<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/NCT03231982</url>
  </required_header>
  <id_info>
    <org_study_id>CJ_CCA_401</org_study_id>
    <nct_id>NCT03231982</nct_id>
  </id_info>
  <brief_title>Study to Confirm the Efficacy and Safety of Fixed-dose Combinations of Amlodipine and Candesartan</brief_title>
  <acronym>MACH</acronym>
  <official_title>A Randomized, Double-blind, Multi-center, Phase Ⅳ Clinical Trial to Evaluate the Antihypertensive Efficacy and Safety Between Amlodipine Besylate/Candesartan Cilexetil Combination Tablets and Co-administration of Amlodipine Besylate and Candesartan Cilexetil in Patients With Essential Hypertension</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>HK inno.N Corporation</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>HK inno.N 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>
      To evaluate the efficacy and safety of amlodipine besylate and candesartan cilexetil&#xD;
      administered in a fixed-dose combination tablet versus co-administered as their separate&#xD;
      formulations in patients with essential hypertension who have shown inadequate response on&#xD;
      monotherapy of amlodipine or candesartan cilexetil or who are with blood pressure adequately&#xD;
      controlled by co-administration of amlodipine besylate and candesartan cilexetil single&#xD;
      agents&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">April 17, 2017</start_date>
  <completion_date type="Anticipated">May 31, 2019</completion_date>
  <primary_completion_date type="Anticipated">April 30, 2019</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in sitting Systolic Blood Pressure(siSBP) from baseline after 8 weeks of treatment</measure>
    <time_frame>Week 8</time_frame>
    <description>For change in siSBP from baseline after 8 weeks of treatment, the mean, standard deviation, median, minimum and maximum will be presented by treatment arm.&#xD;
The LS mean change in siSBP from baseline after 8 weeks of treatment adjusted for baseline siSBP and its standard error will be presented by treatment arm. Non-inferiority test will be conducted using ANCOVA including change in siSBP from baseline after 8 weeks of treatment as response variable and baseline siSBP and treatment arm as independent variables. Amlodipine besylate/candesartan cilexetil combination tablet will be considered non-inferior to co-administration of amlodipine besylate and candesartan cilexetil if the lower bound of 2-sided 95% CI for the LS mean of difference in siSBP change between the treatment arms is greater than -5.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in siSBP from baseline after 4 weeks of treatment</measure>
    <time_frame>Week 4</time_frame>
    <description>For change in siSBP from baseline after 4 weeks of treatment, the mean, standard deviation, median, minimum and maximum will be presented by treatment arm.&#xD;
The LS mean change in siSBP from baseline after 4 weeks of treatment adjusted for baseline siSBP and its standard error will be presented by treatment arm. Non-inferiority test will be conducted using ANCOVA including change in siSBP from baseline after 4 weeks of treatment as response variable and baseline siSBP and treatment arm as independent variables. Amlodipine besylate/candesartan cilexetil combination tablet will be considered non-inferior to co-administration of amlodipine besylate and candesartan cilexetil if the lower bound of 2-sided 95% CI for the LS mean of difference in siSBP change between the treatment arms is greater than -5.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in siDBP from baseline after 4 and 8 weeks of treatment</measure>
    <time_frame>Week 4 and Week 8</time_frame>
    <description>For change in siDBP from baseline after 4 and 8 weeks of treatment, the mean, standard deviation, median, minimum and maximum will be presented by treatment arm.&#xD;
The LS mean change in siSBP from baseline after 4 and 8 weeks of treatment adjusted for baseline siDBP and its standard error will be presented by treatment arm. Non-inferiority test will be conducted using ANCOVA including change in siDBP from baseline after 4 and 8 weeks of treatment as response variable and baseline siDBP and treatment arm as independent variables. Amlodipine besylate/candesartan cilexetil combination tablet will be considered non-inferior to co-administration of amlodipine besylate and candesartan cilexetil if the lower bound of 2-sided 95% CI for the LS mean of difference in siSBP change between the treatment arms is greater than -5.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of subjects with siDBP &lt; 90 mmHg and siSBP &lt;140 mmHg after 8 weeks of treatment</measure>
    <time_frame>Week8</time_frame>
