<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/NCT02215733</url>
  </required_header>
  <id_info>
    <org_study_id>502.599</org_study_id>
    <nct_id>NCT02215733</nct_id>
  </id_info>
  <brief_title>The Use of Angiotensin Receptor Blockers and the Risk of Cancer</brief_title>
  <official_title>The Use of Angiotensin Receptor Blockers and the Risk of Cancer</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 angiotensin blockers (ARBs) and&#xD;
      telmisartan in particular, are associated with an increased overall risk of the four most&#xD;
      common cancers, namely, lung, colorectal, breast and prostate cancers. A secondary objective&#xD;
      was to explore these effects separately for each of the four cancers and in combination with&#xD;
      angiotensin-converting-enzyme-inhibitors (ACEIs).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>February 2011</start_date>
  <primary_completion_date type="Actual">February 2012</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Number of patients with occurrences of lung, colorectal, breast and prostate cancers related to use of ARBs</measure>
    <time_frame>16 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Determination of dose-response in terms of ARB duration of use and cumulative dose and the risk of lung, colorectal, breast and prostate cancers combined</measure>
    <time_frame>16 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Ratio of occurrence of lung, colorectal, breast and prostate cancers related to use of ARBs, relative to beta-blockers and diuretics</measure>
    <time_frame>16 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Ratio of occurrence of lung, colorectal, breast and prostate cancers related to use of telmisartan, relative to beta-blockers and diuretics</measure>
    <time_frame>16 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Ratio of occurrence of lung, colorectal, breast and prostate cancers related to use of telmisartan relative to other ARBs</measure>
    <time_frame>16 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of patients with occurrences of lung cancer related to use of ARBs alone</measure>
    <time_frame>16 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with occurrences of colorectal cancer related to use of ARBs alone</measure>
    <time_frame>16 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with occurrences of breast cancer related to use of ARBs alone</measure>
    <time_frame>16 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with occurrences of prostate cancer related to use of ARBs alone</measure>
    <time_frame>16 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with occurrences of lung cancer related to use of ARBs with ACEI</measure>
    <time_frame>16 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with occurrences of colorectal cancer related to use of ARBs with ACEI</measure>
    <time_frame>16 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with occurrences of breast cancer related to use of ARBs with ACEI</measure>
    <time_frame>16 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with occurrences of prostate cancer related to use of ARBs with ACEI</measure>
    <time_frame>16 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ratio of occurrence of lung cancer related to use of telmisartan relative to other ARBs</measure>
    <time_frame>16 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ratio of occurrence of colorectal cancer related to use of telmisartan relative to other ARBs</measure>
    <time_frame>16 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ratio of occurrence of breast cancer related to use of telmisartan relative to other ARBs</measure>
    <time_frame>16 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ratio of occurrence of prostate cancer related to use of telmisartan relative to other ARBs</measure>
    <time_frame>16 years</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">1165781</enrollment>
  <condition>Neoplasm</condition>
  <arm_group>
    <arm_group_label>Patients prescribed antihypertensives</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ARB</intervention_name>
    <description>other than telmisartan</description>
    <arm_group_label>Patients prescribed antihypertensives</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ACEI</intervention_name>
    <arm_group_label>Patients prescribed antihypertensives</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Beta-blockers</intervention_name>
    <arm_group_label>Patients prescribed antihypertensives</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Diuretics</intervention_name>
    <arm_group_label>Patients prescribed antihypertensives</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Telmisartan</intervention_name>
    <arm_group_label>Patients prescribed antihypertensives</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All patients prescribed an antihypertensive agent between January 1, 1995 and December 31,&#xD;
        2008, with follow-up until December 31, 2010 Information extracted from United Kingdom&#xD;
        General Practice Research Database (GPRD)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients prescribed an antihypertensive agent between 01-JAN-1995 and 31-DEC-2008 with&#xD;
             at least two years of up-to-standard medical history in United Kingdom's General&#xD;
             Practice Research Database (GPRD)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of cancer at any time prior to cohort entry&#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/content/dam/internet/opu/clinicaltrial/com_EN/results/502/502.599_U12-1334-01.pdf</url>
    <description>Related Info</description>
  </link>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>August 12, 2014</study_first_submitted>
  <study_first_submitted_qc>August 12, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 13, 2014</study_first_posted>
  <last_update_submitted>August 12, 2014</last_update_submitted>
  <last_update_submitted_qc>August 12, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 13, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Telmisartan</mesh_term>
    <mesh_term>Diuretics</mesh_term>
    <mesh_term>Adrenergic beta-Antagonists</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/NCT02215733
org study id: 502.599
nct id: NCT02215733
lead sponsor: 
The primary objective of this study was to assess whether angiotensin blockers (ARBs) and
      telmisartan in particular, are associated with an increased overall risk of the four most
      common cancers, namely, lung, colorectal, breast and prostate cancers. A secondary objective
      was to explore these effects separately for each of the four cancers and in combination with
      angiotensin-converting-enzyme-inhibitors (ACEIs).
