<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/NCT03294070</url>
  </required_header>
  <id_info>
    <org_study_id>INTEC-1</org_study_id>
    <nct_id>NCT03294070</nct_id>
  </id_info>
  <brief_title>Fimasartan Plus Amlodipine on Hemodynamic Parameters and Arterial Stiffness in Patients With Hypertension</brief_title>
  <official_title>A 24-week Open-label Clinical Trial to Assess Tolerability and Antihypertensive Effect and in Hemodynamic Parameters and Arterial Stiffness of Fimasartan 60 mg Plus Amlodipine Besylate 5 mg Given Once a Day in Patients With Hypertension in Stadiums 2/3</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centro Universitario de Ciencias de la Salud, Mexico</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centro Universitario de Ciencias de la Salud, Mexico</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>
      24-week open clinical trial to assess tolerability and effect on pressure, hemodynamic&#xD;
      parameters and arterial rigidity of the combined treatment based on Fimasartan 60 mg and&#xD;
      amlodipine besylate 5 mg given once daily in patients with arterial hypertension in stages&#xD;
      2-3&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A prospective, open clinical trial of a cohort of adult patients of both sexes with recent&#xD;
      2-3 years high blood pressure.&#xD;
&#xD;
      Intervention: Fimasartan 60 mg + amlodipine besylate 5 mg once daily&#xD;
&#xD;
      Purpose and justification of the study:&#xD;
&#xD;
      Systemic arterial hypertension (SAH) is a pathology that diminishes the hope and quality of&#xD;
      life and is directly associated with the production or aggravation of other pathologies such&#xD;
      as atherosclerosis, heart failure, ischemic heart disease and / or chronic kidney disease.&#xD;
&#xD;
      Several studies have shown that central pulse pressure (cPP) and central aortic pressure&#xD;
      (CAP) are better predictors of cardiovascular disease, target organ damage and mortality,&#xD;
      than the brachial or peripheral pulse pressure (pPP). More attention should be paid to&#xD;
      central hemodynamics, since its values are those that directly impact the organs that are&#xD;
      commonly damaged as a result of hypertension, brain, kidney and heart. (2) Current&#xD;
      therapeutic strategies for SH, although partially effective, have not adequate control of&#xD;
      tension figures in hypertensive patients, either due to lack of power, by their adverse&#xD;
      effects or by requiring multiple shots that seriously compromise attachment to the treatment.&#xD;
      Fimasartan is a medicine that belongs to the therapeutic class of the selective blockers of&#xD;
      angiotensin II (AT 1) receptors, family of drugs with less adverse effects than other&#xD;
      renin-angiotensin-aldosterone axis inhibitors, with potency adequate antihypertensive and&#xD;
      additional beneficial effects on renal function, hypertrophy ventricular, atheromatosis and&#xD;
      insulin sensitivity. Based on the physico-chemical characteristics of the Fimasartan and the&#xD;
      results obtained in phase I-II and III studies in different populations, including the&#xD;
      Mexican,favoring the adherence and control of blood pressure, it can be an effective and safe&#xD;
      therapeutic option.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">September 2017</start_date>
  <completion_date type="Anticipated">August 2018</completion_date>
  <primary_completion_date type="Anticipated">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>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Reduction of pulse wave velocity</measure>
    <time_frame>24 week</time_frame>
    <description>The administration of combined dose-based treatment of 60 mg of fimasartan plus 5 mg of amlodipine besylate QD administered according to the treatment schedule for 24 weeks reduces VOPcf in Mexican Patients with Essential Arterial Hypertension grades 2 and 3</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Central Aortic Pressure</measure>
    <time_frame>24 week</time_frame>
    <description>The administration of combined dose-based treatment of 60 mg of fimasartan plus 5 mg of amlodipine besylate QD administered according to the treatment schedule for 24 weeks reduces Central Aortic Pressure in Mexican Patients with Essential Arterial Hypertension grades 2 and 3</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Central Pulse Pressure</measure>
    <time_frame>24 week</time_frame>
    <description>The administration of combined dose-based treatment of 60 mg of fimasartan plus 5 mg of amlodipine besylate QD administered according to the treatment schedule for 24 weeks reduces Central Pulse Pressure in Mexican Patients with Essential Arterial Hypertension grades 2 and 3</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rising Index</measure>
    <time_frame>24 week</time_frame>
    <description>The administration of combined dose-based treatment of 60 mg of fimasartan plus 5 mg of amlodipine besylate QD administered according to the treatment schedule for 24 weeks reduces Rising Index in Mexican Patients with Essential Arterial Hypertension grades 2 and 3</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">53</enrollment>
  <condition>Arterial Hypertension</condition>
  <arm_group>