    <description>The frequency and percentage of subjects with siDBP &lt; 90 mmHg and the frequency and percentage of subjects with siSBP &lt; 140 mmHg after 8 weeks of treatment will be presented by treatment arm. Additionally, the frequency and percentage of subjects with both siDBP &lt; 90 mmHg and siSBP &lt;140 mmHg after 8 weeks of treatment will be presented by treatment arm. The difference in proportion between treatment arms will be tested using the χ2 test or Fisher's exact test.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Adverse events</measure>
    <time_frame>Baseline, Week 4 and Week 8</time_frame>
    <description>All patients treated with the investigational product will be included in the safety analyses. For adverse events, adverse drug reactions and serious adverse events, the number of subjects experiencing the events or reactions, 95% 2-sided CI, incidence rate, and number of the events or reactions will be presented by treatment arm. The difference in the incidence between the treatment arms will be tested using the χ2 test or Fisher's exact test. The incidence and percentage of events by severity, causality, actions taken and outcome will be presented by treatment arm.&#xD;
All AEs will be coded per system organ class (SOC) and preferred term (PT) using the MedDRA; for each coded event, the number and percentage of subjects and the number of cases will be summarized by treatment arm. In addition, for each coded event, the number and percentage of subjects by severity, causality, actions taken and outcome will be presented by treatment arm.</description>
  </other_outcome>
  <other_outcome>
    <measure>Clinical laboratory tests</measure>
    <time_frame>Baseline, Wee4 and Week 8</time_frame>
    <description>For continuous variables in clinical laboratory test items, the mean, standard deviation, minimum and maximum of baseline value, post-baseline values and change form baseline to post-baseline will be presented by treatment arm. The difference in change from baseline to post-baseline between treatment arms will be tested using the unpaired t-test or Wilcoxon's rank sum test depending on the normality. The intra-arm change from baseline to post-baseline will be tested using the paired t-test or Wilcoxon's signed rank test depending on the normality. For categorical variables, the shift table for frequency and percentage will be presented. The difference in the percentage of subjects whose test results changed from 'normal' to 'abnormal' between treatment arms will be tested using the χ2 test or Fisher's exact test. The intra-arm change from baseline to post-baseline will be tested using the McNemar's test.</description>
  </other_outcome>
  <other_outcome>
    <measure>Electrocardiogram (ECG)</measure>
    <time_frame>Screening and Week 8</time_frame>
    <description>For each ECG parameters at baseline and post-baseline, the shift table will be presented with frequency and percentage. The difference in the percentage of subjects whose ECG results changed from 'clinically insignificant' to 'clinically significant' between treatment arms will be tested using the χ2 test or Fisher's exact test. The intra-arm change from baseline to post-baseline will be tested using the McNemar's test.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">210</enrollment>
  <condition>Hypertension</condition>
  <arm_group>
    <arm_group_label>Group I</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Fixed-Dose combination of Candesartan cilexetil 8mg and Amlodipine 5mg(or Fixed-Dose combination of Candesartan cilexetil 16mg and Amlodipine 5mg), once a day for 8 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group II</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Candesartan cilexetil 8mg and Amlodipine 5mg(or Candesartan cilexetil 16mg and Amlodipine 5mg), once a day for 8 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Group I</intervention_name>
    <description>Machkhan Tab. 8/5 mg + Atacan Tab. 8 mg placebo + Norvasc Tab. 5 mg placebo for 8 weeks or Machkhan Tab. 16/5 mg + Atacan Tab. 16 mg placebo + Norvasc Tab. 5 mg placebo for 8 weeks</description>
    <arm_group_label>Group I</arm_group_label>
    <other_name>Machkhan Tab. 8/5 mg(or Machkhan Tab. 16/5 mg)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Group II</intervention_name>
    <description>Atacan Tab. 8 mg + Norvasc Tab. 5 mg + Machkhan Tab.8/5 mg placebo for 8 weeks or Atacan Tab. 16 mg + Norvasc Tab. 5 mg + Machkhan Tab.16/5 mg placebo for 8 weeks</description>
    <arm_group_label>Group II</arm_group_label>
    <other_name>Atacan Tab. 8 mg(or Atacan Tab. 16 mg), Norvasc Tab. 5 mg</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Adult male and female aged 19 to 75 years&#xD;
&#xD;
          2. Diagnosed with essential hypertension&#xD;
&#xD;
             Patients with essential hypertension meeting one of the following two inclusion&#xD;
