<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/NCT02242370</url>
  </required_header>
  <id_info>
    <org_study_id>502.461</org_study_id>
    <nct_id>NCT02242370</nct_id>
  </id_info>
  <brief_title>Effectiveness of MICARDIS® (Telmisartan) on Blood Pressure Control and Quality of Live in Patients With Essential Hypertension</brief_title>
  <acronym>MicCAT</acronym>
  <official_title>An Open-label Evaluation of the Effectiveness of MICARDIS® (Telmisartan) on Blood Pressure Control and Quality of Life in Patients With Essential Hypertension The MICARDIS COMMUNITY ACCESS TRIAL (MicCAT)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boehringer Ingelheim</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boehringer Ingelheim</source>
  <brief_summary>
    <textblock>
      Study to assess the effect of Telmisartan on diastolic and systolic blood pressure and to&#xD;
      establish the effect on patient's quality of life scores.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 1999</start_date>
  <primary_completion_date type="Actual">November 2000</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-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 in diastolic blood pressure</measure>
    <time_frame>Pre-dose, up to 6 weeks after start of treatment</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in systolic blood pressure</measure>
    <time_frame>Pre-dose, up to 6 weeks after start of treatment</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes from baseline in the quality of life (QOL) scores by patient self-assessment</measure>
    <time_frame>Pre-dose, 6 weeks after start of treatment</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Assessment of blood pressure control rate</measure>
    <time_frame>Up to 6 weeks after start of treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of systolic blood pressure response rate</measure>
    <time_frame>Up to 6 weeks after start of treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of diastolic blood pressure response rate</measure>
    <time_frame>Up to 6 weeks after start of treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in pulse pressure</measure>
    <time_frame>Pre-dose, up to 6 weeks after start of treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with adverse events</measure>
    <time_frame>Up to 6 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">3045</enrollment>
  <condition>Hypertension</condition>
  <arm_group>
    <arm_group_label>Telmisartan low dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Telmisartan high dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Low dose of telmisartan</intervention_name>
    <arm_group_label>Telmisartan low dose</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>High dose of telmisartan</intervention_name>
    <arm_group_label>Telmisartan high dose</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with Stage I essential Hypertension (diastolic blood pressure 90-99 mmHg,&#xD;
             and/or systolic blood pressure 140-159 mmHg)&#xD;
&#xD;
          -  Signed informed consent form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - Females of childbearing potential&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>93 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <link>
    <url>http://trials.boehringer-ingelheim.com</url>
    <description>Related Info</description>
  </link>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>September 16, 2014</study_first_submitted>
  <study_first_submitted_qc>September 16, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 17, 2014</study_first_posted>
  <last_update_submitted>September 16, 2014</last_update_submitted>
  <last_update_submitted_qc>September 16, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 17, 2014</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>
    <mesh_term>Essential Hypertension</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <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/NCT02242370
org study id: 502.461
nct id: NCT02242370
lead sponsor: 
Study to assess the effect of Telmisartan on diastolic and systolic blood pressure and to
      establish the effect on patient's quality of life scores.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in diastolic blood pressure
time frame: Pre-dose, up to 6 weeks after start of treatment
measure: Change in systolic blood pressure
time frame: Pre-dose, up to 6 weeks after start of treatment
measure: Changes from baseline in the quality of life (QOL) scores by patient self-assessment
time frame: Pre-dose, 6 weeks after start of treatment
measure: Assessment of blood pressure control rate
time frame: Up to 6 weeks after start of treatment
measure: Assessment of systolic blood pressure response rate
time frame: Up to 6 weeks after start of treatment
measure: Assessment of diastolic blood pressure response rate
time frame: Up to 6 weeks after start of treatment
measure: Change from baseline in pulse pressure
time frame: Pre-dose, up to 6 weeks after start of treatment
measure: Number of patients with adverse events
time frame: Up to 6 weeks
arm group label: Telmisartan low dose
arm group type: Experimental
arm group label: Telmisartan high dose
arm group type: Experimental
intervention type: Drug
intervention name: Low dose of telmisartan
arm group label: Telmisartan low dose
intervention type: Drug
intervention name: High dose of telmisartan
arm group label: Telmisartan high dose
criteria: 
gender: All
minimum age: 20 Years
maximum age: 93 Years
healthy volunteers: No
url: http://trials.boehringer-ingelheim.com
description: Related Info
responsible party type: Sponsor
mesh term: Hypertension
mesh term: Essential Hypertension
mesh term: Telmisartan