<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/NCT02242812</url>
  </required_header>
  <id_info>
    <org_study_id>502.393</org_study_id>
    <nct_id>NCT02242812</nct_id>
  </id_info>
  <brief_title>Telmisartan Effectiveness on Left Ventricular Mass Reduction (TELMAR) as Assessed by MRI, in Patients With Mild to Moderate Hypertension</brief_title>
  <official_title>Telmisartan Effectiveness on Left Ventricular MAss Reduction (TELMAR) as Assessed by MRI, in Patients With Mild to Moderate Hypertension - a Prospective, Randomised, Double-blind Comparison of Telmisartan 80 mg Oral, Once Daily, to Metoprolol Succinate 95 mg Oral, Once Daily, Over a Period of 6 Months</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 was to show that telmisartan is not inferior to metoprolol succinate in&#xD;
      respect of the percentage change from baseline in LVMI(H) after a 6.5 months treatment&#xD;
      period. As secondary objectives, the improvement in left ventricular systolic and diastolic&#xD;
      function and blood pressure reduction were assessed&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <start_date>September 2003</start_date>
  <primary_completion_date type="Actual">October 2004</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>Percentage change in left ventricular mass index relative to height (LVMI(H))</measure>
    <time_frame>Baseline, day 180</time_frame>
    <description>based on LVM measurements by magnetic resonance imaging (MRI)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of patients with adverse events</measure>
    <time_frame>up to 6.5 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of left ventricular mass index related to the body surface area (LVMI (BSA)) measured by MRI</measure>
    <time_frame>Baseline, day 180</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of left ventricular end-systolic (LVESV) measured by MRI</measure>
    <time_frame>Baseline, day 180</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of left ventricular end-diastolic volume (LVEDV) as measured by MRI</measure>
    <time_frame>Baseline, day 180</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of left ventricular end-diastolic volume index related to height LVEDVI (H))</measure>
    <time_frame>Baseline, day 180</time_frame>
    <description>based on LV volumetric measurements by MRI</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of left ventricular end-diastolic volume index related to the body mass index (LVEDVI (BSA))</measure>
    <time_frame>Baseline, day 180</time_frame>
    <description>based on LV volumetric measurements by MRI</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of left ventricular ejection fraction (EF)</measure>
    <time_frame>Baseline, day 180</time_frame>
    <description>based on LV volumetric measurements by MRI</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of end-systolic wall stress (ESWS) measured by MRI</measure>
    <time_frame>Baseline, day 180</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of 24-hour mean systolic blood pressure measured by ambulatory blood pressure monitoring (ABPM)</measure>
    <time_frame>Baseline, day 179</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of 24-hour mean diastolic blood pressure as measure by ABPM</measure>
    <time_frame>Baseline, day 179</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of mean seated trough systolic blood pressure measured by manual cuff sphygmomanometer</measure>
    <time_frame>up to day 194</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of mean seated trough diastolic blood pressure measured by manual cuff sphygmomanometer</measure>
    <time_frame>up to day 194</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Hypertension</condition>
  <arm_group>
    <arm_group_label>Telmisartan</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>MICARDIS®</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Metoprolol succinate</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>BELOC ZOK®</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>Metoprolol succinate</intervention_name>
    <arm_group_label>Metoprolol succinate</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Metoprolol succinate</arm_group_label>
    <arm_group_label>Telmisartan</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Caucasian and non-Caucasian patients i.e. Asian patients with untreated essential&#xD;
             hypertension as defined by either a mean systolic blood pressure (SBP) of &gt;= 140 mm Hg&#xD;
             or a mean diastolic blood pressure (DBP) of &gt;= 90 mm Hg during normal daily activities&#xD;
