<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/NCT02242318</url>
  </required_header>
  <id_info>
    <org_study_id>502.376</org_study_id>
    <nct_id>NCT02242318</nct_id>
  </id_info>
  <brief_title>Study to Evaluate Efficacy of Micardis® (Telmisartan) and Valsartan in Patients With Mild-to-moderate Hypertension After Missing One Dose Using Ambulatory Blood Pressure Monitoring</brief_title>
  <official_title>A Prospective, Randomised, Double-blind, Double-dummy Trial to Compare the Efficacy of Micardis® (Telmisartan) (80 mg p.o. Once Daily) and Valsartan (160 mg p.o. Once Daily) in Patients With Mild-to-moderate Hypertension After Missing One Dose 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 primary aim of the trial is to compare telmisartan 80 mg to valsartan 160 mg in lowering&#xD;
      diastolic blood pressure in patients who missed a dose of their medication, as measured by&#xD;
      ABPM (change from baseline in mean DBP over 24 hours), and to compare telmisartan 80 mg to&#xD;
      valsartan 160 mg in lowering DBP during the last six hours of the dosing interval at the end&#xD;
      of a 6 to 8-week treatment period, as measured by ABPM (change from baseline)&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2001</start_date>
  <primary_completion_date type="Actual">September 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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in 24 hour mean Diastolic blood pressure (DBP) after a missed dose</measure>
    <time_frame>Baseline, Day 41, Day 55</time_frame>
    <description>measured by ambulatory blood pressure monitoring (ABPM)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in mean DBP during the last 6 hours of the 24 hour dosing interval</measure>
    <time_frame>up to 8 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in 24-hour mean systolic blood pressure (SBP) after a missed dose</measure>
    <time_frame>Baseline, Day 41, Day 55</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in mean SBP during the last 6 hours of the 24-hour dosing interval</measure>
    <time_frame>up to 8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in pulse pressure (PP)</measure>
    <time_frame>up to 8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in 24-hour mean DBP after an active dose of study medication</measure>
    <time_frame>up to 8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in 24-hour mean SBP after an active dose of study medication</measure>
    <time_frame>up to 8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in mean seated trough SBP/DBP/PP in- clinic manual cuff sphygmomanometer after a missed dose</measure>
    <time_frame>up to 8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the mean seated trough SBP/DBP/PP in- clinic manual cuff sphygmomanometer after an active dose of study medication</measure>
    <time_frame>up to 8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Responder rate measured by ABPM after a missed dose of study medication</measure>
    <time_frame>Baseline, Day 41, Day 55</time_frame>
    <description>ABPM DBP &quot;control&quot; (24-hour mean DBP &lt; 80 mmHg),&#xD;
ABPM DBP &quot;response&quot; (24-hour mean DBP &lt; 80 mmHg and/or reduction from baseline ≥ 10 mmHg),&#xD;
ABPM SBP &quot;response&quot; (24-hour mean SBP &lt; 130 mmHg and/or reduction from baseline ≥ 10 mmHg)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Responder rate measured by ABPM after an active dose of study medication</measure>
    <time_frame>up to 8 weeks</time_frame>
    <description>ABPM DBP &quot;control&quot; (24-hour mean DBP &lt; 80 mmHg),&#xD;
ABPM DBP &quot;response&quot; (24-hour mean DBP &lt; 80 mmHg and/or reduction from baseline ≥ 10 mmHg),&#xD;
ABPM SBP &quot;response&quot; (24-hour mean SBP &lt; 130 mmHg and/or reduction from baseline ≥ 10 mmHg)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Responder rate in- clinic manual trough cuff measurements after a missed dose of study medication</measure>
    <time_frame>Baseline, Day 41, Day 55</time_frame>
    <description>DBP &quot;control&quot; (DBP &lt; 90 mmHg),&#xD;
DBP &quot;response&quot; (DBP &lt; 90 mmHg and/or fall of ≥ 10 mmHg),&#xD;
SBP &quot;response&quot; (SBP &lt; 140 mmHg and/or fall of ≥ 10 mmHg),&#xD;
BP &quot;normal&quot; (SBP &lt; 130 mmHg and DBP &lt; 85 mmHg),&#xD;
BP &quot;normal / high normal&quot; (SBP &lt; 140 mmHg and DBP &lt; 90 mmHg).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Responder rate in- clinic manual trough cuff measurements after an active dose of study medication</measure>
    <time_frame>up to 8 weeks</time_frame>
    <description>DBP &quot;control&quot; (DBP &lt; 90 mmHg),&#xD;
DBP &quot;response&quot; (DBP &lt; 90 mmHg and/or fall of ≥ 10 mmHg),&#xD;
SBP &quot;response&quot; (SBP &lt; 140 mmHg and/or fall of ≥ 10 mmHg),&#xD;
BP &quot;normal&quot; (SBP &lt; 130 mmHg and DBP &lt; 85 mmHg),&#xD;
