xml: <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/NCT06041529</url>
    </required_header>
    <id_info>
      <org_study_id>YMC050</org_study_id>
      <nct_id>NCT06041529</nct_id>
    </id_info>
    <brief_title>Study to Evaluate the Efficacy and Safety of TEL/AML/CTD in Elderly Patients With Essential Hypertension</brief_title>
    <official_title>An Open-Label, Superiority, Randomized, Comparative Study to Evaluate the Efficacy and Safety of Telmisartan, Amlodipine, and Chlorthalidone Fixed-Dose Combination Versus Telmisartan, Amlodipine, and Hydrochlorothiazide in Elderly Patients With Essential Hypertension Uncontrolled by Telmisartan and Amlodipine Combinations</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Yuhan Corporation</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Yuhan Corporation</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>
        This study is to compare the efficacy and safety of Telmisartan, Amlodipine, and&#xD;
        Chlorthalidone Fixed-Dose Combination and Telmisartan, Amlodipine, and Hydrochlorothiazide in&#xD;
        Elderly Patients with Essential Hypertension Uncontrolled by Telmisartan and Amlodipine&#xD;
        Combinations&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is a Phase IV, Randomized, Open-label, Superiority, Comparative study evaluating the&#xD;
        efficacy and safety of Telmisartan, Amlodipine, and Chlorthalidone Fixed-Dose Combination)&#xD;
        versus Telmisartan, Amlodipine, and Hydrochlorothiazide in eledrly patient with essential&#xD;
        hypertension uncontrolled by Telmisartan and Amlodipine Combinations.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 14, 2023</start_date>
    <completion_date type="Anticipated">June 27, 2025</completion_date>
    <primary_completion_date type="Anticipated">February 21, 2025</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>Mean Systolic Blood Pressure (MSBP) in nighttime</measure>
      <time_frame>Week 8</time_frame>
      <description>To evaluate change from baseline in nighttime Mean Systolic Blood Pressure (MSBP) measured by Ambulatory Blood Pressure Monitoring at Week 8</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Mean Systolic Blood Pressure (MSBP) in nighttime</measure>
      <time_frame>Week 26 if applicable</time_frame>
      <description>To evaluate change from baseline in nighttime Mean Systolic Blood Pressure (MSBP) measured by Ambulatory Blood Pressure Monitoring at Week 26 if applicable</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mean Diastolic Blood Pressure (MDBP) in nighttime</measure>
      <time_frame>Week 8 and Week 26 if applicable</time_frame>
      <description>To evaluate change from baseline in nighttime Mean Diastolic Blood Pressure (MDBP) measured by Ambulatory Blood Pressure Monitoring at Week 8 and Week 26 if applicable</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mean Systolic Blood Pressure (MSBP)/Mean Diastolic Blood Pressure (MDBP) in daytime</measure>
      <time_frame>Week 8 and Week 26 if applicable</time_frame>
      <description>To evaluate change from baseline in daytime Mean Systolic Blood Pressure (MSBP)/Mean Diastolic Blood Pressure (MDBP) measured by Ambulatory Blood Pressure Monitoring at Week 8 and Week 26 if applicable</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>24-hour Mean Systolic Blood Pressure (MSBP)/Mean Diastolic Blood Pressure (MDBP)</measure>
      <time_frame>Week 8 and Week 26 if applicable</time_frame>
      <description>To evaluate change from baseline in 24-hour Mean Systolic Blood Pressure (MSBP)/Mean Diastolic Blood Pressure (MDBP) measured by Ambulatory Blood Pressure Monitoring at Week 8 and Week 26 if applicable</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patients Achieving in nighttime Mean Systolic Blood Pressure (MSBP)</measure>
      <time_frame>Week 8</time_frame>
      <description>To evaluate the percentage of patients who reached the treatment goal for nighttime Mean Systolic Blood Pressure (MSBP) (&lt;110/65mmHg) measured by Ambulatory Blood Pressure Monitoring at Week 8</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mean Sitting Systolic Blood Pressure (MSSBP)/ Mean Sitting Diastolic Blood Pressure (MSDBP)</measure>
