<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/NCT01683084</url>
  </required_header>
  <id_info>
    <org_study_id>DAL0041ARG</org_study_id>
    <secondary_id>22647</secondary_id>
    <nct_id>NCT01683084</nct_id>
  </id_info>
  <brief_title>Study of the Effectiveness of Telmisartan in Slowing the Progression of Abdominal Aortic Aneurysms</brief_title>
  <acronym>TEDY</acronym>
  <official_title>Study of the Effectiveness of Telmisartan in Slowing the Progression of Abdominal Aortic Aneurysms</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Palo Alto Veterans Institute for Research</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Medtronic</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>James Cook University, Queensland, Australia</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Palo Alto Veterans Institute for Research</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine if telmisartan is effective in slowing the&#xD;
      progression of abdominal aortic aneurysms and reducing circulating concentrations of&#xD;
      Abdominal Aortic Aneurysms (AAA) biomarkers.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Currently, the only management options for AAA are surgical (open or endovascular) based on&#xD;
      ongoing follow-up with imaging at regular intervals. Telmisartan is currently approved for&#xD;
      use in the United States by the Food and Drug Administration for management of hypertension.&#xD;
      If telmisartan is found to be effective in slowing the progression of abdominal aortic&#xD;
      aneurysms, this would provide a new treatment option for patients with AAA disease.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 19, 2012</start_date>
  <completion_date type="Actual">November 10, 2018</completion_date>
  <primary_completion_date type="Actual">November 10, 2018</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Rate of AAA growth assessed by total infrarenal aortic volume measured on computed tomography angiography (CTA)</measure>
    <time_frame>Patients will be followed for two years following enrollment, with AAA growth determined by comparing total AAA volume at baseline and at two years between control and treatment groups.</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in maximum infrarenal AAA diameter and aortic distensibility on repeat ultrasound</measure>
    <time_frame>Comparison between two groups at baseline and two years.</time_frame>
    <description>Interval assessments of ultrasound-determined diameter will also be performed to reduce the variability of individual ultrasound-derived aortic diameter measurements.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in circulating concentrations of AAA biomarkers (serum OPG, OPN, MMP-9 and TGFB-1) on repeated samples</measure>
    <time_frame>Comparison between baseline and 2 years (24 months) following enrollment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life assessed by the 12-item Assessment of Quality of Life (AQoL)</measure>
    <time_frame>Comparison between baseline and 24 months between the two groups.</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">22</enrollment>
  <condition>Abdominal Aortic Aneurysm</condition>
  <arm_group>
    <arm_group_label>Telmisartan</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>One 40mg telmisartan pill given once daily for 24 months</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>One 40mg placebo pill given once daily for 24 months</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Telmisartan</intervention_name>
    <arm_group_label>Telmisartan</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  50-85 years of age and able to provide written informed consent&#xD;
&#xD;
          -  AAA measuring a maximum diameter of 3.5-4.9 cm on CTA or ultrasound&#xD;
&#xD;
          -  Stable medication regime for the last six months&#xD;
&#xD;
          -  No current indication for AAA repair according to the treating physician or&#xD;
             expectation that this will be revised within the next year&#xD;
&#xD;
          -  High likelihood of compliance with treatment over 24 months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Renal impairment (i.e. creatinine &gt;1.5x upper limit of normal [ULN])&#xD;
&#xD;
          -  Known significant renal stenosis (&gt;70%) of one or both renal arteries&#xD;
&#xD;
          -  Chronic liver disease (i.e. cirrhosis or hepatitis) or abnormal liver function (i.e.&#xD;
             ALT 1.5xULN)&#xD;
&#xD;
          -  Electrolyte imbalance&#xD;
&#xD;
          -  Active gout&#xD;
&#xD;
          -  Current or planned usage of an AT1 blocker or ACE inhibitor&#xD;
&#xD;
          -  Previous abdominal aortic surgery&#xD;
&#xD;
          -  Currently pregnant or intend to become pregnant&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ronald L Dalman, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>PAIRE: Stanford University, VA Palo Alto Health Care System</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>VA Palo Alto Health Care System</name>
