Coffee Interaction With the Antihypertensive Drug Felodipine

August 9, 2018 updated by: David Bailey, Lawson Health Research Institute

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • London, Ontario, Canada
        • Victoria Clinical Trials Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

28 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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
Drug: Felodipine
Other Names:
  • Plendil
  • Renadil
Other: Black Coffee
Active Comparator: Grapefruit Juice plus Felodipine

Grapefruit Juice, 300 ml, 0 and 1 hour

Felodipine extended-release tablet ,10 mg, single dose, 8 hours
Drug: Felodipine
Other Names:
  • Plendil
  • Renadil
Other: Grapefruit Juice

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Change from Baseline to 8 hours Post Dose

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Change from Baseline to 8 hours Post Dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lawson Health Research Institute

Investigators

  • Principal Investigator: David G Bailey, BScPhm, PhD, Lawson Health Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (Actual)

June 1, 2012

Study Completion (Actual)

May 1, 2013

Study Registration Dates

First Submitted

August 28, 2014

First Submitted That Met QC Criteria

September 2, 2014

First Posted (Estimate)

September 5, 2014

Study Record Updates

Last Update Posted (Actual)

August 13, 2018

Last Update Submitted That Met QC Criteria

August 9, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R-11-655
  • NA-7122 (Other Grant/Funding Number: Heart & Stroke Foundation of Ontario)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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