<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/NCT02200653</url>
  </required_header>
  <id_info>
    <org_study_id>502.344</org_study_id>
    <nct_id>NCT02200653</nct_id>
  </id_info>
  <brief_title>A Trial Comparing MICARDIS® (Telmisartan) and COZAAR® / LORZAAR® (Losartan) in Patients With Mild-to-Moderate Hypertension Using Ambulatory Blood Pressure Monitoring (ABPM)</brief_title>
  <acronym>TOPAS</acronym>
  <official_title>A Prospective, Randomised, Double-Blind, Double-Dummy, Titration-to-Response Trial Comparing MICARDIS® (Telmisartan) (40 or 80 mg p.o. Once Daily) and COZAAR® / LORZAAR® (Losartan) (50 or 100 mg p.o. Once Daily) in Patients With Mild-to-Moderate Hypertension Using Ambulatory Blood Pressure Monitoring (TOPAS STUDY = Telmisartan and LOsartan ComParative ABPM Study)</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 aim of the trial is to compare the influence of MICARDIS® (telmisartan) and&#xD;
      COZAAR® / LORZAAR® (losartan) in lowering ambulatory diastolic blood pressure (DBP) during&#xD;
      the last 6 hours of the 24-hour dosing interval as measured by ABPM. Secondary objectives&#xD;
      include evaluations of: 1) change from baseline in mean systolic blood pressure (SBP) during&#xD;
      the last 6 hours of the 24-hour dosing interval as measured by ABPM, 2) changes from baseline&#xD;
      in SBP and DBP during other periods during the 24-hour ABPM profile, 3) changes from baseline&#xD;
      in mean seated trough SBP and DBP as measured by manual cuff sphygmomanometer, and 4)&#xD;
      responder rates based on both ABPM and trough cuff blood pressure&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>May 2000</start_date>
  <primary_completion_date type="Actual">February 2001</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>Double</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline in mean diastolic blood pressure</measure>
    <time_frame>Up to 8 weeks after start of treatment</time_frame>
    <description>Measured during the last 6 hours of the 24-hour dosing interval using ABPM</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in mean systolic blood pressure</measure>
    <time_frame>Up to 8 weeks after start of treatment</time_frame>
    <description>Measured during the last 6 hours of the 24-hour dosing interval using ABPM</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes from baseline in diastolic and systolic blood pressure</measure>
    <time_frame>Up to 8 weeks after start of treatment</time_frame>
    <description>Measured during other times of the 24-hour ABPM profile (e.g. 24-hour mean, morning mean, daytime mean and nighttime mean)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes from baseline in mean seated trough diastolic blood pressure and systolic blood pressure</measure>
    <time_frame>Up to 8 weeks after start of treatment</time_frame>
    <description>Triplicate measurement in two minute intervals after 5 minutes of rest, in seated position using sphygmomanometer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of responder rates on ABPM</measure>
    <time_frame>Baseline, 8 weeks after start of treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of responder rates on trough cuff blood pressure</measure>
    <time_frame>Baseline up to 8 weeks after start of treatment</time_frame>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">387</enrollment>
  <condition>Hypertension</condition>
  <arm_group>
    <arm_group_label>Low dose of MICARDIS®</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>High dose of MICARDIS®</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Low dose of COZAAR® / LORZAAR®</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>High dose of COZAAR® / LORZAAR®</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>High dose of MICARDIS®, once daily</intervention_name>
    <arm_group_label>High dose of MICARDIS®</arm_group_label>
    <other_name>Telmisartan</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Low dose of MICARDIS®, once daily</intervention_name>
    <arm_group_label>Low dose of MICARDIS®</arm_group_label>
    <other_name>Telmisartan</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Low dose of COZAAR® / LORZAAR®, once daily</intervention_name>
    <arm_group_label>Low dose of COZAAR® / LORZAAR®</arm_group_label>