             (6:00 - 21:59 h) and/or a nocturnal (22:00 - 05:59 h) SBP mean of &gt;= 120 mm Hg or a&#xD;
             DBP mean of &gt;= 70 mm Hg as measured by ABPM.&#xD;
&#xD;
          -  Presence of Left Ventricular Hypertrophy (LVH) as defined by MRI:&#xD;
&#xD;
               -  Caucasian patients: Left ventricular mass of &gt; 0.8 g/cm for women or &gt; 1.05 g/cm&#xD;
                  for men. Non-Caucasian i.e. Asian patients: Left ventricular mass of &gt; 0.65 g/cm&#xD;
                  for women or &gt; 0.85 g/cm for men&#xD;
&#xD;
          -  Age between 18 and 80 years&#xD;
&#xD;
          -  Written informed consent in accordance with Good Clinical Practice (GCP) guidelines&#xD;
             and the local regulatory and legal requirements&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Contraindications to the class of drugs under study:&#xD;
&#xD;
               -  Contraindications against β Blocker or angiotensin receptor antagonists&#xD;
&#xD;
               -  A history of angioedema or known hypersensitivity to any component of the&#xD;
                  formulations&#xD;
&#xD;
          -  Contraindications on ethical grounds:&#xD;
&#xD;
               -  there are no specific contraindications ethical grounds foreseen in this study&#xD;
&#xD;
          -  General Contraindications:&#xD;
&#xD;
               -  Pregnancy, lactation or child bearing potential (I.e. Pre-menopausal women (last&#xD;
                  menstruation &lt; 1 year prior to start of run-in phase) who are not surgically&#xD;
                  sterile (hysterectomy, tubal ligation) or who are NOR practicing or do NOT plan&#xD;
                  to practice acceptable means of birth control (Intrauterine Device, oral&#xD;
                  implantable or injectable contraceptives) or who have a positive serum pregnancy&#xD;
                  test at screening or baseline)&#xD;
&#xD;
               -  Factors making follow up difficult (i.e. no fixed address)&#xD;
&#xD;
               -  Treatment with other investigational drugs within one month of signing informed&#xD;
                  consent&#xD;
&#xD;
          -  Clinically significant concomitant diseases:&#xD;
&#xD;
               -  Hepatic and/or renal dysfunction as defined by the following laboratory&#xD;
                  parameters:&#xD;
&#xD;
                    1. Alanine amino transferase (SGPT (ALT)) or Aspartate amino transferase (SGOT&#xD;
                       (AST)) values above two times or Gamma glutaryl transferase (Gamma-GT) three&#xD;
                       times the upper normal limit&#xD;
&#xD;
                    2. Serum creatinine &gt; 150 mol/L&#xD;
&#xD;
               -  Clinically significant sodium or potassium depletion, clinically relevant&#xD;
                  hyperkalaemia&#xD;
&#xD;
               -  Uncorrected volume depletion&#xD;
&#xD;
               -  Primary aldosteronism&#xD;
&#xD;
               -  Hereditary fructose intolerance&#xD;
&#xD;
               -  Biliary obstructive disorders, cholestasis or moderate to severe hepatic&#xD;
                  insufficiency&#xD;
&#xD;
               -  Insulin-dependent diabetes mellitus&#xD;
&#xD;
               -  Congestive heart failure or ejection fraction &lt; 35% New York Heart Association&#xD;
                  (NYHA) class III or IV&#xD;
&#xD;
               -  Unstable Angina&#xD;
&#xD;
               -  Sustained ventricular tachycardia, atrial fibrillation, atrial flutter or other&#xD;
                  clinically relevant cardiac arrhythmias as determined by the investigator&#xD;
&#xD;
               -  Post-renal transplant patients&#xD;
&#xD;
               -  Myocardial infarction or cardiac surgery within the preceding six months&#xD;
&#xD;
          -  Known drug or alcohol abuse within 6 months prior to start of study&#xD;
&#xD;
          -  Patients with MRI contraindications:&#xD;
&#xD;
               -  Implanted pacemaker or defibrillator&#xD;
&#xD;
               -  Implanted vascular clips&#xD;
&#xD;
               -  Gross obesity (i.e. patients weight &gt; 150 kg)&#xD;
&#xD;
          -  Specific exclusion for the disease under study:&#xD;
&#xD;
               -  Known or suspected secondary hypertension&#xD;
&#xD;
               -  Known renal artery stenosis&#xD;
&#xD;
               -  Known endocrine disorders with secondary hypertension&#xD;
&#xD;
               -  Severe arterial hypertension as defined by a mean seated DBP &gt; 115 mmHg or a mean&#xD;
                  seated SBP &gt; 200 mmHg&#xD;
&#xD;
               -  Patients with a complete loss of diurnal BP variation, as defined by the lack of&#xD;
