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Coffee Interaction With the Antihypertensive Drug Felodipine

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ClinicalTrials.gov Identifier: NCT02232269
Recruitment Status : Completed
First Posted : September 5, 2014
Last Update Posted : August 13, 2018
Information provided by (Responsible Party):
David Bailey, Lawson Health Research Institute

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Food-Drug Interactions Other: Black Coffee Other: Grapefruit Juice Other: Water Drug: Felodipine Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 1 Study of the Hemodynamic and Pharmacokinetic Interactions Between Coffee and Felodipine
Study Start Date : February 2012
Actual Primary Completion Date : June 2012
Actual Study Completion Date : May 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Reactions
Drug Information available for: Felodipine

Arm Intervention/treatment
Placebo Comparator: Water plus Felodipine
Felodipine extended-release tablet ,10 mg, single dose, 8 hours
Other: Water
Drug: Felodipine
Other Names:
  • Plendil
  • Renadil

Active Comparator: Black Coffee
Black Coffee, 300 ml, 0 and 1 hour
Other: Black Coffee
Experimental: Black Coffee plus Felodipine

Black Coffee, 300 ml, 0 and 1 hour

Felodipine extended-release tablet ,10 mg, single dose, 8 hours

Other: Black Coffee
Drug: Felodipine
Other Names:
  • Plendil
  • Renadil

Active Comparator: Grapefruit Juice plus Felodipine

Grapefruit Juice, 300 ml, 0 and 1 hour

Felodipine extended-release tablet ,10 mg, single dose, 8 hours

Other: Grapefruit Juice
Drug: Felodipine
Other Names:
  • Plendil
  • Renadil

Primary Outcome Measures :
  1. The effect of felodipine on coffee-mediated increases in peripheral and central blood pressure . [ Time Frame: Change from Baseline to 8 hours Post Dose ]
    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).

Secondary Outcome Measures :
  1. The effect of coffee on the oral pharmacokinetics of felodipine. [ Time Frame: Change from Baseline to 8 hours Post Dose ]
    Area Under Curve (AUC) Time Frame: predose, 1,2,3,4,5,6,7,8 hours post-dose

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Ages Eligible for Study:   30 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • healthy (normal physical exam, blood clinical chemistry)
  • willingly signs ethics approved informed consent form

Exclusion Criteria:

  • history of cardiac, renal, hepatic or gastrointestinal disease or substance abuse
  • significant illness within 2 weeks of starting study
  • history of allergy to felodipine , tablet ingredients or dihydropyridines
  • routinely taking prescription or OTC drugs or natural health products
  • received an investigational drug withing the previous 4 weeks
  • females who are pregnant or breast-feeding

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02232269

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Canada, Ontario
Victoria Clinical Trials Centre
London, Ontario, Canada
Sponsors and Collaborators
Lawson Health Research Institute
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Principal Investigator: David G Bailey, BScPhm, PhD Lawson Health Research Institute
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Responsible Party: David Bailey, Principal Investigator, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT02232269    
Other Study ID Numbers: R-11-655
NA-7122 ( Other Grant/Funding Number: Heart & Stroke Foundation of Ontario )
First Posted: September 5, 2014    Key Record Dates
Last Update Posted: August 13, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by David Bailey, Lawson Health Research Institute:
Grapefruit Juice
Calcium Channel Blocker
Additional relevant MeSH terms:
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Anti-Arrhythmia Agents
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vasodilator Agents