Anti-hypertensive Medication Dosing Regimen in Effective Blood Pressure Control

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
Hellenic Anglo Research Into Morning Or Evening Antihypertensive Drug deliverY Trial

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Drug: Anti-hypertensive Medication -


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Evening medication<br>Anti hypertensive medication in the evening (between 18.00 and 23.00) | Drug: Anti-hypertensive Medication -<br>* 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).<br>* Other names: PR10 Vasodilators;|
| Active Comparator: Morning medication<br>Antihypertensive medication in the morning(between 06.00 and 11.00) | Drug: Anti-hypertensive Medication -<br>* 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).<br>* Other names: PR10 Vasodilators;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in 24 Hour Systolic Blood Pressure | Changes in 24 hour systolic Blood Pressure using ABPM | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Day-time ABPM Systolic BP |  | 6 months | 
| Mean Day-time ABPM Diastolic BP |  | 6 months | 
| Μean Night Time ABPM Systolic BP |  | 6 months | 
| Μean Night Time ABPM Diastolic BP |  | 6 months | 
| Mean Clinic - Systolic BP | This measure was assessed at a clinic. | 6 months | 
| Mean Clinic - Diastolic BP | This measure was assessed at a clinic. | 6 months | 
| Self Reported Side Effects | Serious Adverse Events reported during the trial | 12 months | 
| Quality of Life Score | Quality of Life Score via questionnaire - EQ-5D-5L Score scale is 0-100, 100 optimal health state. | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hypertension