    <other_name>Losartan</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>High dose of COZAAR® / LORZAAR®, once daily</intervention_name>
    <arm_group_label>High dose of COZAAR® / LORZAAR®</arm_group_label>
    <other_name>Losartan</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>High dose of COZAAR® / LORZAAR®</arm_group_label>
    <arm_group_label>High dose of MICARDIS®</arm_group_label>
    <arm_group_label>Low dose of COZAAR® / LORZAAR®</arm_group_label>
    <arm_group_label>Low dose of MICARDIS®</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Mild-to-moderate hypertension defined as a mean seated diastolic blood pressure of ≥&#xD;
             95 mmHg and ≤ 109 mmHg, measured by manual cuff sphygmomanometer, at Visit 3 (baseline&#xD;
             cuff BP)&#xD;
&#xD;
          -  A 24-mean DBP of ≥ 85 mmHg at Visit 4 as measured by ABPM&#xD;
&#xD;
          -  Age 18 years or older&#xD;
&#xD;
          -  Ability to stop current antihypertensive therapy without risk to the patient&#xD;
             (investigator's discretion)&#xD;
&#xD;
          -  Patient's written informed consent in accordance with good clinical practice (GCP) and&#xD;
             local legislation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pre-menopausal women (last menstruation ≤ 1 year prior to start of run-in period) who:&#xD;
&#xD;
               -  are not surgically sterile; and/or&#xD;
&#xD;
               -  are nursing&#xD;
&#xD;
               -  are of child-bearing potential and are NOT practising acceptable means of birth&#xD;
                  control, do NOT plan to continue using this method throughout the study.&#xD;
                  Acceptable methods of birth control include oral, implantable or injectable&#xD;
                  contraceptives&#xD;
&#xD;
          -  Known or suspected secondary hypertension&#xD;
&#xD;
          -  Mean sitting SBP ≥ 180 mmHg or mean sitting DBP ≥ 110 mmHg during any visit of the&#xD;
             placebo run-in period&#xD;
&#xD;
          -  Hepatic and/or renal dysfunction as defined by the following laboratory parameters:&#xD;
&#xD;
               -  Serum glutamate-pyruvate-transaminase (alanine aminotransferase) or serum&#xD;
                  glutamate-oxaloacetate-transaminase (aspartate aminotransferase) &gt; than 2 times&#xD;
                  the upper limit of normal range&#xD;
&#xD;
               -  Serum creatinine &gt; 2.3 mg/dL (or &gt; 203 µmol/l)&#xD;
&#xD;
          -  Bilateral renal artery stenosis; renal artery stenosis in a solitary kidney; patients&#xD;
             post-renal transplant or with only one kidney&#xD;
&#xD;
          -  Clinically relevant sodium depletion, hypokalaemia, or hyperkalaemia&#xD;
&#xD;
          -  Uncorrected volume depletion&#xD;
&#xD;
          -  Primary aldosteronism&#xD;
&#xD;
          -  Hereditary fructose intolerance&#xD;
&#xD;
          -  Biliary obstructive disorders&#xD;
&#xD;
          -  Patients who have previously experienced symptoms characteristic of angioedema during&#xD;
             treatment with ACE inhibitors or angiotensin II receptor antagonists&#xD;
&#xD;
          -  History of drug or alcohol dependency within 6 months&#xD;
&#xD;
          -  Chronic administration of any medications known to affect blood pressure, except&#xD;
             medications allowed by the protocol&#xD;
&#xD;
          -  Any investigational therapy within one month of signing the informed consent form&#xD;
&#xD;
          -  Congestive heart failure (NYHA functional class congestive heart failure (CHF) class&#xD;
             III-IV)&#xD;
&#xD;
          -  Unstable angina within the past six months&#xD;
&#xD;
          -  Stroke within the past six months&#xD;
&#xD;
          -  Myocardial infarction or cardiac surgery within the past six months&#xD;
&#xD;
          -  Percutaneous transluminal coronary angioplasty (PTCA) within the past six months&#xD;
&#xD;
          -  Sustained ventricular tachycardia, atrial fibrillation, atrial flutter or other&#xD;
             clinically relevant cardiac arrhythmias as determined by the investigator&#xD;
&#xD;
          -  Hypertrophic obstructive cardiomyopathy, aortic stenosis, hemodynamically relevant&#xD;
             stenosis of the aortic or mitral valve&#xD;
&#xD;
          -  Patients with insulin-dependent diabetes mellitus whose diabetes hast not been stable&#xD;
