<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/NCT02232269</url>
  </required_header>
  <id_info>
    <org_study_id>R-11-655</org_study_id>
    <secondary_id>NA-7122</secondary_id>
    <nct_id>NCT02232269</nct_id>
  </id_info>
  <brief_title>Coffee Interaction With the Antihypertensive Drug Felodipine</brief_title>
  <official_title>Phase 1 Study of the Hemodynamic and Pharmacokinetic Interactions Between Coffee and Felodipine</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Lawson Health Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Lawson Health Research Institute</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Coffee is a globally popular beverage. More than half of the United States population spends&#xD;
      an estimated $ 40 billion on the purchase of coffee each year. Personal consumption habits&#xD;
      can vary. For example, the frequency of ingestion ranged from 59% for every day to 8% for&#xD;
      less than one day per week consumption in one survey. In the case of occasional consumption,&#xD;
      coffee can markedly elevate blood pressure in normotensive and hypertensive individuals. This&#xD;
      pressor effect can occur with a caffeine dose of 200 - 250 mg, which can be found 2 - 3 cups&#xD;
      of coffee. A major active constituent in coffee is caffeine, which is the most widely used&#xD;
      pharmacological substance in the world.&#xD;
&#xD;
      Drug therapy plays a major role in the management of hypertension. However, the interaction&#xD;
      between coffee or caffeine and blood pressure lowering drugs has been assessed in only three&#xD;
      clinical studies that were reported more than three decades ago.&#xD;
&#xD;
      We conducted a comprehensive interaction study involving a commonly ingested amount of a&#xD;
      particular Colombian coffee and felodipine in healthy middle-aged men and women. Peripheral&#xD;
      (brachial) and central (aortic) hemodynamics and caffeine and felodipine pharmacokinetics&#xD;
      were evaluated.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>February 2012</start_date>
  <completion_date type="Actual">May 2013</completion_date>
  <primary_completion_date type="Actual">June 2012</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>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The effect of felodipine on coffee-mediated increases in peripheral and central blood pressure .</measure>
    <time_frame>Change from Baseline to 8 hours Post Dose</time_frame>
    <description>Peripheral (brachial systolic and diastolic blood pressure) and central (aortic systolic blood pressure) measurements were the mean of at least 3 readings after 5 minutes of sitting at rest. The respective instruments used were BpTRU™ Vital Signs Monitor (BpTRU Medical Devices, Coquitlam BC, Canada) and SphygmoCor® CP Pulse Wave Analysis System - Research (AtCor Medical, Inc., Itasca, IL USA).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The effect of coffee on the oral pharmacokinetics of felodipine.</measure>
    <time_frame>Change from Baseline to 8 hours Post Dose</time_frame>
    <description>Area Under Curve (AUC) Time Frame: predose, 1,2,3,4,5,6,7,8 hours post-dose</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">13</enrollment>
  <condition>Food-Drug Interactions</condition>
  <arm_group>
    <arm_group_label>Water plus Felodipine</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Felodipine extended-release tablet ,10 mg, single dose, 8 hours</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Black Coffee</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Black Coffee, 300 ml, 0 and 1 hour</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Black Coffee plus Felodipine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Black Coffee, 300 ml, 0 and 1 hour&#xD;
Felodipine extended-release tablet ,10 mg, single dose, 8 hours</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Grapefruit Juice plus Felodipine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Grapefruit Juice, 300 ml, 0 and 1 hour&#xD;
Felodipine extended-release tablet ,10 mg, single dose, 8 hours</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Black Coffee</intervention_name>
    <arm_group_label>Black Coffee</arm_group_label>
    <arm_group_label>Black Coffee plus Felodipine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Grapefruit Juice</intervention_name>
    <arm_group_label>Grapefruit Juice plus Felodipine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Water</intervention_name>
    <arm_group_label>Water plus Felodipine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Felodipine</intervention_name>
    <arm_group_label>Black Coffee plus Felodipine</arm_group_label>
    <arm_group_label>Grapefruit Juice plus Felodipine</arm_group_label>
    <arm_group_label>Water plus Felodipine</arm_group_label>
    <other_name>Plendil</other_name>
    <other_name>Renadil</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  healthy (normal physical exam, blood clinical chemistry)&#xD;
&#xD;
          -  willingly signs ethics approved informed consent form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  history of cardiac, renal, hepatic or gastrointestinal disease or substance abuse&#xD;
&#xD;
          -  significant illness within 2 weeks of starting study&#xD;
&#xD;
          -  history of allergy to felodipine , tablet ingredients or dihydropyridines&#xD;
&#xD;
          -  routinely taking prescription or OTC drugs or natural health products&#xD;
&#xD;
          -  received an investigational drug withing the previous 4 weeks&#xD;
&#xD;
          -  females who are pregnant or breast-feeding&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>David G Bailey, BScPhm, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Lawson Health Research Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Victoria Clinical Trials Centre</name>
      <address>
        <city>London</city>
