or mechanic) tonometer after 5 minutes rest.&#xD;
&quot;Change&quot; was calculated as (Value of SBP at week 8 minus Value of SBP at baseline).</description>
        <time_frame>Baseline and week 8 of treatment</time_frame>
        <population>One patient (Kanarb (fimasartan) treatment group) was withdrawn from the study by the time of assessment at week 8</population>
        <group_list>
          <group group_id="O1">
            <title>Kanarb (Fimasartan)</title>
            <description>60/120 mg Kanarb (Fimasartan) administered orally once a day in the morning for 12 weeks period</description>
          </group>
          <group group_id="O2">
            <title>Cozaar® (Losartan)</title>
            <description>50/100 mg Cozaar® (Losartan) administered orally once a day for 12 week period</description>
          </group>
        </group_list>
        <measure>
          <title>Change in SBP After 8 Weeks of Treatment</title>
          <description>The value of SBP( seated) to be registered was mean of the 3 measurements performed with interval no less than 1 minute using the manual (mercury or mechanic) tonometer after 5 minutes rest.&#xD;
&quot;Change&quot; was calculated as (Value of SBP at week 8 minus Value of SBP at baseline).</description>
          <population>One patient (Kanarb (fimasartan) treatment group) was withdrawn from the study by the time of assessment at week 8</population>
          <units>mm Hg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="89"/>
                <count group_id="O2" value="90"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>SBP at Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="152.9" spread="5.9"/>
                    <measurement group_id="O2" value="151.9" spread="5.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline at Week 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-23.5" spread="9.0"/>
                    <measurement group_id="O2" value="-23.9" spread="8.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>=0.662</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>The investigational site was included as random effect. The baseline levels of SBP and the treatment group were included as fixed effects.</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects Who Responded on Therapy</title>
        <description>The subject will be considered a responder if SBP (when seated) &lt;140 mmHg or SBP decrease is &gt;10% from baseline.</description>
        <time_frame>Week 12 of treatment</time_frame>
        <population>Full Analysis Set Population (FAS) - those subjects from Intent-to-treat population (ITT, all randomized patients), who had at least one assessment for efficacy analysis after the start of therapy. Last observation carried forward (LOCF) imputation method.</population>
        <group_list>
          <group group_id="O1">
            <title>Kanarb (Fimasartan)</title>
            <description>60/120 mg Kanarb (Fimasartan) administered orally once a day in the morning for 12 weeks period</description>
          </group>
          <group group_id="O2">
            <title>Cozaar® (Losartan)</title>
            <description>50/100 mg Cozaar® (Losartan) administered orally once a day for 12 week period</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects Who Responded on Therapy</title>
          <description>The subject will be considered a responder if SBP (when seated) &lt;140 mmHg or SBP decrease is &gt;10% from baseline.</description>
          <population>Full Analysis Set Population (FAS) - those subjects from Intent-to-treat population (ITT, all randomized patients), who had at least one assessment for efficacy analysis after the start of therapy. Last observation carried forward (LOCF) imputation method.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="89"/>
                <count group_id="O2" value="90"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="85"/>
                    <measurement group_id="O2" value="90"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>=0.143</p_value>
            <method>Mantel Haenszel</method>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>18 weeks</time_frame>
      <desc>The number and percent of subjects and number and group of AEs will be performed within every organ/system group</desc>
      <group_list>
        <group group_id="E1">
          <title>Kanarb (Fimasartan)</title>
          <description>60/120 mg Kanarb (Fimasartan) administered orally once a day in the morning for 12 weeks period</description>
        </group>
        <group group_id="E2">
          <title>Cozaar® (Losartan)</title>
          <description>50/100 mg Cozaar® (Losartan) administered orally once a day for 12 week period</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="90"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA (16.1)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="20" subjects_at_risk="89"/>
                <counts group_id="E2" subjects_affected="15" subjects_at_risk="90"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="89"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Hypochromic anaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="90"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="90"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Conjunctival oedema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Dry eye</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="90"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Irritable bowel syndrome</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="89"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="90"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="89"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="90"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="89"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Pharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="89"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Respiratory tract infection viral</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="89"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Rhinitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="89"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="90"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Contusion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="89"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="90"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="89"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="89"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Blood alkaline phosphatase increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Blood cholesterol increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="89"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Blood creatine phosphokinase increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="89"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Blood pressure increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="89"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Creatinine renal clearance decreased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="89"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Low density lipoprotein increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="89"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="90"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Hyperkalaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="90"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="90"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="89"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="89"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="90"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Renal impairment</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="90"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="89"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Urticaria</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="89"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="90"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertensive crisis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="90"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>Any study related information could be made public availiable only after Sponsors written permission.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Boris Berezhanskiy, Medical Advisor</name_or_title>
      <organization>R-Pharm</organization>
      <phone>0074959567937 ext 2468</phone>
      <email>berezhanskiy@rpharm.ru</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02248961
org study id: CC09042014
nct id: NCT02248961
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
Assess and compare the efficacy and safety of Kanarb (Fimasartan), manufactured by Boryung
      Pharmaceutical Co., Ltd, Republic of Korea, tablets 60/120 mg and Cozaar® (Losartan),
      manufactured by MERCK SHARP & DOHME B.V., Netherlands, tablet 50/100 mg in adult patients
      with Grade I-II arterial hypertension in 12 weeks of therapy
1. To evaluate efficacy of 12-week Kanarb (Fimasartan), manufactured by Boryung
           Pharmaceutical Co., Ltd, Republic of Korea, tablets 60/120 mg and Cozaar® (Losartan),
           manufactured by MERCK SHARP & DOHME B.V., Netherlands, tablet 50/100 mg in adult
           patients with Grade I-II arterial hypertension.