    <arm_group_label>Fimasartan 60 mg + amlodipine besylate 5 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Fimasartan 60 mg + amlodipine besylate 5 mg. In subjects with a DBP equal to or greater than 90 mmHg and / or SBP equal to or greater than 140 mmHg at week 8, the investigator will have the option, according to his clinical criteria, to add 12.5 mg of HCTZ QD (in these cases, the subject will receive one 60 mg Fimasartan tablet plus 12.5 mg HCTZ plus one 5 mg amlodipine besylate tablet.</description>
  </arm_group>
  <intervention>
    <intervention_type>Combination Product</intervention_type>
    <intervention_name>Fimasartan plus amlodipine besylate</intervention_name>
    <description>Fimasartan 60 mg plus amlodipine besylate 5 mg or Fimasartan plus 12.5 mg HCTZ plus one 5 mg amlodipine besylate</description>
    <arm_group_label>Fimasartan 60 mg + amlodipine besylate 5 mg</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subject capable of understanding and signing voluntarily informed consent.&#xD;
&#xD;
          2. Men and women aged 18-65 years.&#xD;
&#xD;
          3. To have essential hypertension grade 2 or 3 according to the figures of diastolic&#xD;
             blood pressure and / or systolic in office according to NOM-030 SSA.&#xD;
&#xD;
          4. Reliable and willing to attend all study visits for the duration of the study and the&#xD;
             follow-up according to the researcher's criteria.&#xD;
&#xD;
          5. Patients on antihypertensive treatment and who in the judgment of the investigator and&#xD;
             taking care of the health and safety of the patient can undergo 2 weeks of previous&#xD;
             washing to the visit of day 0.&#xD;
&#xD;
             -&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Secondary arterial hypertension.&#xD;
&#xD;
          2. Patients currently under treatment that at the discretion of the investigator can not&#xD;
             be submitted to wash period.&#xD;
&#xD;
          3. Severe renal insufficiency (glomerular filtration rate &lt;30 mL / min / 1.73 m2)&#xD;
&#xD;
          4. Moderate to severe hepatic impairment (Child-Pugh B or C classification).&#xD;
&#xD;
          5. Hypersensitivity to any of the components of the research products&#xD;
&#xD;
          6. Hepatobiliary obstruction&#xD;
&#xD;
          7. Myocardial infarction or severe coronary artery disease (including angina pectoris&#xD;
             unstable) or clinically significant congestive heart failure within 6 months prior to&#xD;
             visit to week-1 (selection).&#xD;
&#xD;
          8. Left ventricular ejection fraction ≤40%&#xD;
&#xD;
          9. Resting heart rate ≥90 lpm&#xD;
&#xD;
         10. Thyroid disorder (treated subjects may be involved who are euthyroid)&#xD;
&#xD;
         11. Clinically significant mitral or aortic valve disease (Grade ≥ 2) Hypertrophic&#xD;
             obstructive cardiomyopathy&#xD;
&#xD;
        13. Clinically significant rhythm disorders 14. Clinically significant abnormal laboratory&#xD;
        parameters in the investigator's judgment.&#xD;
&#xD;
        15. Concurrent treatment that may affect blood pressure and which can not be withdrawn in&#xD;
        the opinion of the investigator. 16. A history of galactose intolerance or&#xD;
        glucose-galactose malabsorption. 17. Pregnancy, breastfeeding. 18. Women capable of&#xD;
        procreation DO NOT adopt an effective contraceptive method according to criterion of the&#xD;
        investigator.&#xD;
&#xD;
        19. Patients participating in or participating in other research protocols within 3 months&#xD;
        prior to week 1 visit (selection). 20. Another reason not previously specified but in the&#xD;
        opinion of the investigator may contraindicate their participation in the study.&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Ernesto G Cardona -Muñoz, PhD</last_name>
    <phone>+52 3336173499</phone>
    <email>cameg1@gmail.com</email>
  </overall_contact>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 22, 2017</study_first_submitted>
  <study_first_submitted_qc>September 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 26, 2017</study_first_posted>
  <last_update_submitted>September 25, 2017</last_update_submitted>
  <last_update_submitted_qc>September 25, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 26, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Centro Universitario de Ciencias de la Salud, Mexico</investigator_affiliation>
    <investigator_full_name>Ernesto German Cardona Muñoz</investigator_full_name>
    <investigator_title>Ernesto German Cardona Muñoz</investigator_title>
  </responsible_party>
  <keyword>hemodynamic parameters</keyword>
  <keyword>arterial stiffness</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>
  </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/NCT03294070
org study id: INTEC-1
nct id: NCT03294070
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
24-week open clinical trial to assess tolerability and effect on pressure, hemodynamic
      parameters and arterial rigidity of the combined treatment based on Fimasartan 60 mg and
      amlodipine besylate 5 mg given once daily in patients with arterial hypertension in stages
      2-3
A prospective, open clinical trial of a cohort of adult patients of both sexes with recent
      2-3 years high blood pressure.