      <time_frame>Week 4, Week 8 and Week 26 if applicable</time_frame>
      <description>To evaluate change from baseline in Mean Sitting Systolic Blood Pressure (MSSBP)/ Mean Sitting Diastolic Blood Pressure (MSDBP) measured by the Institution at Week 4, Week 8 and Week 26 if applicable</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patients Achieving in Mean Sitting Systolic Blood Pressure (MSSBP)</measure>
      <time_frame>Week 4, Week 8 and Week 26 if applicable</time_frame>
      <description>- To evaluate the percentage of patients who reached the treatment goal for Mean Sitting Blood Pressure (MSBP) &lt; 140/90 mmHg measured by the Institution at Week 4, Week 8 and Week 26 if applicable</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Percentage of patients with decreased Mean Sitting Systolic Blood Pressure (MSSBP) and Mean Sitting Diastolic Blood Pressure (MSDBP).</measure>
      <time_frame>Week 4, Week 8 and Week 26 if applicable</time_frame>
      <description>To evaluate the percentage of subjects with a Mean Sitting Systolic Blood Pressure (MSSBP) decrease of ≥20mmHg and a Mean Sitting Diastolic Blood Pressure (MSDBP) decrease of ≥10mmHg at Week 4, Week 8 and Week 26 if applicable</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>T/P ratio</measure>
      <time_frame>Week 8 and Week 26 if applicable</time_frame>
      <description>To evaluate the T/P ratio for systolic/diastolic blood pressure measured by Ambulatory Blood Pressure Monitoring at Week 8 and Week 26 if applicable</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">250</enrollment>
    <condition>Essential Hypertension</condition>
    <arm_group>
      <arm_group_label>Telmisartan/Amlodipine/Chlorthalidonea 40/5/12.5 mg</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Telmisartan/Amlodipine/Chlorthalidonea 40/5/12.5 mg will be orally administered during the study period</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Telmisartan/Amlodipine/Hydrochlorothiazide 40/5/25 mg</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Telmisartan/Amlodipine 40/5 mg and Hydrochlorothiazide 25 mg will be orally administered each during study period</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Telmisartan/Amlodipine/Chlorthalidone 40/5/12.5 mg</intervention_name>
      <description>PO, Once daily(QD), 8 weeks and 26 weeks if applicable</description>
      <arm_group_label>Telmisartan/Amlodipine/Chlorthalidonea 40/5/12.5 mg</arm_group_label>
      <other_name>Truset 40/5/12.5mg</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Telmisartan/Amlodipine/Hydrochlorothiazide 40/5/25 mg</intervention_name>
      <description>PO, Once daily(QD), 8 weeks and 26 weeks if applicable</description>
      <arm_group_label>Telmisartan/Amlodipine/Hydrochlorothiazide 40/5/25 mg</arm_group_label>
      <other_name>Twynsta 40/5 mg, Dichlozid 25 mg</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Signed informed consent&#xD;
  &#xD;
            2. Aged ≥ 65 with essential hypertension&#xD;
  &#xD;
            3. Patient with uncontrolled essential hypertension at screening&#xD;
  &#xD;
                 -  If already taking antihypertensive drugs, mean sitting systolic blood pressure&#xD;
                    (MSSBP) must be 140 mmHg ≤ MSSBP &lt; 200 mmHg&#xD;
  &#xD;
                 -  If not taking any antihypertensive drugs at least 4 weeks, mean sitting systolic&#xD;
                    blood pressure (MSSBP) must be 160 mmHg ≤ MSSBP &lt; 200 mmHg&#xD;
  &#xD;
            4. Medication compliance of investigational product (Run-in) &gt; 70 %&#xD;
  &#xD;
            5. Patient who has measured nighttime blood pressure more than 7 times from the night&#xD;
               before the randomized date to the morning of the day of the randomized date&#xD;
               (22:00~5:59)&#xD;
  &#xD;
            6. Patient with uncontrolled essential hypertension at Visit 2&#xD;
  &#xD;
                 -  140 mmHg ≤ MSSBP &lt; 200 mmHg&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Patient who has secondary hypertension or suspected of secondary hypertension&#xD;
  &#xD;
            2. Patient who has orthostatic hypotension with symptoms&#xD;
