<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/NCT02968160</url>
  </required_header>
  <id_info>
    <org_study_id>YMC017</org_study_id>
    <nct_id>NCT02968160</nct_id>
  </id_info>
  <brief_title>A Clinical Trial of YMC017 in Hypertensive and Hypercholesterolemic Patients With Metabolic Syndrome</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yuhan Corporation</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Linical Korea</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Yuhan Corporation</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a Randomized, open-label, 2 groups, parallel design.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study objective is to compare the safety and efficacy between fixed dose combination&#xD;
      (Duowell® tab) and free pill combination therapy of Telmisartan and Rosuvastatin in&#xD;
      hypertensive and hypercholesterolemic patients with metabolic syndrome.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Due to poor enrollment rate&#xD;
  </why_stopped>
  <start_date>October 2016</start_date>
  <completion_date type="Actual">February 2018</completion_date>
  <primary_completion_date type="Actual">February 2018</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The proportion of subjects that the mean Sitting Diastolic Blood Pressure(siSBP) and Low Density Lipoprotein-Cholesterol(LDL-C) level reach the treatment goals after 8 weeks from investigational product administration.</measure>
    <time_frame>week 8</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change of Low Density Lipoprotein-Cholesterol(LDL-C) from baseline to 4 and 8 weeks</measure>
    <time_frame>From baseline to 4 and 8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of Sitting Systolic Blood Pressure(siSBP) and Sitting Diastolic Blood Pressure(siDBP) from baseline to 4 and 8 weeks</measure>
    <time_frame>From baseline to 4 and 8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The proportion of subjects that the mean sitting blood pressure(siBP) level reaches the treatment goals to 4 and 8 weeks</measure>
    <time_frame>4 and 8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The proportion of subjects that the Low Density Lipoprotein-Cholesterol(LDL-C) level reaches treatment goals in accordance with guideline of National Cholesterol Education Program-Adult Treatment Panel(NCEP ATP) III to 4 and 8 weeks</measure>
    <time_frame>4 and 8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of below indicators from baseline to 4 and 8 weeks</measure>
    <time_frame>baseline to 4 and 8 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">55</enrollment>
  <condition>Metabolic Syndrome</condition>
  <arm_group>
    <arm_group_label>Telmisartan+Rosuvastatin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Duowell ® tablet (Telmisartan 40mg + Rosuvastatin 20mg) 1 tablet, once daily, Oral administration/ 8 weeks&#xD;
* But, the increased Duowell ® tablet (Telmisartan 80mg + Rosuvastatin 20mg) will get administrated orally one tablet once daily to the subjects who have mean systolic blood pressure more than 140mmHg based on arm, which was determined before, at 4week visit.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Telmisartan/Rosuvastatin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Telmisartan 40mg + Rosuvastatin 20mg 2 tablets, once daily, Oral administration/ 8 weeks&#xD;
* But, the increased Telmisartan 80mg + Rosuvastatin 20mg will get administrated orally 2 tablets once daily to the subjects who have mean systolic blood pressure more than 140mmHg based on arm, which was determined before, at 4week visit.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Telmisartan 40mg + Rosuvastatin 20mg</intervention_name>
    <arm_group_label>Telmisartan+Rosuvastatin</arm_group_label>
    <other_name>Duowell ® tablet</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Telmisartan 80mg + Rosuvastatin 20mg</intervention_name>
    <arm_group_label>Telmisartan+Rosuvastatin</arm_group_label>
    <other_name>Duowell ® tablet</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Telmisartan 40mg, 80 mg</intervention_name>
    <arm_group_label>Telmisartan/Rosuvastatin</arm_group_label>
    <other_name>Micardis tablet</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Rosuvastatin 20mg</intervention_name>
    <arm_group_label>Telmisartan/Rosuvastatin</arm_group_label>
    <other_name>Monorova tablet</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Aged between 19 and 79 years old at screening visit&#xD;
&#xD;
          -  Subjects who have being used anti-hypertension drugs and Lipid lowering agents over&#xD;
             4weeks before randomization.&#xD;
&#xD;
          -  Subjects who have been diagnosed with metabolic syndrome according to following&#xD;
             criteria Definition of patients with metabolic syndrome: Patients satisfy two of the&#xD;
             following criteria at least&#xD;
&#xD;
               -  Abdominal obesity: Waist measurement &gt; 90 cm(male), &gt; 80 cm(female)&#xD;
&#xD;
               -  Triglyceride(TG) ≥ 150 mg/dL(&#xD;
&#xD;
               -  High-Density Lipoprotein Cholesterol(HDL-C) &lt; 40 mg/dL(male), &lt; 50 mg/dL (female)&#xD;
&#xD;
               -  Fasting Plasma Glucose(FPG) ≥ 100 mg/dL or Subject who has being used oral&#xD;
                  hypoglycemic agents&#xD;
&#xD;
          -  Childbearing potential women have certainly negative of the pregnancy test at&#xD;
