<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/NCT02264158</url>
  </required_header>
  <id_info>
    <org_study_id>502.378</org_study_id>
    <nct_id>NCT02264158</nct_id>
  </id_info>
  <brief_title>Influence of Telmisartan and Lacidipine, Combined or Alone, on QT Interval in Healthy Volunteers</brief_title>
  <official_title>A Double-blind, Randomised, Placebo Controlled, 6 Parallel Groups Study to Assess the Influence of Telmisartan (40 mg or 160 mg), Lacidipine (4 mg or 6 mg) and Their Combination (Telmisartan 40 mg and Lacidipine 4 mg) p.o. Once Daily for Seven Days on the QT Interval of the ECG in Healthy Male and Female 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>
      Assessment of the influence of telmisartan, lacidipine and their combination on the QTC&#xD;
      interval of the ECG&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2001</start_date>
  <primary_completion_date type="Actual">March 2002</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>Average QTcF (QT interval Fridericia correction) change</measure>
    <time_frame>baseline, day 1, day 7</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in QT interval</measure>
    <time_frame>baseline, day 1, day 7</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in QTcB (QT interval Bazett correction) interval</measure>
    <time_frame>baseline, day 1, day 7</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in PQ interval</measure>
    <time_frame>baseline, day 1, day 7</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in QRS interval</measure>
    <time_frame>baseline, day 1, day 7</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in RR interval</measure>
    <time_frame>baseline, day 1, day 7</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in heart rate (HR)</measure>
    <time_frame>baseline, day 1, day 7</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Occurrence of ECG abnormalities</measure>
    <time_frame>baseline, day 1, day 7</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in T wave morphology</measure>
    <time_frame>baseline, day 1, day 7</time_frame>
    <description>normal, flat, inverted, biphasic</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in U wave morphology</measure>
    <time_frame>baseline, day 1, day 7</time_frame>
    <description>normal, abnormal</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area under the plasma concentration time curve (AUC)</measure>
    <time_frame>day 1, day 7</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum plasma concentration (Cmax)</measure>
    <time_frame>day 1, day 7</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to attain maximum plasma concentration (tmax)</measure>
    <time_frame>day 1, day 7</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Trough plasma concentration at steady state (Cmin,ss)</measure>
    <time_frame>day 7</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with adverse events</measure>
    <time_frame>up to 8 days after last treatment</time_frame>
  </secondary_outcome>
  <number_of_arms>6</number_of_arms>
  <enrollment type="Actual">149</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Telmisartan high</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Telmisartan low</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Lacidipine high</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Lacidipine low</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Telmisartan+Lacidipine</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 high</intervention_name>
    <arm_group_label>Telmisartan high</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Telmisartan low</intervention_name>
    <arm_group_label>Telmisartan low</arm_group_label>
    <arm_group_label>Telmisartan+Lacidipine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lacidipine high</intervention_name>
    <arm_group_label>Lacidipine high</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lacidipine low</intervention_name>
    <arm_group_label>Lacidipine low</arm_group_label>
    <arm_group_label>Telmisartan+Lacidipine</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;
        All participants in the study should be healthy males/females, range from 21 to 50 years of&#xD;
        age and their body mass index (BMI) be within 18.5 to 29.9 kg/m2.&#xD;
&#xD;
        In accordance with Good Clinical Practice and local legislation all volunteers will have&#xD;
        given their written informed consent prior to admission to the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any finding of the medical examination (including blood pressure, heart rate and ECG)&#xD;
             deviating from normal and of clinical relevance&#xD;
&#xD;
          -  Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic,&#xD;
