<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/NCT02222987</url>
  </required_header>
  <id_info>
    <org_study_id>528.23</org_study_id>
    <nct_id>NCT02222987</nct_id>
  </id_info>
  <brief_title>Influence of Clopidogrel on the Pharmacodynamics and Safety of Terbogrel in Healthy Male Subjects</brief_title>
  <official_title>Influence of Oral Doses of 75 mg Clopidogrel on the Pharmacodynamics and Safety of Oral Doses of 100 mg Terbogrel Bid Over 8 Days in Healthy Male Subjects. An Intra-individual, Open Trial.</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 influence of 75 mg clopidogrel on the pharmacodynamics and safety of 100&#xD;
      mg terbogrel bid.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>February 1999</start_date>
  <primary_completion_date type="Actual">March 1999</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>Change in inhibition of platelet aggregation in platelet rich plasma (PRP)</measure>
    <time_frame>baseline, up to day 17</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in thromboxane receptor occupancy (TRO)</measure>
    <time_frame>baseline, up to day 17</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in 6-keto-prostaglandinF-1-alpha</measure>
    <time_frame>baseline, up to day 17</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in thromboxan synthesis inhibition (TSI)</measure>
    <time_frame>baseline, up to day 17</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Plasma levels of terbogrel</measure>
    <time_frame>up to day 17</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with adverse events</measure>
    <time_frame>up to day 17</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in bleeding time</measure>
    <time_frame>baseline, up to day 17</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in systolic and diastolic blood pressure</measure>
    <time_frame>baseline, up to day 17</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in pulse rate</measure>
    <time_frame>baseline, up to day 17</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with haematuria</measure>
    <time_frame>up to day 17</time_frame>
    <description>dipstick test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with positive Haemoccult test</measure>
    <time_frame>up to day 17</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with clinically significant laboratory findings</measure>
    <time_frame>up to day 17</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">14</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Terbogrel</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Terbogrel with Clopidogrel</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Clopidogrel</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Terbogrel</intervention_name>
    <arm_group_label>Terbogrel</arm_group_label>
    <arm_group_label>Terbogrel with Clopidogrel</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Clopidogrel</intervention_name>
    <arm_group_label>Clopidogrel</arm_group_label>
    <arm_group_label>Terbogrel with Clopidogrel</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Written informed consent in accordance with Good Clinical Practice (GCP) and local&#xD;
             legislation&#xD;
&#xD;
          -  Healthy male subjects&#xD;
&#xD;
          -  Age &gt;= 18 and &lt;= 45 years&#xD;
&#xD;
          -  Broca &gt;= -20% and &lt;= +20 %&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any findings of the medical examination (including blood pressure, pulse rate and ECG)&#xD;
             deviating from normal and of clinical relevance&#xD;
&#xD;
          -  History or current gastrointestinal, hepatic, renal, respiratory, cardiovascular,&#xD;
             metabolic, immunological or hormonal disorders&#xD;
&#xD;
          -  History of orthostatic hypotension, fainting spells or blackouts&#xD;
&#xD;
          -  Diseases of the central nervous system (such as epilepsy) or psychiatric disorders&#xD;
&#xD;
          -  Chronic or relevant acute infections&#xD;
&#xD;
          -  History of&#xD;
&#xD;
               -  allergy/hypersensitivity (including drug allergy) which is deemed relevant to the&#xD;
                  trial as judged by the investigator&#xD;
&#xD;
               -  any bleeding disorder including prolonged or habitual bleeding&#xD;
&#xD;
               -  other hematologic disease&#xD;
&#xD;
               -  cerebral bleeding (e.g. after car accident)&#xD;
&#xD;
               -  commotio cerebri&#xD;
&#xD;
          -  Intake of drugs with a long half-life (&gt; 24 hours) within 1 month prior to&#xD;
             administration&#xD;
&#xD;
          -  Use of any drugs which might influence the results of the trial within 10 days prior&#xD;
             to administration or during the trial&#xD;
&#xD;
          -  Participation in another trial with an investigational drug within 2 months days prior&#xD;
             to administration or during the trial&#xD;
&#xD;
          -  Smoker (&gt; 10 cigarettes or 3 cigars or 3 pipes/day) or inability to refrain from&#xD;
             smoking on study days&#xD;
&#xD;
          -  Alcohol (&gt; 60 g/day) abuse&#xD;
&#xD;
          -  Drug abuse&#xD;
&#xD;
          -  Blood donation within 1 month prior to administration or during the trial&#xD;
&#xD;
          -  Excessive physical activities within 5 days prior to administration or during the&#xD;
             trial&#xD;
&#xD;
          -  Any laboratory value outside the reference range of clinical relevance&#xD;
&#xD;
          -  History of any familial bleeding disorder&#xD;
&#xD;
          -  Thrombocytes &lt; 150000/µl&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 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 21, 2014</study_first_submitted>
  <study_first_submitted_qc>August 21, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 22, 2014</study_first_posted>
  <last_update_submitted>August 21, 2014</last_update_submitted>
  <last_update_submitted_qc>August 21, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 22, 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>Clopidogrel</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/NCT02222987
org study id: 528.23
nct id: NCT02222987
lead sponsor: 
Study to assess the influence of 75 mg clopidogrel on the pharmacodynamics and safety of 100
      mg terbogrel bid.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in inhibition of platelet aggregation in platelet rich plasma (PRP)
time frame: baseline, up to day 17
measure: Change in thromboxane receptor occupancy (TRO)
time frame: baseline, up to day 17
measure: Change in 6-keto-prostaglandinF-1-alpha
time frame: baseline, up to day 17
measure: Change in thromboxan synthesis inhibition (TSI)
time frame: baseline, up to day 17
measure: Plasma levels of terbogrel
time frame: up to day 17
measure: Number of patients with adverse events
time frame: up to day 17
measure: Change in bleeding time
time frame: baseline, up to day 17
measure: Change in systolic and diastolic blood pressure
time frame: baseline, up to day 17
measure: Change in pulse rate
time frame: baseline, up to day 17
measure: Number of patients with haematuria
time frame: up to day 17
description: dipstick test
measure: Number of patients with positive Haemoccult test
time frame: up to day 17
measure: Number of patients with clinically significant laboratory findings
time frame: up to day 17
arm group label: Terbogrel
arm group type: Active Comparator
arm group label: Terbogrel with Clopidogrel
arm group type: Experimental
arm group label: Clopidogrel
arm group type: Active Comparator
intervention type: Drug
intervention name: Terbogrel
arm group label: Terbogrel
arm group label: Terbogrel with Clopidogrel
intervention type: Drug
intervention name: Clopidogrel
arm group label: Clopidogrel
arm group label: Terbogrel with Clopidogrel
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
url: http://trials.boehringer-ingelheim.com
description: Related Info
responsible party type: Sponsor
mesh term: Clopidogrel