<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/NCT02969265</url>
  </required_header>
  <id_info>
    <org_study_id>TCV-116CCB_302</org_study_id>
    <secondary_id>U1111-1184-7520</secondary_id>
    <secondary_id>CTR20160750</secondary_id>
    <nct_id>NCT02969265</nct_id>
  </id_info>
  <brief_title>An Efficacy and Safety Study Evaluating the Fixed-Dose Combination of Candesartan Plus Amlodipine in Participants With Mild/Moderate Essential Hypertension</brief_title>
  <official_title>A Phase-3 Randomized, Double-Blind, Parallel-Group Efficacy and Safety Study Evaluating the Fixed-Dose Combination of Candesartan Plus Amlodipine (8/5 mg) in Chinese Subjects With Mild/Moderate Essential Hypertension, Who Do Not Achieve Target Blood Pressure Following Treatment With Amlodipine 5 mg Monotherapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Takeda</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Takeda</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>
      The purpose of this study is to evaluate the efficacy and safety of TCV-116CCB (candesartan&#xD;
      cilexetil and amlodipine besylate fixed-dose combination) in Chinese participants with mild&#xD;
      to moderate hypertension who do not reach target blood pressure following 4 weeks of&#xD;
      treatment with amlodipine monotherapy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The drug being tested in this study is called TCV-116CCB (candesartan cilexetil and&#xD;
      amlodipine besylate fixed-dose combination). This study will look at blood pressure in&#xD;
      Chinese participants with grade 1 or 2 essential hypertension.&#xD;
&#xD;
      The study will enroll approximately 370 patients. Prior to the start of study treatment,&#xD;
      participants will undergo run-in period of 2 weeks followed by single-blind treatment period&#xD;
      of 4 weeks. Upon completion of single-blind treatment period, participants will be randomly&#xD;
      assigned (by chance, like flipping a coin) to one of the two treatment groups-which will&#xD;
      remain undisclosed to the participant and study doctor during the study (unless there is an&#xD;
      urgent medical need):&#xD;
&#xD;
        -  Amlodipine 5 mg&#xD;
&#xD;
        -  TCV-116CCB (Candesartan 8 mg Plus Amlodipine 5 mg)&#xD;
&#xD;
      All participants will be asked to take one tablet/capsule at the same time each day&#xD;
      throughout the study up to 8 weeks.&#xD;
&#xD;
      This multicenter trial will be conducted China. The overall time to participate in this study&#xD;
      is 19 weeks. Participants will make multiple visits to the clinic, and will be contacted by&#xD;
      telephone plus a final visit 14 days after receiving their last dose of drug for a follow-up&#xD;
      assessment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Business reasons unrelated to product safety&#xD;
  </why_stopped>
  <start_date type="Anticipated">May 9, 2017</start_date>
  <completion_date type="Anticipated">July 26, 2018</completion_date>
  <primary_completion_date type="Anticipated">July 12, 2018</primary_completion_date>
  <phase>Phase 3</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change From Baseline in Trough, Sitting, Clinic Systolic Blood Pressure (SBP) at Week 8</measure>
    <time_frame>Baseline and Week 8</time_frame>
    <description>The change between trough SBP measured at Week 8 relative to baseline. It is the arithmetic mean of the 3 trough sitting systolic blood pressure measurements.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Trough, Sitting, Clinic Diastolic Blood Pressure (DBP) at Week 8</measure>
    <time_frame>Baseline and Week 8</time_frame>
    <description>The change between trough DBP measured at Week 8 relative to baseline. It is the arithmetic mean of the 3 trough sitting diastolic blood pressure measurements.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants who Achieved Target Blood Pressure at Week 8</measure>
    <time_frame>Week 8</time_frame>
    <description>Target blood pressure is defined as trough, sitting clinic SBP &lt;140 mm Hg, trough, sitting, clinic DBP &lt;90 mm Hg or achieving both trough, sitting clinic SBP (&lt;140 mm Hg) and DBP targets (&lt;90 mm Hg).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Hypertension</condition>
  <arm_group>