        <state>Ontario</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <reference>
    <citation>Bailey DG, Dresser GK, Urquhart BL, Freeman DJ, Arnold JM. Coffee-Antihypertensive Drug Interaction: A Hemodynamic and Pharmacokinetic Study With Felodipine. Am J Hypertens. 2016 Dec 1;29(12):1386-1393. doi: 10.1093/ajh/hpw081.</citation>
    <PMID>27481881</PMID>
  </reference>
  <reference>
    <citation>Dresser GK, Urquhart BL, Proniuk J, Tieu A, Freeman DJ, Arnold JM, Bailey DG. Coffee inhibition of CYP3A4 in vitro was not translated to a grapefruit-like pharmacokinetic interaction clinically. Pharmacol Res Perspect. 2017 Oct;5(5):e00346. doi: 10.1002/prp2.346.</citation>
    <PMID>28971609</PMID>
  </reference>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>August 28, 2014</study_first_submitted>
  <study_first_submitted_qc>September 2, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 5, 2014</study_first_posted>
  <last_update_submitted>August 9, 2018</last_update_submitted>
  <last_update_submitted_qc>August 9, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 13, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Lawson Health Research Institute</investigator_affiliation>
    <investigator_full_name>David Bailey</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Coffee</keyword>
  <keyword>Grapefruit Juice</keyword>
  <keyword>Felodipine</keyword>
  <keyword>Calcium Channel Blocker</keyword>
  <keyword>Hemodynamics</keyword>
  <keyword>CYP3A4</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Felodipine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT02232269
org study id: R-11-655
secondary id: NA-7122
nct id: NCT02232269
lead sponsor: 
has dmc: No
Coffee is a globally popular beverage. More than half of the United States population spends
      an estimated $ 40 billion on the purchase of coffee each year. Personal consumption habits
      can vary. For example, the frequency of ingestion ranged from 59% for every day to 8% for
      less than one day per week consumption in one survey. In the case of occasional consumption,
      coffee can markedly elevate blood pressure in normotensive and hypertensive individuals. This
      pressor effect can occur with a caffeine dose of 200 - 250 mg, which can be found 2 - 3 cups
      of coffee. A major active constituent in coffee is caffeine, which is the most widely used
      pharmacological substance in the world.

      Drug therapy plays a major role in the management of hypertension. However, the interaction
      between coffee or caffeine and blood pressure lowering drugs has been assessed in only three
      clinical studies that were reported more than three decades ago.

      We conducted a comprehensive interaction study involving a commonly ingested amount of a
      particular Colombian coffee and felodipine in healthy middle-aged men and women. Peripheral
      (brachial) and central (aortic) hemodynamics and caffeine and felodipine pharmacokinetics
      were evaluated.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: The effect of felodipine on coffee-mediated increases in peripheral and central blood pressure .
time frame: Change from Baseline to 8 hours Post Dose
description: Peripheral (brachial systolic and diastolic blood pressure) and central (aortic systolic blood pressure) measurements were the mean of at least 3 readings after 5 minutes of sitting at rest. The respective instruments used were BpTRU™ Vital Signs Monitor (BpTRU Medical Devices, Coquitlam BC, Canada) and SphygmoCor® CP Pulse Wave Analysis System - Research (AtCor Medical, Inc., Itasca, IL USA).
measure: The effect of coffee on the oral pharmacokinetics of felodipine.
time frame: Change from Baseline to 8 hours Post Dose
description: Area Under Curve (AUC) Time Frame: predose, 1,2,3,4,5,6,7,8 hours post-dose
arm group label: Water plus Felodipine
arm group type: Placebo Comparator
description: Felodipine extended-release tablet ,10 mg, single dose, 8 hours
arm group label: Black Coffee
arm group type: Active Comparator
description: Black Coffee, 300 ml, 0 and 1 hour
arm group label: Black Coffee plus Felodipine
arm group type: Experimental
description: Black Coffee, 300 ml, 0 and 1 hour
Felodipine extended-release tablet ,10 mg, single dose, 8 hours
arm group label: Grapefruit Juice plus Felodipine
arm group type: Active Comparator
description: Grapefruit Juice, 300 ml, 0 and 1 hour
Felodipine extended-release tablet ,10 mg, single dose, 8 hours
intervention type: Other
intervention name: Black Coffee
arm group label: Black Coffee
arm group label: Black Coffee plus Felodipine
intervention type: Other
intervention name: Grapefruit Juice
arm group label: Grapefruit Juice plus Felodipine
intervention type: Other
intervention name: Water
arm group label: Water plus Felodipine
intervention type: Drug
intervention name: Felodipine
arm group label: Black Coffee plus Felodipine
arm group label: Grapefruit Juice plus Felodipine
arm group label: Water plus Felodipine
other name: Plendil
other name: Renadil
criteria: 
gender: All
minimum age: 30 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: David G Bailey, BScPhm, PhD
role: Principal Investigator
affiliation: Lawson Health Research Institute
facility: 
country: Canada
citation: Bailey DG, Dresser GK, Urquhart BL, Freeman DJ, Arnold JM. Coffee-Antihypertensive Drug Interaction: A Hemodynamic and Pharmacokinetic Study With Felodipine. Am J Hypertens. 2016 Dec 1;29(12):1386-1393. doi: 10.1093/ajh/hpw081.
PMID: 27481881
citation: Dresser GK, Urquhart BL, Proniuk J, Tieu A, Freeman DJ, Arnold JM, Bailey DG. Coffee inhibition of CYP3A4 in vitro was not translated to a grapefruit-like pharmacokinetic interaction clinically. Pharmacol Res Perspect. 2017 Oct;5(5):e00346. doi: 10.1002/prp2.346.
PMID: 28971609
responsible party type: Principal Investigator
investigator affiliation: Lawson Health Research Institute
investigator full name: David Bailey
investigator title: Principal Investigator
mesh term: Felodipine
sharing ipd: No