<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/NCT02231788</url>
  </required_header>
  <id_info>
    <org_study_id>330HT13010</org_study_id>
    <nct_id>NCT02231788</nct_id>
  </id_info>
  <brief_title>The Efficacy of a Combination of Telmisartan/S-Amlodipine Compared With Telmisartan Monotherapy</brief_title>
  <acronym>TENUVA-BP</acronym>
  <official_title>A Multicenter, Prospective, Randomized, Open-label, Phase 4 Trial to Evaluate the Efficacy of Telmisartan/S-Amlodipine(Telminuvo® Tab. 40/2.5mg) on 24-hour Ambulatory BP Control Compared With Telmisartan Monotherapy in Hypertensive Patients Inadequately Controlled by Telmisartan Monotherapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chong Kun Dang Pharmaceutical</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chong Kun Dang Pharmaceutical</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The Efficacy of a Fixed Dose Combination of Telmisartan/S-Amlodipine on 24-hour Ambulatory BP&#xD;
      Control Compared with Telmisartan Monotherapy&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A multicenter, Prospective, Randomized, Open-label, Phase 4 Trial designed to Evaluate the&#xD;
      Efficacy of a Fixed Dose Combination of Telmisartan/S-Amlodipine on 24-hour Ambulatory BP&#xD;
      Control Compared with Telmisartan Monotherapy&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 2014</start_date>
  <completion_date type="Actual">March 2018</completion_date>
  <primary_completion_date type="Actual">March 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>Change from baseline in the 24hr mean blood pressure by ambulatory blood pressure monitoring(ABPM) at week 8.</measure>
    <time_frame>Baseline and week 8</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in the 24hr mean daytime, nighttime, morning blood pressure by ABPM at week 8.</measure>
    <time_frame>Baseline and week 8</time_frame>
    <description>Each timepoint is as following:&#xD;
Daytime: 06:00~21:59&#xD;
Nighttime: 22:00~05:59&#xD;
Morning: 06:00~11:59</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in the clinic mean blood pressure at week 8.</measure>
    <time_frame>Baseline and week 8</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>24hr ABPM and Clinic BP control at week 8.</measure>
    <time_frame>Baseline and week 8</time_frame>
    <description>&lt;24hr ABPM&gt;&#xD;
24hr mean BP: 24hr mean Systolic blood pressure(SBP)&lt;130mmHg and 24hr mean Diastolic blood pressure(DBP)&lt;80mmHg&#xD;
Daytime BP: Daytime mean SBP&lt;135mmHg and Daytime mean DBP&lt;85mmHg&#xD;
Night time BP: Night time mean SBP&lt;120mmHg and Night time mean DBP&lt;70mmHg&#xD;
&lt;Clinic BP&gt;&#xD;
: Mean sitting systolic blood pressure(MSSBP)&lt;140mmHg and Mean sitting diastolic blood pressure(MSDBP)&lt;90mmHg (If Hypertension with Diabetes mellitus or Chronic kidney disease: MSSBP&lt;130mmHg and MSDBP&lt;80mmHg)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>24hr ABPM and Clinic BP response at week 8.</measure>
    <time_frame>Baseline and week 8</time_frame>
    <description>&lt;24hr ABPM&gt; 24hr mean SBP and DBP reduction≥10mmHg&#xD;
&lt;Clinic BP&gt; MSSBP and MSDBP≥10mmHg</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">217</enrollment>
  <condition>Hypertension</condition>
  <arm_group>
    <arm_group_label>Telminuvo®Tab. 40/2.5mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Telminuvo®Tab.(Telmisartan/S-Amlodipine) 40/2.5mg</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Telmitrend®Tab. 80mg</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Telmitrend®Tab.(Telmisartan) 80mg</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Telminuvo®Tab. 40/2.5mg</intervention_name>
    <description>Telminuvo®Tab. 40/2.5mg, Once daily, Per oral for 8weeks after 2~4weeks run-in period with Telmitrend®Tab. 40mg</description>
    <arm_group_label>Telminuvo®Tab. 40/2.5mg</arm_group_label>
    <other_name>Telmisartan/S-Amlodipine 40/2.5mg</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Telmitrend®Tab. 80mg</intervention_name>
    <description>Telmitrend®Tab. 80mg, Once daily, Per oral for 8weeks after 2~4weeks run-in period with Telmitrend®Tab. 40mg</description>
    <arm_group_label>Telmitrend®Tab. 80mg</arm_group_label>
    <other_name>Telmisartan 80mg</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. More than 19 years in hypertension patient&#xD;
&#xD;
          2. Hypertension is satisfied with the Clinic blood pressure that was measured at the time&#xD;
             of randomization&#xD;
&#xD;
               -  Clinic MSSBP ≥ 140mmHg&#xD;