             immunological or hormonal disorders&#xD;
&#xD;
          -  Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or&#xD;
             neurological 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) within at least one month or less&#xD;
             than ten half-lives of the respective drug before enrolment in the study or during the&#xD;
             study&#xD;
&#xD;
          -  Use of any drugs which might influence the results of the trial up to 7 days prior to&#xD;
             enrolment in the study or during the study&#xD;
&#xD;
          -  Participation in another tiral with an investigational drug (&lt;= two 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 trial days&#xD;
&#xD;
          -  Alcohol abuse (&gt; 60 g/day)&#xD;
&#xD;
          -  Drug abuse&#xD;
&#xD;
          -  Blood donation (&gt;= 100 ml within four weeks prior to administration or during the&#xD;
             trial)&#xD;
&#xD;
          -  Any laboratory value outside the clinically accepted reference range&#xD;
&#xD;
          -  Excessive physical activities within the last week before the trial or during the&#xD;
             trial&#xD;
&#xD;
        Following exclusion criteria are of special interest for this study:&#xD;
&#xD;
          -  Hypersensitivity to telmisartan, lacidipine and/or related drugs of these classes&#xD;
&#xD;
          -  Supine blood pressure at screening of systolic &lt;= 110 mmHg and diastolic &lt;= 60 mmHg&#xD;
&#xD;
          -  Any ECG value outside of the reference range of clinical relevance, but not limited to&#xD;
             PR interval &gt; 240 ms, QRS interval &gt; 110 ms, QTcB &gt; 470 ms for females and QTcB &gt; 450&#xD;
             ms for males&#xD;
&#xD;
        For female subjects:&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Positive pregnancy test&#xD;
&#xD;
          -  No adequate contraception (adequate contraception e.g. sterilisation, intrauterine&#xD;
             pessary (IUP), oral contraceptives)&#xD;
&#xD;
          -  Inability to maintain this adequate contraception during the whole study period&#xD;
&#xD;
          -  Lactation period&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 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>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>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/NCT02264158
org study id: 502.378
nct id: NCT02264158
lead sponsor: 
Assessment of the influence of telmisartan, lacidipine and their combination on the QTC
      interval of the ECG
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double
measure: Average QTcF (QT interval Fridericia correction) change
time frame: baseline, day 1, day 7
measure: Change in QT interval
time frame: baseline, day 1, day 7
measure: Change in QTcB (QT interval Bazett correction) interval
time frame: baseline, day 1, day 7
measure: Change in PQ interval
time frame: baseline, day 1, day 7
measure: Change in QRS interval
time frame: baseline, day 1, day 7
measure: Change in RR interval
time frame: baseline, day 1, day 7
measure: Change in heart rate (HR)
time frame: baseline, day 1, day 7
measure: Occurrence of ECG abnormalities
time frame: baseline, day 1, day 7
measure: Change in T wave morphology
time frame: baseline, day 1, day 7
description: normal, flat, inverted, biphasic
measure: Change in U wave morphology
time frame: baseline, day 1, day 7
description: normal, abnormal
measure: Area under the plasma concentration time curve (AUC)
time frame: day 1, day 7
measure: Maximum plasma concentration (Cmax)
time frame: day 1, day 7
measure: Time to attain maximum plasma concentration (tmax)
time frame: day 1, day 7
measure: Trough plasma concentration at steady state (Cmin,ss)
time frame: day 7
measure: Number of participants with adverse events
time frame: up to 8 days after last treatment
arm group label: Telmisartan high
arm group type: Experimental
arm group label: Telmisartan low
arm group type: Experimental
arm group label: Lacidipine high
arm group type: Active Comparator
arm group label: Lacidipine low
arm group type: Active Comparator
arm group label: Telmisartan+Lacidipine
arm group type: Experimental
arm group label: Placebo
arm group type: Placebo Comparator
intervention type: Drug
intervention name: Telmisartan high
arm group label: Telmisartan high
intervention type: Drug
intervention name: Telmisartan low
arm group label: Telmisartan low
arm group label: Telmisartan+Lacidipine
intervention type: Drug
intervention name: Lacidipine high
arm group label: Lacidipine high
intervention type: Drug
intervention name: Lacidipine low
arm group label: Lacidipine low
arm group label: Telmisartan+Lacidipine
intervention type: Drug
intervention name: Placebo
arm group label: Placebo
criteria: 
gender: All
minimum age: 21 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