<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/NCT02251184</url>
  </required_header>
  <id_info>
    <org_study_id>9.146</org_study_id>
    <nct_id>NCT02251184</nct_id>
  </id_info>
  <brief_title>Pharmacokinetics of Dipyridamole Administered as Aggrenox® (Dipyridamole Extended Release Plus Aspirin) Capsule Versus Dipyridamole Immediate Release Plus Aspirin Following Alteration of Stomach pH</brief_title>
  <official_title>Comparison of Pharmacokinetics of Dipyridamole Administered as Aggrenox® (Dipyridamole Extended Release Plus Aspirin) Capsule Versus Dipyridamole Immediate Release Plus Aspirin Following Alteration of Stomach pH by the Prior Administration of a Proton-pump Inhibitor: An Open-label 2-way Randomized Cross-over Study in Healthy Male and Female Subjects Age 40-65.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boehringer Ingelheim</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boehringer Ingelheim</source>
  <brief_summary>
    <textblock>
      Comparison of pharmacokinetics of dipyridamole administered as Aggrenox versus dipyridamole&#xD;
      administered as the immediate release formulation plus aspirin, under conditions of reduced&#xD;
      stomach acidity.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2000</start_date>
  <primary_completion_date type="Actual">November 2000</primary_completion_date>
  <phase>Phase 4</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>area under the concentration time curve (AUC0-12)</measure>
    <time_frame>up to 12 hours</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>area under the concentration time curve 0-48 hours (AUC0-48)</measure>
    <time_frame>up to 48 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>area under the concentration time curve extrapolated to infinity (AUC0-inf)</measure>
    <time_frame>up to 3 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>maximum observed plasma concentration (Cmax)</measure>
    <time_frame>up to 3 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>time to maximum observed plasma concentration (Tmax)</measure>
    <time_frame>up to 3 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>terminal half life (t1/2)</measure>
    <time_frame>up to 3 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>number of subjects with adverse events</measure>
    <time_frame>up to 3 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>number of subjects with clinically significant changes in laboratory findings</measure>
    <time_frame>up to 17 days</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">31</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Aggrenox</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>extended release</description>
  </arm_group>
  <arm_group>
    <arm_group_label>dipyridamole+aspirin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>immediate release</description>
  </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>Dipyridamole</intervention_name>
    <arm_group_label>dipyridamole+aspirin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Aspirin</intervention_name>
    <arm_group_label>dipyridamole+aspirin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lansoprazole</intervention_name>
    <arm_group_label>Aggrenox</arm_group_label>
    <arm_group_label>dipyridamole+aspirin</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy subjects as determined by results of screening&#xD;
&#xD;
          -  Signed written informed consent in accordance with Good Clinical Practice (GCP) and&#xD;
             local legislation&#xD;
&#xD;
          -  Age 40 - 65 years, inclusive, at time of Visit 1&#xD;
&#xD;
          -  Stomach pH &gt; 4.0 on three consecutive measurements separated by at least five minutes,&#xD;
             measured at Visits 3B and 5B prior to dosing with Aggrenox or dipyridamole-aspirin&#xD;
             (DP-ASA)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any findings of the medical examination (including blood pressure, pulse rate and ECG)&#xD;
             deviating from normal and considered by the investigator to be of clinical relevance&#xD;
&#xD;
          -  Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic,&#xD;
             immunological or hormonal disorders considered by the investigator to be of clinical&#xD;
             relevance&#xD;
&#xD;
          -  History of gastro-intestinal ulcer, perforation or bleeding&#xD;
&#xD;
          -  Surgery of the gastro-intestinal tract (except appendectomy)&#xD;
&#xD;
          -  Diseases of the central nervous system (such as epilepsy), neurological disorders, or&#xD;
             psychiatric disorders&#xD;
&#xD;
          -  Chronic or relevant acute infections. Screening tests will be performed for HIV,&#xD;
             hepatitis B, and hepatitis C&#xD;
&#xD;
          -  History of hypersensitivity to Aggrenox or any of the components or excipients&#xD;
&#xD;
          -  Intake of drugs with a long dominant half-life (&gt;24 hours) 1 month or less prior to&#xD;
             Visit 1&#xD;
&#xD;
          -  Use of any drugs which might influence the results of the trial ten days or less prior&#xD;
             to Visit 1&#xD;
&#xD;
          -  Participation in another trial with an investigational drug 1 month or less prior to&#xD;
             Visit 1&#xD;
&#xD;
          -  Known alcohol abuse&#xD;
&#xD;
          -  Known drug abuse (a drug screening test will be performed at Visits 1, 3, and 5)&#xD;
&#xD;
          -  Blood donation 1 month or less prior to Visit 1&#xD;
&#xD;
          -  Excessive physical activities five days or less prior to Visit 1&#xD;
&#xD;
          -  History of hemorrhagic diathesis&#xD;
&#xD;
          -  History of bronchial asthma&#xD;
&#xD;
          -  Any laboratory value outside the reference range, considered by the investigator to be&#xD;
             of clinical relevance&#xD;
&#xD;
        For female subjects:&#xD;
&#xD;
          -  Nursing&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Positive pregnancy test&#xD;
&#xD;
          -  No adequate contraception (adequate contraception includes sterilization, intrauterine&#xD;
             device, or oral contraceptives)&#xD;
&#xD;
          -  Inability to maintain adequate contraception during the whole study period&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>65 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>September 2014</verification_date>
  <study_first_submitted>September 25, 2014</study_first_submitted>
  <study_first_submitted_qc>September 25, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 29, 2014</study_first_posted>
  <last_update_submitted>September 25, 2014</last_update_submitted>
  <last_update_submitted_qc>September 25, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 29, 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>Lansoprazole</mesh_term>
    <mesh_term>Dexlansoprazole</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/NCT02251184
org study id: 9.146
nct id: NCT02251184
lead sponsor: 
Comparison of pharmacokinetics of dipyridamole administered as Aggrenox versus dipyridamole
      administered as the immediate release formulation plus aspirin, under conditions of reduced
      stomach acidity.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: area under the concentration time curve (AUC0-12)
time frame: up to 12 hours
measure: area under the concentration time curve 0-48 hours (AUC0-48)
time frame: up to 48 hours
measure: area under the concentration time curve extrapolated to infinity (AUC0-inf)
time frame: up to 3 days
measure: maximum observed plasma concentration (Cmax)
time frame: up to 3 days
measure: time to maximum observed plasma concentration (Tmax)
time frame: up to 3 days
measure: terminal half life (t1/2)
time frame: up to 3 days
measure: number of subjects with adverse events
time frame: up to 3 weeks
measure: number of subjects with clinically significant changes in laboratory findings
time frame: up to 17 days
arm group label: Aggrenox
arm group type: Experimental
description: extended release
arm group label: dipyridamole+aspirin
arm group type: Active Comparator
description: immediate release
intervention type: Drug
intervention name: Aggrenox
arm group label: Aggrenox
intervention type: Drug
intervention name: Dipyridamole
arm group label: dipyridamole+aspirin
intervention type: Drug
intervention name: Aspirin
arm group label: dipyridamole+aspirin
intervention type: Drug
intervention name: Lansoprazole
arm group label: Aggrenox
arm group label: dipyridamole+aspirin
criteria: 
gender: All
minimum age: 40 Years
maximum age: 65 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: Lansoprazole
mesh term: Dexlansoprazole
mesh term: Aspirin, Dipyridamole Drug Combination