&#xD;
               -  Clinic MSSBP ≥ 130mmHg in diabetes mellitus or chronic kidney disease&#xD;
&#xD;
                    -  Diabetes mellitus&#xD;
&#xD;
                         -  Before screening, diagnosed with diabetes mellitus being treated with&#xD;
                            oral hypoglycemic agents at least 30 days OR&#xD;
&#xD;
                         -  Patients who meet the following results of laboratory tests at the time&#xD;
                            of randomization. : Fasting plasma glucose ≥ 126mg/dL&#xD;
&#xD;
                    -  Chronic kidney disease&#xD;
&#xD;
                         -  Patients who meet the following results of laboratory tests at the time&#xD;
                            of randomization.: 15mL/min/1.73m2 ≤ estimated glomerular filtration&#xD;
                            rate ≤ 60mL/min/1.73m2&#xD;
&#xD;
          3. Patient who decided to participate and signed on an informed consent form willingly&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Clinic MSSBP ≥ 200mmHg or Clinic MSDBP ≥ 120mmHg at the time of Screening and&#xD;
             Randomization&#xD;
&#xD;
          2. As night workers who sleep during the day and whose working hours including 00:00 to&#xD;
             04:00&#xD;
&#xD;
          3. Abnormal laboratory test results&#xD;
&#xD;
               -  Aspartate aminotransferase/Alanine aminotransferase &gt; Upper normal limit X 3&#xD;
&#xD;
               -  Serum creatinine &gt; Upper normal limit X 4&#xD;
&#xD;
          4. Secondary hypertension patient without diabetes mellitus, chronic kidney disease:&#xD;
             coarctation of aorta, cushing's syndrome, pheochromocytoma, primary aldosteronism etc.&#xD;
&#xD;
          5. Severe heart disease(Heart failure; New York Heart Association(NYHA) class 3, 4) and&#xD;
             recent unstable angina or myocardial infarction or valvular heart disease or&#xD;
             arrhythmia requiring treatment within the past 3 months&#xD;
&#xD;
          6. Severe cerebrovascular disorders such as cerebral infarction, cerebral hemorrhage&#xD;
             within 6 months&#xD;
&#xD;
          7. Patient who is planning for a renal transplantation during the trial&#xD;
&#xD;
          8. Severe or malignant retinopathy&#xD;
&#xD;
          9. Acute of chronic inflammatory status requiring treatment&#xD;
&#xD;
         10. A history of cancer within five years&#xD;
&#xD;
         11. A history of angioedema with ACE inhibitors or angiotensin-Ⅱ receptor blockers&#xD;
&#xD;
         12. Severe hypersensitivity to amlodipine or telmisartan&#xD;
&#xD;
         13. Surgical or medical conditions&#xD;
&#xD;
               -  History of major gastrointestinal surgery&#xD;
&#xD;
               -  History of active inflammatory bowel syndrome within 12 months&#xD;
&#xD;
               -  Abnormal pancreatic functions&#xD;
&#xD;
               -  Gastrointestinal/rectal bleeding&#xD;
&#xD;
               -  Urinary tract obstruction&#xD;
&#xD;
         14. Need for other antihypertensive drugs during the trial&#xD;
&#xD;
         15. Need for prohibited medication specified in the protocol&#xD;
&#xD;
         16. Administration of other Investigational Product within 30 days&#xD;
&#xD;
         17. History of drug or alcohol abuse within 6 months&#xD;
&#xD;
         18. Pregnant, breast-feeding and childbearing age who don't use adequate contraception&#xD;
&#xD;
         19. Another clinical condition in investigator's judgement&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hyo-Soo Kim, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Seoul University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Korea University Ansan Hospital</name>
      <address>
        <city>Gyeonggi-do</city>
        <state>Ansan-si</state>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jeju National University Hospital</name>
      <address>
        <city>Jeju</city>
        <state>Aran</state>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bundang Cha Hospital</name>
      <address>
        <city>Seongnam</city>
        <state>Bundang-gu</state>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seoul University Bundang Hospital</name>
      <address>
        <city>Seongnam</city>
        <state>Bundang-gu</state>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>KyungHee University Medical Center</name>
      <address>
        <city>Seoul</city>
        <state>Dongdaemun-gu</state>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gangnam Severance Hospital</name>
      <address>
