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Completed

NCT Number: NCT02232269

Coffee Interaction With the Antihypertensive Drug Felodipine

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.

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Key information

Age range

30 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Victoria Clinical Trials Centre

London, Ontario, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Black Coffee

Other

Grapefruit Juice

Other

Water

Other

Felodipine

Drug

Other names: Plendil, Renadil

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Other

Registry information

Official study title

Phase 1 Study of the Hemodynamic and Pharmacokinetic Interactions Between Coffee and Felodipine

Important dates

Study start
2012
Primary completion
2012
Study completion
2013
First posted
Sep 5, 2014
Registry last updated
Aug 13, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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