BP &quot;normal / high normal&quot; (SBP &lt; 140 mmHg and DBP &lt; 90 mmHg).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with adverse events</measure>
    <time_frame>up to 8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in 24-hour Pulse Pressure (PP) after a missed dose</measure>
    <time_frame>Baseline, Day 41, Day 55</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">440</enrollment>
  <condition>Hypertension</condition>
  <arm_group>
    <arm_group_label>Telmisartan</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>low dose for two weeks, then up titration to high dose, once daily</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Valsartan</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>low dose for two weeks, then up titration to high dose, once daily</description>
  </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>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Valsartan</intervention_name>
    <arm_group_label>Valsartan</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_label>Telmisartan</arm_group_label>
    <arm_group_label>Valsartan</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. 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 2&#xD;
&#xD;
          2. 24-hour mean DBP of ≥ 85 mmHg at Visit 3 as measured by ABPM&#xD;
&#xD;
          3. Age 18 years or older&#xD;
&#xD;
          4. Ability to stop any current antihypertensive therapy without risk to the patient&#xD;
             (investigator's discretion)&#xD;
&#xD;
          5. Patient's written informed consent in accordance with Good Clinical Practice (GCP) and&#xD;
             local legislation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Pre-menopausal women (last menstruation ≤ 1 year prior to start of run-in period) who&#xD;
&#xD;
               1. are not surgically sterile,&#xD;
&#xD;
               2. are nursing,&#xD;
&#xD;
               3. are of child-bearing potential and are NOT practising acceptable methods of birth&#xD;
                  control, or do NOT plan to continue practising an acceptable method throughout&#xD;
                  the study. Acceptable methods of birth control include oral, implantable or&#xD;
                  injectable contraceptives and Intra Uterine Devices (IUD)&#xD;
&#xD;
          2. Known or suspected secondary hypertension&#xD;
&#xD;
          3. Mean sitting SBP ≥180 mmHg or mean sitting DBP ≥110 mmHg during any visit of the&#xD;
             placebo run-in period&#xD;
&#xD;
          4. Hepatic and/or renal dysfunction as defined by the following laboratory parameters:&#xD;
&#xD;
               1. Serum Glutamate-Pyruvate-Transaminase (Alanine Aminotransferase) (SGPT (ALT)) or&#xD;
                  Serum Glutamate-Oxaloacetate-Transaminase (Aspartate Aminotransferase) (SGOT&#xD;
                  (AST)) &gt; than 2 times the upper limit of normal range,&#xD;
&#xD;
               2. Serum creatinine &gt; 2.3 mg/dL (or &gt; 203 μmol/l)&#xD;
&#xD;
          5. Bilateral renal artery stenosis, renal artery stenosis in a solitary kidney, patients&#xD;
             postrenal transplant or with only one kidney&#xD;
&#xD;
          6. Clinically relevant sodium depletion, hypokalaemia or hyperkalaemia&#xD;
&#xD;
          7. Uncorrected volume depletion&#xD;
&#xD;
          8. Primary aldosteronism&#xD;
&#xD;
          9. Hereditary fructose intolerance&#xD;
&#xD;
         10. Biliary obstructive disorders&#xD;
&#xD;
         11. Patients who have previously experienced symptoms characteristic of angioedema during&#xD;
             treatment with ACE inhibitors or angiotensin II receptor antagonists&#xD;
&#xD;
         12. History of drug or alcohol dependency within six months prior to start of run-in&#xD;
             period&#xD;
&#xD;
         13. Concomitant administration of any medications known to affect blood pressure, except&#xD;
             medication allowed by the protocol&#xD;
&#xD;
         14. Any investigational therapy within one month of signing the informed consent form&#xD;
&#xD;
         15. Congestive heart failure (New York Heart Association (NYHA) functional class&#xD;
             Congestive Heart Failure (CHF III-IV))&#xD;
&#xD;
         16. Unstable angina within the past three months prior to start of run-in period&#xD;
&#xD;
         17. Stroke within the past six months prior to start of run-in period&#xD;
&#xD;
         18. Myocardial infarction or cardiac surgery within the past three months prior to start&#xD;
             of run-in period&#xD;
&#xD;
         19. Percutaneous Transluminal Coronary Angioplasty (PTCA) within the past three months&#xD;
             prior to start of run-in period&#xD;
&#xD;
         20. Sustained ventricular tachycardia, atrial fibrillation, atrial flutter or other&#xD;
             clinically relevant cardiac arrhythmias as determined by the investigator&#xD;
&#xD;
         21. Hypertrophic obstructive cardiomyopathy, aortic stenosis, hemodynamically relevant&#xD;
