<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/NCT02200575</url>
  </required_header>
  <id_info>
    <org_study_id>502.359</org_study_id>
    <nct_id>NCT02200575</nct_id>
  </id_info>
  <brief_title>Pharmacovigilance and Patient Compliance in Hypertensive Patients</brief_title>
  <official_title>Pharmacovigilance and Patient Compliance in Hypertensive Patients. Observational Study</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 confirm the safety profile of telmisartan (benefit-risk ratio) under normal&#xD;
      conditions of use after market launch and to supplement the present data on the safety of&#xD;
      telmisartan. Furthermore to assess effectiveness of a single dose of telmisartan per day to&#xD;
      control blood pressure for 24 hours, especially during the last few hours of the dosage&#xD;
      interval. Additionally to evaluate compliance with treatment, as an indirect measurement, and&#xD;
      to confirm the efficacy and possible risks associated with treatment.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>May 1999</start_date>
  <primary_completion_date type="Actual">December 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>Assessment of changes in heart rate</measure>
    <time_frame>Baseline, up to 8 weeks after start of treatment</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Assessment for patients with changes in laboratory values</measure>
    <time_frame>Baseline, up to 8 weeks after start of treatment</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of patients with adverse events</measure>
    <time_frame>Up to 8 weeks after start of treatment</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in mean systolic and diastolic blood pressure values</measure>
    <time_frame>Baseline, up to 8 weeks after start of treatment</time_frame>
    <description>Measured by means of ambulatory blood pressure monitoring (ABPM) over 24 hours</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in mean systolic and diastolic blood pressure values</measure>
    <time_frame>Baseline, up to 8 weeks after start of treatment</time_frame>
    <description>Measured three times at intervals of two minutes with the patient seated and lying down for 5 minutes, using a sphygmomanometer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of treatment compliance as percentage of tablets planned</measure>
    <time_frame>Up to 8 weeks after start of treatment</time_frame>
    <description>(number of tablets taken / total number of days) x 100</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">10333</enrollment>
  <condition>Hypertension</condition>
  <arm_group>
    <arm_group_label>Patients with non-secondary, essential hypertension</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Telmisartan</intervention_name>
    <arm_group_label>Patients with non-secondary, essential hypertension</arm_group_label>
    <other_name>Micardis®</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Outpatients over 18 years of age suffering non-secondary, essential hypertension, treated&#xD;
        by general practitioners and/or specialists&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - Patients of either sex over the age of 18 years suffering from non-secondary essential&#xD;
        hypertension with values of at least 90 mmHg (diastolic) and 140 mmHg (systolic)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - corresponding to the contraindications listed in the summary of product characteristics&#xD;
        of the drug&#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>July 2014</verification_date>
  <study_first_submitted>July 24, 2014</study_first_submitted>
  <study_first_submitted_qc>July 24, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 25, 2014</study_first_posted>
  <last_update_submitted>July 24, 2014</last_update_submitted>
  <last_update_submitted_qc>July 24, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 25, 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/NCT02200575
org study id: 502.359
nct id: NCT02200575
lead sponsor: 
Study to confirm the safety profile of telmisartan (benefit-risk ratio) under normal
      conditions of use after market launch and to supplement the present data on the safety of
      telmisartan. Furthermore to assess effectiveness of a single dose of telmisartan per day to
      control blood pressure for 24 hours, especially during the last few hours of the dosage
      interval. Additionally to evaluate compliance with treatment, as an indirect measurement, and
      to confirm the efficacy and possible risks associated with treatment.
observational model: Cohort
time perspective: Prospective
measure: Assessment of changes in heart rate
time frame: Baseline, up to 8 weeks after start of treatment
measure: Assessment for patients with changes in laboratory values
time frame: Baseline, up to 8 weeks after start of treatment
measure: Number of patients with adverse events
time frame: Up to 8 weeks after start of treatment
measure: Changes in mean systolic and diastolic blood pressure values
time frame: Baseline, up to 8 weeks after start of treatment
description: Measured by means of ambulatory blood pressure monitoring (ABPM) over 24 hours
measure: Changes in mean systolic and diastolic blood pressure values
time frame: Baseline, up to 8 weeks after start of treatment
description: Measured three times at intervals of two minutes with the patient seated and lying down for 5 minutes, using a sphygmomanometer
measure: Evaluation of treatment compliance as percentage of tablets planned
time frame: Up to 8 weeks after start of treatment
description: (number of tablets taken / total number of days) x 100
arm group label: Patients with non-secondary, essential hypertension
intervention type: Drug
intervention name: Telmisartan
arm group label: Patients with non-secondary, essential hypertension
other name: Micardis®
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