<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/NCT04457323</url>
  </required_header>
  <id_info>
    <org_study_id>NEU-03.17</org_study_id>
    <nct_id>NCT04457323</nct_id>
  </id_info>
  <brief_title>S-Metoprolol XR 25-50 mg Tablets vs Metoprolol Zok 50-100 mg Tablets in Hypertension Patients.</brief_title>
  <official_title>Comparison of Efficacy and Safety of S-Metoprolol XR 25-50 mg Tablets and Metoprolol Zok 50-100 mg Tablets in Hypertensive Patients.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Neutec Ar-Ge San ve Tic A.Ş</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Neutec Ar-Ge San ve Tic A.Ş</source>
  <oversight_info>
    <has_dmc>No</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 aim of this study is to compare the efficacy and safety of S-Metoprolol XR 25 and 50 mg&#xD;
      Film Coated Tablets and Beloc® (Metoprolol) Zok 50 and 100 mg Controlled Release Film Tablets&#xD;
      administered once daily, in the treatment of hypertension.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Not yet recruiting</overall_status>
  <start_date type="Anticipated">January 15, 2022</start_date>
  <completion_date type="Anticipated">December 15, 2022</completion_date>
  <primary_completion_date type="Anticipated">October 15, 2022</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in systolic and diastolic blood pressure between 0-4 weeks of treatment</measure>
    <time_frame>4-weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in systolic blood pressure between 0-8 weeks of treatment.</measure>
    <time_frame>8-weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in diastolic blood pressure between 0-8 weeks of treatment.</measure>
    <time_frame>8-weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in diastolic blood pressure between 4-8 weeks of treatment.</measure>
    <time_frame>4-weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in sistolic blood pressure between 4-8 weeks of treatment.</measure>
    <time_frame>8-weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Treatment response rates</measure>
    <time_frame>4-weeks</time_frame>
    <description>Target blood pressure values were determined by decreasing more than 20mmHg in systolic blood pressure and / or decreasing more than 10mmHg in diastolic pressure (under systolic 140 mmHg, below diastolic 90 mmHg).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">126</enrollment>
  <condition>Hypertension</condition>
  <arm_group>
    <arm_group_label>Test</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>S-Metoprolol XR 25 mg Film Coated Tablets (first four weeks) S-Metoprolol XR 50 mg Film Coated Tablets (second four weeks)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>REFERENCE</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Beloc® (Metoprolol) Zok 50 mg Controlled Release Film Tablets (first four weeks) Beloc® (Metoprolol) Zok 100 mg Controlled Release Film Tablets (second four weeks)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Metoprolol</intervention_name>
    <description>S-Metoprolol XR 25 mg and 50 mg Film Coated Tablets</description>
    <arm_group_label>Test</arm_group_label>
    <other_name>S-metoprolol</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Metoprolol</intervention_name>
    <description>Beloc® (Metoprolol) Zok 50 mg and 100 mg Controlled Release Film Tablets</description>
    <arm_group_label>REFERENCE</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female patients: between the ages of 18-70,&#xD;
&#xD;
          -  Stage 1 and 2 hypertension patients who have not received any antihypertensive&#xD;
             treatment in the past month * (≥ 140 mmHg SKB &lt;180 mmHg, ≥ 90 mmHg DKB &lt;110 mmHg,&#xD;
&#xD;
          -  Patients with minute heart rate ≥ 70 / min,&#xD;
&#xD;
          -  Patients followed up with outpatient treatment,&#xD;
&#xD;
          -  Patients who give written informed consent without any influence, (Stage 1&#xD;
             Hypertension; SKB: 140-159 mmHg and DKB: 90-99 mmHg, Stage 2 Hypertension; SKB:&#xD;
             160--179 mmHg and DKB: 100--109 mmHg)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant patients or breastfeeding mothers or women with childbearing potential who do&#xD;
             not use any effective contraceptive methods,&#xD;
&#xD;
          -  Patients with allergies or hypersensitivity to betabloker drugs,&#xD;
&#xD;
          -  Patients who have received antihypertensive treatment in the past month,&#xD;
&#xD;
          -  Patients with secondary hypertension,&#xD;
&#xD;
          -  Patients who were followed up for the following diseases from the beginning of the&#xD;
