<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/NCT02262637</url>
  </required_header>
  <id_info>
    <org_study_id>502.441</org_study_id>
    <secondary_id>502.442, 502.443</secondary_id>
    <nct_id>NCT02262637</nct_id>
  </id_info>
  <brief_title>Micardis® / MicardisPlus® Program for Therapy Optimization With Telmisartan in Cardiovascular Diseases (PROTEKT)</brief_title>
  <official_title>Micardis® / MicardisPlus® PROTEKT (Program for Therapy Optimization With Telmisartan in Cardiovascular Diseases)</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®/MicardisPlus® under usual&#xD;
      daily-practice prescribing-conditions with emphasis on effects on endorgan damage in the&#xD;
      clientele of cardiologists, nephrologists, and diabetologists&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2003</start_date>
  <primary_completion_date type="Actual">March 2006</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 in systolic blood pressure (SBP)</measure>
    <time_frame>baseline, up to 6 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in diastolic blood pressure (DBP)</measure>
    <time_frame>baseline, up to 6 months</time_frame>
  </primary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">4814</enrollment>
  <condition>Hypertension</condition>
  <arm_group>
    <arm_group_label>Hypertensive patients - Cardiologists</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Hypertensive patients - Nephrologists</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Hypertensive patients - Diabetologists</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Micardis®</intervention_name>
    <arm_group_label>Hypertensive patients - Cardiologists</arm_group_label>
    <arm_group_label>Hypertensive patients - Diabetologists</arm_group_label>
    <arm_group_label>Hypertensive patients - Nephrologists</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>MicardisPlus®</intervention_name>
    <arm_group_label>Hypertensive patients - Cardiologists</arm_group_label>
    <arm_group_label>Hypertensive patients - Diabetologists</arm_group_label>
    <arm_group_label>Hypertensive patients - Nephrologists</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Outpatients with hypertension recruited at Cardiologists, Nephrologists, Diabetologists&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age &gt;= 18 years&#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>October 2014</verification_date>
  <study_first_submitted>October 10, 2014</study_first_submitted>
  <study_first_submitted_qc>October 10, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 13, 2014</study_first_posted>
  <last_update_submitted>October 10, 2014</last_update_submitted>
  <last_update_submitted_qc>October 10, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 13, 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>Cardiovascular Diseases</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Telmisartan</mesh_term>
    <mesh_term>Telmisartan, hydrochlorothiazide drug combination</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/NCT02262637
org study id: 502.441
secondary id: 502.442, 502.443
nct id: NCT02262637
lead sponsor: 
Study to evaluate efficacy and tolerability of Micardis®/MicardisPlus® under usual
      daily-practice prescribing-conditions with emphasis on effects on endorgan damage in the
      clientele of cardiologists, nephrologists, and diabetologists
observational model: Cohort
time perspective: Prospective
measure: Change in systolic blood pressure (SBP)
time frame: baseline, up to 6 months
measure: Change in diastolic blood pressure (DBP)
time frame: baseline, up to 6 months
arm group label: Hypertensive patients - Cardiologists
arm group label: Hypertensive patients - Nephrologists
arm group label: Hypertensive patients - Diabetologists
intervention type: Drug
intervention name: Micardis®
arm group label: Hypertensive patients - Cardiologists
arm group label: Hypertensive patients - Diabetologists
arm group label: Hypertensive patients - Nephrologists
intervention type: Drug
intervention name: MicardisPlus®
arm group label: Hypertensive patients - Cardiologists
arm group label: Hypertensive patients - Diabetologists
arm group label: Hypertensive patients - Nephrologists
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: Cardiovascular Diseases
mesh term: Telmisartan
mesh term: Telmisartan, hydrochlorothiazide drug combination