<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/NCT02183701</url>
  </required_header>
  <id_info>
    <org_study_id>502.257</org_study_id>
    <nct_id>NCT02183701</nct_id>
  </id_info>
  <brief_title>Telmisartan Compared to Losartan + Hydrochlorothiazide in Patients With Mild-to-moderate Essential Hypertension</brief_title>
  <official_title>A Prospective Randomised Open-Label Blinded Endpoint Trial Comparing Telmisartan 80 mg and Losartan 50 mg + Hydrochlorothiazide 12.5 mg (Fixed Dose Combination) in Patients With Mild-to-Moderate Essential Hypertension Using Ambulatory Blood Pressure Monitoring</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 general aim and clinical objective of this trial is to determine the effect of&#xD;
      telmisartan 80 mg compared to losartan 50 mg + HCTZ (Hydrochlorothiazide) 12.5 mg on&#xD;
      reduction of blood pressure (BP) in patients with mild to moderate hypertension as assessed&#xD;
      by 24 hour Ambulatory Blood Pressure Monitoring (ABPM) and trough sitting BP cuff&#xD;
      measurements at the end of the treatment.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>April 1998</start_date>
  <primary_completion_date type="Actual">December 1998</primary_completion_date>
  <phase>Phase 3</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline in 24-hour mean diastolic blood pressure measured by ABPM</measure>
    <time_frame>Baseline (Day 28 of run-in period) and day 42</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in 24-hour mean systolic blood pressure measured by ABPM</measure>
    <time_frame>Baseline (Day 28 of run-in period) and day 42</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in systolic and diastolic blood pressures during other time periods during the 24-hour ABPM profile</measure>
    <time_frame>Baseline (Day 28 of run-in period) and day 42</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline (Visit 2) in trough systolic and diastolic blood pressures measured by cuff sphygmomanometer</measure>
    <time_frame>Baseline (Day 28 of run-in period) and day 42</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patient with of adverse events</measure>
    <time_frame>up to 10 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes from baseline in pulse rate</measure>
    <time_frame>Baseline (Day 28 of run-in period) and day 42</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in physical examination</measure>
    <time_frame>Screening and day 43</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in laboratory parameters</measure>
    <time_frame>Screening and day 43</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in 12-lead electrocardiogram (ECG)</measure>
    <time_frame>Baseline (Day 29 of run-in period) and day 43</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">715</enrollment>
  <condition>Hypertension</condition>
  <arm_group>
    <arm_group_label>Telmisartan</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>4 weeks placebo run-in, 6-weeks fixed dose period</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Losartan + Hydrochlorothiazide</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>4 weeks placebo run-in, 6-weeks fixed dose period (Losartan 50 mg / HCTZ 12.5 mg)</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>Losartan + Hydrochlorothiazide</intervention_name>
    <arm_group_label>Losartan + Hydrochlorothiazide</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Losartan + Hydrochlorothiazide</arm_group_label>
    <arm_group_label>Telmisartan</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Mild-to-moderate essential hypertension defined as a mean seated diastolic blood&#xD;
             pressure measurement of ≥ 95 mmHg measured by manual cuff sphygmomanometer, on Visit 2&#xD;
             of the four-week placebo run-in period (baseline)&#xD;
&#xD;
          -  Mean seated systolic blood pressure ≥ 140 mmHg, measured by manual cuff at baseline&#xD;
             (Visit 2)&#xD;
&#xD;
          -  A 24-hour mean diastolic blood pressure , measured by ABPM, of ≥ 85 mmHg evaluated at&#xD;
             baseline (Visit 3)&#xD;
&#xD;
          -  Age 18 or older&#xD;
&#xD;
          -  Patient's written informed consent in accordance with GCP (Good Clinical Practice) and&#xD;
             local legislation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pre-menopausal women (last menstruation ≤ 1 year prior to date of consent):&#xD;
&#xD;
               -  Who are not surgically sterile (hysterectomy, tubal ligation)&#xD;
&#xD;
               -  Who are NOT practising acceptable means of birth control or who do NOT plan to&#xD;
                  continue using an acceptable method throughout the trial. Acceptable methods of&#xD;
                  birth control include IUD (intrauterine device), oral, implantable or injectable&#xD;
                  contraceptives&#xD;
&#xD;
               -  Who have a positive urine pregnancy test&#xD;
&#xD;
               -  Who are nursing&#xD;
&#xD;
          -  Mean seated diastolic blood pressure (DBP) &gt; 114 mmHg or mean seated systolic BP &gt; 200&#xD;
             mmHg, by manual cuff&#xD;
&#xD;
          -  Any known hepatic and/or renal dysfunction as defined by the following laboratory&#xD;
             parameters:&#xD;
&#xD;
               -  SGPT (serum glutamate pyruvate transaminase) (ALT) or SGOT (serum glutamate&#xD;
                  oxaloacetate transaminase) (AST) greater than two times the upper limit of normal&#xD;