             criteria:&#xD;
&#xD;
             2.1. Patients with essential hypertension who have shown inadequate response (mean&#xD;
             siSBP ≥ 140 mmHg or mean siDBP ≥ 90 mmHg) to treatment with amlodipine or candesartan&#xD;
             cilexetil.&#xD;
&#xD;
             2.2. Patients with essential hypertension with blood pressure adequately controlled by&#xD;
             co-administration of amlodipine besylate and candesartan cilexetil (mean siSBP &lt; 140&#xD;
             mmHg and mean siDBP &lt; 90 mmHg).&#xD;
&#xD;
          3. Voluntarily consented to participate in the study and signed the informed consent form&#xD;
             after receiving the explanation of the objectives, methods and effects of the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. The difference in blood pressure between the selected arm versus non-selected arm is ≥&#xD;
             20 mmHg for siSBP and ≥ 10 mmHg for siDBP at Visit 1 (screening).&#xD;
&#xD;
          2. Blood pressure taken at screening and randomization is ≥ 180 mmHg for siSBP or ≥ 110&#xD;
             mmHg for siDBP.&#xD;
&#xD;
          3. Diagnosed with secondary hypertension or suspected of secondary hypertension [e.g.,&#xD;
             renovascular disease, adrenal medullary and cortical hyperfunction, coarctation of the&#xD;
             aorta, hyperaldosteronism, unilateral or bilateral renal artery stenosis, Cushing's&#xD;
             syndrome, pheochromocytoma, polycystic kidney disease, etc.]&#xD;
&#xD;
          4. Patients with symptomatic orthostatic hypertension (the difference in the blood&#xD;
             pressures between measured at supine position and measured at standing position is ≥&#xD;
             20 mmHg for siSBP and ≥ 10 mmHg for siDBP)&#xD;
&#xD;
          5. Diagnosis of type 1 diabetes mellitus (DM) or uncontrolled DM (patients on insulin&#xD;
             therapy or with HbA1c &gt; 9%)&#xD;
&#xD;
          6. Patients with severe cardiac conditions: heart failure (NYHA Class 3 or 4), history of&#xD;
             ischemic cardiac disease (unstable angina, myocardial infarction), peripheral vascular&#xD;
             diseases, percutaneous transluminal angioplasty or coronary artery bypass graft within&#xD;
             recent 6 months.&#xD;
&#xD;
          7. Patients with clinically significant ventricular tachycardia, atrial fibrillation,&#xD;
             atrial flutter or other clinically significant arrhythmia at the discretion of the&#xD;
             investigator&#xD;
&#xD;
          8. Patients with hypertrophic occlusive myocardiopathy, severe occlusive coronary artery&#xD;
             disease, aortic stenosis, hemodynamically significant aortic valve or mitral valve&#xD;
             stenosis&#xD;
&#xD;
          9. History of cardiogenic shock&#xD;
&#xD;
         10. Presence of severe cerebrovascular disorders (diagnosis of stroke, cerebral infarction&#xD;
             or cerebral hemorrhage within recent 6 months)&#xD;
&#xD;
         11. History or current evidence of wasting, autoimmune (such as rheumatoid arthritis and&#xD;
             systemic lupus erythematosus) or connective tissue diseases&#xD;
&#xD;
         12. Known diagnosis of moderate or malignant retinopathy (including retinal hemorrhage,&#xD;
             visual disturbance and retinal microaneurysm within 6 months)&#xD;
&#xD;
         13. Patients with surgical or medical intestinal diseases or having received surgeries&#xD;
             that could interfere with drug absorption distribution, metabolism and elimination&#xD;
&#xD;
         14. History of malignancy including leukemia and lymphoma within recent 5 years except for&#xD;
             localized basal cell carcinoma of the skin)&#xD;
&#xD;
         15. Patients with any inflammatory diseases requiring chronic anti-inflammatory therapy&#xD;
&#xD;
         16. Renal failure on dialysis&#xD;
&#xD;
         17. Laboratory abnormalities as follows:&#xD;
&#xD;
               -  AST or ALT &gt;2 x upper limit of normal (ULN)&#xD;
&#xD;
               -  Serum creatinine &gt; 1.5 x ULN&#xD;
&#xD;
               -  Serum potassium &lt; 3.5 mmol/L or &gt;5.5 mmol/L&#xD;
&#xD;
         18. Needs for co-administration of non-study antihypertensive agents or contraindicated&#xD;
             medications during the study&#xD;
&#xD;
         19. History of hypersensitivity to ARBs or dihydropyridines&#xD;
&#xD;
         20. History of angioedema to treatment with ACE inhibitors or ARBs&#xD;
&#xD;
         21. Pregnant or lactating women and female volunteers of childbearing potential (except&#xD;
             for women who are surgically sterile) who are not willing to use an adequate method of&#xD;
             contraception (oral contraceptives, intrauterine device, condom, etc.) during the&#xD;
