Treatment of HYpertension: Morning Versus Evening

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-31

Study Completion Date

2017-05-31

Brief Summary

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Rationale:

The nocturnal blood pressure mean is an independent and stronger predictor of cardiovascular disease (CVD) risk than either daytime office, awake or 24hour mean blood pressure. In general, when nocturnal blood pressure does not decline CVD risk is higher, usually referred to as "dippers" versus "non-dippers". Evening administration of treatment might lower nocturnal blood pressure more effectively than morning administration, which is most commonly advised.

The main hypothesis of this study is that evening administration of antihypertensive medication might resume the dipping pattern in non-dippers and as a consequence might reduce CVD risk more than morning administration.

Primary objective (in short):

-to prove that evening administration of enalapril/hydrochlorothiazide in non-dippers can resume a dipping blood pressure pattern in non-dippers

Study design: A double-blind placebo-controlled cross-over study Each person will use for one period of six weeks enalapril/hydrochlorothiazide in the morning and placebo in the evening, and one period of six weeks the other way around

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Detailed Description

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Conditions

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Essential Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Enalapril/hydrochlorothiazide

This arm will start with six weeks of administration of enalapril/hydrochlorothiazide in the evening and placebo in the morning, followed by six weeks of active treatment in the morning and placebo in the evening

Group Type ACTIVE_COMPARATOR

Enalapril/hydrochlorothiazide

Intervention Type DRUG

The intervention implies that morning and evening administration of enalapril/hydrochlorothiazide will be compared

Placebo

Intervention Type DRUG

Placebo

This arm will start with six weeks of morning administration of enalapril/hydrochlorothiazide in the morning and placebo in the evening, followed by six weeks of placebo in the morning and active treatment in the evening

Group Type PLACEBO_COMPARATOR

Enalapril/hydrochlorothiazide

Intervention Type DRUG

The intervention implies that morning and evening administration of enalapril/hydrochlorothiazide will be compared

Placebo

Intervention Type DRUG

Interventions

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Enalapril/hydrochlorothiazide

The intervention implies that morning and evening administration of enalapril/hydrochlorothiazide will be compared

Intervention Type DRUG

Placebo

Intervention Type DRUG

Other Intervention Names

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To be determined

Eligibility 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No