        2. To evaluate safety of 12-week Kanarb (Fimasartan), manufactured by Boryung
           Pharmaceutical Co., Ltd, Republic of Korea, tablets 60/120 mg and Cozaar® (Losartan),
           manufactured by MERCK SHARP & DOHME B.V., Netherlands, tablet 50/100 mg in adult
           patients with Grade I-II arterial hypertension.

        3. Assess the pharmacokinetics parameters of Kanarb (Fimasartan), manufactured by Boryung
           Pharmaceutical Co., Ltd, Republic of Korea in adult patients with arterial hypertension
           I-II stage after a single dose.

      Starting dose of Kanarb (Fimasartan), manufactured by Boryung Pharmaceutical Co., Ltd,
      Republic of Korea is 60 mg, orally, once a day in the morning.

      The planned study duration for each subject is 18 weeks maximum:

      The screening period could takes up to 2 weeks (including the 1-week "wash-out" period ) -
      the screening period duration depends on the prior anti-hypertensive therapy:

        -  "naive" subjects who never received therapy (which must be reflected in the source
           documents), may be randomized after completion of all screening procedures;

        -  Subjects receiving anti-hypertensive therapy which may be discontinued without prior
           dose reduction must undergo a 7 days "wash-out" period, so the screening period will
           take at least 7 days;

        -  Subjects, receiving anti-hypertensive therapy which requires dose reduction before
           discontinuation must undergo the 7 days "wash-out" period after the last dose
           administration, so the screening period will consist of dose reduction period and a
           "wash-out" period.

      Treatment period - 12 weeks. Follow-up period - 4 weeks. The subjects will visit the clinical
      site every 4 weeks to measure ABP. The dose will be doubled in case if SBP ≥140 mmHg or DBP
      ≥90 mmHg at Visit 3 (Day 28) or at Visit 4 (Day 56).

      If necessary, the dose of the study drug may be increased based on the assessment of
      patient's condition performed at the phone contact (Day14±3). Patient may be called for an
      unscheduled visit for treatment adjustment (decided individually, with possibility of dose
      titration as per investigator's judgment, indicated in source documents).

      When possibilities are, the patient should be administrated by the study medication at the
      same time in the morning. Governing conditions for defining the time of the drug
      administration is the subject comfort and the time of its visits the research center.

      If laboratory tests are scheduled, a patient should come to the research center fasting (food
      is prohibited for 8 hours before the visit).