             study until the last 12 months,&#xD;
&#xD;
               -  Severe hypertension (SKB&gt; 180 mmHg and / or DKB&gt; 110 mmHg),&#xD;
&#xD;
               -  Myocardial infarction,&#xD;
&#xD;
               -  NYHA stage 2-4 heart failure,&#xD;
&#xD;
               -  Patients with a history of cerebrovascular disease, previous ischemic attack,&#xD;
                  encephalopathy,&#xD;
&#xD;
               -  Patients undergoing percutaneous coronary intervention or coronary artery bypass&#xD;
                  surgery,&#xD;
&#xD;
               -  2nd or 3rd degree heart block or symptomatic arrhythmia without pacemaker,&#xD;
&#xD;
               -  Clinically significant heart valve disease,&#xD;
&#xD;
               -  Simultaneous life-threatening potential or symptomatic arrhythmia,&#xD;
&#xD;
               -  Simultaneous unstable angina pectoris,&#xD;
&#xD;
               -  Type 1 DM,&#xD;
&#xD;
               -  Atrial fibrillation,&#xD;
&#xD;
               -  Uncontrollable Type 2 DM (HbA1C&gt; 7%),&#xD;
&#xD;
          -  Patients with significant liver disease (initial ALT, AST&gt; 2xULN, esophageal varices,&#xD;
             portocaval shunt),&#xD;
&#xD;
          -  Patients with significant kidney disease (GFR &lt;60 ml / min according to the&#xD;
             Cockcroft-Gault formula),&#xD;
&#xD;
          -  Patients with volume depletion,&#xD;
&#xD;
          -  Patients with pancreatic disease,&#xD;
&#xD;
          -  Patients with gastrointestinal disease affecting absorption,&#xD;
&#xD;
          -  Drug/substance and alcohol abuse in the last 12 months,&#xD;
&#xD;
          -  Patients with central nervous system disease and using drugs for this reason,&#xD;
&#xD;
          -  A history of incompatibility with medical regimens, or patients' unwillingness to&#xD;
             comply with the study protocol,&#xD;
&#xD;
          -  Patients directly involved in the management of this protocol.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Neutec RD</last_name>
    <phone>00905051747902</phone>
    <email>iremkaraman@neutecrdc.com</email>
  </overall_contact>
  <verification_date>December 2021</verification_date>
  <study_first_submitted>June 25, 2020</study_first_submitted>
  <study_first_submitted_qc>June 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>December 9, 2021</last_update_submitted>
  <last_update_submitted_qc>December 9, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">December 10, 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>Metoprolol</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04457323
org study id: NEU-03.17
nct id: NCT04457323
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to compare the efficacy and safety of S-Metoprolol XR 25 and 50 mg
      Film Coated Tablets and Beloc® (Metoprolol) Zok 50 and 100 mg Controlled Release Film Tablets
      administered once daily, in the treatment of hypertension.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Change in systolic and diastolic blood pressure between 0-4 weeks of treatment
time frame: 4-weeks
measure: Change in systolic blood pressure between 0-8 weeks of treatment.
time frame: 8-weeks
measure: Change in diastolic blood pressure between 0-8 weeks of treatment.
time frame: 8-weeks
measure: Change in diastolic blood pressure between 4-8 weeks of treatment.
time frame: 4-weeks
measure: Change in sistolic blood pressure between 4-8 weeks of treatment.
time frame: 8-weeks
measure: Treatment response rates
time frame: 4-weeks
description: Target blood pressure values were determined by decreasing more than 20mmHg in systolic blood pressure and / or decreasing more than 10mmHg in diastolic pressure (under systolic 140 mmHg, below diastolic 90 mmHg).
arm group label: Test
arm group type: Experimental
description: S-Metoprolol XR 25 mg Film Coated Tablets (first four weeks) S-Metoprolol XR 50 mg Film Coated Tablets (second four weeks)
arm group label: REFERENCE
arm group type: Active Comparator
description: Beloc® (Metoprolol) Zok 50 mg Controlled Release Film Tablets (first four weeks) Beloc® (Metoprolol) Zok 100 mg Controlled Release Film Tablets (second four weeks)
intervention type: Drug
intervention name: Metoprolol
description: S-Metoprolol XR 25 mg and 50 mg Film Coated Tablets
arm group label: Test
other name: S-metoprolol
intervention type: Drug
intervention name: Metoprolol
description: Beloc® (Metoprolol) Zok 50 mg and 100 mg Controlled Release Film Tablets
arm group label: REFERENCE
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Neutec RD
phone: 00905051747902
email: iremkaraman@neutecrdc.com
responsible party type: Sponsor
mesh term: Hypertension
mesh term: Metoprolol
sharing ipd: Undecided