        <city>Seoul</city>
        <state>Gangnam-gu</state>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kumi cha Hospital</name>
      <address>
        <city>Gumi</city>
        <state>Gyeongsangbuk-do</state>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seoul University Hospital</name>
      <address>
        <city>Seoul</city>
        <state>Jongro-gu</state>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Medical Center</name>
      <address>
        <city>Seoul</city>
        <state>Jung-gu</state>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kosin University Gospel Hospital</name>
      <address>
        <city>Busan</city>
        <state>Seo-gu</state>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hallym University Kangnam Sacred Heart Hosipital</name>
      <address>
        <city>Seoul</city>
        <state>Yeongdeungpo-gu</state>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>March 2018</verification_date>
  <study_first_submitted>September 1, 2014</study_first_submitted>
  <study_first_submitted_qc>September 3, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 4, 2014</study_first_posted>
  <last_update_submitted>January 29, 2020</last_update_submitted>
  <last_update_submitted_qc>January 29, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 31, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Telminuvo</keyword>
  <keyword>Telmitrend</keyword>
  <keyword>Hypertension</keyword>
  <keyword>24hr ABPM</keyword>
  <keyword>Telmisartan</keyword>
  <keyword>S-amlodipine</keyword>
  <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>
    <mesh_term>Telmisartan</mesh_term>
  </intervention_browse>
  <!-- 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/NCT02231788
org study id: 330HT13010
nct id: NCT02231788
lead sponsor: 
has dmc: No
The Efficacy of a Fixed Dose Combination of Telmisartan/S-Amlodipine on 24-hour Ambulatory BP
      Control Compared with Telmisartan Monotherapy
A multicenter, Prospective, Randomized, Open-label, Phase 4 Trial designed to Evaluate the
      Efficacy of a Fixed Dose Combination of Telmisartan/S-Amlodipine on 24-hour Ambulatory BP
      Control Compared with Telmisartan Monotherapy
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change from baseline in the 24hr mean blood pressure by ambulatory blood pressure monitoring(ABPM) at week 8.
time frame: Baseline and week 8
measure: Change from baseline in the 24hr mean daytime, nighttime, morning blood pressure by ABPM at week 8.
time frame: Baseline and week 8
description: Each timepoint is as following:
Daytime: 06:00~21:59
Nighttime: 22:00~05:59
Morning: 06:00~11:59
measure: Change from baseline in the clinic mean blood pressure at week 8.
time frame: Baseline and week 8
measure: 24hr ABPM and Clinic BP control at week 8.
time frame: Baseline and week 8
description: <24hr ABPM>
24hr mean BP: 24hr mean Systolic blood pressure(SBP)<130mmHg and 24hr mean Diastolic blood pressure(DBP)<80mmHg
Daytime BP: Daytime mean SBP<135mmHg and Daytime mean DBP<85mmHg
Night time BP: Night time mean SBP<120mmHg and Night time mean DBP<70mmHg
<Clinic BP>
: Mean sitting systolic blood pressure(MSSBP)<140mmHg and Mean sitting diastolic blood pressure(MSDBP)<90mmHg (If Hypertension with Diabetes mellitus or Chronic kidney disease: MSSBP<130mmHg and MSDBP<80mmHg)
measure: 24hr ABPM and Clinic BP response at week 8.
time frame: Baseline and week 8
description: <24hr ABPM> 24hr mean SBP and DBP reduction≥10mmHg
<Clinic BP> MSSBP and MSDBP≥10mmHg
arm group label: Telminuvo®Tab. 40/2.5mg
arm group type: Experimental
description: Telminuvo®Tab.(Telmisartan/S-Amlodipine) 40/2.5mg
arm group label: Telmitrend®Tab. 80mg
arm group type: Active Comparator
description: Telmitrend®Tab.(Telmisartan) 80mg
intervention type: Drug
intervention name: Telminuvo®Tab. 40/2.5mg
description: Telminuvo®Tab. 40/2.5mg, Once daily, Per oral for 8weeks after 2~4weeks run-in period with Telmitrend®Tab. 40mg
arm group label: Telminuvo®Tab. 40/2.5mg
other name: Telmisartan/S-Amlodipine 40/2.5mg
intervention type: Drug
intervention name: Telmitrend®Tab. 80mg
description: Telmitrend®Tab. 80mg, Once daily, Per oral for 8weeks after 2~4weeks run-in period with Telmitrend®Tab. 40mg
arm group label: Telmitrend®Tab. 80mg
other name: Telmisartan 80mg
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
healthy volunteers: No
last name: Hyo-Soo Kim, Professor
role: Principal Investigator
affiliation: Seoul University Hospital
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Hypertension
mesh term: Amlodipine
mesh term: Telmisartan