<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/NCT03267329</url>
  </required_header>
  <id_info>
    <org_study_id>YMC023</org_study_id>
    <nct_id>NCT03267329</nct_id>
  </id_info>
  <brief_title>Duowell® vs. Telmisartan Monotherapy in Mild Dyslipidemia Patients With Hypertension</brief_title>
  <official_title>A Randomized, Open, Parallel, Multicenter, Phase 4 Study to Evaluate the Central Aortic Pressure Effect Between Fixed Dose Combination (Duowell® Tab) and Monotherapy of Telmisartan in Mild Dyslipidemia Patients With Hypertension</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yuhan Corporation</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Yuhan Corporation</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is to evaluate effect and safety on central blood pressure with Duowell compared&#xD;
      to telmisartan monotherapy in mild dyslipidemia patients with hypertension during 16 weeks.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 11, 2017</start_date>
  <completion_date type="Actual">September 2, 2020</completion_date>
  <primary_completion_date type="Actual">September 2, 2020</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>Changes from baseline in mean central systolic blood pressure</measure>
    <time_frame>at week 16</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes from baseline in mean brachial systolic blood pressure</measure>
    <time_frame>at week 4 and at week 16 and at week 28</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes from baseline in mean brachial pulse pressure</measure>
    <time_frame>at week 4 and at week 16 and and at week 28</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes from mean brachial diastolic blood pressure</measure>
    <time_frame>at week 4 and at week 16 and at week 28</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes from baseline in augmentation index</measure>
    <time_frame>at week 16 and at week 28</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes from baseline in carotid femoral pulse wave velocity</measure>
    <time_frame>at week 16 and at week 28</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Changes from baseline in central blood pressure according to the frequency of access in mobile application</measure>
    <time_frame>up to 4 weeks and up to 16 weeks</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Drug compliance between over 50% and less 50% of assessment in mobile application</measure>
    <time_frame>at week 4 weeks and at week 16</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Drug compliance between over 50% and less 50% of assessment in mobile application</measure>
    <time_frame>up to 3 months end of study</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Changes from the end of treatment in central systolic blood pressure after 3 months</measure>
    <time_frame>at 3 months from the end of study</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Numbers of inconvenience reported by mobile application at each visit</measure>
    <time_frame>up to 16 weeks</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">80</enrollment>
  <condition>Hypertension</condition>
  <condition>Dyslipidemia</condition>
  <arm_group>
    <arm_group_label>Duowell® Tab.</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Once daily during 16 wks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Telmisartan</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Once daily during 16 wks</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Duowell®</intervention_name>
    <description>telmisartan 80mg/rosuvastatin 10mg for ASCVD risk=5%~7.5% or telmisartan 80mg/rosuvastatin 20mg for ASCVD risk≥7.5%</description>
    <arm_group_label>Duowell® Tab.</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Telmisartan</intervention_name>
    <description>telmisartan 80mg</description>
    <arm_group_label>Telmisartan</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria (All of the followings)&#xD;
&#xD;
          -  40 to 75 years old diagnosed with hypertension&#xD;
&#xD;
          -  at screening, SBP ≥ 140 mmHg&#xD;
&#xD;
          -  at randomization, 130 mmHg ≤ SBP ≤160 mmHg or 80 mmHg ≤ DBP ≤ 100 mmHg&#xD;
&#xD;
          -  at screening, ASCVD risk ≥ 5 %&#xD;
&#xD;
          -  Those who did not take the dyslipidemic medications during screening or who stopped&#xD;
             medication for more than 2 months&#xD;
&#xD;
          -  at screening, 130 mg/dL ≤ Calculated (or Measured) Serum LDL-C ≤ 190 mg/dL&#xD;
&#xD;
          -  Pregnancy test negative and and who has agreed to perform effective contraception&#xD;
             during the clinical trial&#xD;
&#xD;
        Exclusion Criteria (Any of the followings)&#xD;
&#xD;
          -  known hypersensitivity to AT-1 receptor blockers or statins&#xD;
&#xD;
          -  Those who are treated with secondary hypertension during screening&#xD;