&#xD;
               -  Serum creatinine &gt; 1.8 mg/dl (or 159 µmol/l)&#xD;
&#xD;
          -  Clinically relevant hypokalemia&#xD;
&#xD;
          -  Known or suspected secondary hypertension&#xD;
&#xD;
          -  Known bilateral renal artery stenosis; renal artery stenosis in a solitary kidney;&#xD;
             post-renal transplant patients, presence of only one functioning kidney.&#xD;
&#xD;
          -  Congestive heart failure (CHF) (NYHA (New York Heart Association) class CHF III-IV)&#xD;
&#xD;
          -  Unstable angina within the past 3 months; stable angina where a change in nitrate&#xD;
             therapy (dose or frequency) during the run-in period was required&#xD;
&#xD;
          -  Stroke within the past 6 months prior to start of run-in period&#xD;
&#xD;
          -  Myocardial infarction or cardiac surgery within the past 3 months prior to start of&#xD;
             run-in period&#xD;
&#xD;
          -  PTCA (percutaneous transluminal coronary angioplasty) within the past 3 months prior&#xD;
             to start of run-in period&#xD;
&#xD;
          -  Previous history of angioedema&#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, hemodynamically relevant stenosis of the&#xD;
             aortic or mitral valve&#xD;
&#xD;
          -  Patients with unstable insulin-dependent diabetes mellitus (risk of hypoglycemia or&#xD;
             HbA1c ≥ 10 % in history within 6 months prior to start of run-in period)&#xD;
&#xD;
          -  Known drug or alcohol dependency within the past 6 months period prior to start of&#xD;
             run-in period&#xD;
&#xD;
          -  Concomitant administration of medications known to affect blood pressure, except&#xD;
             medications allowed by the protocol&#xD;
&#xD;
          -  Patients receiving any investigational therapy within one month of signing the&#xD;
             informed consent form&#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;
&#xD;
          -  Concomitant use of lithium or cholestyramine or colestipol resins (potential drug&#xD;
             interactions with HCTZ)&#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/content/dam/internet/opu/clinicaltrial/com_EN/results/502/502.257_U99-1695.pdf</url>
    <description>Related Info</description>
  </link>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 7, 2014</study_first_submitted>
  <study_first_submitted_qc>July 7, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 8, 2014</study_first_posted>
  <last_update_submitted>July 7, 2014</last_update_submitted>
  <last_update_submitted_qc>July 7, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 8, 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>
    <mesh_term>Essential 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>Hydrochlorothiazide</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/NCT02183701
org study id: 502.257
nct id: NCT02183701
lead sponsor: 
The general aim and clinical objective of this trial is to determine the effect of
      telmisartan 80 mg compared to losartan 50 mg + HCTZ (Hydrochlorothiazide) 12.5 mg on
      reduction of blood pressure (BP) in patients with mild to moderate hypertension as assessed
      by 24 hour Ambulatory Blood Pressure Monitoring (ABPM) and trough sitting BP cuff
      measurements at the end of the treatment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change from baseline in 24-hour mean diastolic blood pressure measured by ABPM
time frame: Baseline (Day 28 of run-in period) and day 42
measure: Change from baseline in 24-hour mean systolic blood pressure measured by ABPM
time frame: Baseline (Day 28 of run-in period) and day 42
measure: Change from baseline in systolic and diastolic blood pressures during other time periods during the 24-hour ABPM profile
time frame: Baseline (Day 28 of run-in period) and day 42
measure: Change from baseline (Visit 2) in trough systolic and diastolic blood pressures measured by cuff sphygmomanometer
time frame: Baseline (Day 28 of run-in period) and day 42
measure: Number of patient with of adverse events
time frame: up to 10 weeks
measure: Changes from baseline in pulse rate
time frame: Baseline (Day 28 of run-in period) and day 42
measure: Changes in physical examination
time frame: Screening and day 43
measure: Changes in laboratory parameters
time frame: Screening and day 43
measure: Changes in 12-lead electrocardiogram (ECG)
time frame: Baseline (Day 29 of run-in period) and day 43
arm group label: Telmisartan
arm group type: Experimental
description: 4 weeks placebo run-in, 6-weeks fixed dose period
arm group label: Losartan + Hydrochlorothiazide
arm group type: Active Comparator
description: 4 weeks placebo run-in, 6-weeks fixed dose period (Losartan 50 mg / HCTZ 12.5 mg)
intervention type: Drug
intervention name: Telmisartan
arm group label: Telmisartan
intervention type: Drug
intervention name: Losartan + Hydrochlorothiazide
arm group label: Losartan + Hydrochlorothiazide
intervention type: Drug
intervention name: Placebo
arm group label: Losartan + Hydrochlorothiazide
arm group label: Telmisartan
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
url: http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/502/502.257_U99-1695.pdf
description: Related Info
responsible party type: Sponsor
mesh term: Hypertension
mesh term: Essential Hypertension
mesh term: Losartan
mesh term: Hydrochlorothiazide
mesh term: Telmisartan