             screening visit (visit 1), and agree to implement the effective contraception during&#xD;
             the study period(including the medically non-pregnant state)&#xD;
&#xD;
          -  Subjects who have signed after fully understanding the purpose, content,&#xD;
             characteristics and risk of the investigational product and get explained enough.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects who taking anti-hypertension drugs more than three agent&#xD;
&#xD;
          -  Subjects who have mean Sitting Systolic Blood Pressure(siSBP) &gt; 160 mmHg (excluded if&#xD;
             appliable, one of the arms)&#xD;
&#xD;
          -  Subjects who have blood pressure ≥ 140/90 mmHg with taking 2 or more anti-hypertension&#xD;
             drugs (except if any of the arms)&#xD;
&#xD;
          -  Subjects that Low Density Lipoprotein-Cholesterol(LDL-C) isn't properly controlled&#xD;
             according to National Cholesterol Education Program Adults Treatment Panel (NCEP ATP)&#xD;
             III criteria&#xD;
&#xD;
          -  Subjects who have triglyceride (TG) ≥ 400mg/dL&#xD;
&#xD;
          -  Subjects who have a difference more than 20mmHg at the mean Sitting Diastolic Blood&#xD;
             Pressure(siSBP) measured three times in both arms.&#xD;
&#xD;
          -  Other exclusions applied&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>79 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Dongguk University Medical Center</name>
      <address>
        <city>Ilsan</city>
        <zip>10326</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>May 2017</verification_date>
  <study_first_submitted>November 10, 2016</study_first_submitted>
  <study_first_submitted_qc>November 15, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 18, 2016</study_first_posted>
  <last_update_submitted>April 10, 2019</last_update_submitted>
  <last_update_submitted_qc>April 10, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 12, 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>Metabolic Syndrome</mesh_term>
    <mesh_term>Syndrome</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Telmisartan</mesh_term>
    <mesh_term>Rosuvastatin Calcium</mesh_term>
  </intervention_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/NCT02968160
org study id: YMC017
nct id: NCT02968160
lead sponsor: 
collaborator: 
has dmc: No
This is a Randomized, open-label, 2 groups, parallel design.
This study objective is to compare the safety and efficacy between fixed dose combination
      (Duowell® tab) and free pill combination therapy of Telmisartan and Rosuvastatin in
      hypertensive and hypercholesterolemic patients with metabolic syndrome.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: The proportion of subjects that the mean Sitting Diastolic Blood Pressure(siSBP) and Low Density Lipoprotein-Cholesterol(LDL-C) level reach the treatment goals after 8 weeks from investigational product administration.
time frame: week 8
measure: Change of Low Density Lipoprotein-Cholesterol(LDL-C) from baseline to 4 and 8 weeks
time frame: From baseline to 4 and 8 weeks
measure: Change of Sitting Systolic Blood Pressure(siSBP) and Sitting Diastolic Blood Pressure(siDBP) from baseline to 4 and 8 weeks
time frame: From baseline to 4 and 8 weeks
measure: The proportion of subjects that the mean sitting blood pressure(siBP) level reaches the treatment goals to 4 and 8 weeks
time frame: 4 and 8 weeks
measure: The proportion of subjects that the Low Density Lipoprotein-Cholesterol(LDL-C) level reaches treatment goals in accordance with guideline of National Cholesterol Education Program-Adult Treatment Panel(NCEP ATP) III to 4 and 8 weeks
time frame: 4 and 8 weeks
measure: Change of below indicators from baseline to 4 and 8 weeks
time frame: baseline to 4 and 8 weeks
arm group label: Telmisartan+Rosuvastatin
arm group type: Experimental
description: Duowell ® tablet (Telmisartan 40mg + Rosuvastatin 20mg) 1 tablet, once daily, Oral administration/ 8 weeks
* But, the increased Duowell ® tablet (Telmisartan 80mg + Rosuvastatin 20mg) will get administrated orally one tablet once daily to the subjects who have mean systolic blood pressure more than 140mmHg based on arm, which was determined before, at 4week visit.
arm group label: Telmisartan/Rosuvastatin
arm group type: Active Comparator
description: Telmisartan 40mg + Rosuvastatin 20mg 2 tablets, once daily, Oral administration/ 8 weeks
* But, the increased Telmisartan 80mg + Rosuvastatin 20mg will get administrated orally 2 tablets once daily to the subjects who have mean systolic blood pressure more than 140mmHg based on arm, which was determined before, at 4week visit.
intervention type: Drug
intervention name: Telmisartan 40mg + Rosuvastatin 20mg
arm group label: Telmisartan+Rosuvastatin
other name: Duowell ® tablet
intervention type: Drug
intervention name: Telmisartan 80mg + Rosuvastatin 20mg
arm group label: Telmisartan+Rosuvastatin
other name: Duowell ® tablet
intervention type: Drug
intervention name: Telmisartan 40mg, 80 mg
arm group label: Telmisartan/Rosuvastatin
other name: Micardis tablet
intervention type: Drug
intervention name: Rosuvastatin 20mg
arm group label: Telmisartan/Rosuvastatin
other name: Monorova tablet
criteria: 
gender: All
minimum age: 19 Years
maximum age: 79 Years
healthy volunteers: No
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Metabolic Syndrome
mesh term: Syndrome
mesh term: Telmisartan
mesh term: Rosuvastatin Calcium
sharing ipd: No