  &#xD;
            3. Patient who has severe hypotension and severe heart disease (NYHA class III~IV)&#xD;
  &#xD;
            4. Patient who has been diagnosed with or treated with the following diseases within the&#xD;
               last 6 months judged by the investigator to be clinically significant&#xD;
  &#xD;
                 -  Patient who has ischemic heart disease, peripheral vascular disease, percutaneous&#xD;
                    transluminal coronary angioplasty, or coronary artery bypass surgery&#xD;
  &#xD;
                 -  Patient who has clinically significant ventricular tachycardia, atrial&#xD;
                    fibrillation, atrial flutter, or other arrhythmia judged clinically significant&#xD;
                    by the investigator&#xD;
  &#xD;
                 -  Patient who has hypertrophic obstructive cardiomyopathy, severe obstructive&#xD;
                    coronary artery disease, aortic stenosis, aortic valve hemodynamically&#xD;
                    significant or mitral valve stenosis/reflux&#xD;
  &#xD;
                 -  Patient who has severe cerebrovascular disease&#xD;
  &#xD;
                 -  Known moderate or malignant retinopathy&#xD;
  &#xD;
            5. Patient who has sleep disorders or apnea during sleep&#xD;
  &#xD;
            6. Any surgical or medical condition which might significantly alter the absorption,&#xD;
               distribution, metabolism, or excretion of investigational products&#xD;
  &#xD;
            7. Patient who has untreated addison's disease, symptomatic hyperuricemia,&#xD;
               hyperparathyroidism, sympathetic nerve resection, shock patients&#xD;
  &#xD;
            8. Patient with anuria&#xD;
  &#xD;
            9. History of malignant tumor&#xD;
  &#xD;
           10. Patient with any chronic inflammation disease needed to chronic inflammation therapy&#xD;
  &#xD;
           11. Patient with mental defects that may interfere with participation in clinical trials&#xD;
  &#xD;
           12. Patient who has history of drug allergic reactions&#xD;
  &#xD;
           13. Patient who has angioedema related to ACE inhibitors, ARBs or diuretics&#xD;
  &#xD;
           14. Patient who has galactose intolerance, Lapp lactase deficiency or glucose-galactose&#xD;
               malabsorpiton.&#xD;
  &#xD;
           15. Known hypersensitivity to components of the investigational product&#xD;
  &#xD;
           16. Patient who is unable to stop taking prohibited drugs&#xD;
  &#xD;
           17. Test results showing the following values at screening&#xD;
  &#xD;
                 -  The change of MSSBP ≥ 20 mmHg and MSDBP ≥ 10 mmHg on target arm between 1st and&#xD;
                    2nd measurements&#xD;
  &#xD;
           18. Hepatic or renal dysfunction as defined by the following laboratory parameters (eGFR &lt;&#xD;
               30 mL/min/1.73m2, Serum creatinine ≥ 3 mg/dL, AST/ALT &gt; UNL X 3)&#xD;
  &#xD;
           19. Hypokalemia (Serum K &lt; 3.0 mmol/L) or hyperkalemia (Serum K &gt; 5.5 mmol/L),&#xD;
               hyponatremia (Serum Na &lt; 132.0 mmol/L) or uncontrolled diabetes (HbA1c &gt; 9.0%)&#xD;
  &#xD;
           20. Pregnant or lactating women&#xD;
  &#xD;
           21. Patient who is unable to maintain proper night sleep&#xD;
  &#xD;
           22. History of drug or alcohol dependency within 1 year prior to screening&#xD;
  &#xD;
           23. Malnutrition, starvation, debilitating factors, A person who is being forcibly&#xD;
               detained for the treatment of mental or physical&#xD;
  &#xD;
           24. Administration of other investigational products within 3 months prior to screening.&#xD;
  &#xD;
           25. An impossible one who participates in clinical trial by investigator's decision&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>65 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Sanghyun Ihm</last_name>
      <role>Principal Investigator</role>
      <affiliation>The Catholic University of Korea Bucheon St.Mary's Hospita</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Yujun Kim</last_name>
      <phone>+82-2-828-0394</phone>
      <email>yjkim@yuhan.co.kr</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Minjun Kim</last_name>
