<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/NCT02260089</url>
  </required_header>
  <id_info>
    <org_study_id>502.363</org_study_id>
    <nct_id>NCT02260089</nct_id>
  </id_info>
  <brief_title>Telmisartan in Mild to Moderate Hypertensive Patients</brief_title>
  <official_title>A Multicenter Open-label Study of the Efficacy and Safety of Telmisartan in Mild to Moderate Hypertensive Patients</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 evaluate the efficacy and tolerability of telmisartan, given once a day to patients with&#xD;
      mild to moderate hypertension, as well as to assess the 24-hour blood pressure profile with&#xD;
      ABPM&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>March 2000</start_date>
  <primary_completion_date type="Actual">July 2002</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in systolic blood pressure (SBP) and diastolic blood pressure (DBP)</measure>
    <time_frame>Baseline, up to 12 weeks after start of treatment</time_frame>
    <description>Blood pressure values were obtained 24 hours after the last dose (through values) at the office</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Assessment of treatment response for SBP/DBP (in %)</measure>
    <time_frame>Baseline, up to 12 weeks after start of treatment</time_frame>
    <description>Response categories:&#xD;
SBP &lt; 140 mm Hg or&#xD;
DBP &lt; 90 mm Hg or&#xD;
BP reduction ≥ 10 mm Hg</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes from baseline in blood pressure values</measure>
    <time_frame>Baseline, up to 12 weeks after start of treatment</time_frame>
    <description>Analysis performed for the ambulatory blood pressure monitoring (ABPM) - subgroup</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with adverse events</measure>
    <time_frame>Up to 16 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with clinically significant changes in laboratory values</measure>
    <time_frame>Up to 16 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with clinically significant changes in ECG</measure>
    <time_frame>Up to 16 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">134</enrollment>
  <condition>Hypertension</condition>
  <arm_group>
    <arm_group_label>Low dose of telmisartan</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>4 week placebo run-in phase followed by 6 weeks of treatment with low dose of telmisartan</description>
  </arm_group>
  <arm_group>
    <arm_group_label>High dose of telmisartan</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>After 6 weeks of treatment with low dose of telmisartan, titration to high dose of telmisartan if blood pressure level is higher than 140/90 mm Hg</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Low dose of telmisartan</intervention_name>
    <arm_group_label>Low dose of telmisartan</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>High dose of telmisartan</intervention_name>
    <arm_group_label>High dose of telmisartan</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Low dose of telmisartan</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with blood pressure levels of 140/90 mm Hg or higher (confirmed on 2&#xD;
             consecutive visits), who were 18 years old and older, regardless of sex&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Suspected or known diagnosis of arterial hypertension with a secondary cause&#xD;
&#xD;
          -  Women who were not using an effective method of contraception, or who were pregnant,&#xD;
             or breast-feeding&#xD;
&#xD;
          -  Systolic blood pressure &gt; 200 mm Hg or diastolic blood pressure &gt; 115 mm Hg&#xD;
&#xD;
          -  Laboratory test values two fold above the upper normal limit&#xD;
&#xD;
          -  Previous intolerance to angiotensin conversion enzyme inhibitors or angiotensin II&#xD;
             blocker (AIIAR)&#xD;
&#xD;
          -  New York Heart Association class III or IV heart failure&#xD;
&#xD;
          -  History of stroke in the 6 months prior to entry into the study&#xD;
&#xD;
          -  Uncontrolled type 2 diabetes mellitus, defined as fasting glucose levels &gt; 140 mg/dL&#xD;
             on 3 consecutive assessments&#xD;
&#xD;
          -  Patients who were included in another investigational drug study in the past 30 days&#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>October 2014</verification_date>
  <study_first_submitted>October 8, 2014</study_first_submitted>
  <study_first_submitted_qc>October 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 9, 2014</study_first_posted>
  <last_update_submitted>October 8, 2014</last_update_submitted>
  <last_update_submitted_qc>October 8, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 9, 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>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/NCT02260089
org study id: 502.363
nct id: NCT02260089
lead sponsor: 
To evaluate the efficacy and tolerability of telmisartan, given once a day to patients with
      mild to moderate hypertension, as well as to assess the 24-hour blood pressure profile with
      ABPM
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Changes in systolic blood pressure (SBP) and diastolic blood pressure (DBP)
time frame: Baseline, up to 12 weeks after start of treatment
description: Blood pressure values were obtained 24 hours after the last dose (through values) at the office
measure: Assessment of treatment response for SBP/DBP (in %)
time frame: Baseline, up to 12 weeks after start of treatment
description: Response categories:
SBP < 140 mm Hg or
DBP < 90 mm Hg or
BP reduction ≥ 10 mm Hg
measure: Changes from baseline in blood pressure values
time frame: Baseline, up to 12 weeks after start of treatment
description: Analysis performed for the ambulatory blood pressure monitoring (ABPM) - subgroup
measure: Number of patients with adverse events
time frame: Up to 16 weeks
measure: Number of patients with clinically significant changes in laboratory values
time frame: Up to 16 weeks
measure: Number of patients with clinically significant changes in ECG
time frame: Up to 16 weeks
arm group label: Low dose of telmisartan
arm group type: Experimental
description: 4 week placebo run-in phase followed by 6 weeks of treatment with low dose of telmisartan
arm group label: High dose of telmisartan
arm group type: Experimental
description: After 6 weeks of treatment with low dose of telmisartan, titration to high dose of telmisartan if blood pressure level is higher than 140/90 mm Hg
intervention type: Drug
intervention name: Low dose of telmisartan
arm group label: Low dose of telmisartan
intervention type: Drug
intervention name: High dose of telmisartan
arm group label: High dose of telmisartan
intervention type: Drug
intervention name: Placebo
arm group label: Low dose of telmisartan
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: Telmisartan