&#xD;
          -  Those who are being treated for malignant hypertension during screening&#xD;
&#xD;
          -  Those who are taking concurrent medication that may affect blood pressure during&#xD;
             screening&#xD;
&#xD;
          -  Those who have been diagnosed with myocardial infarction or unstable angina or stroke&#xD;
             within the last 6 months at screening&#xD;
&#xD;
          -  Patients with heart failure NYHA III-IV or Left Ventricular Ejection Fraction &lt;40%&#xD;
             within the last 6 months at screening&#xD;
&#xD;
          -  Patients with valve disease with hemodynamically significant (over moderate degree)&#xD;
             obstructive&#xD;
&#xD;
          -  Those with known atrial fibrillation or atrioventricular conduction disturbance&#xD;
&#xD;
          -  Those who show the following numerical values during the screening test&#xD;
&#xD;
               1. CPK ≥ 3 times the normal upper limit&#xD;
&#xD;
               2. Serum Creatinine &gt; 3 mg/dL&#xD;
&#xD;
               3. Serum Potassium &gt; 5.5 mmol/L&#xD;
&#xD;
               4. ALT or AST ≥ 3 times the upper normal limit&#xD;
&#xD;
          -  Those with known bilateral renal artery stenosis&#xD;
&#xD;
          -  Patients who underwent open heart surgery within 4 weeks prior to randomization and&#xD;
             who had a cardiac surgery plan&#xD;
&#xD;
          -  Those taking statins within 8 weeks before randomization&#xD;
&#xD;
          -  Those with severe obstructive, limited or other pulmonary disease history&#xD;
&#xD;
          -  Those with non-cardiac disease that can significantly shorten the expected life span&#xD;
             to less than 2 years (eg, severe cancer)&#xD;
&#xD;
          -  at screening, Anti-HIV Ab, HBsAg, HCV Ab positive&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Seoul National University Hospital</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>August 28, 2017</study_first_submitted>
  <study_first_submitted_qc>August 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 30, 2017</study_first_posted>
  <last_update_submitted>April 4, 2021</last_update_submitted>
  <last_update_submitted_qc>April 4, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 6, 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>
    <mesh_term>Dyslipidemias</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Telmisartan</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/NCT03267329
org study id: YMC023
nct id: NCT03267329
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This study is to evaluate effect and safety on central blood pressure with Duowell compared
      to telmisartan monotherapy in mild dyslipidemia patients with hypertension during 16 weeks.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Changes from baseline in mean central systolic blood pressure
time frame: at week 16
measure: Changes from baseline in mean brachial systolic blood pressure
time frame: at week 4 and at week 16 and at week 28
measure: Changes from baseline in mean brachial pulse pressure
time frame: at week 4 and at week 16 and and at week 28
measure: Changes from mean brachial diastolic blood pressure
time frame: at week 4 and at week 16 and at week 28
measure: Changes from baseline in augmentation index
time frame: at week 16 and at week 28
measure: Changes from baseline in carotid femoral pulse wave velocity
time frame: at week 16 and at week 28
measure: Changes from baseline in central blood pressure according to the frequency of access in mobile application
time frame: up to 4 weeks and up to 16 weeks
measure: Drug compliance between over 50% and less 50% of assessment in mobile application
time frame: at week 4 weeks and at week 16
measure: Drug compliance between over 50% and less 50% of assessment in mobile application
time frame: up to 3 months end of study
measure: Changes from the end of treatment in central systolic blood pressure after 3 months
time frame: at 3 months from the end of study
measure: Numbers of inconvenience reported by mobile application at each visit
time frame: up to 16 weeks
arm group label: Duowell® Tab.
arm group type: Experimental
description: Once daily during 16 wks
arm group label: Telmisartan
arm group type: Active Comparator
description: Once daily during 16 wks
intervention type: Drug
intervention name: Duowell®
description: telmisartan 80mg/rosuvastatin 10mg for ASCVD risk=5%~7.5% or telmisartan 80mg/rosuvastatin 20mg for ASCVD risk≥7.5%
arm group label: Duowell® Tab.
intervention type: Drug
intervention name: Telmisartan
description: telmisartan 80mg
arm group label: Telmisartan
criteria: 
gender: All
minimum age: 40 Years
maximum age: 75 Years
healthy volunteers: No
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Hypertension
mesh term: Dyslipidemias
mesh term: Telmisartan
sharing ipd: No