      All of the clinical evaluations are conducted on the next morning after taking the
      medication. On the visit day a patient comes to the research center not taking the drug, and
      after all the planned procedures are conducted the patient is administrated by the drug.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in Systolic Blood Pressure (SBP) After 12 Weeks of Treatment
time frame: Baseline and week 12 of treatment
description: The value of SBP (seated) to be registered was mean of the 3 measurements performed with interval no less than 1 minute using the manual (mercury or mechanic) tonometer after 5 minutes rest.
"Change" was calculated as (Value of SBP at week 12 minus Value of SBP at baseline).
measure: Change in Diastolic Blood Pressure (DBP) After 4 Weeks of Treatment
time frame: Baseline and week 4 of treatment
description: The value of DBP (seated) to be registered was mean of the 3 measurements performed with interval no less than 1 minute using the manual (mercury or mechanic) tonometer after 5 minutes rest.
"Change" was calculated as (Value of DBP at week 4 minus Value of SBP at baseline).
measure: Change in DBP After 8 Weeks of Treatment
time frame: Baseline and week 8 of treatment
description: The value of DBP (seated) to be registered was mean of the 3 measurements performed with interval no less than 1 minute using the manual (mercury or mechanic) tonometer after 5 minutes rest.
"Change" was calculated as (Value of DBP at week 8 minus Value of SBP at baseline).
measure: Change in DBP After 12 Weeks of Treatment
time frame: Baseline and week 12 of treatment
description: The value of DBP (seated) to be registered was mean of the 3 measurements performed with interval no less than 1 minute using the manual (mercury or mechanic) tonometer after 5 minutes rest.
"Change" was calculated as (Value of DBP at week 12 minus Value of SBP at baseline).
measure: Change in SBP After 4 Weeks of Treatment
time frame: Baseline and week 4 of treatment
description: The value of SBP (seated) to be registered was mean of the 3 measurements performed with interval no less than 1 minute using the manual (mercury or mechanic) tonometer after 5 minutes rest.
"Change" was calculated as (Value of SBP at week 4 minus Value of SBP at baseline).
measure: Change in SBP After 8 Weeks of Treatment
time frame: Baseline and week 8 of treatment
description: The value of SBP( seated) to be registered was mean of the 3 measurements performed with interval no less than 1 minute using the manual (mercury or mechanic) tonometer after 5 minutes rest.
"Change" was calculated as (Value of SBP at week 8 minus Value of SBP at baseline).
measure: Number of Subjects Who Responded on Therapy
time frame: Week 12 of treatment
description: The subject will be considered a responder if SBP (when seated) <140 mmHg or SBP decrease is >10% from baseline.
arm group label: Kanarb (Fimasartan)
arm group type: Experimental
description: 88 subjects will receive Kanarb (Fimasartan), manufactured by Boryung Pharmaceutical Co., Ltd, Republic of Korea, tablets 60/120 mg for 12 weeks
arm group label: Cozaar® (Losartan)
arm group type: Active Comparator
description: 88 subjects will receive Cozaar® (Losartan), manufactured by MERCK SHARP & DOHME B.V., Netherlands, tablets 50/100 mg for 12 weeks
intervention type: Drug
intervention name: Fimasartan
description: Starting dose of Kanarb (Fimasartan) is 60 mg, orally, once a day in the morning. The subjects will visit the clinical site every 4 weeks to measure Arterial blood pressure (ABP). The dose will be doubled in case if SBP ≥140 mmHg or DBP ≥90 mmHg at Visit 3 (Day 28) or at Visit 4 (Day 56).
If necessary, the dose of the study drug may be increased based on the assessment of patient's condition performed at the phone contact (Day14±3). Patient may be called for an unscheduled visit for treatment adjustment (decided individually, with possibility of dose titration as per investigator's judgment, indicated in source documents).
When possibilities are, the patient should be administrated by the study medication at the same time in the morning.
arm group label: Kanarb (Fimasartan)
other name: Kanarb
intervention type: Drug
intervention name: Losartan
description: Cozaar® (Losartan), manufactured by MERCK SHARP & DOHME B.V., Netherlands, tablets 50/100 mg
arm group label: Cozaar® (Losartan)
other name: Cozaar®
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Russian Federation
responsible party type: Sponsor
mesh term: Hypertension
mesh term: Losartan
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 