      <address>
        <city>Palo Alto</city>
        <state>California</state>
        <zip>94304</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Golledge J, Tsao PS, Dalman RL, Norman PE. Circulating markers of abdominal aortic aneurysm presence and progression. Circulation. 2008 Dec 2;118(23):2382-92. doi: 10.1161/CIRCULATIONAHA.108.802074. No abstract available.</citation>
    <PMID>19047592</PMID>
  </reference>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>September 5, 2012</study_first_submitted>
  <study_first_submitted_qc>September 7, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 11, 2012</study_first_posted>
  <disposition_first_submitted>March 16, 2020</disposition_first_submitted>
  <disposition_first_submitted_qc>May 21, 2020</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">May 26, 2020</disposition_first_posted>
  <last_update_submitted>May 21, 2020</last_update_submitted>
  <last_update_submitted_qc>May 21, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 26, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Palo Alto Veterans Institute for Research</investigator_affiliation>
    <investigator_full_name>Ronald L. Dalman, MD</investigator_full_name>
    <investigator_title>Chidester Professor of Surgery and Chief, Stanford Vascular Surgery</investigator_title>
  </responsible_party>
  <keyword>Abdominal Aortic Aneurysm</keyword>
  <keyword>AAA</keyword>
  <keyword>telmisartan</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aneurysm</mesh_term>
    <mesh_term>Aortic Aneurysm</mesh_term>
    <mesh_term>Aortic Aneurysm, Abdominal</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, but a results disposition has been submitted           -->
</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/NCT01683084
org study id: DAL0041ARG
secondary id: 22647
nct id: NCT01683084
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
The purpose of this study is to determine if telmisartan is effective in slowing the
      progression of abdominal aortic aneurysms and reducing circulating concentrations of
      Abdominal Aortic Aneurysms (AAA) biomarkers.
Currently, the only management options for AAA are surgical (open or endovascular) based on
      ongoing follow-up with imaging at regular intervals. Telmisartan is currently approved for
      use in the United States by the Food and Drug Administration for management of hypertension.
      If telmisartan is found to be effective in slowing the progression of abdominal aortic
      aneurysms, this would provide a new treatment option for patients with AAA disease.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Rate of AAA growth assessed by total infrarenal aortic volume measured on computed tomography angiography (CTA)
time frame: Patients will be followed for two years following enrollment, with AAA growth determined by comparing total AAA volume at baseline and at two years between control and treatment groups.
measure: Change in maximum infrarenal AAA diameter and aortic distensibility on repeat ultrasound
time frame: Comparison between two groups at baseline and two years.
description: Interval assessments of ultrasound-determined diameter will also be performed to reduce the variability of individual ultrasound-derived aortic diameter measurements.
measure: Change in circulating concentrations of AAA biomarkers (serum OPG, OPN, MMP-9 and TGFB-1) on repeated samples
time frame: Comparison between baseline and 2 years (24 months) following enrollment
measure: Quality of life assessed by the 12-item Assessment of Quality of Life (AQoL)
time frame: Comparison between baseline and 24 months between the two groups.
arm group label: Telmisartan
arm group type: Active Comparator
description: One 40mg telmisartan pill given once daily for 24 months
arm group label: Placebo
arm group type: Placebo Comparator
description: One 40mg placebo pill given once daily for 24 months
intervention type: Drug
intervention name: Telmisartan
arm group label: Telmisartan
intervention type: Drug
intervention name: Placebo
arm group label: Placebo
criteria: 
gender: All
minimum age: 50 Years
maximum age: 85 Years
healthy volunteers: No
last name: Ronald L Dalman, M.D.
role: Principal Investigator
affiliation: PAIRE: Stanford University, VA Palo Alto Health Care System
facility: 
country: United States
citation: Golledge J, Tsao PS, Dalman RL, Norman PE. Circulating markers of abdominal aortic aneurysm presence and progression. Circulation. 2008 Dec 2;118(23):2382-92. doi: 10.1161/CIRCULATIONAHA.108.802074. No abstract available.
PMID: 19047592
responsible party type: Principal Investigator
investigator affiliation: Palo Alto Veterans Institute for Research
investigator full name: Ronald L. Dalman, MD
investigator title: Chidester Professor of Surgery and Chief, Stanford Vascular Surgery
mesh term: Aneurysm
mesh term: Aortic Aneurysm
mesh term: Aortic Aneurysm, Abdominal
mesh term: Telmisartan