observational model: Cohort
time perspective: Retrospective
measure: Number of patients with occurrences of lung, colorectal, breast and prostate cancers related to use of ARBs
time frame: 16 years
measure: Determination of dose-response in terms of ARB duration of use and cumulative dose and the risk of lung, colorectal, breast and prostate cancers combined
time frame: 16 years
measure: Ratio of occurrence of lung, colorectal, breast and prostate cancers related to use of ARBs, relative to beta-blockers and diuretics
time frame: 16 years
measure: Ratio of occurrence of lung, colorectal, breast and prostate cancers related to use of telmisartan, relative to beta-blockers and diuretics
time frame: 16 years
measure: Ratio of occurrence of lung, colorectal, breast and prostate cancers related to use of telmisartan relative to other ARBs
time frame: 16 years
measure: Number of patients with occurrences of lung cancer related to use of ARBs alone
time frame: 16 years
measure: Number of patients with occurrences of colorectal cancer related to use of ARBs alone
time frame: 16 years
measure: Number of patients with occurrences of breast cancer related to use of ARBs alone
time frame: 16 years
measure: Number of patients with occurrences of prostate cancer related to use of ARBs alone
time frame: 16 years
measure: Number of patients with occurrences of lung cancer related to use of ARBs with ACEI
time frame: 16 years
measure: Number of patients with occurrences of colorectal cancer related to use of ARBs with ACEI
time frame: 16 years
measure: Number of patients with occurrences of breast cancer related to use of ARBs with ACEI
time frame: 16 years
measure: Number of patients with occurrences of prostate cancer related to use of ARBs with ACEI
time frame: 16 years
measure: Ratio of occurrence of lung cancer related to use of telmisartan relative to other ARBs
time frame: 16 years
measure: Ratio of occurrence of colorectal cancer related to use of telmisartan relative to other ARBs
time frame: 16 years
measure: Ratio of occurrence of breast cancer related to use of telmisartan relative to other ARBs
time frame: 16 years
measure: Ratio of occurrence of prostate cancer related to use of telmisartan relative to other ARBs
time frame: 16 years
arm group label: Patients prescribed antihypertensives
intervention type: Drug
intervention name: ARB
description: other than telmisartan
arm group label: Patients prescribed antihypertensives
intervention type: Drug
intervention name: ACEI
arm group label: Patients prescribed antihypertensives
intervention type: Drug
intervention name: Beta-blockers
arm group label: Patients prescribed antihypertensives
intervention type: Drug
intervention name: Diuretics
arm group label: Patients prescribed antihypertensives
intervention type: Drug
intervention name: Telmisartan
arm group label: Patients prescribed antihypertensives
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
url: http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/502/502.599_U12-1334-01.pdf
description: Related Info
responsible party type: Sponsor
mesh term: Telmisartan
mesh term: Diuretics
mesh term: Adrenergic beta-Antagonists