    <arm_group_label>TCV-116CCB (Candesartan 8 mg Plus Amlodipine 5 mg)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Run-in Period: TCV-116CCB placebo-matching tablets, orally, once daily along with amlodipine placebo-matching capsules, orally, once daily up to 2 weeks.&#xD;
Single-blind monotherapy treatment period: TCV-116CCB placebo-matching tablets, orally, once daily along with amlodipine 5 mg capsules, orally, once daily up to 4 weeks.&#xD;
Double-blind treatment period: TCV-116CCB 8/5 mg tablets, orally, once daily along with amlodipine placebo-matching capsules, orally, once daily up to 8 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Amlodipine 5 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Run-in Period: TCV-116CCB placebo-matching tablets, orally, once daily along with amlodipine placebo-matching capsules, orally, once daily up to 2 weeks.&#xD;
Monotherapy treatment period: TCV-116CCB placebo-matching tablets, orally, once daily along with amlodipine 5 mg capsules, orally, once daily up to 4 weeks.&#xD;
Double-blind treatment period: Amlodipine 5 mg capsules, orally, once daily along with TCV-116CCB placebo-matching tablets, orally, once daily up to 8 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Amlodipine</intervention_name>
    <description>Amlodipine Capsules</description>
    <arm_group_label>Amlodipine 5 mg</arm_group_label>
    <arm_group_label>TCV-116CCB (Candesartan 8 mg Plus Amlodipine 5 mg)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>TCV-116CCB</intervention_name>
    <description>TCV-116CCB Tablets</description>
    <arm_group_label>TCV-116CCB (Candesartan 8 mg Plus Amlodipine 5 mg)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Amlodipine Placebo</intervention_name>
    <description>Amlodipine placebo-matching capsules</description>
    <arm_group_label>Amlodipine 5 mg</arm_group_label>
    <arm_group_label>TCV-116CCB (Candesartan 8 mg Plus Amlodipine 5 mg)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>TCV-116CCB Placebo</intervention_name>
    <description>TCV-116CCB 8/5 mg placebo-matching tablets</description>
    <arm_group_label>Amlodipine 5 mg</arm_group_label>
    <arm_group_label>TCV-116CCB (Candesartan 8 mg Plus Amlodipine 5 mg)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Has grade 1 or 2 essential hypertension which is not adequately controlled, as defined&#xD;
             by mean, trough, sitting, clinic systolic blood pressure (SBP):&#xD;
&#xD;
               1. ≥155 to &lt;180 mm Hg in participants who have not received any antihypertensive&#xD;
                  medication in the 14 days prior to Visit 1.&#xD;
&#xD;
               2. ≥145 to ≤170 mm Hg in participants taking 1 antihypertensive medication at Visit&#xD;
                  1.&#xD;
&#xD;
               3. ≥140 to &lt;160 mm Hg in participants taking 2 antihypertensive medications at Visit&#xD;
                  1.&#xD;
&#xD;
          2. Is willing to discontinue current antihypertensive medications.&#xD;
&#xD;
             Entering amlodipine 5 mg monotherapy:&#xD;
&#xD;
          3. Must have a clinic SBP measurement of 155 to 179 mm Hg inclusive (determined by the&#xD;
             mean of 3 sitting, trough, measurements on Day -28, using same arm throughout study)&#xD;
             to qualify for entry in to the 4 week single-blind amlodipine 5 mg monotherapy&#xD;
             treatment period.&#xD;
&#xD;
             At double-blind randomization:&#xD;
&#xD;
          4. Has not achieved target blood pressure (defined as clinic SBP ≥140 mm Hg as determined&#xD;
             by the mean of 3 sitting, trough, measurements) following 4 weeks single-blind&#xD;
             treatment with amlodipine 5 mg monotherapy at Day 1 prior to randomization to&#xD;
             double-blind treatment.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Has clinic SBP ≥180 mm Hg or DBP ≥110 mm Hg.&#xD;
&#xD;
          2. The participant's 3 SBP measurements differ by more than 15 mm Hg (confirmed by a&#xD;
             second set of three measurements).&#xD;
&#xD;
          3. Has been randomized/enrolled in an amlodipine or candesartan or candesartan/amlodipine&#xD;
             Fixed dose combination study.&#xD;
&#xD;
          4. Has secondary hypertension of any etiology (e.g., renovascular disease documented as&#xD;
             the cause of hypertension, pheochromocytoma, Cushing's syndrome).&#xD;
&#xD;
          5. Has any history of myocardial infarction, heart failure, unstable angina, coronary&#xD;
