<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/NCT02262546</url>
  </required_header>
  <id_info>
    <org_study_id>248.545</org_study_id>
    <nct_id>NCT02262546</nct_id>
  </id_info>
  <brief_title>Influence of Pramipexole on the QT Interval of the ECG in Healthy Male and Female Volunteers</brief_title>
  <official_title>A Double-blind, Randomised, Placebo Controlled Study With Two Sequential Two-way Cross-over Parts to Demonstrate That the Influence of Pramipexole up to 4.5 mg Daily on the QT Interval of the ECG in Healthy Male and Female Volunteers is Comparable With Placebo, With a Positive Control (Two-way Cross-over Moxifloxacin Versus Placebo)</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 objective of the study is to assess that pramipexole does not prolong the QT interval&#xD;
      more than placebo&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>May 2007</start_date>
  <primary_completion_date type="Actual">October 2007</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mean of the individually heart rate corrected QT interval (QTcI) values</measure>
    <time_frame>1 to 4 hours after dosing on day 21</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mean of the QTcI values</measure>
    <time_frame>1 to 4 hours after dosing at day 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>QTcI at any point in time</measure>
    <time_frame>between 1 and 7 hours after dosing at day 12 and day 21</time_frame>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Pramipexole</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Moxifloxacin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Pramipexole Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Moxifloxacin Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Pramipexole extended-release (ER) tablets</intervention_name>
    <arm_group_label>Pramipexole</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Pramipexole immediate-release (IR) tablets</intervention_name>
    <arm_group_label>Pramipexole</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Moxifloxacin</intervention_name>
    <arm_group_label>Moxifloxacin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Pramipexole Placebo</intervention_name>
    <arm_group_label>Pramipexole Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Moxifloxacin Placebo</intervention_name>
    <arm_group_label>Moxifloxacin Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All participants in the study need to be healthy males or females 21 to 50 years of&#xD;
             age&#xD;
&#xD;
          -  Body mass index (BMI) ranging from 18.5 to 29.9 kg/m2&#xD;
&#xD;
          -  Signed written informed consent prior to admission to the study in accordance with&#xD;
             Good Clinical Practice and the local legislation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any finding of the medical examination (including blood pressure, pulse rate and ECG)&#xD;
             deviating from normal and of clinical relevance&#xD;
&#xD;
          -  Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic,&#xD;
             immunological or hormonal disorders&#xD;
&#xD;
          -  Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or&#xD;
             neurological disorders&#xD;
&#xD;
          -  History of orthostatic hypotension, fainting spells or blackouts&#xD;
&#xD;
          -  Chronic or relevant acute infections&#xD;
&#xD;
          -  History of allergy/hypersensitivity (including drug allergy) which is deemed relevant&#xD;
             to the trial as judged by the investigator&#xD;
&#xD;
          -  Intake of drugs with a long half-life (&gt; 24 hours) within at least one month or less&#xD;
             than ten half-lives of the respective drug before enrolment in the study or during the&#xD;
             study&#xD;
&#xD;
          -  Use of any drugs which might influence the results of the trial up to 7 days prior to&#xD;
             enrolment in the study or during the study&#xD;
&#xD;
          -  Participation in another trial with an investigational drug (≤ 30 days prior to&#xD;
             administration or during the trial)&#xD;
&#xD;
          -  Heavy smoker (&gt; 10 cigarettes or &gt; 3 cigars of &gt; 3 pipes/day)&#xD;
&#xD;
          -  Inability to refrain from smoking on trial days&#xD;
&#xD;
          -  Alcohol abuse (&gt; 60 g/day)&#xD;
&#xD;
          -  Drug abuse&#xD;
&#xD;
          -  Blood donation (≥ 100 mL within four weeks prior to administration or during the&#xD;
             trial)&#xD;
&#xD;
          -  Any deviation of a laboratory value that is considered to be of clinical relevance&#xD;
&#xD;
          -  Excessive physical activities within the last week before the trial or during the&#xD;
             trial&#xD;
&#xD;
          -  Hypersensitivity to pramipexole, moxifloxacin and/or related drugs of these classes&#xD;
&#xD;
          -  Supine blood pressure at screening of systolic &lt; 100 mmHg and diastolic &lt; 60 mmHg&#xD;
&#xD;
          -  Heart rate at screening of &gt; 80 beats per minute (bpm) or &lt; 40 bpm&#xD;
&#xD;
          -  Any screening ECG value outside of the reference range of clinical relevance&#xD;
             including, but not limited to Pulse Rate interval &gt; 220 ms, QRS interval &gt; 115 ms,&#xD;
             QTcB or QTcF &gt; 450 ms, or QT (uncorrected) &gt; 470 ms&#xD;
&#xD;
          -  Subjects involved in passenger transport or operation of dangerous machines&#xD;
&#xD;
        For Female Subjects:&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Positive pregnancy test&#xD;
&#xD;
          -  No adequate contraception (adequate contraception: e.g. sterilization, intrauterine&#xD;
             device, oral contraceptives)&#xD;
&#xD;
          -  Inability to maintain this adequate contraception during the whole study period&#xD;
&#xD;
          -  Lactation period&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <link>
    <url>http://trials.boehringer-ingelheim.com</url>
    <description>Related Info</description>
  </link>
  <verification_date>October 2014</verification_date>
  <study_first_submitted>October 9, 2014</study_first_submitted>
  <study_first_submitted_qc>October 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 13, 2014</study_first_posted>
  <last_update_submitted>October 9, 2014</last_update_submitted>
  <last_update_submitted_qc>October 9, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 13, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Moxifloxacin</mesh_term>
    <mesh_term>Pramipexole</mesh_term>
    <mesh_term>Norgestimate, ethinyl estradiol drug combination</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/NCT02262546
org study id: 248.545
nct id: NCT02262546
lead sponsor: 
The objective of the study is to assess that pramipexole does not prolong the QT interval
      more than placebo
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Double
measure: Mean of the individually heart rate corrected QT interval (QTcI) values
time frame: 1 to 4 hours after dosing on day 21
measure: Mean of the QTcI values
time frame: 1 to 4 hours after dosing at day 12
measure: QTcI at any point in time
time frame: between 1 and 7 hours after dosing at day 12 and day 21
arm group label: Pramipexole
arm group type: Experimental
arm group label: Moxifloxacin
arm group type: Active Comparator
arm group label: Pramipexole Placebo
arm group type: Placebo Comparator
arm group label: Moxifloxacin Placebo
arm group type: Placebo Comparator
intervention type: Drug
intervention name: Pramipexole extended-release (ER) tablets
arm group label: Pramipexole
intervention type: Drug
intervention name: Pramipexole immediate-release (IR) tablets
arm group label: Pramipexole
intervention type: Drug
intervention name: Moxifloxacin
arm group label: Moxifloxacin
intervention type: Drug
intervention name: Pramipexole Placebo
arm group label: Pramipexole Placebo
intervention type: Drug
intervention name: Moxifloxacin Placebo
arm group label: Moxifloxacin Placebo
criteria: 
gender: All
minimum age: 21 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
url: http://trials.boehringer-ingelheim.com
description: Related Info
responsible party type: Sponsor
mesh term: Moxifloxacin
mesh term: Pramipexole
mesh term: Norgestimate, ethinyl estradiol drug combination