<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/NCT02187705</url>
  </required_header>
  <id_info>
    <org_study_id>502.322</org_study_id>
    <nct_id>NCT02187705</nct_id>
  </id_info>
  <brief_title>Micardis® in Patients With Essential Hypertension</brief_title>
  <official_title>Observation of Therapy With Micardis® (Telmisartan) in Patients With Essential Hypertension in Hospitals</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boehringer Ingelheim</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boehringer Ingelheim</source>
  <brief_summary>
    <textblock>
      The aim of this observational study was to supplement the data on efficacy, safety, and&#xD;
      tolerability of telmisartan under daily conditions in hospitals&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>May 1999</start_date>
  <primary_completion_date type="Actual">May 2000</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 from baseline in blood pressure</measure>
    <time_frame>Up to 14 days</time_frame>
    <description>Evaluation was performed separately for three patient groups depending on their hypertension status at baseline (normotension, essential hypertension and isolated hypertension)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of patients with adverse events</measure>
    <time_frame>Up to 14 days</time_frame>
  </primary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">1688</enrollment>
  <condition>Hypertension</condition>
  <arm_group>
    <arm_group_label>Patients with normotension at baseline</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Patients with essential hypertension at baseline</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Patients with isolated hypertension at baseline</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Telmisartan tablets</intervention_name>
    <description>All patients were treated with different doses of telmisartan for 14 days</description>
    <arm_group_label>Patients with essential hypertension at baseline</arm_group_label>
    <arm_group_label>Patients with isolated hypertension at baseline</arm_group_label>
    <arm_group_label>Patients with normotension at baseline</arm_group_label>
    <other_name>Micardis®</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with essential hypertension&#xD;
&#xD;
          -  Minimum age of 18 years&#xD;
&#xD;
        Exclusion Criteria: Not applicable&#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/content/dam/internet/opu/clinicaltrial/com_EN/results/502/502.322_U03-1043.pdf</url>
    <description>Related Info</description>
  </link>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 9, 2014</study_first_submitted>
  <study_first_submitted_qc>July 10, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 11, 2014</study_first_posted>
  <last_update_submitted>July 10, 2014</last_update_submitted>
  <last_update_submitted_qc>July 10, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 11, 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/NCT02187705
org study id: 502.322
nct id: NCT02187705
lead sponsor: 
The aim of this observational study was to supplement the data on efficacy, safety, and
      tolerability of telmisartan under daily conditions in hospitals
observational model: Cohort
time perspective: Prospective
measure: Changes from baseline in blood pressure
time frame: Up to 14 days
description: Evaluation was performed separately for three patient groups depending on their hypertension status at baseline (normotension, essential hypertension and isolated hypertension)
measure: Number of patients with adverse events
time frame: Up to 14 days
arm group label: Patients with normotension at baseline
arm group label: Patients with essential hypertension at baseline
arm group label: Patients with isolated hypertension at baseline
intervention type: Drug
intervention name: Telmisartan tablets
description: All patients were treated with different doses of telmisartan for 14 days
arm group label: Patients with essential hypertension at baseline
arm group label: Patients with isolated hypertension at baseline
arm group label: Patients with normotension at baseline
other name: Micardis®
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
url: http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/502/502.322_U03-1043.pdf
description: Related Info
responsible party type: Sponsor
mesh term: Hypertension
mesh term: Essential Hypertension
mesh term: Telmisartan