             artery bypass graft, percutaneous coronary intervention, hypertensive encephalopathy,&#xD;
             cerebrovascular accident, persistent or permanent atrial fibrillation or transient&#xD;
             ischemic attack.&#xD;
&#xD;
          6. Has clinically significant cardiac conduction defects (e.g., third-degree&#xD;
             atrioventricular block, sick sinus syndrome).&#xD;
&#xD;
          7. Has hemodynamically significant left ventricular outflow obstruction due to aortic&#xD;
             valvular disease or hypertrophic cardiomyopathy.&#xD;
&#xD;
          8. Has a history of cancer that has not been in remission for at least 5 years prior to&#xD;
             the first dose of single-blind amlodipine monotherapy study drug. (This criterion does&#xD;
             not apply to those participants with basal cell or Stage 1 squamous cell carcinoma of&#xD;
             the skin).&#xD;
&#xD;
          9. Has poorly-controlled type 1 or 2 diabetes mellitus (hemoglobin A1c [HbA1c] &gt;8.0%) at&#xD;
             Screening.&#xD;
&#xD;
         10. Has severe renal dysfunction or disease (based on estimated Glomerular filtration rate&#xD;
             [GFR] &lt;30 mL/min/1.73m^2) at Screening.&#xD;
&#xD;
         11. Has hypokalemia or hyperkalemia (defined as serum potassium outside of the normal&#xD;
             reference range) at Screening.&#xD;
&#xD;
         12. Has an alanine aminotransferase or aspartate aminotransferase level &gt;2.5 times the&#xD;
             upper limit of normal, active liver disease, or jaundice at Screening.&#xD;
&#xD;
         13. Works a night (third) shift (defined as 10 PM [2200] to 6 AM [0600]) (Only for&#xD;
             participants with ambulatory blood pressure monitoring [ABPM]).&#xD;
&#xD;
         14. Has an upper arm circumference &lt;24 cm or &gt;42 cm (Only for participants with ABPM).&#xD;
&#xD;
             Entering amlodipine 5 mg monotherapy period:&#xD;
&#xD;
         15. Has a clinic SBP ≥180 mm Hg or DBP ≥110 mm Hg.&#xD;
&#xD;
         16. Is non-compliant (&lt;80% or &gt;120%) with study medication during the placebo run-in&#xD;
             period.&#xD;
&#xD;
             Post-single-blind amlodipine 5 mg treatment period:&#xD;
&#xD;
         17. Achieves target blood pressure (defined as clinic SBP&lt;140 mm Hg as determined by the&#xD;
             mean of 3 sitting, trough measurements) following 4 weeks single-blind treatment with&#xD;
             amlodipine 5 mg monotherapy at Day 1, prior to randomization to double-blind&#xD;
             treatment.&#xD;
&#xD;
         18. Has a clinic SBP ≥180 mm Hg or/and DBP ≥110 mm Hg.&#xD;
&#xD;
         19. Is non-compliant (&lt;80% or &gt;120%) with study medication during the amlodipine 5 mg&#xD;
             single-blind treatment period.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Medical Director Clinical Science</last_name>
    <role>Study Director</role>
    <affiliation>Takeda</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Fuwai Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100037</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beijing Friendship Hospital, Capital Medical University</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100050</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Peking Union Medical College Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100730</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Second Hospital of Lanzhou University</name>
      <address>
        <city>Lanzhou</city>
        <state>Gansu</state>
        <zip>730030</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Second Affiliated Hospital of Sun Yat-sen University</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510120</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Affiliated Hospital of Guizhou Medical University</name>
      <address>
        <city>Guiyang</city>
        <state>Guizhou</state>
        <zip>550004</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fourth Hospital of Hebei Medical University</name>
      <address>
        <city>Shijiazhuang</city>
        <state>Hebei</state>
        <zip>050011</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Daqing first hospital</name>
      <address>
        <city>Daqing</city>
        <state>Heilongjiang</state>
        <zip>163001</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Harbin Medical University</name>
      <address>
        <city>Harbin</city>
