<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/NCT02242877</url>
  </required_header>
  <id_info>
    <org_study_id>502.510</org_study_id>
    <nct_id>NCT02242877</nct_id>
  </id_info>
  <brief_title>TELSYS - TELmisartan Effectiveness in Isolated SYStolic Hypertension Versus Systolic/Diastolic Hypertension Patients Aged 55 or Older</brief_title>
  <acronym>TELSYS</acronym>
  <official_title>Observational Study in Everyday Medical Practice of the Effectiveness of Telmisartan for Treatment of Isolated Systolic Hypertension in Comparison With Systolic/Diastolic Hypertension in Patients Aged 55 or Older</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 aim of this study is to compare the effect of treatment with telmisartan on patients in&#xD;
      whom the systolic BP is approximately 12 weeks after starting treatment under control for the&#xD;
      first time between patients with isolated systolic hypertension (ISH) at the beginning to&#xD;
      patients with systolic/diastolic hypertension (SDH)&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>February 2006</start_date>
  <primary_completion_date type="Actual">October 2006</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>Normalization of arterial systolic hypertension</measure>
    <time_frame>Up to 12 weeks after start of treatment</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Assessment of systolic blood pressure (SBP) response</measure>
    <time_frame>Up to 12 weeks after start of treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean decrease in systolic blood pressure</measure>
    <time_frame>Up to 12 weeks after start of treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with adverse events</measure>
    <time_frame>Up to 12 weeks</time_frame>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">3320</enrollment>
  <condition>Hypertension</condition>
  <arm_group>
    <arm_group_label>Isolated systolic hypertension</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Systolic and diastolic hypertension</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Telmisartan</intervention_name>
    <arm_group_label>Isolated systolic hypertension</arm_group_label>
    <arm_group_label>Systolic and diastolic hypertension</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Telmisartan combined with hydrochlorothiazide</intervention_name>
    <arm_group_label>Isolated systolic hypertension</arm_group_label>
    <arm_group_label>Systolic and diastolic hypertension</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients aged 55 years or older with either isolated systolic- or with systolic and&#xD;
        diastolic hyptertension&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥ 55, with no upper limit&#xD;
&#xD;
          -  Patient who has been treated and followed up for more than 12 months by the same&#xD;
             general practitioner (GP)&#xD;
&#xD;
          -  Hypertension measured at least once during the past 12 months and not under control at&#xD;
             the time of inclusion in the study:&#xD;
&#xD;
               -  isolated systolic hypertension, namely systolic blood pressure ≥ 140 mmHg and&#xD;
                  diastolic blood pressure &lt; 90 mmHg or&#xD;
&#xD;
               -  systolic/diastolic hypertension, namely systolic blood pressure ≥ 140 mmHg and&#xD;
                  diastolic blood pressure ≥ 90 mmHg; or&#xD;
&#xD;
               -  systolic blood pressure ≥ 130 and diastolic blood pressure ≥ 80 mmHg, if the&#xD;
                  patient has diabetes or chronic renal insufficiency&#xD;
&#xD;
          -  Treatment with one or more antihypertensives which remains unchanged during the month&#xD;
             prior to collecting the data&#xD;
&#xD;
          -  Decision by the GP to add telmisartan (either in combination with hydrochlorothiazide&#xD;
             (HCTZ) or not) to the antihypertensive treatment; this decision is made by the&#xD;
             treating doctor regardless of participation in the study. The prescription is issued&#xD;
             in the normal way, in accordance with the conditions set down in the marketing&#xD;
             authorisation&#xD;
&#xD;
          -  Written informed consent of the patient to collect his/her data&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The patient refuses to allow his/her data to be collected&#xD;
&#xD;
          -  Change in the antihypertensive treatment during the month prior to collection of the&#xD;
             data&#xD;
&#xD;
          -  Blood pressure under control&#xD;
&#xD;
          -  The recommended target values corresponding to control of diastolic and systolic blood&#xD;
             pressure are important because of the diseases associated with hypertension&#xD;
             consequently, and in order to prevent the collection process becoming too complicated,&#xD;
             data from patients with severe renal insufficiency or with proteinuria of ≥ 1 g/L or&#xD;
             more are not collected in the context of this study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>55 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>
    <mesh_term>Isolated Systolic Hypertension</mesh_term>
    <mesh_term>Systolic Murmurs</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>
  </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/NCT02242877
org study id: 502.510
nct id: NCT02242877
lead sponsor: 
The aim of this study is to compare the effect of treatment with telmisartan on patients in
      whom the systolic BP is approximately 12 weeks after starting treatment under control for the
      first time between patients with isolated systolic hypertension (ISH) at the beginning to
      patients with systolic/diastolic hypertension (SDH)
observational model: Cohort
time perspective: Prospective
measure: Normalization of arterial systolic hypertension
time frame: Up to 12 weeks after start of treatment
measure: Assessment of systolic blood pressure (SBP) response
time frame: Up to 12 weeks after start of treatment
measure: Mean decrease in systolic blood pressure
time frame: Up to 12 weeks after start of treatment
measure: Number of patients with adverse events
time frame: Up to 12 weeks
arm group label: Isolated systolic hypertension
arm group label: Systolic and diastolic hypertension
intervention type: Drug
intervention name: Telmisartan
arm group label: Isolated systolic hypertension
arm group label: Systolic and diastolic hypertension
intervention type: Drug
intervention name: Telmisartan combined with hydrochlorothiazide
arm group label: Isolated systolic hypertension
arm group label: Systolic and diastolic hypertension
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 55 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: Isolated Systolic Hypertension
mesh term: Systolic Murmurs
mesh term: Hydrochlorothiazide
mesh term: Telmisartan