<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/NCT02218684</url>
  </required_header>
  <id_info>
    <org_study_id>1173.1</org_study_id>
    <nct_id>NCT02218684</nct_id>
  </id_info>
  <brief_title>Tolerability and Pharmacokinetics of Telmisartan in Combination With Lacidipine in Healthy Male Subjects</brief_title>
  <official_title>Tolerability and Pharmacokinetics of 80 mg Telmisartan in Combination With 2, 4, or 6 mg Lacidipine. An Open, Single Rising Dose Group Comparison Trial - Placebo Randomised Double Blind in Each Dose Group - in Male Healthy Subjects</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 trial objectives were to investigate the tolerability and pharmacokinetics of 80 mg&#xD;
      telmisartan and 2, 4 or 6 mg lacidipine administered concurrently.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 1998</start_date>
  <primary_completion_date type="Actual">November 1998</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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cmax (Maximum measured concentration of the analyte in plasma)</measure>
    <time_frame>up to 72 hours after drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of subjects with adverse events</measure>
    <time_frame>up to 72 hours after drug administration</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>AUC (Area under the concentration-time curve of the analyte in plasma)</measure>
    <time_frame>up to 72 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>tmax (Time from dosing to the maximum concentration of the analyte in plasma)</measure>
    <time_frame>up to 72 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CL/F (Apparent clearance of the analyte in plasma following extravascular administration)</measure>
    <time_frame>up to 72 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vz/F (Apparent volume of distribution of the analyte during the terminal phase)</measure>
    <time_frame>up to 72 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MRT (Mean residence time of the analyte in the body)</measure>
    <time_frame>up to 72 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>t½ (Terminal half-life of the analyte in plasma)</measure>
    <time_frame>up to 72 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of subjects with abnormal changes in laboratory parameters</measure>
    <time_frame>up to 72 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of subjects with clinically significant changes in vital signs</measure>
    <time_frame>up to 72 hours after drug administration</time_frame>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">27</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Telmisartan + Lacidipine - low dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Telmisartan + Lacidipine - medium dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Telmisartan + Lacidipine - high dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Telmisartan</intervention_name>
    <arm_group_label>Telmisartan + Lacidipine - high dose</arm_group_label>
    <arm_group_label>Telmisartan + Lacidipine - low dose</arm_group_label>
    <arm_group_label>Telmisartan + Lacidipine - medium dose</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lacidipine</intervention_name>
    <arm_group_label>Telmisartan + Lacidipine - high dose</arm_group_label>
    <arm_group_label>Telmisartan + Lacidipine - low dose</arm_group_label>
    <arm_group_label>Telmisartan + Lacidipine - medium dose</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy male caucasian subjects as determined by results of screening&#xD;
&#xD;
          -  Written informed consent in accordance with Good Clinical Practice and local&#xD;
             legislation given&#xD;
&#xD;
          -  Age &gt;= 18 and &lt;= 50 years&#xD;
&#xD;
          -  Broca &gt;= -20% and &lt;= + 20%&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any finding of the medical examination (including blood pressure, pulse rate and&#xD;
             Electrocardiogram (ECG) deviating from normal and of clinical relevance&#xD;
&#xD;
          -  Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic,&#xD;
             immunological or hormonal disorders&#xD;
&#xD;
          -  Surgery of gastrointestinal tract (except appendectomy)&#xD;
&#xD;
          -  Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or&#xD;
             neurologic 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) (&lt;= 1 month prior to administration&#xD;
             or during the trial)&#xD;
&#xD;
          -  Use of any drugs which might influence the results of the trial (&lt;= 10 days prior to&#xD;
             administration or during the trial)&#xD;
&#xD;
          -  Participation in another trial with an investigational drug (&lt;= 2 months prior to&#xD;
             administration or during the trial)&#xD;
&#xD;
          -  Smoker (&gt; 10 cigarettes or &gt; 3 cigars or &gt; 3 pipes/day)&#xD;
&#xD;
          -  Inability to refrain from smoking on study days&#xD;
&#xD;
          -  Alcohol abuse (&gt; 60g/day)&#xD;
&#xD;
          -  Drug abuse&#xD;
&#xD;
          -  Blood donation &gt; 100 ml (&lt;= 4 weeks prior to administration or during the trial)&#xD;
&#xD;
          -  Excessive physical activities (&lt;= 10 days prior to administration or during the trial)&#xD;
&#xD;
          -  Any laboratory value outside the reference range of clinical relevance&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 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>July 2014</verification_date>
  <study_first_submitted>August 15, 2014</study_first_submitted>
  <study_first_submitted_qc>August 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 18, 2014</study_first_posted>
  <last_update_submitted>August 15, 2014</last_update_submitted>
  <last_update_submitted_qc>August 15, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 18, 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>Telmisartan</mesh_term>
    <mesh_term>Lacidipine</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/NCT02218684
org study id: 1173.1
nct id: NCT02218684
lead sponsor: 
The trial objectives were to investigate the tolerability and pharmacokinetics of 80 mg
      telmisartan and 2, 4 or 6 mg lacidipine administered concurrently.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double
measure: Cmax (Maximum measured concentration of the analyte in plasma)
time frame: up to 72 hours after drug administration
measure: Number of subjects with adverse events
time frame: up to 72 hours after drug administration
measure: AUC (Area under the concentration-time curve of the analyte in plasma)
time frame: up to 72 hours after drug administration
measure: tmax (Time from dosing to the maximum concentration of the analyte in plasma)
time frame: up to 72 hours after drug administration
measure: CL/F (Apparent clearance of the analyte in plasma following extravascular administration)
time frame: up to 72 hours after drug administration
measure: Vz/F (Apparent volume of distribution of the analyte during the terminal phase)
time frame: up to 72 hours after drug administration
measure: MRT (Mean residence time of the analyte in the body)
time frame: up to 72 hours after drug administration
measure: t½ (Terminal half-life of the analyte in plasma)
time frame: up to 72 hours after drug administration
measure: Number of subjects with abnormal changes in laboratory parameters
time frame: up to 72 hours after drug administration
measure: Number of subjects with clinically significant changes in vital signs
time frame: up to 72 hours after drug administration
arm group label: Telmisartan + Lacidipine - low dose
arm group type: Experimental
arm group label: Telmisartan + Lacidipine - medium dose
arm group type: Experimental
arm group label: Telmisartan + Lacidipine - high dose
arm group type: Experimental
arm group label: Placebo
arm group type: Placebo Comparator
intervention type: Drug
intervention name: Telmisartan
arm group label: Telmisartan + Lacidipine - high dose
arm group label: Telmisartan + Lacidipine - low dose
arm group label: Telmisartan + Lacidipine - medium dose
intervention type: Drug
intervention name: Lacidipine
arm group label: Telmisartan + Lacidipine - high dose
arm group label: Telmisartan + Lacidipine - low dose
arm group label: Telmisartan + Lacidipine - medium dose
intervention type: Drug
intervention name: Placebo
arm group label: Placebo
criteria: 
gender: Male
minimum age: 18 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: Telmisartan
mesh term: Lacidipine