<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/NCT02245464</url>
  </required_header>
  <id_info>
    <org_study_id>502.479</org_study_id>
    <nct_id>NCT02245464</nct_id>
  </id_info>
  <brief_title>Post Marketing Surveillance (PMS) Study to Assess Safety and Efficacy of Micardis in Patients With Essential Hypertension</brief_title>
  <official_title>The Post Marketing Surveillance Study Conducted With a Continuous Enrollment Method to Assess Serious Adverse Events, Adverse Events, Safety, Efficacy of Micardis Tablet (Telmisartan 20, 40, 80mg p.o. Once Daily Over 2 Weeks)</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 objective of this PMS study was to monitor and assess the safety of Micardis tablets in&#xD;
      patients with hypertension over a period of 6 years&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2000</start_date>
  <primary_completion_date type="Actual">November 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>Blood pressure reduction</measure>
    <time_frame>Up to 6 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Final assessment of efficacy on a 3-point scale</measure>
    <time_frame>Up to 6 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Assessment of efficacy based on subject's demographics on a two-point scale</measure>
    <time_frame>Up to 6 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of patients with adverse events</measure>
    <time_frame>Up to 6 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence rate of adverse events</measure>
    <time_frame>Up to 6 years</time_frame>
    <description>based on demographic factors</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Assessment of safety on a 4-point scale</measure>
    <time_frame>Up to 6 years</time_frame>
    <description>based on adverse events and changes in abnormality of clinical laboratory tests</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">13066</enrollment>
  <condition>Hypertension</condition>
  <arm_group>
    <arm_group_label>Patients with essential hypertension</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Telmisartan</intervention_name>
    <arm_group_label>Patients with essential hypertension</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with essential hypertension and without prior Micardis experience&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male and female patients diagnosed with essential hypertension&#xD;
&#xD;
          -  Patients without prior experience with Micardis tablet&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known hypersensitivity to Micardis tablet&#xD;
&#xD;
          -  Pregnancy or breastfeeding&#xD;
&#xD;
          -  Biliary atresia&#xD;
&#xD;
          -  Severe hepatic failure patients&#xD;
&#xD;
          -  Severe renal failure patients&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</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 18, 2014</study_first_submitted>
  <study_first_submitted_qc>September 18, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 19, 2014</study_first_posted>
  <last_update_submitted>September 18, 2014</last_update_submitted>
  <last_update_submitted_qc>September 18, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 19, 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/NCT02245464
org study id: 502.479
nct id: NCT02245464
lead sponsor: 
The objective of this PMS study was to monitor and assess the safety of Micardis tablets in
      patients with hypertension over a period of 6 years
observational model: Cohort
time perspective: Prospective
measure: Blood pressure reduction
time frame: Up to 6 years
measure: Final assessment of efficacy on a 3-point scale
time frame: Up to 6 years
measure: Assessment of efficacy based on subject's demographics on a two-point scale
time frame: Up to 6 years
measure: Number of patients with adverse events
time frame: Up to 6 years
measure: Incidence rate of adverse events
time frame: Up to 6 years
description: based on demographic factors
measure: Assessment of safety on a 4-point scale
time frame: Up to 6 years
description: based on adverse events and changes in abnormality of clinical laboratory tests
arm group label: Patients with essential hypertension
intervention type: Drug
intervention name: Telmisartan
arm group label: Patients with essential hypertension
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
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