Anti-hypertensive Medication Dosing Regimen in Effective Blood Pressure Control

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

103 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2015-07-31

Brief Summary

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A randomised crossover trial of anti-hypertensive medication dosing regimen in effective blood pressure control.

To investigate whether there is a difference in 24 hour blood pressure (BP) control when antihypertensive medications are taken in the morning compared with the evening.

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Detailed Description

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The identification of any significant difference could lead to more effective therapeutic management of arterial hypertension, which in turn would result in a reduced cardiovascular burden, lower costs and a better quality of life for hypertensive patients.

Conditions

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Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Evening medication

Anti hypertensive medication in the evening (between 18.00 and 23.00)

Group Type ACTIVE_COMPARATOR

Anti-hypertensive Medication -

Intervention Type DRUG

Patients will be taking their routine blood pressure lowering medication prescribed by their GP, different patients will be using different blood pressure lowering medication.

Dosing regimen either in the morning (between 06.00 and 11.00) or in the evening (between 18.00 and 23.00).

Morning medication

Antihypertensive medication in the morning(between 06.00 and 11.00)

Group Type ACTIVE_COMPARATOR

Anti-hypertensive Medication -

Intervention Type DRUG

Patients will be taking their routine blood pressure lowering medication prescribed by their GP, different patients will be using different blood pressure lowering medication.

Dosing regimen either in the morning (between 06.00 and 11.00) or in the evening (between 18.00 and 23.00).

Interventions

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Anti-hypertensive Medication -

Patients will be taking their routine blood pressure lowering medication prescribed by their GP, different patients will be using different blood pressure lowering medication.

Dosing regimen either in the morning (between 06.00 and 11.00) or in the evening (between 18.00 and 23.00).

Intervention Type DRUG

Other Intervention Names

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PR1 Diruetics PR3 Beta Blockers PR4 Calcium channel blockers PR5 ACE inhibitors PR6 Angiotensin II Receptor Blockers PR7 Centrally acting agents PR8 Alpha blockers PR9 Direct Renin Inhibitors PR10 Vasodilators

Eligibility Criteria

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Inclusion Criteria

* Caucasian patients aged 18-80 years;
* History of any grade of hypertension for at least 1 year, including at least 3 months of constant antihypertensive medication (consisting of ≥ 1 antihypertensive drugs, each administered in one dose daily), with reasonably controlled BP (≤150/90 mmHg and ≥ 115/75 mmHg on usual medication) based on previous clinic records, in the last 3 months.

Exclusion Criteria

* BP levels \> 150/90 mmHg or \< 115/75 mmHg in the last 3 months.
* Postural hypotension, defined as symptoms resulting from a \> 20 mm Hg drop of systolic BP or a \> 10 mm Hg drop of diastolic BP or both between 1 and 3 min after standing from the sitting position.
* Known Extreme dippers at baseline (fall of mean night time SBP \> 20% of mean day time SBP)
* Individuals with jobs which require night-time shift work.
* Pregnant women or those planning to become pregnant.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No