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Completed

NCT Number: NCT01669928

Anti-hypertensive Medication Dosing Regimen in Effective Blood Pressure Control

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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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Aristotle University of Thessaloniki, Thessaloniki, Greece

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Anti-hypertensive Medication -

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).

Other names: 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

Primary outcomes

  1. Changes in 24 Hour Systolic Blood Pressure

    Time frame: 6 months

    Changes in 24 hour systolic Blood Pressure using ABPM

Secondary outcomes

  1. Mean Day-time ABPM Systolic BP

    Time frame: 6 months

  2. Mean Day-time ABPM Diastolic BP

    Time frame: 6 months

  3. Μean Night Time ABPM Systolic BP

    Time frame: 6 months

  4. Μean Night Time ABPM Diastolic BP

    Time frame: 6 months

  5. Mean Clinic - Systolic BP

    Time frame: 6 months

    This measure was assessed at a clinic.

  6. Mean Clinic - Diastolic BP

    Time frame: 6 months

    This measure was assessed at a clinic.

  7. Self Reported Side Effects

    Time frame: 12 months

    Serious Adverse Events reported during the trial

  8. Quality of Life Score

    Time frame: 6 months

    Quality of Life Score via questionnaire - EQ-5D-5L Score scale is 0-100, 100 optimal health state.

Sponsors and collaborators

Lead sponsor

Imperial College London

Other

Collaborators

  • Aristotle University Of Thessaloniki

Registry information

Official study title

Hellenic Anglo Research Into Morning Or Evening Antihypertensive Drug deliverY Trial

Acronym: HARMONY

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Aug 21, 2012
Registry last updated
Mar 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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