<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/NCT02248129</url>
  </required_header>
  <id_info>
    <org_study_id>502.508</org_study_id>
    <nct_id>NCT02248129</nct_id>
  </id_info>
  <brief_title>Pharmaco-epidemiological Study Describing a Population of Hypertensive Patients Treated With a Fixed-dose Combination of Telmisartan and Hydrochlorothiazide</brief_title>
  <official_title>Pharmaco-epidemiological Study Describing a Population of Hypertensive Patients Treated in General Practice With a Fixed-dose Combination of Telmisartan and Hydrochlorothiazide, the Level of Blood Pressure Control and the Modalities of Arterial Hypertension Management</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boehringer Ingelheim</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boehringer Ingelheim</source>
  <brief_summary>
    <textblock>
      Study to compare the level of blood pressure control in hypertensive, hypertensive diabetics&#xD;
      and hypertensive with renal insufficiency (observed data) in the study population, with the&#xD;
      objectives of the High Authority for Health recommendations (benchmark)&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>April 2006</start_date>
  <primary_completion_date type="Actual">December 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>Percentage of patients with low blood pressure</measure>
    <time_frame>up to 4 weeks</time_frame>
    <description>lower than 140/90 mmHg in the general population of hypertensive patients, hypertensive diabetics and hypertensive with renal insufficiency</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of patients with adverse events</measure>
    <time_frame>up to 4 weeks</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">4255</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 and hydrochlorothiazide</intervention_name>
    <arm_group_label>Hypertensive patients</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Hypertensive patients treated in general practice&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Hypertensive patients already treated for at least 1 month with Telmisartan plus&#xD;
             hydrochlorothiazide, consulting the physician consecutively for whatever reason&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  NA&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</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 22, 2014</study_first_submitted>
  <study_first_submitted_qc>September 22, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2014</study_first_posted>
  <last_update_submitted>September 22, 2014</last_update_submitted>
  <last_update_submitted_qc>September 22, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 25, 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>
  </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/NCT02248129
org study id: 502.508
nct id: NCT02248129
lead sponsor: 
Study to compare the level of blood pressure control in hypertensive, hypertensive diabetics
      and hypertensive with renal insufficiency (observed data) in the study population, with the
      objectives of the High Authority for Health recommendations (benchmark)
observational model: Cohort
time perspective: Prospective
measure: Percentage of patients with low blood pressure
time frame: up to 4 weeks
description: lower than 140/90 mmHg in the general population of hypertensive patients, hypertensive diabetics and hypertensive with renal insufficiency
measure: Number of patients with adverse events
time frame: up to 4 weeks
arm group label: Hypertensive patients
intervention type: Drug
intervention name: Telmisartan and hydrochlorothiazide
arm group label: Hypertensive patients
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
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: Hydrochlorothiazide
mesh term: Telmisartan