      <phone>+82-2-828-0508</phone>
      <email>minjun.kim@yuhan.co.kr</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>The Catholic University of Korea Bucheon St.Mary's Hospital</name>
        <address>
          <city>Seoul</city>
          <state>Gyeonggi-do</state>
          <zip>14647</zip>
          <country>Korea, Republic of</country>
        </address>
      </facility>
      <investigator>
        <last_name>Sanghyun lhm</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>The Catholic University of Korea Daejeon ST. Mary's Hospital</name>
        <address>
          <city>Daejeon</city>
          <zip>34943</zip>
          <country>Korea, Republic of</country>
        </address>
      </facility>
      <investigator>
        <last_name>Jungsun Cho</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Chonnam National University Hospital</name>
        <address>
          <city>Gwangju</city>
          <zip>61469</zip>
          <country>Korea, Republic of</country>
        </address>
      </facility>
      <investigator>
        <last_name>Juhan Kim</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>The Catholic University of Korea, ST. Vincent's Hospital</name>
        <address>
          <city>Gyeonggi-do</city>
          <zip>16247</zip>
          <country>Korea, Republic of</country>
        </address>
      </facility>
      <investigator>
        <last_name>Jihee Kim</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>he Catholic University of Korea, Incheon ST. Mary's Hospital</name>
        <address>
          <city>Incheon</city>
          <zip>21431</zip>
          <country>Korea, Republic of</country>
        </address>
      </facility>
      <investigator>
        <last_name>Mijung Kim</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>The Catholic University of Korea, Eunpyeong St. Mary's Hospital</name>
        <address>
          <city>Seoul</city>
          <zip>03312</zip>
          <country>Korea, Republic of</country>
        </address>
      </facility>
      <investigator>
        <last_name>Sukmin Seo</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Hanyang university medical center</name>
        <address>
          <city>Seoul</city>
          <zip>04763</zip>
          <country>Korea, Republic of</country>
        </address>
      </facility>
      <investigator>
        <last_name>Jinho Shin</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>The Catholic University of Korea</name>
        <address>
          <city>Seoul</city>
          <zip>06591</zip>
          <country>Korea, Republic of</country>
        </address>
      </facility>
      <investigator>
        <last_name>Eunho Choo</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>The Catholic University of Korea, Yeouido ST. Mary's Hospital</name>
        <address>
          <city>Seoul</city>
          <zip>07345</zip>
          <country>Korea, Republic of</country>
        </address>
      </facility>
      <investigator>
        <last_name>Eunjoo Cho</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Korea University Guro Hospital</name>
        <address>
          <city>Seoul</city>
          <zip>08308</zip>
          <country>Korea, Republic of</country>
        </address>
      </facility>
      <investigator>
        <last_name>Jinoh Na</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>The Catholic University of Korea, Uijeongbu ST. Mary's Hospital</name>
        <address>
          <city>Seoul</city>
          <zip>11765</zip>
          <country>Korea, Republic of</country>
        </address>
      </facility>
      <investigator>
        <last_name>Hyosuk Ahn</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Seoul national University Budang hospital</name>
        <address>
          <city>Seoul</city>
          <zip>13620</zip>
          <country>Korea, Republic of</country>
        </address>
      </facility>
      <investigator>
        <last_name>Kwangil Kim</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Korea, Republic of</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 4, 2023</study_first_submitted>
