<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/NCT02202525</url>
  </required_header>
  <id_info>
    <org_study_id>502.362</org_study_id>
    <nct_id>NCT02202525</nct_id>
  </id_info>
  <brief_title>Evolution of Pulse Pressure Following Initiation of Antihypertensive Therapy in Patients With Essential Arterial Hypertension</brief_title>
  <official_title>Evolution of Pulse Pressure Following Initiation of Antihypertensive Therapy</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 main purpose of this prospective, multicentre, french observational study is to analyse&#xD;
      the evolution of pulse pressure (PP) and to identify its prognostic factors in hypertensive&#xD;
      patients three months after initiation of a new hypertensive therapy. The PP is defined as&#xD;
      the difference between systolic blood pressure (SBP) and diastolic blood pressure (DBP).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2001</start_date>
  <primary_completion_date type="Actual">March 2002</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>Changes from baseline in pulse pressure</measure>
    <time_frame>Up to 3 months after start of treatment</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of patients with adverse drug reactions</measure>
    <time_frame>Up to 3 months after start of treatment</time_frame>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">2148</enrollment>
  <condition>Hypertension</condition>
  <arm_group>
    <arm_group_label>Essential arterial hypertension</arm_group_label>
    <description>Patients with essential arterial hypertension needing a new antihypertensive therapy</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Micardis®</intervention_name>
    <arm_group_label>Essential arterial hypertension</arm_group_label>
    <other_name>Telmisartan</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Other hypertensives</intervention_name>
    <arm_group_label>Essential arterial hypertension</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with essential hypertenstion treated by private or hospital cardiologists&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with essential arterial hypertension needing a new antihypertensive therapy&#xD;
&#xD;
          -  A patient was included by the physician only if he/she had agreed after being informed&#xD;
             about the study&#xD;
&#xD;
        Exclusion Criteria:&#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>July 2014</verification_date>
  <study_first_submitted>July 28, 2014</study_first_submitted>
  <study_first_submitted_qc>July 28, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 29, 2014</study_first_posted>
  <last_update_submitted>July 28, 2014</last_update_submitted>
  <last_update_submitted_qc>July 28, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 29, 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/NCT02202525
org study id: 502.362
nct id: NCT02202525
lead sponsor: 
The main purpose of this prospective, multicentre, french observational study is to analyse
      the evolution of pulse pressure (PP) and to identify its prognostic factors in hypertensive
      patients three months after initiation of a new hypertensive therapy. The PP is defined as
      the difference between systolic blood pressure (SBP) and diastolic blood pressure (DBP).
observational model: Cohort
time perspective: Prospective
measure: Changes from baseline in pulse pressure
time frame: Up to 3 months after start of treatment
measure: Number of patients with adverse drug reactions
time frame: Up to 3 months after start of treatment
arm group label: Essential arterial hypertension
description: Patients with essential arterial hypertension needing a new antihypertensive therapy
intervention type: Drug
intervention name: Micardis®
arm group label: Essential arterial hypertension
other name: Telmisartan
intervention type: Drug
intervention name: Other hypertensives
arm group label: Essential arterial hypertension
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: Telmisartan