<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/NCT02226926</url>
  </required_header>
  <id_info>
    <org_study_id>9.142</org_study_id>
    <nct_id>NCT02226926</nct_id>
  </id_info>
  <brief_title>Mechanism of Dipyridamole Action in Platelets: in Vivo Study With Healthy Volunteers</brief_title>
  <official_title>Mechanism of Dipyridamole Action in Platelets: in Vivo Study With Healthy Volunteers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boehringer Ingelheim</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boehringer Ingelheim</source>
  <brief_summary>
    <textblock>
      Investigation of the mechanism of dipyridamole action in platelets in an in-vivo study with&#xD;
      healthy volunteers treated Aggrenox in comparison with volunteers treated with Persantin&#xD;
      Retard or Acetylsalicylic Acid using platelet Vasodilator-Stimulated-Phosphoprotein&#xD;
      (VASP)-phosphorylation as indication for an action and measurements of dipyridamole plasma&#xD;
      levels&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2000</start_date>
  <primary_completion_date type="Actual">September 2000</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>VASP-Ser239 / VASP-Ser157-phosphorylation</measure>
    <time_frame>up to day 10</time_frame>
    <description>induced by sodium nitroprusside (SNP) 0.5µM or SNP 0.3µM and prostaglandin E1 (PG-E1) 0.3nM (Western Blot)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Dipyridamole plasma levels</measure>
    <time_frame>up to day 10</time_frame>
    <description>by High Performance Liquid Chromatography (HPLC)</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">15</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Aggrenox</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Dipyridamole extended release / Acetylsalicylic acid</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Persantin Retard</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Dipyridamole extended release</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Acetylsalicylic acid</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Aggrenox</intervention_name>
    <arm_group_label>Aggrenox</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Persantin Retard</intervention_name>
    <arm_group_label>Persantin Retard</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Acetylsalicylic acid</intervention_name>
    <arm_group_label>Acetylsalicylic acid</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy females/males&#xD;
&#xD;
          -  Age range from 18 to 60&#xD;
&#xD;
          -  Volunteers will have given their written informed consent in accordance with local&#xD;
             ethics committee and local legislation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic,&#xD;
             immunological or hormonal disorders&#xD;
&#xD;
          -  Diseases of the nervous system (such as epilepsy) or with psychiatric disorders or&#xD;
             neurological disorders&#xD;
&#xD;
          -  Known 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;
          -  Drug intake with long half-life (&gt; 24 hours), &lt; 1 month prior to administration or&#xD;
             during the trial&#xD;
&#xD;
          -  Volunteers received any other drugs which might influence the results of the trial, &lt;&#xD;
             10 days prior to administration or during the trial&#xD;
&#xD;
          -  Participation in another study with an investigational drug, &lt; 1 month prior to&#xD;
             administration or during the trial&#xD;
&#xD;
          -  Smoking more than 15 cigarettes or 4 cigars or 4 pipes/day&#xD;
&#xD;
          -  Drinking more than 60 g of alcohol per day&#xD;
&#xD;
          -  Unable to refrain from excessive consumption of methylxanthine containing drinks or&#xD;
             food&#xD;
&#xD;
          -  Drug addiction&#xD;
&#xD;
          -  Blood donation (&gt; 400 ml), &lt; 4 weeks prior to administration or during the trial&#xD;
&#xD;
          -  Participation in excessive physical activities, &lt; 5 days prior to administration or&#xD;
             during the trial&#xD;
&#xD;
        For female volunteers:&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Positive pregnancy test&#xD;
&#xD;
          -  No adequate contraception (acceptable: oral contraceptives, condoms, etc.)&#xD;
&#xD;
          -  Lactation period&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 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>August 2014</verification_date>
  <study_first_submitted>August 26, 2014</study_first_submitted>
  <study_first_submitted_qc>August 26, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 27, 2014</study_first_posted>
  <last_update_submitted>August 26, 2014</last_update_submitted>
  <last_update_submitted_qc>August 26, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 27, 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>Aspirin</mesh_term>
    <mesh_term>Dipyridamole</mesh_term>
    <mesh_term>Aspirin, Dipyridamole 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/NCT02226926
org study id: 9.142
nct id: NCT02226926
lead sponsor: 
Investigation of the mechanism of dipyridamole action in platelets in an in-vivo study with
      healthy volunteers treated Aggrenox in comparison with volunteers treated with Persantin
      Retard or Acetylsalicylic Acid using platelet Vasodilator-Stimulated-Phosphoprotein
      (VASP)-phosphorylation as indication for an action and measurements of dipyridamole plasma
      levels
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: VASP-Ser239 / VASP-Ser157-phosphorylation
time frame: up to day 10
description: induced by sodium nitroprusside (SNP) 0.5µM or SNP 0.3µM and prostaglandin E1 (PG-E1) 0.3nM (Western Blot)
measure: Change in Dipyridamole plasma levels
time frame: up to day 10
description: by High Performance Liquid Chromatography (HPLC)
arm group label: Aggrenox
arm group type: Experimental
description: Dipyridamole extended release / Acetylsalicylic acid
arm group label: Persantin Retard
arm group type: Active Comparator
description: Dipyridamole extended release
arm group label: Acetylsalicylic acid
arm group type: Active Comparator
intervention type: Drug
intervention name: Aggrenox
arm group label: Aggrenox
intervention type: Drug
intervention name: Persantin Retard
arm group label: Persantin Retard
intervention type: Drug
intervention name: Acetylsalicylic acid
arm group label: Acetylsalicylic acid
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
url: http://trials.boehringer-ingelheim.com
description: Related Info
responsible party type: Sponsor
mesh term: Aspirin
mesh term: Dipyridamole
mesh term: Aspirin, Dipyridamole Drug Combination