<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/NCT02261116</url>
  </required_header>
  <id_info>
    <org_study_id>502.402</org_study_id>
    <nct_id>NCT02261116</nct_id>
  </id_info>
  <brief_title>Study to Assess Potential Different Properties of Telmisartan Compared to Candesartan in Healthy Volunteers</brief_title>
  <official_title>Does Telmisartan Compared to Candesartan Due to a Distinctly Larger Volume of Distribution Exert Stronger Effects in Relevant Peripheral Tissues, e.g. Renal and Adrenal Tissues</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 assess potential different properties of telmisartan, which due to its Vd, should&#xD;
      result in stronger &quot;beneficial&quot; effects of AT1 blockade in tissues (e.g. aldosterone&#xD;
      suppression and renin increase) plus stronger AT2 stimulation compared to candesartan&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>April 2002</start_date>
  <primary_completion_date type="Actual">August 2002</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>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Slope of PRA increase versus DR-1</measure>
    <time_frame>Predose and 2, 4, 8 h following trial medication</time_frame>
    <description>analysis of variance</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Assessment of angiotensin-1 (AT1) pressor antagonism in vivo (DR-1)</measure>
    <time_frame>Predose and 2, 4, 8 h following trial medication</time_frame>
    <description>rightward shift (DR-1) of diastolic blood pressure response to Angiotensin II dose escalating challenges</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of plasma aldosterone concentration after stimulation with Angiotensin II</measure>
    <time_frame>Predose and 2, 4, 8 h following trial medication</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reactive response of the plasma renin activity (PRA)</measure>
    <time_frame>Predose and 2, 4, 8 h following trial medication</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of subjects with adverse events</measure>
    <time_frame>up to 42 days</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Telmisartan</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Candesartan</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Telmisartan</intervention_name>
    <arm_group_label>Telmisartan</arm_group_label>
    <other_name>Micardis®</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Candesartan</intervention_name>
    <arm_group_label>Candesartan</arm_group_label>
    <other_name>Blopress</other_name>
  </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;
          1. Males, aged 18 to 45 years.&#xD;
&#xD;
          2. Absence of any relevant disease as determined by no clinically deviation from normal&#xD;
             in medical history, clinical laboratory determination, ECGs and physical examinations&#xD;
&#xD;
          3. Systolic blood pressure (SBP) between 100 and 140 mmHg systolic and below 85 mmHg&#xD;
             diastolic (both left and right arm) and a heart rate of ≥50 bpm&#xD;
&#xD;
          4. Signed informed consent form&#xD;
&#xD;
          5. No intake of drugs inbetween a waiting time of ten times of half-life&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Contraindications to Ang II antagonists, known hypersensitivity, history of&#xD;
             angioedema, serious allergy, asthma, allergic skin rash, significant allergic rhinitis&#xD;
             or sensitivity to any drug&#xD;
&#xD;
          2. History of cardiovascular diseases: any clinically significant cardio-vascular&#xD;
             disease, a supine diastolic blood pressure &gt;86 mmHg and systolic &gt;141 mmHg measured by&#xD;
             a standard sphygmomanometer or a heart rate ≤49 bpm&#xD;
&#xD;
          3. Cerebrovascular diseases: history of stroke or transitory ischemic attacks (TIAs) or&#xD;
             history of any cerebral bleeding&#xD;
&#xD;
          4. Renal diseases: serum creatinine &gt;1.5 mg/dL&#xD;
&#xD;
          5. Gastrointestinal/Hepatic diseases: Aspartate aminotransferase (ASAT) &gt;40 U/l or&#xD;
             Alanine aminotransferase (ALAT) &gt;40 U/L, serum bilirubin &gt;2x upper limit of normal,&#xD;
             history of malabsorption or inability to tolerate oral medication, history of gastric&#xD;
             or duodenal ulcers, history of significant gastrointestinal bleeding, history of&#xD;
             hepatitis within the past years&#xD;
&#xD;
          6. Any history of alcohol or drug abuse&#xD;
&#xD;
          7. Use of any of the following drugs within 4 weeks of study enrolment (e.g. agents known&#xD;
             to induce drug metabolizing enzymes): anabolic steroids and corticoids,&#xD;
             antiarrhythmics (amiodarone, mexiletine, quinidine, propafenone), antibiotics&#xD;
             (chloramphenicol, tetracyclines, sulfonamides, macrolides, cephalosporins, rifampicin,&#xD;
             nalidixic acid), antiepileptics (phenytoin, carbamazepine), antifungals (e.g.&#xD;
             griseofulvin), barbiturates, cimetidine, ethacrynic acid, fibrates, furosemide,&#xD;
             haloperidol, lipid lowering agents (cholestyramine, hydroxymethylglutaryl, coenzyme A&#xD;
             (HMG CoA) reductase inhibitors, dextrothyroxin), thyroid replacement therapy hormones&#xD;
             or thyrostatics (thioureylene-type). The use of nonsteroidal antiinflammatory drugs&#xD;
             (NSAIDs) should be discontinued 2 weeks prior to study enrolment, the one exception of&#xD;
             aspirin should be one (1) week prior to study enrolment&#xD;
&#xD;
          8. Participation in any other investigational study, within the 30 days prior to&#xD;
             enrolment&#xD;
&#xD;
          9. Blood donation within the previous 3 months&#xD;
&#xD;
         10. The investigator might disqualify a subject for a sound medical or psychiatric reason&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <link>
    <url>http://trials.boehringer-ingelheim.com</url>
    <description>Related Info</description>
  </link>
  <verification_date>October 2014</verification_date>
  <study_first_submitted>October 9, 2014</study_first_submitted>
  <study_first_submitted_qc>October 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 10, 2014</study_first_posted>
  <last_update_submitted>October 9, 2014</last_update_submitted>
  <last_update_submitted_qc>October 9, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 10, 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>Candesartan</mesh_term>
    <mesh_term>Candesartan cilexetil</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/NCT02261116
org study id: 502.402
nct id: NCT02261116
lead sponsor: 
Study to assess potential different properties of telmisartan, which due to its Vd, should
      result in stronger "beneficial" effects of AT1 blockade in tissues (e.g. aldosterone
      suppression and renin increase) plus stronger AT2 stimulation compared to candesartan
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Single
measure: Slope of PRA increase versus DR-1
time frame: Predose and 2, 4, 8 h following trial medication
description: analysis of variance
measure: Assessment of angiotensin-1 (AT1) pressor antagonism in vivo (DR-1)
time frame: Predose and 2, 4, 8 h following trial medication
description: rightward shift (DR-1) of diastolic blood pressure response to Angiotensin II dose escalating challenges
measure: Assessment of plasma aldosterone concentration after stimulation with Angiotensin II
time frame: Predose and 2, 4, 8 h following trial medication
measure: Reactive response of the plasma renin activity (PRA)
time frame: Predose and 2, 4, 8 h following trial medication
measure: Number of subjects with adverse events
time frame: up to 42 days
arm group label: Telmisartan
arm group type: Experimental
arm group label: Candesartan
arm group type: Active Comparator
arm group label: Placebo
arm group type: Placebo Comparator
intervention type: Drug
intervention name: Telmisartan
arm group label: Telmisartan
other name: Micardis®
intervention type: Drug
intervention name: Candesartan
arm group label: Candesartan
other name: Blopress
intervention type: Drug
intervention name: Placebo
arm group label: Placebo
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
url: http://trials.boehringer-ingelheim.com
description: Related Info
responsible party type: Sponsor
mesh term: Telmisartan
mesh term: Candesartan
mesh term: Candesartan cilexetil