<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/NCT03255551</url>
  </required_header>
  <id_info>
    <org_study_id>LEARN BP</org_study_id>
    <nct_id>NCT03255551</nct_id>
  </id_info>
  <brief_title>Blood Pressure Lowering Effects of Amosartan Regarding Proviso iN Patients With High Blood Pressure</brief_title>
  <official_title>Blood Pressure Lowering Effects of Amosartan Regarding Proviso in Patients With Hypertension: Prospective, Multicenter, Observational Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seoul National University Bundang Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Seoul National University Bundang Hospital</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>
      Blood Pressure Lowering Effects of Amosartan Regarding Proviso in Patients with Hypertension&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      After taking Amozatan (AMS, amlodipine / rozanthin combination) in patients with essential&#xD;
      hypertension, the percentage of patients who reached the mean systolic target blood pressure&#xD;
      was evaluated&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2014</start_date>
  <completion_date type="Actual">December 31, 2015</completion_date>
  <primary_completion_date type="Actual">June 30, 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Patients with essential hypertension evaluated the mean blood pressure after taking amosartan.</measure>
    <time_frame>6 month</time_frame>
    <description>Blood Pressure Lowering Effects of Amosartan Regarding Proviso in Patients with Hypertension</description>
  </primary_outcome>
  <enrollment type="Actual">50</enrollment>
  <condition>Hypertension</condition>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Amosartan</intervention_name>
    <description>amosartan is a combination of amlodipine, which is a calcium channel blocker (CCB), and rozatan, an angiotensin II receptor antagonist (ARB), and is an antihypertensive agent</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Estimated total number of patients: 3,150 Estimated number of centers: 37&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with essential hypertension whose blood pressure is not adequately controlled&#xD;
             by amlodipine or rosartan monotherapy&#xD;
&#xD;
          -  In patients with stage 2 hypertension (SBP 160-179 mmHg), patients requiring a&#xD;
             combination therapy to reach the target blood pressure&#xD;
&#xD;
          -  Patients who were changed to amosartan while using other hypertensive agents&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with hypersensitivity to dihydropyridine derivatives of amosartan&#xD;
&#xD;
          -  Women who are pregnant or who may be pregnant and breastfeeding&#xD;
&#xD;
          -  Patients with severe hepatic dysfunction&#xD;
&#xD;
          -  Patients with severe aortic stenosis&#xD;
&#xD;
          -  Patients at risk of shock&#xD;
&#xD;
          -  Patients participating in other clinical studies&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <reference>
    <citation>Kim SH, Ryu KH, Lee NH, Kang JH, Kim WS, Park SW, Lee HY, Kim JJ, Ahn YK, Suh SY. Efficacy of fixed-dose amlodipine and losartan combination compared with amlodipine monotherapy in stage 2 hypertension: a randomized, double blind, multicenter study. BMC Res Notes. 2011 Oct 28;4:461. doi: 10.1186/1756-0500-4-461.</citation>
    <PMID>22035131</PMID>
  </reference>
  <reference>
    <citation>Law MR, Wald NJ, Morris JK, Jordan RE. Value of low dose combination treatment with blood pressure lowering drugs: analysis of 354 randomised trials. BMJ. 2003 Jun 28;326(7404):1427. doi: 10.1136/bmj.326.7404.1427.</citation>
    <PMID>12829555</PMID>
  </reference>
  <reference>
    <citation>Choi SM, Seo MJ, Kang KK, Kim JH, Ahn BO, Yoo M. Beneficial effects of the combination of amlodipine and losartan for lowering blood pressure in spontaneously hypertensive rats. Arch Pharm Res. 2009 Mar;32(3):353-8. doi: 10.1007/s12272-009-1307-x. Epub 2009 Apr 23.</citation>
    <PMID>19387578</PMID>
  </reference>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 16, 2017</study_first_submitted>
  <study_first_submitted_qc>August 16, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 21, 2017</study_first_posted>
  <last_update_submitted>August 16, 2017</last_update_submitted>
  <last_update_submitted_qc>August 16, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 21, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Seoul National University Bundang Hospital</investigator_affiliation>
    <investigator_full_name>Dong-Ju Choi</investigator_full_name>
    <investigator_title>Seoul National University Bundang Hospital</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertension</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03255551
org study id: LEARN BP
nct id: NCT03255551
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Blood Pressure Lowering Effects of Amosartan Regarding Proviso in Patients with Hypertension
After taking Amozatan (AMS, amlodipine / rozanthin combination) in patients with essential
      hypertension, the percentage of patients who reached the mean systolic target blood pressure
      was evaluated
observational model: Case-Control
time perspective: Prospective
measure: Patients with essential hypertension evaluated the mean blood pressure after taking amosartan.
time frame: 6 month
description: Blood Pressure Lowering Effects of Amosartan Regarding Proviso in Patients with Hypertension
intervention type: Drug
intervention name: Amosartan
description: amosartan is a combination of amlodipine, which is a calcium channel blocker (CCB), and rozatan, an angiotensin II receptor antagonist (ARB), and is an antihypertensive agent
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
citation: Kim SH, Ryu KH, Lee NH, Kang JH, Kim WS, Park SW, Lee HY, Kim JJ, Ahn YK, Suh SY. Efficacy of fixed-dose amlodipine and losartan combination compared with amlodipine monotherapy in stage 2 hypertension: a randomized, double blind, multicenter study. BMC Res Notes. 2011 Oct 28;4:461. doi: 10.1186/1756-0500-4-461.
PMID: 22035131
citation: Law MR, Wald NJ, Morris JK, Jordan RE. Value of low dose combination treatment with blood pressure lowering drugs: analysis of 354 randomised trials. BMJ. 2003 Jun 28;326(7404):1427. doi: 10.1136/bmj.326.7404.1427.
PMID: 12829555
citation: Choi SM, Seo MJ, Kang KK, Kim JH, Ahn BO, Yoo M. Beneficial effects of the combination of amlodipine and losartan for lowering blood pressure in spontaneously hypertensive rats. Arch Pharm Res. 2009 Mar;32(3):353-8. doi: 10.1007/s12272-009-1307-x. Epub 2009 Apr 23.
PMID: 19387578
responsible party type: Principal Investigator
investigator affiliation: Seoul National University Bundang Hospital
investigator full name: Dong-Ju Choi
investigator title: Seoul National University Bundang Hospital
mesh term: Hypertension
sharing ipd: No