<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/NCT02238275</url>
  </required_header>
  <id_info>
    <org_study_id>502.390</org_study_id>
    <nct_id>NCT02238275</nct_id>
  </id_info>
  <brief_title>Post-Marketing Surveillance Study of Micardis® Plus in Patients With Hypertension</brief_title>
  <official_title>Post-Marketing Surveillance Study Micardis® Plus</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 evaluate efficacy and tolerability of Micardis® plus under usual daily-practice&#xD;
      prescribing-conditions&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>June 2002</start_date>
  <primary_completion_date type="Actual">December 2002</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>Change from baseline in morning blood pressure</measure>
    <time_frame>Baseline, after 6 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline in classification of blood pressure</measure>
    <time_frame>Baseline, after 6 weeks</time_frame>
    <description>according to Word Health Organisation - Isolated systolic hypertension (WHO-ISH) - definition of 'Deutsche Hochdruckliga'</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of patients with adverse drug reactions</measure>
    <time_frame>up to 6 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of efficacy by investigator on 5-point scale</measure>
    <time_frame>after 6 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of tolerability by investigator on a 5-point scale</measure>
    <time_frame>after 6 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in heart rate</measure>
    <time_frame>Baseline, after 6 weeks</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">8135</enrollment>
  <condition>Hypertension</condition>
  <arm_group>
    <arm_group_label>Patients with hypertension</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Micardis® plus</intervention_name>
    <arm_group_label>Patients with hypertension</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Outpatients with hypertension&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult (Age &gt;= 18 years) males and females for whom a medical antihypertensive therapy&#xD;
             is indicated&#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 11, 2014</study_first_submitted>
  <study_first_submitted_qc>September 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 12, 2014</study_first_posted>
  <last_update_submitted>September 11, 2014</last_update_submitted>
  <last_update_submitted_qc>September 11, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 12, 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>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/NCT02238275
org study id: 502.390
nct id: NCT02238275
lead sponsor: 
Study to evaluate efficacy and tolerability of Micardis® plus under usual daily-practice
      prescribing-conditions
observational model: Cohort
time perspective: Prospective
measure: Change from baseline in morning blood pressure
time frame: Baseline, after 6 weeks
measure: Change from baseline in classification of blood pressure
time frame: Baseline, after 6 weeks
description: according to Word Health Organisation - Isolated systolic hypertension (WHO-ISH) - definition of 'Deutsche Hochdruckliga'
measure: Number of patients with adverse drug reactions
time frame: up to 6 weeks
measure: Assessment of efficacy by investigator on 5-point scale
time frame: after 6 weeks
measure: Assessment of tolerability by investigator on a 5-point scale
time frame: after 6 weeks
measure: Change from baseline in heart rate
time frame: Baseline, after 6 weeks
arm group label: Patients with hypertension
intervention type: Drug
intervention name: Micardis® plus
arm group label: Patients with 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: Telmisartan