<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/NCT02240641</url>
  </required_header>
  <id_info>
    <org_study_id>231.334</org_study_id>
    <nct_id>NCT02240641</nct_id>
  </id_info>
  <brief_title>Effect of Caldine® on Renal Function in Balanced Hypertension</brief_title>
  <official_title>Study on Protective Effect of Caldine® on Renal Function in Patients With a Balanced Hypertension</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 study aimed at comparing the evolution of renal function in patients showing a&#xD;
      hypertension treated by various therapeutic strategies.&#xD;
&#xD;
      Due to the contract research organisation (CRO) decision in September 2000, the database was&#xD;
      locked and not accessible for Boehringer Ingelheim France. Consequently it was decided to&#xD;
      stop the study and not proceed to the analysis. Thus, only safety data were processed in the&#xD;
      safety database.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <start_date>May 1998</start_date>
  <primary_completion_date type="Actual">September 2000</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>Number of patients with adverse events</measure>
    <time_frame>up to two years</time_frame>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">5417</enrollment>
  <condition>Hypertension</condition>
  <arm_group>
    <arm_group_label>hypertension treatment strategies</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lacidipine</intervention_name>
    <arm_group_label>hypertension treatment strategies</arm_group_label>
    <other_name>Caldine</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Diuretics</intervention_name>
    <arm_group_label>hypertension treatment strategies</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>antihypertensive drugs</intervention_name>
    <arm_group_label>hypertension treatment strategies</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>alpha blockers</intervention_name>
    <arm_group_label>hypertension treatment strategies</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Angiotensin-Converting Enzyme Inhibitors</intervention_name>
    <arm_group_label>hypertension treatment strategies</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>beta blockers</intervention_name>
    <arm_group_label>hypertension treatment strategies</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        patients with hypertension requiring treatment&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients with hypertension requiring treatment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  none&#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>August 28, 2014</study_first_submitted>
  <study_first_submitted_qc>September 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 16, 2014</study_first_posted>
  <last_update_submitted>September 15, 2014</last_update_submitted>
  <last_update_submitted_qc>September 15, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 16, 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>Antihypertensive Agents</mesh_term>
    <mesh_term>Lacidipine</mesh_term>
    <mesh_term>Diuretics</mesh_term>
    <mesh_term>Adrenergic beta-Antagonists</mesh_term>
    <mesh_term>Enzyme Inhibitors</mesh_term>
    <mesh_term>Angiotensin-Converting Enzyme Inhibitors</mesh_term>
    <mesh_term>Adrenergic alpha-Antagonists</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/NCT02240641
org study id: 231.334
nct id: NCT02240641
lead sponsor: 
The study aimed at comparing the evolution of renal function in patients showing a
      hypertension treated by various therapeutic strategies.

      Due to the contract research organisation (CRO) decision in September 2000, the database was
      locked and not accessible for Boehringer Ingelheim France. Consequently it was decided to
      stop the study and not proceed to the analysis. Thus, only safety data were processed in the
      safety database.
observational model: Cohort
time perspective: Prospective
measure: Number of patients with adverse events
time frame: up to two years
arm group label: hypertension treatment strategies
intervention type: Drug
intervention name: Lacidipine
arm group label: hypertension treatment strategies
other name: Caldine
intervention type: Drug
intervention name: Diuretics
arm group label: hypertension treatment strategies
intervention type: Drug
intervention name: antihypertensive drugs
arm group label: hypertension treatment strategies
intervention type: Drug
intervention name: alpha blockers
arm group label: hypertension treatment strategies
intervention type: Drug
intervention name: Angiotensin-Converting Enzyme Inhibitors
arm group label: hypertension treatment strategies
intervention type: Drug
intervention name: beta blockers
arm group label: hypertension treatment strategies
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: Antihypertensive Agents
mesh term: Lacidipine
mesh term: Diuretics
mesh term: Adrenergic beta-Antagonists
mesh term: Enzyme Inhibitors
mesh term: Angiotensin-Converting Enzyme Inhibitors
mesh term: Adrenergic alpha-Antagonists