Coffee Interaction With the Antihypertensive Drug Felodipine
Information source: Lawson Health Research Institute
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Food-Drug Interactions
Intervention: Black Coffee (Other); Grapefruit Juice (Other); Water (Other); Felodipine (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Lawson Health Research Institute Official(s) and/or principal investigator(s):
David G Bailey, BScPhm, PhD, Principal Investigator, Affiliation: Lawson Health Research Institute
Summary
Hypertension affects an estimated 1. 5 billion people world-wide and is a chief contributor
to death, stroke, congestive heart failure, kidney disease, coronary artery disease and
dementia. A number of important causal environmental factors have been identified and
include excessive salt or alcohol consumption, physical inactivity, inadequate fruit,
vegetable and potassium intake and obesity. Although there have been significant
improvements in management, a high percentage of patients still do not achieve target blood
pressures.
Coffee is a popular beverage globally and elevates blood pressure variably among
individuals. Customers in the United States comprise more than half of the population over
the age of 18 years, consume an average of 1 cup (typical size: 270 ml) of coffee three
times per day and spend an estimated $ 40 billion on the purchase of it each year. 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. Concomitant intake of
coffee is likely substantial. However, the interaction between coffee or caffeine and blood
pressure lowering drugs has been assessed in only a few clinical studies conducted more than
two decades ago. Moreover, it appears to have the potential to confound the routine drug
management of hypertension.
This clinical investigation reports the actions of a customary amount of coffee on the
circulatory effects and blood concentrations of felodipine, a drug belonging to a class of
drugs commonly used to treat hypertension. Application of results from this study to
clinical practice has the possibility to improve the management of hypertension.
Clinical Details
Official title: Phase 1 Study of the Hemodynamic and Pharmacokinetic Interactions Between Coffee and Felodipine
Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: The effect of felodipine on coffee-mediated increases in peripheral and central blood pressure .
Secondary outcome: The effect of coffee on the oral pharmacokinetics of felodipine.
Eligibility
Minimum age: 30 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Victoria Clinical Trials Centre, London, Ontario, Canada
Additional Information
Starting date: February 2012
Last updated: September 2, 2014
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