<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/NCT02242383</url>
  </required_header>
  <id_info>
    <org_study_id>502.485</org_study_id>
    <nct_id>NCT02242383</nct_id>
  </id_info>
  <brief_title>Evaluation of Efficacy and Tolerability of Micardis® / MicardisPlus® Under Usual Daily-practice Prescribing in Patients With Hypertension</brief_title>
  <official_title>Morning Hypertension and Monitoring of Metabolism (AWB Morgenhochdruck &amp; Stoffwechselmonitoring)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boehringer Ingelheim</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boehringer Ingelheim</source>
  <brief_summary>
    <textblock>
      To evaluate efficacy and tolerability of Micardis® / MicardisPlus® under usual daily-practice&#xD;
      prescribing conditions with a special emphasis on controlling morning blood pressure&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2005</start_date>
  <primary_completion_date type="Actual">October 2005</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in morning blood pressure (BP)</measure>
    <time_frame>Pre-dose, up to 6 months after start of treatment</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in metabolic laboratory parameters</measure>
    <time_frame>Pre-dose, up to 6 months after start of treatment</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in morning blood pressure in patients with or without telemonitoring (TM) of BP</measure>
    <time_frame>Pre-dose, up to 6 months after start of treatment</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Investigator assessment of efficacy in reducing morning hypertension on a 5-point rating scale</measure>
    <time_frame>Up to 6 months after start of treatment</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Investigator assessment of effects on metabolism on a 3-point rating scale</measure>
    <time_frame>Up to 6 months after start of treatment</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Investigator assessment of tolerability on a 5-point rating scale</measure>
    <time_frame>Up to 6 months after start of treatment</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of patients with adverse events</measure>
    <time_frame>Up to 6 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in morning heart rate</measure>
    <time_frame>Pre-dose, up to 6 months after start of treatment</time_frame>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">13248</enrollment>
  <condition>Hypertension</condition>
  <arm_group>
    <arm_group_label>Essential hypertension</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Telmisartan</intervention_name>
    <arm_group_label>Essential hypertension</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Telmisartan in combination with hydrochlorothiazide</intervention_name>
    <arm_group_label>Essential hypertension</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Outpatients with essential hypertension&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - Age ≥ 18 years, insufficiently treated hypertension&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - Age &lt; 18 years&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</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>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hydrochlorothiazide</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/NCT02242383
org study id: 502.485
nct id: NCT02242383
lead sponsor: 
To evaluate efficacy and tolerability of Micardis® / MicardisPlus® under usual daily-practice
      prescribing conditions with a special emphasis on controlling morning blood pressure
observational model: Cohort
time perspective: Prospective
measure: Changes in morning blood pressure (BP)
time frame: Pre-dose, up to 6 months after start of treatment
measure: Changes in metabolic laboratory parameters
time frame: Pre-dose, up to 6 months after start of treatment
measure: Changes in morning blood pressure in patients with or without telemonitoring (TM) of BP
time frame: Pre-dose, up to 6 months after start of treatment
measure: Investigator assessment of efficacy in reducing morning hypertension on a 5-point rating scale
time frame: Up to 6 months after start of treatment
measure: Investigator assessment of effects on metabolism on a 3-point rating scale
time frame: Up to 6 months after start of treatment
measure: Investigator assessment of tolerability on a 5-point rating scale
time frame: Up to 6 months after start of treatment
measure: Number of patients with adverse events
time frame: Up to 6 months
measure: Changes in morning heart rate
time frame: Pre-dose, up to 6 months after start of treatment
arm group label: Essential hypertension
intervention type: Drug
intervention name: Telmisartan
arm group label: Essential hypertension
intervention type: Drug
intervention name: Telmisartan in combination with hydrochlorothiazide
arm group label: Essential hypertension
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
url: http://trials.boehringer-ingelheim.com
description: Related Info
responsible party type: Sponsor
mesh term: Hypertension
mesh term: Hydrochlorothiazide
mesh term: Telmisartan