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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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19 February 2015 |
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Main ID: |
NCT02214498 |
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Date of registration:
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08/08/2014 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Treatment of HYpertension: Morning Versus Evening
THYME |
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Scientific title:
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Treatment of HYpertension: Morning Versus Evening |
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Date of first enrolment:
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May 2015 |
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Target sample size:
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120 |
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Recruitment status: |
Not yet recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT02214498 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Phase:
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Phase 4
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Countries of recruitment
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Netherlands
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Contacts
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Name:
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Jorie Versmissen, MD, 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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Erasmus MC |
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Name:
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Jorie Versmissen, MD, PhD |
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Address:
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Telephone:
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Email:
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j.versmissen@erasmusmc.nl |
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Affiliation:
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Name:
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Jorie Versmissen, MD, PhD |
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Address:
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Telephone:
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Email:
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j.versmissen@erasmusmc.nl |
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Affiliation:
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Name:
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Eric Sijbrands, Prof |
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Address:
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Telephone:
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Email:
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Affiliation:
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Erasmus MC |
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Name:
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Teun Van Gelder, Prof |
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Address:
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Telephone:
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Email:
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Affiliation:
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Erasmus MC |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Essential hypertension
- Stable blood pressure on treatment with Angiotensin Converting Enzyme Inhibitor
(ACEI) or Angiotensin II Receptor Blocker (ARB) and hydrochlorothiazide
- Age between 18 and 85 years
- WHO performance status 0-1
- Available for a time period of 15 weeks
- Written informed consent
- Dippers: Nocturnal blood pressure fall of 10-20% of daytime values.20
- Non-dippers: -Nocturnal blood pressure fall of <10% of daytime values
Exclusion Criteria:
- secondary cause of hypertension
- use of ARB because of intolerability (e.g. dry cough) of ACEI
- nocturnal blood pressure fall of >20% or rise
- renal insufficiency (GFR<60 ml/min)
- shift work
- pregnancy or wish to get pregnant
- use of other antihypertensive medication than ACEI, ARB, hydrochlorothiazide or a
calcium channel blocker
- use of sleeping medication
Age minimum:
18 Years
Age maximum:
85 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Essential Hypertension
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Intervention(s)
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Drug: Placebo
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Drug: Enalapril/hydrochlorothiazide
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Primary Outcome(s)
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Average nocturnal blood pressure, percentage dipping and nadir of nocturnal blood pressure
[Time Frame: 24 hours]
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Secondary Outcome(s)
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Urine: Sodium, potassium, protein, melatonin, creatinin
[Time Frame: Two times within 24 hours at the end of six weeks of treatment according to one of the two regimes]
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Plasma: enalapril, cortisol, melatonin, aldosterone, ACE activity, gene expression of clock genes
[Time Frame: Moring of 24 hour blood pressure measurement after six weeks of treatment according to a certain regime]
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Percentage of nocturnal diastolic blood pressure measurements below 65 mm hg
[Time Frame: 24 hours]
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Secondary ID(s)
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2014_THYME
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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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