Ignite Creation Date:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2026-02-20 @ 10:46 PM
Study NCT ID:
NCT02232269
Status:
COMPLETED
Last Update Posted:
2018-08-13
First Post:
2014-08-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Coffee Interaction With the Antihypertensive Drug Felodipine
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D014867', 'term': 'Water'}, {'id': 'D015736', 'term': 'Felodipine'}], 'ancestors': [{'id': 'D006878', 'term': 'Hydroxides'}, {'id': 'D000468', 'term': 'Alkalies'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D000838', 'term': 'Anions'}, {'id': 'D007477', 'term': 'Ions'}, {'id': 'D004573', 'term': 'Electrolytes'}, {'id': 'D010087', 'term': 'Oxides'}, {'id': 'D017601', 'term': 'Oxygen Compounds'}, {'id': 'D004095', 'term': 'Dihydropyridines'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-09', 'studyFirstSubmitDate': '2014-08-28', 'studyFirstSubmitQcDate': '2014-09-02', 'lastUpdatePostDateStruct': {'date': '2018-08-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-09-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The effect of felodipine on coffee-mediated increases in peripheral and central blood pressure .', 'timeFrame': 'Change from Baseline to 8 hours Post Dose', 'description': '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).'}], 'secondaryOutcomes': [{'measure': 'The effect of coffee on the oral pharmacokinetics of felodipine.', 'timeFrame': 'Change from Baseline to 8 hours Post Dose', 'description': 'Area Under Curve (AUC) Time Frame: predose, 1,2,3,4,5,6,7,8 hours post-dose'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Coffee', 'Grapefruit Juice', 'Felodipine', 'Calcium Channel Blocker', 'Hemodynamics', 'CYP3A4'], 'conditions': ['Food-Drug Interactions']}, 'referencesModule': {'references': [{'pmid': '27481881', 'type': 'BACKGROUND', 'citation': 'Bailey DG, Dresser GK, Urquhart BL, Freeman DJ, Arnold JM. Coffee-Antihypertensive Drug Interaction: A Hemodynamic and Pharmacokinetic Study With Felodipine. Am J Hypertens. 2016 Dec 1;29(12):1386-1393. doi: 10.1093/ajh/hpw081.'}, {'pmid': '28971609', 'type': 'BACKGROUND', 'citation': 'Dresser GK, Urquhart BL, Proniuk J, Tieu A, Freeman DJ, Arnold JM, Bailey DG. Coffee inhibition of CYP3A4 in vitro was not translated to a grapefruit-like pharmacokinetic interaction clinically. Pharmacol Res Perspect. 2017 Oct;5(5):e00346. doi: 10.1002/prp2.346.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nDrug 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.\n\nWe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '30 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healthy (normal physical exam, blood clinical chemistry)\n* willingly signs ethics approved informed consent form\n\nExclusion Criteria:\n\n* history of cardiac, renal, hepatic or gastrointestinal disease or substance abuse\n* significant illness within 2 weeks of starting study\n* history of allergy to felodipine , tablet ingredients or dihydropyridines\n* routinely taking prescription or OTC drugs or natural health products\n* received an investigational drug withing the previous 4 weeks\n* females who are pregnant or breast-feeding'}, 'identificationModule': {'nctId': 'NCT02232269', 'briefTitle': 'Coffee Interaction With the Antihypertensive Drug Felodipine', 'organization': {'class': 'OTHER', 'fullName': "London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's"}, 'officialTitle': 'Phase 1 Study of the Hemodynamic and Pharmacokinetic Interactions Between Coffee and Felodipine', 'orgStudyIdInfo': {'id': 'R-11-655'}, 'secondaryIdInfos': [{'id': 'NA-7122', 'type': 'OTHER_GRANT', 'domain': 'Heart & Stroke Foundation of Ontario'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Water plus Felodipine', 'description': 'Felodipine extended-release tablet ,10 mg, single dose, 8 hours', 'interventionNames': ['Other: Water', 'Drug: Felodipine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Black Coffee', 'description': 'Black Coffee, 300 ml, 0 and 1 hour', 'interventionNames': ['Other: Black Coffee']}, {'type': 'EXPERIMENTAL', 'label': 'Black Coffee plus Felodipine', 'description': 'Black Coffee, 300 ml, 0 and 1 hour\n\nFelodipine extended-release tablet ,10 mg, single dose, 8 hours', 'interventionNames': ['Other: Black Coffee', 'Drug: Felodipine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Grapefruit Juice plus Felodipine', 'description': 'Grapefruit Juice, 300 ml, 0 and 1 hour\n\nFelodipine extended-release tablet ,10 mg, single dose, 8 hours', 'interventionNames': ['Other: Grapefruit Juice', 'Drug: Felodipine']}], 'interventions': [{'name': 'Black Coffee', 'type': 'OTHER', 'armGroupLabels': ['Black Coffee', 'Black Coffee plus Felodipine']}, {'name': 'Grapefruit Juice', 'type': 'OTHER', 'armGroupLabels': ['Grapefruit Juice plus Felodipine']}, {'name': 'Water', 'type': 'OTHER', 'armGroupLabels': ['Water plus Felodipine']}, {'name': 'Felodipine', 'type': 'DRUG', 'otherNames': ['Plendil', 'Renadil'], 'armGroupLabels': ['Black Coffee plus Felodipine', 'Grapefruit Juice plus Felodipine', 'Water plus Felodipine']}]}, 'contactsLocationsModule': {'locations': [{'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Victoria Clinical Trials Centre', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}], 'overallOfficials': [{'name': 'David G Bailey, BScPhm, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'David Bailey', 'investigatorAffiliation': "London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's"}}}}