             and controlled for at least the past three months as defined by an HbA1c ≥ 10%&#xD;
&#xD;
          -  Night shift workers who routinely sleep during the daytime and whose work hours&#xD;
             include midnight to 4:00 ante meridiem (AM)&#xD;
&#xD;
          -  Known hypersensitivity to any component of the formulations&#xD;
&#xD;
          -  Any clinical condition which, in the opinion of the investigator would not allow safe&#xD;
             completion of the protocol and safe administration of trial medication&#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>July 2014</verification_date>
  <study_first_submitted>July 24, 2014</study_first_submitted>
  <study_first_submitted_qc>July 24, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 25, 2014</study_first_posted>
  <last_update_submitted>July 24, 2014</last_update_submitted>
  <last_update_submitted_qc>July 24, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 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>Losartan</mesh_term>
    <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/NCT02200653
org study id: 502.344
nct id: NCT02200653
lead sponsor: 
The primary aim of the trial is to compare the influence of MICARDIS® (telmisartan) and
      COZAAR® / LORZAAR® (losartan) in lowering ambulatory diastolic blood pressure (DBP) during
      the last 6 hours of the 24-hour dosing interval as measured by ABPM. Secondary objectives
      include evaluations of: 1) change from baseline in mean systolic blood pressure (SBP) during
      the last 6 hours of the 24-hour dosing interval as measured by ABPM, 2) changes from baseline
      in SBP and DBP during other periods during the 24-hour ABPM profile, 3) changes from baseline
      in mean seated trough SBP and DBP as measured by manual cuff sphygmomanometer, and 4)
      responder rates based on both ABPM and trough cuff blood pressure
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double
measure: Change from baseline in mean diastolic blood pressure
time frame: Up to 8 weeks after start of treatment
description: Measured during the last 6 hours of the 24-hour dosing interval using ABPM
measure: Change from baseline in mean systolic blood pressure
time frame: Up to 8 weeks after start of treatment
description: Measured during the last 6 hours of the 24-hour dosing interval using ABPM
measure: Changes from baseline in diastolic and systolic blood pressure
time frame: Up to 8 weeks after start of treatment
description: Measured during other times of the 24-hour ABPM profile (e.g. 24-hour mean, morning mean, daytime mean and nighttime mean)
measure: Changes from baseline in mean seated trough diastolic blood pressure and systolic blood pressure
time frame: Up to 8 weeks after start of treatment
description: Triplicate measurement in two minute intervals after 5 minutes of rest, in seated position using sphygmomanometer
measure: Assessment of responder rates on ABPM
time frame: Baseline, 8 weeks after start of treatment
measure: Assessment of responder rates on trough cuff blood pressure
time frame: Baseline up to 8 weeks after start of treatment
arm group label: Low dose of MICARDIS®
arm group type: Experimental
arm group label: High dose of MICARDIS®
arm group type: Experimental
arm group label: Low dose of COZAAR® / LORZAAR®
arm group type: Active Comparator
arm group label: High dose of COZAAR® / LORZAAR®
arm group type: Active Comparator
intervention type: Drug
intervention name: High dose of MICARDIS®, once daily
arm group label: High dose of MICARDIS®
other name: Telmisartan
intervention type: Drug
intervention name: Low dose of MICARDIS®, once daily
arm group label: Low dose of MICARDIS®
other name: Telmisartan
intervention type: Drug
intervention name: Low dose of COZAAR® / LORZAAR®, once daily
arm group label: Low dose of COZAAR® / LORZAAR®
other name: Losartan
intervention type: Drug
intervention name: High dose of COZAAR® / LORZAAR®, once daily
arm group label: High dose of COZAAR® / LORZAAR®
other name: Losartan
intervention type: Drug
intervention name: Placebo
arm group label: High dose of COZAAR® / LORZAAR®
arm group label: High dose of MICARDIS®
arm group label: Low dose of COZAAR® / LORZAAR®
arm group label: Low dose of MICARDIS®
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: Losartan
mesh term: Telmisartan