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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02232269 |
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Date of registration:
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28/08/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Coffee Interaction With the Antihypertensive Drug Felodipine
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Scientific title:
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Phase 1 Study of the Hemodynamic and Pharmacokinetic Interactions Between Coffee and Felodipine |
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Date of first enrolment:
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February 2012 |
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Target sample size:
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13 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02232269 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 1
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Countries of recruitment
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Canada
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Contacts
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Name:
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David G Bailey, BScPhm, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Lawson Health Research Institute |
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Key inclusion & exclusion criteria
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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
Age minimum:
30 Years
Age maximum:
65 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Food-Drug Interactions
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Intervention(s)
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Other: Black Coffee
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Drug: Felodipine
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Other: Grapefruit Juice
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Other: Water
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Primary Outcome(s)
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The effect of felodipine on coffee-mediated increases in peripheral and central blood pressure .
[Time Frame: Change from Baseline to 8 hours Post Dose]
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Secondary Outcome(s)
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The effect of coffee on the oral pharmacokinetics of felodipine.
[Time Frame: Change from Baseline to 8 hours Post Dose]
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Secondary ID(s)
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NA-7122
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R-11-655
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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