             stenosis of the aortic or mitral valve&#xD;
&#xD;
         22. Patients with insulin-dependent diabetes mellitus whose diabetes has not been stable&#xD;
             and controlled for at least the past three months as defined by an HbA1C ≥ 10%&#xD;
&#xD;
         23. Night shift workers who routinely sleep during the daytime and whose work hours&#xD;
             include midnight to 4:00 Ante Meridiem (AM)&#xD;
&#xD;
         24. Known hypersensitivity to any component of the formulations&#xD;
&#xD;
         25. 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;
         26. Inability to comply with the protocol&#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>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>Valsartan</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/NCT02242318
org study id: 502.376
nct id: NCT02242318
lead sponsor: 
The primary aim of the trial is to compare telmisartan 80 mg to valsartan 160 mg in lowering
      diastolic blood pressure in patients who missed a dose of their medication, as measured by
      ABPM (change from baseline in mean DBP over 24 hours), and to compare telmisartan 80 mg to
      valsartan 160 mg in lowering DBP during the last six hours of the dosing interval at the end
      of a 6 to 8-week treatment period, as measured by ABPM (change from baseline)
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double
measure: Change in 24 hour mean Diastolic blood pressure (DBP) after a missed dose
time frame: Baseline, Day 41, Day 55
description: measured by ambulatory blood pressure monitoring (ABPM)
measure: Change in mean DBP during the last 6 hours of the 24 hour dosing interval
time frame: up to 8 weeks
measure: Change in 24-hour mean systolic blood pressure (SBP) after a missed dose
time frame: Baseline, Day 41, Day 55
measure: Change in mean SBP during the last 6 hours of the 24-hour dosing interval
time frame: up to 8 weeks
measure: Change in pulse pressure (PP)
time frame: up to 8 weeks
measure: Change in 24-hour mean DBP after an active dose of study medication
time frame: up to 8 weeks
measure: Change in 24-hour mean SBP after an active dose of study medication
time frame: up to 8 weeks
measure: Change in mean seated trough SBP/DBP/PP in- clinic manual cuff sphygmomanometer after a missed dose
time frame: up to 8 weeks
measure: Change in the mean seated trough SBP/DBP/PP in- clinic manual cuff sphygmomanometer after an active dose of study medication
time frame: up to 8 weeks
measure: Responder rate measured by ABPM after a missed dose of study medication
time frame: Baseline, Day 41, Day 55
description: ABPM DBP "control" (24-hour mean DBP < 80 mmHg),
ABPM DBP "response" (24-hour mean DBP < 80 mmHg and/or reduction from baseline ≥ 10 mmHg),
ABPM SBP "response" (24-hour mean SBP < 130 mmHg and/or reduction from baseline ≥ 10 mmHg)
measure: Responder rate measured by ABPM after an active dose of study medication
time frame: up to 8 weeks
description: ABPM DBP "control" (24-hour mean DBP < 80 mmHg),
ABPM DBP "response" (24-hour mean DBP < 80 mmHg and/or reduction from baseline ≥ 10 mmHg),
ABPM SBP "response" (24-hour mean SBP < 130 mmHg and/or reduction from baseline ≥ 10 mmHg)
measure: Responder rate in- clinic manual trough cuff measurements after a missed dose of study medication
time frame: Baseline, Day 41, Day 55
description: DBP "control" (DBP < 90 mmHg),
DBP "response" (DBP < 90 mmHg and/or fall of ≥ 10 mmHg),
SBP "response" (SBP < 140 mmHg and/or fall of ≥ 10 mmHg),
BP "normal" (SBP < 130 mmHg and DBP < 85 mmHg),
BP "normal / high normal" (SBP < 140 mmHg and DBP < 90 mmHg).
measure: Responder rate in- clinic manual trough cuff measurements after an active dose of study medication
time frame: up to 8 weeks
description: DBP "control" (DBP < 90 mmHg),
DBP "response" (DBP < 90 mmHg and/or fall of ≥ 10 mmHg),
SBP "response" (SBP < 140 mmHg and/or fall of ≥ 10 mmHg),
BP "normal" (SBP < 130 mmHg and DBP < 85 mmHg),
BP "normal / high normal" (SBP < 140 mmHg and DBP < 90 mmHg).
measure: Number of patients with adverse events
time frame: up to 8 weeks
measure: Change in 24-hour Pulse Pressure (PP) after a missed dose
time frame: Baseline, Day 41, Day 55
arm group label: Telmisartan
arm group type: Experimental
description: low dose for two weeks, then up titration to high dose, once daily
arm group label: Valsartan
arm group type: Active Comparator
description: low dose for two weeks, then up titration to high dose, once daily
arm group label: Placebo
arm group type: Placebo Comparator
intervention type: Drug
intervention name: Telmisartan
arm group label: Telmisartan
intervention type: Drug
intervention name: Valsartan
arm group label: Valsartan
intervention type: Drug
intervention name: Placebo
arm group label: Placebo
arm group label: Telmisartan
arm group label: Valsartan
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: Valsartan
mesh term: Telmisartan