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Anti-hypertensive Medication Dosing Regimen in Effective Blood Pressure Control (HARMONY)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01669928
First Posted: August 21, 2012
Last Update Posted: September 9, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Aristotle University Of Thessaloniki
Information provided by (Responsible Party):
Imperial College London
  Purpose

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. 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.


Condition Intervention Phase
Hypertension Drug: Anti-hypertensive Medication - Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Hellenic Anglo Research Into Morning Or Evening Antihypertensive Drug deliverY Trial

Resource links provided by NLM:


Further study details as provided by Imperial College London:

Primary Outcome Measures:
  • 3mm Hg difference in mean 24 hour systolic Blood Pressure [ Time Frame: 24 weeks ]

Secondary Outcome Measures:
  • Mean day-time ABPM systolic BP [ Time Frame: 24 weeks ]
  • Mean day-time ABPM diastolic BP [ Time Frame: 24 weeks ]
  • Μean night time ABPM systolic BP [ Time Frame: 24 weeks ]
  • Μean night time ABPM diastolic BP [ Time Frame: 24 weeks ]
  • Mean clinic - systolic BP [ Time Frame: 24 weeks ]
  • Mean clinic - diastolic BP [ Time Frame: 24 weeks ]
  • Concordance with taking drug treatment [ Time Frame: 24 weeks ]
  • Self reported side effects [ Time Frame: 24 weeks ]
  • Quality of Life [ Time Frame: 24 weeks ]
  • Clinical events (extra GP or hospital visits and procedures and hospitalization) [ Time Frame: 24 weeks ]

Enrollment: 103
Study Start Date: April 2012
Study Completion Date: July 2015
Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Group B
Anti hypertensive medication in the evening (between 18.00 and 23.00)
Drug: 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).

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
Active Comparator: Group A
Antihypertensive medication in the morning(between 06.00 and 11.00)
Drug: 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).

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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01669928


Locations
Greece
Aristotle University of Thessaloniki
Thessaloniki, Greece
United Kingdom
Imperial Clinical Trials Unit
London, United Kingdom, W2 1LA
Sponsors and Collaborators
Imperial College London
Aristotle University Of Thessaloniki
Investigators
Principal Investigator: Neil Poulter, MRCS LRCP MBBS MRCP MSc FRCP Imperial College London
  More Information

Publications:
Lemmer B. Clinical chronopharmacology: the importance of time in drug treatment. Ciba Found Symp. 1995;183:235-47; discussion 247-53. Review.
Bruguerolle B. Chronopharmacokinetics. Current status. Clin Pharmacokinet. 1998 Aug;35(2):83-94. Review.
Rothwell PM, Howard SC, Dolan E, O'Brien E, Dobson JE, Dahlöf B, Sever PS, Poulter NR. Prognostic significance of visit-to-visit variability, maximum systolic blood pressure, and episodic hypertension. Lancet. 2010 Mar 13;375(9718):895-905. doi: 10.1016/S0140-6736(10)60308-X.
Smolensky MH, Hermida RC, Ayala DE, Tiseo R, Portaluppi F. Administration-time-dependent effects of blood pressure-lowering medications: basis for the chronotherapy of hypertension. Blood Press Monit. 2010 Aug;15(4):173-80. doi: 10.1097/MBP.0b013e32833c7308. Review.
Hermida RC, Ayala DE, Mojón A, Fernández JR. Influence of circadian time of hypertension treatment on cardiovascular risk: results of the MAPEC study. Chronobiol Int. 2010 Sep;27(8):1629-51. doi: 10.3109/07420528.2010.510230.
Heart Outcomes Prevention Evaluation Study Investigators, Yusuf S, Sleight P, Pogue J, Bosch J, Davies R, Dagenais G. Effects of an angiotensin-converting-enzyme inhibitor, ramipril, on cardiovascular events in high-risk patients. N Engl J Med. 2000 Jan 20;342(3):145-53. Erratum in: 2000 May 4;342(18):1376. N Engl J Med 2000 Mar 9;342(10):748.
Mayet J, Chapman N, Li CK, Shahi M, Poulter NR, Sever PS, Foale RA, Thom SA. Ethnic differences in the hypertensive heart and 24-hour blood pressure profile. Hypertension. 1998 May;31(5):1190-4.

Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT01669928     History of Changes
Other Study ID Numbers: CRO1749
First Submitted: July 2, 2012
First Posted: August 21, 2012
Last Update Posted: September 9, 2015
Last Verified: February 2015

Additional relevant MeSH terms:
Antihypertensive Agents
Angiotensin II
Calcium Channel Blockers
Angiotensin Receptor Antagonists
Vasoconstrictor Agents
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action


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