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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

Page last updated: August 23, 2015

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