             study. Women of childbearing potential who are not surgically sterile will be allowed&#xD;
             to participate in the study only if they have negative pregnancy test at Visit 1&#xD;
             (screening) and should continue to use medically acceptable method of contraception&#xD;
             (basic body temperature method and rhythm method will not be allowed). Women with no&#xD;
             menses for ≥ 12 months will be considered as postmenopausal state and method of&#xD;
             contraception using hormonal contraception such as oral contraceptive should be&#xD;
             initiated from or prior to the screening.&#xD;
&#xD;
         22. History of drug or alcohol abuse within recent 1 year&#xD;
&#xD;
         23. Patients having received any other investigational product within recent 12 weeks&#xD;
&#xD;
         24. Conditions which render a subject ineligible for the study at the discretion of the&#xD;
             investigator&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>SangJun Youn, Ph.D.</last_name>
    <phone>82-8-6477-0240</phone>
    <email>sangjun.youn@cj.net</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>ChungHyun Choi, MS</last_name>
    <phone>82-8-6477-0236</phone>
    <email>chunghyun.choi@cj.net</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Yonsei University Severance Cardiovascular Hospital</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Donghoon Choi, M.D., Ph.D.</last_name>
      <phone>82-2-2228-8200</phone>
      <email>cdhlyj@yuhs.ac</email>
    </contact>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>July 25, 2017</study_first_submitted>
  <study_first_submitted_qc>July 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 27, 2017</study_first_posted>
  <last_update_submitted>October 15, 2018</last_update_submitted>
  <last_update_submitted_qc>October 15, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 16, 2018</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>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Amlodipine</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/NCT03231982
org study id: CJ_CCA_401
nct id: NCT03231982
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To evaluate the efficacy and safety of amlodipine besylate and candesartan cilexetil
      administered in a fixed-dose combination tablet versus co-administered as their separate
      formulations in patients with essential hypertension who have shown inadequate response on
      monotherapy of amlodipine or candesartan cilexetil or who are with blood pressure adequately
      controlled by co-administration of amlodipine besylate and candesartan cilexetil single
      agents
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Change in sitting Systolic Blood Pressure(siSBP) from baseline after 8 weeks of treatment
time frame: Week 8
description: For change in siSBP from baseline after 8 weeks of treatment, the mean, standard deviation, median, minimum and maximum will be presented by treatment arm.
The LS mean change in siSBP from baseline after 8 weeks of treatment adjusted for baseline siSBP and its standard error will be presented by treatment arm. Non-inferiority test will be conducted using ANCOVA including change in siSBP from baseline after 8 weeks of treatment as response variable and baseline siSBP and treatment arm as independent variables. Amlodipine besylate/candesartan cilexetil combination tablet will be considered non-inferior to co-administration of amlodipine besylate and candesartan cilexetil if the lower bound of 2-sided 95% CI for the LS mean of difference in siSBP change between the treatment arms is greater than -5.
measure: Change in siSBP from baseline after 4 weeks of treatment
time frame: Week 4
description: For change in siSBP from baseline after 4 weeks of treatment, the mean, standard deviation, median, minimum and maximum will be presented by treatment arm.
The LS mean change in siSBP from baseline after 4 weeks of treatment adjusted for baseline siSBP and its standard error will be presented by treatment arm. Non-inferiority test will be conducted using ANCOVA including change in siSBP from baseline after 4 weeks of treatment as response variable and baseline siSBP and treatment arm as independent variables. Amlodipine besylate/candesartan cilexetil combination tablet will be considered non-inferior to co-administration of amlodipine besylate and candesartan cilexetil if the lower bound of 2-sided 95% CI for the LS mean of difference in siSBP change between the treatment arms is greater than -5.
measure: Change in siDBP from baseline after 4 and 8 weeks of treatment
time frame: Week 4 and Week 8
description: For change in siDBP from baseline after 4 and 8 weeks of treatment, the mean, standard deviation, median, minimum and maximum will be presented by treatment arm.