    <study_first_submitted_qc>September 11, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 18, 2023</study_first_posted>
    <last_update_submitted>September 11, 2023</last_update_submitted>
    <last_update_submitted_qc>September 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Telmisartan/Amlodipine/Chlorthalidone Fixed-Dose Combination</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Hypertension</mesh_term>
      <mesh_term>Essential Hypertension</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Amlodipine</mesh_term>
      <mesh_term>Hydrochlorothiazide</mesh_term>
      <mesh_term>Telmisartan</mesh_term>
      <mesh_term>Chlorthalidone</mesh_term>
      <mesh_term>Telmisartan amlodipine combination</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06041529
  org study id: YMC050
  nct id: NCT06041529
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This study is to compare the efficacy and safety of Telmisartan, Amlodipine, and
        Chlorthalidone Fixed-Dose Combination and Telmisartan, Amlodipine, and Hydrochlorothiazide in
        Elderly Patients with Essential Hypertension Uncontrolled by Telmisartan and Amlodipine
        Combinations
  This is a Phase IV, Randomized, Open-label, Superiority, Comparative study evaluating the
        efficacy and safety of Telmisartan, Amlodipine, and Chlorthalidone Fixed-Dose Combination)
        versus Telmisartan, Amlodipine, and Hydrochlorothiazide in eledrly patient with essential
        hypertension uncontrolled by Telmisartan and Amlodipine Combinations.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Mean Systolic Blood Pressure (MSBP) in nighttime
  time frame: Week 8
  description: To evaluate change from baseline in nighttime Mean Systolic Blood Pressure (MSBP) measured by Ambulatory Blood Pressure Monitoring at Week 8
  measure: Mean Systolic Blood Pressure (MSBP) in nighttime
  time frame: Week 26 if applicable
  description: To evaluate change from baseline in nighttime Mean Systolic Blood Pressure (MSBP) measured by Ambulatory Blood Pressure Monitoring at Week 26 if applicable
  measure: Mean Diastolic Blood Pressure (MDBP) in nighttime
  time frame: Week 8 and Week 26 if applicable
  description: To evaluate change from baseline in nighttime Mean Diastolic Blood Pressure (MDBP) measured by Ambulatory Blood Pressure Monitoring at Week 8 and Week 26 if applicable
  measure: Mean Systolic Blood Pressure (MSBP)/Mean Diastolic Blood Pressure (MDBP) in daytime
  time frame: Week 8 and Week 26 if applicable
  description: To evaluate change from baseline in daytime Mean Systolic Blood Pressure (MSBP)/Mean Diastolic Blood Pressure (MDBP) measured by Ambulatory Blood Pressure Monitoring at Week 8 and Week 26 if applicable
  measure: 24-hour Mean Systolic Blood Pressure (MSBP)/Mean Diastolic Blood Pressure (MDBP)
  time frame: Week 8 and Week 26 if applicable
  description: To evaluate change from baseline in 24-hour Mean Systolic Blood Pressure (MSBP)/Mean Diastolic Blood Pressure (MDBP) measured by Ambulatory Blood Pressure Monitoring at Week 8 and Week 26 if applicable
  measure: Patients Achieving in nighttime Mean Systolic Blood Pressure (MSBP)
  time frame: Week 8
  description: To evaluate the percentage of patients who reached the treatment goal for nighttime Mean Systolic Blood Pressure (MSBP) (<110/65mmHg) measured by Ambulatory Blood Pressure Monitoring at Week 8
  measure: Mean Sitting Systolic Blood Pressure (MSSBP)/ Mean Sitting Diastolic Blood Pressure (MSDBP)
  time frame: Week 4, Week 8 and Week 26 if applicable
  description: To evaluate change from baseline in Mean Sitting Systolic Blood Pressure (MSSBP)/ Mean Sitting Diastolic Blood Pressure (MSDBP) measured by the Institution at Week 4, Week 8 and Week 26 if applicable
  measure: Patients Achieving in Mean Sitting Systolic Blood Pressure (MSSBP)
  time frame: Week 4, Week 8 and Week 26 if applicable
  description: - To evaluate the percentage of patients who reached the treatment goal for Mean Sitting Blood Pressure (MSBP) < 140/90 mmHg measured by the Institution at Week 4, Week 8 and Week 26 if applicable
  measure: Percentage of patients with decreased Mean Sitting Systolic Blood Pressure (MSSBP) and Mean Sitting Diastolic Blood Pressure (MSDBP).
