<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/NCT02236741</url>
  </required_header>
  <id_info>
    <org_study_id>248.672</org_study_id>
    <nct_id>NCT02236741</nct_id>
  </id_info>
  <brief_title>The Use of Pramipexole and Other Dopamine Agonists and the Risks of Heart Failure and Pneumonia</brief_title>
  <official_title>The Use of Pramipexole and Other Dopamine Agonists and the Risks of Heart Failure and Pneumonia</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 assess the risk of incident heart failure associated with the use of pramipexole&#xD;
      compared with other dopamine agonists and additionally, to assess the risk of incident heart&#xD;
      failure associated with the use of dopamine agonists in comparison with no use of dopamine&#xD;
      agonist therapy&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2009</start_date>
  <primary_completion_date type="Actual">December 2010</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Assessment of first-time clinical diagnosis of heart failure</measure>
    <time_frame>150 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall rate of heart failure</measure>
    <time_frame>150 months</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">26814</enrollment>
  <condition>Heart Failure</condition>
  <arm_group>
    <arm_group_label>users of anti-parkinsonian drugs</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Mirapexin® (Sifrol®)</intervention_name>
    <arm_group_label>users of anti-parkinsonian drugs</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Users of anti-parkinsonian drugs registered with an up-to-standard practice from the United&#xD;
        Kingdom's General Practice Research Database (GPRD)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients between 40 and 89 years of age who received at least one prescription for&#xD;
             anti-parkinsonian drugs during the period 1997-2009&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with a diagnosis of heart failure or with prescriptions for two or more among&#xD;
             the digitalis, angiotensin-converting enzyme (ACE) inhibitors/angiotensin receptor&#xD;
             blocker (ARB), and diuretic drug classes prior to cohort entry&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>89 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 10, 2014</study_first_submitted>
  <study_first_submitted_qc>September 10, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 11, 2014</study_first_posted>
  <last_update_submitted>September 10, 2014</last_update_submitted>
  <last_update_submitted_qc>September 10, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 11, 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>Pneumonia</mesh_term>
    <mesh_term>Heart Failure</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pramipexole</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/NCT02236741
org study id: 248.672
nct id: NCT02236741
lead sponsor: 
Study to assess the risk of incident heart failure associated with the use of pramipexole
      compared with other dopamine agonists and additionally, to assess the risk of incident heart
      failure associated with the use of dopamine agonists in comparison with no use of dopamine
      agonist therapy
observational model: Cohort
time perspective: Retrospective
measure: Assessment of first-time clinical diagnosis of heart failure
time frame: 150 months
measure: Overall rate of heart failure
time frame: 150 months
arm group label: users of anti-parkinsonian drugs
intervention type: Drug
intervention name: Mirapexin® (Sifrol®)
arm group label: users of anti-parkinsonian drugs
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 40 Years
maximum age: 89 Years
healthy volunteers: No
url: http://trials.boehringer-ingelheim.com
description: Related Info
responsible party type: Sponsor
mesh term: Pneumonia
mesh term: Heart Failure
mesh term: Pramipexole