<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/NCT02265289</url>
  </required_header>
  <id_info>
    <org_study_id>509.302</org_study_id>
    <nct_id>NCT02265289</nct_id>
  </id_info>
  <brief_title>Influence of Clopidogrel on the Pharmacodynamics and Safety of Fradafiban in Healthy Male Subjects</brief_title>
  <official_title>Influence of Oral Doses of 75 mg Clopidogrel on the Pharmacodynamics and Safety of Fradafiban After Oral Doses of 30 mg Lefradafiban Tid 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>
      To assess the influence of 75 mg Clopidogrel on the pharmacodynamics and safety of 30 mg&#xD;
      Lefradafiban tid&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 1999</start_date>
  <primary_completion_date type="Actual">February 1999</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Inhibition of platelet aggregation in platelet rich plasma (PRP)</measure>
    <time_frame>Up to 383:30 hours after first drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Fibrinogen receptor occupancy levels (FRO)</measure>
    <time_frame>Up to 383:30 hours after first drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Maximum concentration of the analyte in plasma at steady state (Cmax)</measure>
    <time_frame>Up to 383:30 hours after first drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Area under the concentration-time curve of the analyte in plasma (AUC)</measure>
    <time_frame>Up to 383:30 hours after first drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Amount of the analyte excreted unchanged in the urine (Ae)</measure>
    <time_frame>Up to 176:00 hours after first drug administration</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of subjects with adverse events</measure>
    <time_frame>up to 5 days after last drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes from baseline in 12-lead ECG</measure>
    <time_frame>Pre-dose and 384:30 hours after first drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of subjects with clinically significant findings in vital signs</measure>
    <time_frame>up to 5 days after last drug administration</time_frame>
    <description>systolic and diastolic blood pressure, pulse rate</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes from baseline in bleeding time</measure>
    <time_frame>Pre-dose and 384:30 hours after first drug administration</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">14</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Lefradafiban with clopidogrel</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All patients received the same treatment:&#xD;
Lefradafiban only (day 1-4)&#xD;
Lefradafiban in combination with Clopidogrel (day 5-8)&#xD;
Clopidogrel only (day 9-12)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lefradafiban</intervention_name>
    <arm_group_label>Lefradafiban with clopidogrel</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Clopidogrel</intervention_name>
    <arm_group_label>Lefradafiban 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 ≥ 18 and ≤ 45 years&#xD;
&#xD;
          -  Broca ≥ - 20 % and ≤ + 20 %&#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;
          -  History or current gastrointestinal, hepatic, renal, respiratory, cardiovascular,&#xD;
             metabolic, immunological, hormonal disorders&#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 a 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 prior to&#xD;
             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 abuse (&gt; 60 g/day)&#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 clinically accepted reference range&#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>October 2014</verification_date>
  <study_first_submitted>October 14, 2014</study_first_submitted>
  <study_first_submitted_qc>October 14, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 15, 2014</study_first_posted>
  <last_update_submitted>October 14, 2014</last_update_submitted>
  <last_update_submitted_qc>October 14, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 15, 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/NCT02265289
org study id: 509.302
nct id: NCT02265289
lead sponsor: 
To assess the influence of 75 mg Clopidogrel on the pharmacodynamics and safety of 30 mg
      Lefradafiban tid
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Inhibition of platelet aggregation in platelet rich plasma (PRP)
time frame: Up to 383:30 hours after first drug administration
measure: Fibrinogen receptor occupancy levels (FRO)
time frame: Up to 383:30 hours after first drug administration
measure: Maximum concentration of the analyte in plasma at steady state (Cmax)
time frame: Up to 383:30 hours after first drug administration
measure: Area under the concentration-time curve of the analyte in plasma (AUC)
time frame: Up to 383:30 hours after first drug administration
measure: Amount of the analyte excreted unchanged in the urine (Ae)
time frame: Up to 176:00 hours after first drug administration
measure: Number of subjects with adverse events
time frame: up to 5 days after last drug administration
measure: Changes from baseline in 12-lead ECG
time frame: Pre-dose and 384:30 hours after first drug administration
measure: Number of subjects with clinically significant findings in vital signs
time frame: up to 5 days after last drug administration
description: systolic and diastolic blood pressure, pulse rate
measure: Changes from baseline in bleeding time
time frame: Pre-dose and 384:30 hours after first drug administration
arm group label: Lefradafiban with clopidogrel
arm group type: Experimental
description: All patients received the same treatment:
Lefradafiban only (day 1-4)
Lefradafiban in combination with Clopidogrel (day 5-8)
Clopidogrel only (day 9-12)
intervention type: Drug
intervention name: Lefradafiban
arm group label: Lefradafiban with clopidogrel
intervention type: Drug
intervention name: Clopidogrel
arm group label: Lefradafiban 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