                  drop of BP during sleeping time or a drop of less than 5% when compared to daily&#xD;
                  mean BP&#xD;
&#xD;
               -  Hypertrophic obstructive cardiomyopathy, clinically relevant aortic valve&#xD;
                  stenosis or clinically relevant mitral valve disease; vascular disease affecting&#xD;
                  BP (coarctation; stenosis of A. subclavia)&#xD;
&#xD;
          -  Specific concomitant therapy exclusions:&#xD;
&#xD;
               -  Use of antihypertensive medication within the previous six months&#xD;
&#xD;
               -  Chronic administration of digoxin or other digitalis-type drugs, without regular&#xD;
                  monitoring of plasma level&#xD;
&#xD;
               -  Chronic administration of any medications known to affect blood pressure, except&#xD;
                  medications allowed by the protocol&#xD;
&#xD;
               -  Continuous (for more than two weeks) treatment within the last three months using&#xD;
                  at least on of the following drugs: β blockers, angiotensin converting enzyme&#xD;
                  inhibitors, angiotensin receptor blockers&#xD;
&#xD;
          -  Participation in another drug trial&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</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 16, 2014</study_first_submitted>
  <study_first_submitted_qc>September 16, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 17, 2014</study_first_posted>
  <last_update_submitted>September 16, 2014</last_update_submitted>
  <last_update_submitted_qc>September 16, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 17, 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>Metoprolol</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/NCT02242812
org study id: 502.393
nct id: NCT02242812
lead sponsor: 
The primary objective was to show that telmisartan is not inferior to metoprolol succinate in
      respect of the percentage change from baseline in LVMI(H) after a 6.5 months treatment
      period. As secondary objectives, the improvement in left ventricular systolic and diastolic
      function and blood pressure reduction were assessed
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double
measure: Percentage change in left ventricular mass index relative to height (LVMI(H))
time frame: Baseline, day 180
description: based on LVM measurements by magnetic resonance imaging (MRI)
measure: Number of patients with adverse events
time frame: up to 6.5 months
measure: Change of left ventricular mass index related to the body surface area (LVMI (BSA)) measured by MRI
time frame: Baseline, day 180
measure: Change of left ventricular end-systolic (LVESV) measured by MRI
time frame: Baseline, day 180
measure: Change of left ventricular end-diastolic volume (LVEDV) as measured by MRI
time frame: Baseline, day 180
measure: Change of left ventricular end-diastolic volume index related to height LVEDVI (H))
time frame: Baseline, day 180
description: based on LV volumetric measurements by MRI
measure: Change of left ventricular end-diastolic volume index related to the body mass index (LVEDVI (BSA))
time frame: Baseline, day 180
description: based on LV volumetric measurements by MRI
measure: Change of left ventricular ejection fraction (EF)
time frame: Baseline, day 180
description: based on LV volumetric measurements by MRI
measure: Change of end-systolic wall stress (ESWS) measured by MRI
time frame: Baseline, day 180
measure: Change of 24-hour mean systolic blood pressure measured by ambulatory blood pressure monitoring (ABPM)
time frame: Baseline, day 179
measure: Change of 24-hour mean diastolic blood pressure as measure by ABPM
time frame: Baseline, day 179
measure: Change of mean seated trough systolic blood pressure measured by manual cuff sphygmomanometer
time frame: up to day 194
measure: Change of mean seated trough diastolic blood pressure measured by manual cuff sphygmomanometer
time frame: up to day 194
arm group label: Telmisartan
arm group type: Experimental
description: MICARDIS®
arm group label: Metoprolol succinate
arm group type: Active Comparator
description: BELOC ZOK®
intervention type: Drug
intervention name: Telmisartan
arm group label: Telmisartan
intervention type: Drug
intervention name: Metoprolol succinate
arm group label: Metoprolol succinate
intervention type: Drug
intervention name: Placebo
arm group label: Metoprolol succinate
arm group label: Telmisartan
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
url: http://trials.boehringer-ingelheim.com
description: Related Info
responsible party type: Sponsor
mesh term: Hypertension
mesh term: Metoprolol
mesh term: Telmisartan