      Intervention: Fimasartan 60 mg + amlodipine besylate 5 mg once daily

      Purpose and justification of the study:

      Systemic arterial hypertension (SAH) is a pathology that diminishes the hope and quality of
      life and is directly associated with the production or aggravation of other pathologies such
      as atherosclerosis, heart failure, ischemic heart disease and / or chronic kidney disease.

      Several studies have shown that central pulse pressure (cPP) and central aortic pressure
      (CAP) are better predictors of cardiovascular disease, target organ damage and mortality,
      than the brachial or peripheral pulse pressure (pPP). More attention should be paid to
      central hemodynamics, since its values are those that directly impact the organs that are
      commonly damaged as a result of hypertension, brain, kidney and heart. (2) Current
      therapeutic strategies for SH, although partially effective, have not adequate control of
      tension figures in hypertensive patients, either due to lack of power, by their adverse
      effects or by requiring multiple shots that seriously compromise attachment to the treatment.
      Fimasartan is a medicine that belongs to the therapeutic class of the selective blockers of
      angiotensin II (AT 1) receptors, family of drugs with less adverse effects than other
      renin-angiotensin-aldosterone axis inhibitors, with potency adequate antihypertensive and
      additional beneficial effects on renal function, hypertrophy ventricular, atheromatosis and
      insulin sensitivity. Based on the physico-chemical characteristics of the Fimasartan and the
      results obtained in phase I-II and III studies in different populations, including the
      Mexican,favoring the adherence and control of blood pressure, it can be an effective and safe
      therapeutic option.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Reduction of pulse wave velocity
time frame: 24 week
description: The administration of combined dose-based treatment of 60 mg of fimasartan plus 5 mg of amlodipine besylate QD administered according to the treatment schedule for 24 weeks reduces VOPcf in Mexican Patients with Essential Arterial Hypertension grades 2 and 3
measure: Central Aortic Pressure
time frame: 24 week
description: The administration of combined dose-based treatment of 60 mg of fimasartan plus 5 mg of amlodipine besylate QD administered according to the treatment schedule for 24 weeks reduces Central Aortic Pressure in Mexican Patients with Essential Arterial Hypertension grades 2 and 3
measure: Central Pulse Pressure
time frame: 24 week
description: The administration of combined dose-based treatment of 60 mg of fimasartan plus 5 mg of amlodipine besylate QD administered according to the treatment schedule for 24 weeks reduces Central Pulse Pressure in Mexican Patients with Essential Arterial Hypertension grades 2 and 3
measure: Rising Index
time frame: 24 week
description: The administration of combined dose-based treatment of 60 mg of fimasartan plus 5 mg of amlodipine besylate QD administered according to the treatment schedule for 24 weeks reduces Rising Index in Mexican Patients with Essential Arterial Hypertension grades 2 and 3
arm group label: Fimasartan 60 mg + amlodipine besylate 5 mg
arm group type: Experimental
description: Fimasartan 60 mg + amlodipine besylate 5 mg. In subjects with a DBP equal to or greater than 90 mmHg and / or SBP equal to or greater than 140 mmHg at week 8, the investigator will have the option, according to his clinical criteria, to add 12.5 mg of HCTZ QD (in these cases, the subject will receive one 60 mg Fimasartan tablet plus 12.5 mg HCTZ plus one 5 mg amlodipine besylate tablet.
intervention type: Combination Product
intervention name: Fimasartan plus amlodipine besylate
description: Fimasartan 60 mg plus amlodipine besylate 5 mg or Fimasartan plus 12.5 mg HCTZ plus one 5 mg amlodipine besylate
arm group label: Fimasartan 60 mg + amlodipine besylate 5 mg
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Ernesto G Cardona -Muñoz, PhD
phone: +52 3336173499
email: cameg1@gmail.com
responsible party type: Principal Investigator
investigator affiliation: Centro Universitario de Ciencias de la Salud, Mexico
investigator full name: Ernesto German Cardona Muñoz
investigator title: Ernesto German Cardona Muñoz
mesh term: Hypertension
mesh term: Amlodipine