<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/NCT02206659</url>
  </required_header>
  <id_info>
    <org_study_id>502.367</org_study_id>
    <nct_id>NCT02206659</nct_id>
  </id_info>
  <brief_title>Effects of Telmisartan by Ambulatory Blood Pressure Monitoring (ABPM) in Chinese Patients With Mild to Moderate Essential Hypertension</brief_title>
  <official_title>An Open-label Evaluation of Trough and Peak Effects of 40 mg Telmisartan Tablet by Ambulatory Blood Pressure Monitoring in Chinese Patients With Mild to Moderate Essential Hypertension</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boehringer Ingelheim</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boehringer Ingelheim</source>
  <brief_summary>
    <textblock>
      To assess the trough/peak ratio of 40 mg Telmisartan tablet by ambulatory blood pressure&#xD;
      monitoring in Chinese patients with mild to moderate essential hypertension&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2000</start_date>
  <primary_completion_date type="Actual">February 2001</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mean of trough/peak (T/P) ratio for diastolic blood pressure (DBP) and systolic blood pressure (SBP)</measure>
    <time_frame>42 days after start of treatment</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Median of T/P ratio for DBP and SBP</measure>
    <time_frame>42 days after start of treatment</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in mean 24-hr DBP and SBP</measure>
    <time_frame>Day -13, 42 days after start of treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in daytime mean for SBP and DBP</measure>
    <time_frame>Day -13, 42 days after start of treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in nighttime mean for SBP and DBP</measure>
    <time_frame>Day -13, 42 days after start of treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in mean of DBP and SBP for last 6-hr dosing interval</measure>
    <time_frame>Day -13, 42 days after start of treatment</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Hypertension</condition>
  <arm_group>
    <arm_group_label>Telmisartan</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>2-week placebo run-in period followed by 6 weeks of treatment with telmisartan</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>Placebo</intervention_name>
    <arm_group_label>Telmisartan</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Chinese male or female aged 18 to 75 years&#xD;
&#xD;
          -  Mild to moderate hypertension defined as a morning DBP _95 and &lt;110 mm Hg at visit1&#xD;
             and visit 2. Mean sitting systolic pressure (SBP) must be &lt;180 mm Hg&#xD;
&#xD;
          -  Ability to provide written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Women who are pregnant or breast-feeding, or of childbearing potential without an&#xD;
             effective method of birth control (effective birth control methods are: uterine&#xD;
             device, surgical sterilisation, progestogens alone)&#xD;
&#xD;
          -  Known or suspected secondary hypertension&#xD;
&#xD;
          -  Known history of any chronic hepatic disease&#xD;
&#xD;
          -  Bilateral renal artery stenosis; renal artery stenosis in a solitary kidney;&#xD;
             post-renal transplant&#xD;
&#xD;
          -  New York Heart Association (NYHA) functional class congestive heart failure (CHF)&#xD;
             III-IV&#xD;
&#xD;
          -  Unstable angina pectoris&#xD;
&#xD;
          -  Myocardial infarction or percutaneous transluminal coronary angiography (PTCA) or&#xD;
             cardiac surgery within the preceding three months&#xD;
&#xD;
          -  Clinical relevant cardiac arrhythmias as determined by the clinical investigator&#xD;
&#xD;
          -  Hypertrophic obstructive cardiomyopathy or clinically significant valvular disease&#xD;
&#xD;
          -  Evidence of retinal hemorrhages/exudates&#xD;
&#xD;
          -  Clinical significant hyperkalemia as defined by serum potassium level &gt;6.0&#xD;
             milliequivalents (mEq)/L&#xD;
&#xD;
          -  Insulin-dependent diabetes mellitus&#xD;
&#xD;
          -  Non-insulin-dependent diabetes mellitus with poor glucose control as defined by&#xD;
             persistent fasting blood sugar &gt;200 mg/dl, peripheral neuropathy or autonomic&#xD;
             neuropathy&#xD;
&#xD;
          -  Known drug or alcohol dependency&#xD;
&#xD;
          -  Administration of any diuretic, ACE inhibitor or angiotensin II receptor antagonist&#xD;
             within two weeks before run-in period&#xD;
&#xD;
          -  Administration of medication known to affect blood pressure during trial period&#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 formulation&#xD;
&#xD;
          -  Any other clinical condition which, in the opinion of the principal investigator,&#xD;
             would not allow safe completion of the protocol and safe administration of trial&#xD;
             medication&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</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 31, 2014</study_first_submitted>
  <study_first_submitted_qc>July 31, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 1, 2014</study_first_posted>
  <last_update_submitted>July 31, 2014</last_update_submitted>
  <last_update_submitted_qc>July 31, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 1, 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>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/NCT02206659
org study id: 502.367
nct id: NCT02206659
lead sponsor: 
To assess the trough/peak ratio of 40 mg Telmisartan tablet by ambulatory blood pressure
      monitoring in Chinese patients with mild to moderate essential hypertension
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Mean of trough/peak (T/P) ratio for diastolic blood pressure (DBP) and systolic blood pressure (SBP)
time frame: 42 days after start of treatment
measure: Median of T/P ratio for DBP and SBP
time frame: 42 days after start of treatment
measure: Change in mean 24-hr DBP and SBP
time frame: Day -13, 42 days after start of treatment
measure: Change in daytime mean for SBP and DBP
time frame: Day -13, 42 days after start of treatment
measure: Change in nighttime mean for SBP and DBP
time frame: Day -13, 42 days after start of treatment
measure: Change in mean of DBP and SBP for last 6-hr dosing interval
time frame: Day -13, 42 days after start of treatment
arm group label: Telmisartan
arm group type: Experimental
description: 2-week placebo run-in period followed by 6 weeks of treatment with telmisartan
intervention type: Drug
intervention name: Telmisartan
arm group label: Telmisartan
intervention type: Drug
intervention name: Placebo
arm group label: Telmisartan
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
url: http://trials.boehringer-ingelheim.com
description: Related Info
responsible party type: Sponsor
mesh term: Hypertension
mesh term: Essential Hypertension
mesh term: Telmisartan