<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/NCT02242851</url>
  </required_header>
  <id_info>
    <org_study_id>502.450</org_study_id>
    <nct_id>NCT02242851</nct_id>
  </id_info>
  <brief_title>Study Describing the Hypertensive Population Treated With Telmisartan and Conditions of Use by Medical Practitioners and Patients</brief_title>
  <official_title>Pharmaco-epidemiological Study Describing the Hypertensive Population Treated With Telmisartan and Conditions of Use by Medical Practitioners and Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boehringer Ingelheim</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boehringer Ingelheim</source>
  <brief_summary>
    <textblock>
      Primary objective: to characterize hypertensive patients treated for at least 1 month with&#xD;
      Telmisartan (alone or in combination with other drugs) in order to define the beneficiary&#xD;
      population (those actually receiving the treatment).&#xD;
&#xD;
      Secondary objectives:&#xD;
&#xD;
        -  to describe the patients' blood pressure values (when self-monitored) and satisfaction&#xD;
           with the treatment (ease of use, efficacy, safety) on the basis of a patient&#xD;
           self-questionnaire, filled out 4 weeks after consultation.&#xD;
&#xD;
        -  to compare the characteristics of the beneficiary population to those of the initial&#xD;
           target population defined in the SPC (summary of product characteristics) for&#xD;
           Telmisartan&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2004</start_date>
  <primary_completion_date type="Actual">May 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>Characteristics of hypertensive patients</measure>
    <time_frame>Baseline, after 1 month of treatment</time_frame>
    <description>Questionnaire to determine the beneficiary population</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in blood pressure</measure>
    <time_frame>Up to 1 month</time_frame>
    <description>Self-monitored by patient</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of patients satisfaction with treatment</measure>
    <time_frame>Up to 1 month</time_frame>
    <description>Based on a patient 6-point self-questionnaire</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">5018</enrollment>
  <condition>Hypertension</condition>
  <arm_group>
    <arm_group_label>Hypertensive patients</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Telmisartan</intervention_name>
    <arm_group_label>Hypertensive patients</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Hypertensive patients treated with Telmisartan for at least one month recruited by ceneral&#xD;
        practitioners and cardiologists&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Hypertensive patients treated with Telmisartan for at least one month, consulting a&#xD;
             medical practitioner (for whatever reason)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>94 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>
  </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/NCT02242851
org study id: 502.450
nct id: NCT02242851
lead sponsor: 
Primary objective: to characterize hypertensive patients treated for at least 1 month with
      Telmisartan (alone or in combination with other drugs) in order to define the beneficiary
      population (those actually receiving the treatment).

      Secondary objectives:

        -  to describe the patients' blood pressure values (when self-monitored) and satisfaction
           with the treatment (ease of use, efficacy, safety) on the basis of a patient
           self-questionnaire, filled out 4 weeks after consultation.

        -  to compare the characteristics of the beneficiary population to those of the initial
           target population defined in the SPC (summary of product characteristics) for
           Telmisartan
observational model: Cohort
time perspective: Prospective
measure: Characteristics of hypertensive patients
time frame: Baseline, after 1 month of treatment
description: Questionnaire to determine the beneficiary population
measure: Changes in blood pressure
time frame: Up to 1 month
description: Self-monitored by patient
measure: Evaluation of patients satisfaction with treatment
time frame: Up to 1 month
description: Based on a patient 6-point self-questionnaire
arm group label: Hypertensive patients
intervention type: Drug
intervention name: Telmisartan
arm group label: Hypertensive patients
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 21 Years
maximum age: 94 Years
healthy volunteers: No
url: http://trials.boehringer-ingelheim.com
description: Related Info
responsible party type: Sponsor
mesh term: Hypertension
mesh term: Telmisartan