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

This study has been completed.
Sponsor:
Collaborator:
Aristotle University Of Thessaloniki
Information provided by (Responsible Party):
Imperial College London
ClinicalTrials.gov Identifier:
NCT01669928
First received: July 2, 2012
Last updated: September 8, 2015
Last verified: February 2015

July 2, 2012
September 8, 2015
April 2012
July 2015   (final data collection date for primary outcome measure)
3mm Hg difference in mean 24 hour systolic Blood Pressure [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01669928 on ClinicalTrials.gov Archive Site
  • Mean day-time ABPM systolic BP [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Mean day-time ABPM diastolic BP [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Μean night time ABPM systolic BP [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Μean night time ABPM diastolic BP [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Mean clinic - systolic BP [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Mean clinic - diastolic BP [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Concordance with taking drug treatment [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Self reported side effects [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
  • Quality of Life [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Clinical events (extra GP or hospital visits and procedures and hospitalization) [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Anti-hypertensive Medication Dosing Regimen in Effective Blood Pressure Control
Hellenic Anglo Research Into Morning Or Evening Antihypertensive Drug deliverY Trial

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Hypertension
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 B
    Anti hypertensive medication in the evening (between 18.00 and 23.00)
    Intervention: Drug: Anti-hypertensive Medication -
  • Active Comparator: Group A
    Antihypertensive medication in the morning(between 06.00 and 11.00)
    Intervention: Drug: Anti-hypertensive Medication -

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
103
July 2015
July 2015   (final data collection date for primary outcome measure)

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.
Both
18 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Greece,   United Kingdom
 
NCT01669928
CRO1749
No
Not Provided
Not Provided
Imperial College London
Imperial College London
Aristotle University Of Thessaloniki
Principal Investigator: Neil Poulter, MRCS LRCP MBBS MRCP MSc FRCP Imperial College London
Imperial College London
February 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP