<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/NCT02248896</url>
  </required_header>
  <id_info>
    <org_study_id>502.590</org_study_id>
    <nct_id>NCT02248896</nct_id>
  </id_info>
  <brief_title>Antihypertensive Medications and the Risk of Sepsis</brief_title>
  <official_title>Antihypertensive Medications and the Risk of Sepsis</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 primary objective of this study was to assess whether there is an increased risk of&#xD;
      sepsis with the use of telmisartan compared with other ARBs and with the other major&#xD;
      antihypertensive classes, including ACEIs, beta-blockers, CCBs and thiazide diuretics. A&#xD;
      secondary objective was to assess whether the use of ARBs and ACEIs, compared with the other&#xD;
      three major antihypertensive classes and with untreated hypertension, is associated with an&#xD;
      increased risk of sepsis. A third objective was to evaluate whether the use of telmisartan&#xD;
      compared with other ARBs, ACEIs and other major antihypertensive classes is associated with&#xD;
      an increased risk of worse outcomes due to sepsis, in particular acute kidney injury and&#xD;
      death&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2010</start_date>
  <primary_completion_date type="Actual">March 2011</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Occurence of sepsis, including severe sepsis</measure>
    <time_frame>Up to 9 years and 5 months</time_frame>
    <description>Severe sepsis defined as cases that develop renal failure or die within 30 days</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">1129062</enrollment>
  <condition>Hypertension</condition>
  <arm_group>
    <arm_group_label>Hypertensive patients</arm_group_label>
    <description>Hypertensive patients or patients treated with antihypertensive drugs with linked GPRD and hospital episodes statistics database (HES) data</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Telmisartan</intervention_name>
    <arm_group_label>Hypertensive patients</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Other angiotensin-receptor blockers (ARBs)</intervention_name>
    <arm_group_label>Hypertensive patients</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Angiotensin-converting enzyme inhibitors (ACEIs)</intervention_name>
    <arm_group_label>Hypertensive patients</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Other major antihypertensive medication classes</intervention_name>
    <description>e.g. beta-blockers, calcium channel blockers (CCBs), diuretics</description>
    <arm_group_label>Hypertensive patients</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with a diagnosis of, or treatment for hypertension&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - Patients, 18 years or older, with at least two-year follow-up in United Kingdom's general&#xD;
        practice research database (GPRD), who had a diagnosis of or treatment for hypertension&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - Sepsis, chronic renal failure or on dialysis in the two-year period prior to cohort entry&#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 24, 2014</study_first_submitted>
  <study_first_submitted_qc>September 24, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2014</study_first_posted>
  <last_update_submitted>September 24, 2014</last_update_submitted>
  <last_update_submitted_qc>September 24, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 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>
    <mesh_term>Antihypertensive Agents</mesh_term>
    <mesh_term>Angiotensin Receptor Antagonists</mesh_term>
    <mesh_term>Enzyme Inhibitors</mesh_term>
    <mesh_term>Angiotensin-Converting Enzyme Inhibitors</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/NCT02248896
org study id: 502.590
nct id: NCT02248896
lead sponsor: 
The primary objective of this study was to assess whether there is an increased risk of
      sepsis with the use of telmisartan compared with other ARBs and with the other major
      antihypertensive classes, including ACEIs, beta-blockers, CCBs and thiazide diuretics. A
      secondary objective was to assess whether the use of ARBs and ACEIs, compared with the other
      three major antihypertensive classes and with untreated hypertension, is associated with an
      increased risk of sepsis. A third objective was to evaluate whether the use of telmisartan
      compared with other ARBs, ACEIs and other major antihypertensive classes is associated with
      an increased risk of worse outcomes due to sepsis, in particular acute kidney injury and
      death
observational model: Case-Control
time perspective: Retrospective
measure: Occurence of sepsis, including severe sepsis
time frame: Up to 9 years and 5 months
description: Severe sepsis defined as cases that develop renal failure or die within 30 days
arm group label: Hypertensive patients
description: Hypertensive patients or patients treated with antihypertensive drugs with linked GPRD and hospital episodes statistics database (HES) data
intervention type: Drug
intervention name: Telmisartan
arm group label: Hypertensive patients
intervention type: Drug
intervention name: Other angiotensin-receptor blockers (ARBs)
arm group label: Hypertensive patients
intervention type: Drug
intervention name: Angiotensin-converting enzyme inhibitors (ACEIs)
arm group label: Hypertensive patients
intervention type: Drug
intervention name: Other major antihypertensive medication classes
description: e.g. beta-blockers, calcium channel blockers (CCBs), diuretics
arm group label: Hypertensive patients
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
mesh term: Antihypertensive Agents
mesh term: Angiotensin Receptor Antagonists
mesh term: Enzyme Inhibitors
mesh term: Angiotensin-Converting Enzyme Inhibitors