<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/NCT02242396</url>
  </required_header>
  <id_info>
    <org_study_id>502.496</org_study_id>
    <nct_id>NCT02242396</nct_id>
  </id_info>
  <brief_title>A Study of a Hypertensive Population Under Treatment With Micardis® and Micardis Plus® to Control the Early Morning BP Rise (SURGE II)</brief_title>
  <official_title>A Study of a Hypertensive Population Under Treatment With Micardis® and Micardis Plus® Under Real Clinical Conditions With the Goal to Control the Early Morning BP Rise (SURGE II)</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 evaluate, through the use of Home blood pressure monitoring&#xD;
      (HBPM), the degree of BP control in the early morning hours after 8 weeks of treatment in&#xD;
      patients with essential hypertension under treatment with Micardis®, Telmisartan or Micardis&#xD;
      Plus®, Telmisartan hydrochlorothiazide.&#xD;
&#xD;
      The co-primary endpoints were the degree of BP control, and change from baseline until study&#xD;
      end in mean systolic blood pressure (mSBP) and mean diastolic blood pressure (mDBP) HBPM in&#xD;
      the early morning hours after 8 weeks of treatment with Micardis®, Telmisartan or Micardis&#xD;
      Plus®, Telmisartan hydrochlorothiazide.&#xD;
&#xD;
      Secondary endpoints were office BP control rates, office BP response rates, and reduction in&#xD;
      mSBP and mDBP Office blood pressure measurement (OBPM) from baseline to final visit,&#xD;
      discontinuations and tolerability&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2005</start_date>
  <primary_completion_date type="Actual">November 2007</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Change of degree of Blood Pressure (BP) control in the early morning hours</measure>
    <time_frame>8 weeks of treatment</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline in mSBP and mDBP by HBPM in the early morning</measure>
    <time_frame>Baseline, after 8 weeks of treatment</time_frame>
    <description>BP control during the morning time-periods (6:00 to 11:59), BP &lt; 135/85 mmHg (HBPM: mean of morning measurements)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in office BP control rates</measure>
    <time_frame>Baseline, after 8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in office BP response rates</measure>
    <time_frame>Baseline, after 8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reduction in mSBP and mDBP by OBPM</measure>
    <time_frame>Baseline, after 8 weeks</time_frame>
  </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>Global Assessment of tolerability by investigator on a 6-point scale</measure>
    <time_frame>after 8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Global assessment efficacy by investigator on 6-point scale</measure>
    <time_frame>after 8 weeks</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">5248</enrollment>
  <condition>Hypertension</condition>
  <arm_group>
    <arm_group_label>Hypertensive patients</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Telmisartan</intervention_name>
    <arm_group_label>Hypertensive patients</arm_group_label>
    <other_name>Micardis®</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Telmisartan hydrochlorothiazide</intervention_name>
    <arm_group_label>Hypertensive patients</arm_group_label>
    <other_name>Micardis Plus®</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Hypertensive population under real life clinical practice in an ambulatory setting&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients male or female between 18 and 80 years of age&#xD;
&#xD;
          -  Patients with mild to moderate essential hypertension&#xD;
&#xD;
          -  Patients diagnosed with hypertension that are not currently taking antihypertensive&#xD;
             medication or previously diagnosed hypertensive patients who are uncontrolled with&#xD;
             their current treatment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pre-menopausal women who have no birth control, who are pregnant or nursing&#xD;
&#xD;
          -  Patients with advanced hepatic impairment or advanced renal impairment&#xD;
&#xD;
          -  Patients with New York Heart Association (NYHA) functional class III or IV congestive&#xD;
             heart failure (CHF), unstable angina, acute myocardial infarction, heart surgery or&#xD;
             stroke within the previous six months&#xD;
&#xD;
          -  Patients with any type of relevant arrhythmia according to the assessment of the&#xD;
             investigator&#xD;
&#xD;
          -  Patients with any valvular disease with hemodynamic repercussion&#xD;
&#xD;
          -  Patients receiving chronic administration of oral anticoagulants or digoxin&#xD;
&#xD;
          -  Patients with known hypersensitivity to any component in the formulation of Micardis®,&#xD;
             Telmisartan or Micardis Plus®, Telmisartan hydrochlorothiazide&#xD;
&#xD;
          -  Patients with previous history of angioedema associated with angiotensin converting&#xD;
             enzyme (ACE) inhibitors&#xD;
&#xD;
          -  Patients with severe, uncontrolled hypertension or any form of secondary hypertension&#xD;
&#xD;
          -  Patients with any other clinical conditions which, in the opinion of the investigator,&#xD;
             would not allow for the safe completion of the protocol&#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>Hydrochlorothiazide</mesh_term>
    <mesh_term>Telmisartan</mesh_term>
    <mesh_term>Telmisartan, hydrochlorothiazide drug combination</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/NCT02242396
org study id: 502.496
nct id: NCT02242396
lead sponsor: 
The primary objective was to evaluate, through the use of Home blood pressure monitoring
      (HBPM), the degree of BP control in the early morning hours after 8 weeks of treatment in
      patients with essential hypertension under treatment with Micardis®, Telmisartan or Micardis
      Plus®, Telmisartan hydrochlorothiazide.

      The co-primary endpoints were the degree of BP control, and change from baseline until study
      end in mean systolic blood pressure (mSBP) and mean diastolic blood pressure (mDBP) HBPM in
      the early morning hours after 8 weeks of treatment with Micardis®, Telmisartan or Micardis
      Plus®, Telmisartan hydrochlorothiazide.

      Secondary endpoints were office BP control rates, office BP response rates, and reduction in
      mSBP and mDBP Office blood pressure measurement (OBPM) from baseline to final visit,
      discontinuations and tolerability
observational model: Cohort
time perspective: Prospective
measure: Change of degree of Blood Pressure (BP) control in the early morning hours
time frame: 8 weeks of treatment
measure: Change from baseline in mSBP and mDBP by HBPM in the early morning
time frame: Baseline, after 8 weeks of treatment
description: BP control during the morning time-periods (6:00 to 11:59), BP < 135/85 mmHg (HBPM: mean of morning measurements)
measure: Change from baseline in office BP control rates
time frame: Baseline, after 8 weeks
measure: Change from baseline in office BP response rates
time frame: Baseline, after 8 weeks
measure: Reduction in mSBP and mDBP by OBPM
time frame: Baseline, after 8 weeks
measure: Number of patients with adverse events
time frame: up to 8 weeks
measure: Global Assessment of tolerability by investigator on a 6-point scale
time frame: after 8 weeks
measure: Global assessment efficacy by investigator on 6-point scale
time frame: after 8 weeks
arm group label: Hypertensive patients
intervention type: Drug
intervention name: Telmisartan
arm group label: Hypertensive patients
other name: Micardis®
intervention type: Drug
intervention name: Telmisartan hydrochlorothiazide
arm group label: Hypertensive patients
other name: Micardis Plus®
study pop: 
sampling method: Non-Probability Sample
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: Hydrochlorothiazide
mesh term: Telmisartan
mesh term: Telmisartan, hydrochlorothiazide drug combination