<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/NCT03038451</url>
  </required_header>
  <id_info>
    <org_study_id>NEU-07.12</org_study_id>
    <nct_id>NCT03038451</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety of S-amlodipine 2,5 mg and 5 mg in Hypertension Patients</brief_title>
  <official_title>Efficacy and Safety of S-amlodipine 2,5 mg and 5 mg in Hypertension Patients: Open-label, Local, Phase IV Study</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      s-amlodipine besylate 2,5 mg tablet will be administered to patients have not received any&#xD;
      hypertension treatment before or have received any of anti-hypertensive mono-therapy for the&#xD;
      first four weeks of treatment. By increasing dose, s-amlodipine besylate 5 mg tablet will be&#xD;
      administered for the last four weeks (4-8 weeks).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 20, 2013</start_date>
  <completion_date type="Actual">February 14, 2017</completion_date>
  <primary_completion_date type="Actual">February 14, 2017</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Evaluation of change in systolic blood pressure up to 4th week of the treatment</measure>
    <time_frame>4 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Evaluation of change in diastolic blood pressure up to 4th week of the treatment</measure>
    <time_frame>4 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of change in diastolic blood pressure up to 8th week of the treatment</measure>
    <time_frame>8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of change in systolic blood pressure up to 8th week of the treatment</measure>
    <time_frame>8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of change in systolic blood pressure from 4th to 8th week of the treatment</measure>
    <time_frame>4 to 8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of change in diastolic blood pressure from 4th to 8th week of the treatment</measure>
    <time_frame>4 to 8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of treatment response rates from 4th to 8th week of the treatment</measure>
    <time_frame>4 to 8 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">43</enrollment>
  <condition>Hypertension</condition>
  <arm_group>
    <arm_group_label>s-amlodipine besylate 2,5 and 5 mg tablets</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>S-NOR (s-amlodipine) 2,5 mg &amp; 5 mg tablet</intervention_name>
    <arm_group_label>s-amlodipine besylate 2,5 and 5 mg tablets</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female outpatients 18 years and older.&#xD;
&#xD;
          -  Hypertension patients have not received any anti-hypertensive treatment before ( ≥ 140&#xD;
             mmHg MSSBP &lt; 160 mmHg, ≥ 90 mmHg MSDBP &lt; 100mmHg).&#xD;
&#xD;
          -  Hypertension patients controlled with single medicine.&#xD;
&#xD;
          -  Patients giving written informed consent without being under any influence.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant patients, nursing mothers or female patients who have potential for&#xD;
             childbearing and do not use any effective contraceptive method.&#xD;
&#xD;
          -  Allergy or hypersensitivity to dihydropyridines.&#xD;
&#xD;
          -  Patients receive more than one anti-hypertensive medicine.&#xD;
&#xD;
          -  Patients with seconder hypertension.&#xD;
&#xD;
          -  Patients with severe hypertension, myocardial infarction, NYHA stage 2-4 cardiac&#xD;
             insufficiency, history of cerebrovascular disease, past ischemic attack,&#xD;
             encephalopathy, underwent coronary artery bypass surgery or percutaneous coronary&#xD;
             intervention, second or third degree heart block or symptomatic arrhythmia without&#xD;
             pacemaker, clinically significant heart valve disease, potential life-threatening or&#xD;
             symptomatic arrhythmia, simultaneous unstable angina pectoris, type I diabetes&#xD;
             mellitus, atrial fibrillation until the last 12 months.&#xD;
&#xD;
          -  Uncontrolled type II diabetes mellitus.&#xD;
&#xD;
          -  Patients with significant liver disease (ALT, AST must be &gt; 2XULN in beginning,&#xD;
             patients with esophageal varices, portacaval shunt).&#xD;
&#xD;
          -  Patients with significant kidney disease (GFR &lt;60 ml/min according to Cockcroft-Gault&#xD;
             formula).&#xD;
&#xD;
          -  Patients with volume depletion.&#xD;
&#xD;
          -  Patients with pancreas disease.&#xD;
&#xD;
          -  Patients with gastrointestinal disease which may effect absorption.&#xD;
&#xD;
          -  Drug/narcotic and alcohol abuse until the last 12 months.&#xD;
&#xD;
          -  Patients with central nervous system disease and taking medicine for this reason.&#xD;
&#xD;
          -  History of incompatibility with medical regimes or patients do not want to adhere the&#xD;
             study protocol.&#xD;
&#xD;
          -  Persons directly involved in the management of this protocol.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Istanbul University Istanbul Medical Faculty Clinical Pharmacology Department</name>
      <address>
        <city>Istanbul</city>
        <state>Fatih</state>
        <zip>34093</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <results_reference>
    <citation>Sen S, Demir M, Yigit Z, Uresin AY. Efficacy and Safety of S-Amlodipine 2.5 and 5 mg/d in Hypertensive Patients Who Were Treatment-Naive or Previously Received Antihypertensive Monotherapy. J Cardiovasc Pharmacol Ther. 2018 Jul;23(4):318-328. doi: 10.1177/1074248418769054. Epub 2018 Apr 12.</citation>
    <PMID>29649885</PMID>
  </results_reference>
  <verification_date>June 2018</verification_date>
  <study_first_submitted>January 14, 2017</study_first_submitted>
  <study_first_submitted_qc>January 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 31, 2017</study_first_posted>
  <last_update_submitted>June 13, 2018</last_update_submitted>
  <last_update_submitted_qc>June 13, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">June 15, 2018</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>Amlodipine</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/NCT03038451
org study id: NEU-07.12
nct id: NCT03038451
lead sponsor: 
has dmc: No
s-amlodipine besylate 2,5 mg tablet will be administered to patients have not received any
      hypertension treatment before or have received any of anti-hypertensive mono-therapy for the
      first four weeks of treatment. By increasing dose, s-amlodipine besylate 5 mg tablet will be
      administered for the last four weeks (4-8 weeks).
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Evaluation of change in systolic blood pressure up to 4th week of the treatment
time frame: 4 weeks
measure: Evaluation of change in diastolic blood pressure up to 4th week of the treatment
time frame: 4 weeks
measure: Evaluation of change in diastolic blood pressure up to 8th week of the treatment
time frame: 8 weeks
measure: Evaluation of change in systolic blood pressure up to 8th week of the treatment
time frame: 8 weeks
measure: Evaluation of change in systolic blood pressure from 4th to 8th week of the treatment
time frame: 4 to 8 weeks
measure: Evaluation of change in diastolic blood pressure from 4th to 8th week of the treatment
time frame: 4 to 8 weeks
measure: Evaluation of treatment response rates from 4th to 8th week of the treatment
time frame: 4 to 8 weeks
arm group label: s-amlodipine besylate 2,5 and 5 mg tablets
arm group type: Experimental
intervention type: Drug
intervention name: S-NOR (s-amlodipine) 2,5 mg & 5 mg tablet
arm group label: s-amlodipine besylate 2,5 and 5 mg tablets
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Turkey
citation: Sen S, Demir M, Yigit Z, Uresin AY. Efficacy and Safety of S-Amlodipine 2.5 and 5 mg/d in Hypertensive Patients Who Were Treatment-Naive or Previously Received Antihypertensive Monotherapy. J Cardiovasc Pharmacol Ther. 2018 Jul;23(4):318-328. doi: 10.1177/1074248418769054. Epub 2018 Apr 12.
PMID: 29649885
responsible party type: Sponsor
mesh term: Hypertension
mesh term: Amlodipine
sharing ipd: Undecided