        <state>Heilongjiang</state>
        <zip>150001</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>People's Hospital of Wuhan University</name>
      <address>
        <city>Wuhan</city>
        <state>Hubei</state>
        <zip>430060</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Xiangya Hospitalof Central South University</name>
      <address>
        <city>Changsha</city>
        <state>Hunan</state>
        <zip>410008</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Soochow University</name>
      <address>
        <city>Suzhou</city>
        <state>Jiangsu</state>
        <zip>215006</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jilin Siping Central Hospital</name>
      <address>
        <city>Siping</city>
        <state>Jilin</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Second Affiliated Hospital of Dalian Medical University</name>
      <address>
        <city>Dalian</city>
        <state>Liaoning</state>
        <zip>116027</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shengjing Hospital of China Medical University</name>
      <address>
        <city>Shenyang</city>
        <state>Liaoning</state>
        <zip>110004</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>People's Hospital of Liaoning Province</name>
      <address>
        <city>Shenyang</city>
        <state>Liaoning</state>
        <zip>110016</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>General Hospital of Ningxia Medical University</name>
      <address>
        <city>Yinchuan</city>
        <state>Ningxia</state>
        <zip>750004</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rui Jin Hospital Shanghai Jiao Tong University School of Medicine</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200025</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>the Central Hospital of Xuhui District, Shanghai</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200031</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shanghai Putuo Center Hospital</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200062</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>First Affiliated Hospital of Xian Jiaotong University</name>
      <address>
        <city>Xi'an</city>
        <state>Shanxi</state>
        <zip>710061</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>West China Hospital, Sichuan Univeisity</name>
      <address>
        <city>Chengdu</city>
        <state>Sichuan</state>
        <zip>610041</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sir Run Run Hospital of Zhejiang University</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <zip>310016</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Taizhou Hospital of Zhejiang Province</name>
      <address>
        <city>Linhai</city>
        <state>Zhejiang</state>
        <zip>317000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lishui Hospital of Zhejiang Province</name>
      <address>
        <city>Lishui</city>
        <state>Zhejiang</state>
        <zip>323000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>June 2017</verification_date>
  <study_first_submitted>November 17, 2016</study_first_submitted>
  <study_first_submitted_qc>November 17, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 21, 2016</study_first_posted>
  <last_update_submitted>June 8, 2017</last_update_submitted>
  <last_update_submitted_qc>June 8, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">June 9, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Drug therapy</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>Candesartan cilexetil</mesh_term>
    <mesh_term>Candesartan</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/NCT02969265
org study id: TCV-116CCB_302
secondary id: U1111-1184-7520
secondary id: CTR20160750
nct id: NCT02969265
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to evaluate the efficacy and safety of TCV-116CCB (candesartan
      cilexetil and amlodipine besylate fixed-dose combination) in Chinese participants with mild
      to moderate hypertension who do not reach target blood pressure following 4 weeks of
      treatment with amlodipine monotherapy.
The drug being tested in this study is called TCV-116CCB (candesartan cilexetil and
      amlodipine besylate fixed-dose combination). This study will look at blood pressure in
      Chinese participants with grade 1 or 2 essential hypertension.