The LS mean change in siSBP from baseline after 4 and 8 weeks of treatment adjusted for baseline siDBP and its standard error will be presented by treatment arm. Non-inferiority test will be conducted using ANCOVA including change in siDBP from baseline after 4 and 8 weeks of treatment as response variable and baseline siDBP and treatment arm as independent variables. Amlodipine besylate/candesartan cilexetil combination tablet will be considered non-inferior to co-administration of amlodipine besylate and candesartan cilexetil if the lower bound of 2-sided 95% CI for the LS mean of difference in siSBP change between the treatment arms is greater than -5.
measure: Proportion of subjects with siDBP < 90 mmHg and siSBP <140 mmHg after 8 weeks of treatment
time frame: Week8
description: The frequency and percentage of subjects with siDBP < 90 mmHg and the frequency and percentage of subjects with siSBP < 140 mmHg after 8 weeks of treatment will be presented by treatment arm. Additionally, the frequency and percentage of subjects with both siDBP < 90 mmHg and siSBP <140 mmHg after 8 weeks of treatment will be presented by treatment arm. The difference in proportion between treatment arms will be tested using the χ2 test or Fisher's exact test.
measure: Adverse events
time frame: Baseline, Week 4 and Week 8
description: All patients treated with the investigational product will be included in the safety analyses. For adverse events, adverse drug reactions and serious adverse events, the number of subjects experiencing the events or reactions, 95% 2-sided CI, incidence rate, and number of the events or reactions will be presented by treatment arm. The difference in the incidence between the treatment arms will be tested using the χ2 test or Fisher's exact test. The incidence and percentage of events by severity, causality, actions taken and outcome will be presented by treatment arm.
All AEs will be coded per system organ class (SOC) and preferred term (PT) using the MedDRA; for each coded event, the number and percentage of subjects and the number of cases will be summarized by treatment arm. In addition, for each coded event, the number and percentage of subjects by severity, causality, actions taken and outcome will be presented by treatment arm.
measure: Clinical laboratory tests
time frame: Baseline, Wee4 and Week 8
description: For continuous variables in clinical laboratory test items, the mean, standard deviation, minimum and maximum of baseline value, post-baseline values and change form baseline to post-baseline will be presented by treatment arm. The difference in change from baseline to post-baseline between treatment arms will be tested using the unpaired t-test or Wilcoxon's rank sum test depending on the normality. The intra-arm change from baseline to post-baseline will be tested using the paired t-test or Wilcoxon's signed rank test depending on the normality. For categorical variables, the shift table for frequency and percentage will be presented. The difference in the percentage of subjects whose test results changed from 'normal' to 'abnormal' between treatment arms will be tested using the χ2 test or Fisher's exact test. The intra-arm change from baseline to post-baseline will be tested using the McNemar's test.
measure: Electrocardiogram (ECG)
time frame: Screening and Week 8
description: For each ECG parameters at baseline and post-baseline, the shift table will be presented with frequency and percentage. The difference in the percentage of subjects whose ECG results changed from 'clinically insignificant' to 'clinically significant' between treatment arms will be tested using the χ2 test or Fisher's exact test. The intra-arm change from baseline to post-baseline will be tested using the McNemar's test.
arm group label: Group I
arm group type: Experimental
description: Fixed-Dose combination of Candesartan cilexetil 8mg and Amlodipine 5mg(or Fixed-Dose combination of Candesartan cilexetil 16mg and Amlodipine 5mg), once a day for 8 weeks
arm group label: Group II
arm group type: Active Comparator
description: Candesartan cilexetil 8mg and Amlodipine 5mg(or Candesartan cilexetil 16mg and Amlodipine 5mg), once a day for 8 weeks
intervention type: Drug
intervention name: Group I
description: Machkhan Tab. 8/5 mg + Atacan Tab. 8 mg placebo + Norvasc Tab. 5 mg placebo for 8 weeks or Machkhan Tab. 16/5 mg + Atacan Tab. 16 mg placebo + Norvasc Tab. 5 mg placebo for 8 weeks
arm group label: Group I
other name: Machkhan Tab. 8/5 mg(or Machkhan Tab. 16/5 mg)
intervention type: Drug
intervention name: Group II
description: Atacan Tab. 8 mg + Norvasc Tab. 5 mg + Machkhan Tab.8/5 mg placebo for 8 weeks or Atacan Tab. 16 mg + Norvasc Tab. 5 mg + Machkhan Tab.16/5 mg placebo for 8 weeks
arm group label: Group II
other name: Atacan Tab. 8 mg(or Atacan Tab. 16 mg), Norvasc Tab. 5 mg
criteria: 
gender: All
minimum age: 19 Years
maximum age: 75 Years
healthy volunteers: No
last name: SangJun Youn, Ph.D.
phone: 82-8-6477-0240
email: sangjun.youn@cj.net
last name: ChungHyun Choi, MS
phone: 82-8-6477-0236
email: chunghyun.choi@cj.net
facility: 
status: Recruiting
contact: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Hypertension
mesh term: Amlodipine
sharing ipd: No