  time frame: Week 4, Week 8 and Week 26 if applicable
  description: To evaluate the percentage of subjects with a Mean Sitting Systolic Blood Pressure (MSSBP) decrease of ≥20mmHg and a Mean Sitting Diastolic Blood Pressure (MSDBP) decrease of ≥10mmHg at Week 4, Week 8 and Week 26 if applicable
  measure: T/P ratio
  time frame: Week 8 and Week 26 if applicable
  description: To evaluate the T/P ratio for systolic/diastolic blood pressure measured by Ambulatory Blood Pressure Monitoring at Week 8 and Week 26 if applicable
  arm group label: Telmisartan/Amlodipine/Chlorthalidonea 40/5/12.5 mg
  arm group type: Experimental
  description: Telmisartan/Amlodipine/Chlorthalidonea 40/5/12.5 mg will be orally administered during the study period
  arm group label: Telmisartan/Amlodipine/Hydrochlorothiazide 40/5/25 mg
  arm group type: Active Comparator
  description: Telmisartan/Amlodipine 40/5 mg and Hydrochlorothiazide 25 mg will be orally administered each during study period
  intervention type: Drug
  intervention name: Telmisartan/Amlodipine/Chlorthalidone 40/5/12.5 mg
  description: PO, Once daily(QD), 8 weeks and 26 weeks if applicable
  arm group label: Telmisartan/Amlodipine/Chlorthalidonea 40/5/12.5 mg
  other name: Truset 40/5/12.5mg
  intervention type: Drug
  intervention name: Telmisartan/Amlodipine/Hydrochlorothiazide 40/5/25 mg
  description: PO, Once daily(QD), 8 weeks and 26 weeks if applicable
  arm group label: Telmisartan/Amlodipine/Hydrochlorothiazide 40/5/25 mg
  other name: Twynsta 40/5 mg, Dichlozid 25 mg
  criteria: 
  gender: All
  minimum age: 65 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Sanghyun Ihm
  role: Principal Investigator
  affiliation: The Catholic University of Korea Bucheon St.Mary's Hospita
  last name: Yujun Kim
  phone: +82-2-828-0394
  email: yjkim@yuhan.co.kr
  last name: Minjun Kim
  phone: +82-2-828-0508
  email: minjun.kim@yuhan.co.kr
  facility: 
  investigator: 
  facility: 
  investigator: 
  facility: 
  investigator: 
  facility: 
  investigator: 
  facility: 
  investigator: 
  facility: 
  investigator: 
  facility: 
  investigator: 
  facility: 
  investigator: 
  facility: 
  investigator: 
  facility: 
  investigator: 
  facility: 
  investigator: 
  facility: 
  investigator: 
  country: Korea, Republic of
  responsible party type: Sponsor
  mesh term: Hypertension
  mesh term: Essential Hypertension
  mesh term: Amlodipine
  mesh term: Hydrochlorothiazide
  mesh term: Telmisartan
  mesh term: Chlorthalidone
  mesh term: Telmisartan amlodipine combination
  sharing ipd: No