      The study will enroll approximately 370 patients. Prior to the start of study treatment,
      participants will undergo run-in period of 2 weeks followed by single-blind treatment period
      of 4 weeks. Upon completion of single-blind treatment period, participants will be randomly
      assigned (by chance, like flipping a coin) to one of the two treatment groups-which will
      remain undisclosed to the participant and study doctor during the study (unless there is an
      urgent medical need):

        -  Amlodipine 5 mg

        -  TCV-116CCB (Candesartan 8 mg Plus Amlodipine 5 mg)

      All participants will be asked to take one tablet/capsule at the same time each day
      throughout the study up to 8 weeks.

      This multicenter trial will be conducted China. The overall time to participate in this study
      is 19 weeks. Participants will make multiple visits to the clinic, and will be contacted by
      telephone plus a final visit 14 days after receiving their last dose of drug for a follow-up
      assessment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Change From Baseline in Trough, Sitting, Clinic Systolic Blood Pressure (SBP) at Week 8
time frame: Baseline and Week 8
description: The change between trough SBP measured at Week 8 relative to baseline. It is the arithmetic mean of the 3 trough sitting systolic blood pressure measurements.
measure: Change From Baseline in Trough, Sitting, Clinic Diastolic Blood Pressure (DBP) at Week 8
time frame: Baseline and Week 8
description: The change between trough DBP measured at Week 8 relative to baseline. It is the arithmetic mean of the 3 trough sitting diastolic blood pressure measurements.
measure: Percentage of Participants who Achieved Target Blood Pressure at Week 8
time frame: Week 8
description: Target blood pressure is defined as trough, sitting clinic SBP <140 mm Hg, trough, sitting, clinic DBP <90 mm Hg or achieving both trough, sitting clinic SBP (<140 mm Hg) and DBP targets (<90 mm Hg).
arm group label: TCV-116CCB (Candesartan 8 mg Plus Amlodipine 5 mg)
arm group type: Experimental
description: Run-in Period: TCV-116CCB placebo-matching tablets, orally, once daily along with amlodipine placebo-matching capsules, orally, once daily up to 2 weeks.
Single-blind monotherapy treatment period: TCV-116CCB placebo-matching tablets, orally, once daily along with amlodipine 5 mg capsules, orally, once daily up to 4 weeks.
Double-blind treatment period: TCV-116CCB 8/5 mg tablets, orally, once daily along with amlodipine placebo-matching capsules, orally, once daily up to 8 weeks.
arm group label: Amlodipine 5 mg
arm group type: Experimental
description: Run-in Period: TCV-116CCB placebo-matching tablets, orally, once daily along with amlodipine placebo-matching capsules, orally, once daily up to 2 weeks.
Monotherapy treatment period: TCV-116CCB placebo-matching tablets, orally, once daily along with amlodipine 5 mg capsules, orally, once daily up to 4 weeks.
Double-blind treatment period: Amlodipine 5 mg capsules, orally, once daily along with TCV-116CCB placebo-matching tablets, orally, once daily up to 8 weeks.
intervention type: Drug
intervention name: Amlodipine
description: Amlodipine Capsules
arm group label: Amlodipine 5 mg
arm group label: TCV-116CCB (Candesartan 8 mg Plus Amlodipine 5 mg)
intervention type: Drug
intervention name: TCV-116CCB
description: TCV-116CCB Tablets
arm group label: TCV-116CCB (Candesartan 8 mg Plus Amlodipine 5 mg)
intervention type: Drug
intervention name: Amlodipine Placebo
description: Amlodipine placebo-matching capsules
arm group label: Amlodipine 5 mg
arm group label: TCV-116CCB (Candesartan 8 mg Plus Amlodipine 5 mg)
intervention type: Drug
intervention name: TCV-116CCB Placebo
description: TCV-116CCB 8/5 mg placebo-matching tablets
arm group label: Amlodipine 5 mg
arm group label: TCV-116CCB (Candesartan 8 mg Plus Amlodipine 5 mg)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Medical Director Clinical Science
role: Study Director
affiliation: Takeda
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country: China
responsible party type: Sponsor
mesh term: Hypertension
mesh term: Essential Hypertension
mesh term: Amlodipine
mesh term: Candesartan cilexetil
mesh term: Candesartan