Anti-hypertensive Medication Dosing Regimen in Effective Blood Pressure Control (HARMONY)
This study is not yet open for participant recruitment.
Verified August 2012 by Imperial College London
Sponsor:
Imperial College London
Collaborator:
Aristotle University Of Thessaloniki
Information provided by (Responsible Party):
Imperial College London
ClinicalTrials.gov Identifier:
NCT01669928
First received: July 2, 2012
Last updated: August 17, 2012
Last verified: August 2012
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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 Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: 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 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 ]
| Estimated Enrollment: | 100 |
| Study Start Date: | August 2012 |
| Estimated Study Completion Date: | August 2013 |
| Estimated Primary Completion Date: | August 2013 (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:
|
|
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:
|
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01669928
Contacts
| Contact: Neeraja Thirunavukkarasu, MSc | +44 2075941330 | n.thirunavukkarasu@imperial.ac.uk |
Locations
| Greece | |
| Aristotle University of Thessaloniki | Not yet recruiting |
| Thessaloniki, Greece | |
| Contact: Apostolos Hatzitolios + 30 2310994783 a.hatzitolios@imperial.ac.uk | |
| Contact: Christos Savopoulos c.savopoulos@imperial.ac.uk | |
| Principal Investigator: Apostolos Hatzitolios | |
| Sub-Investigator: Cristos Savopoulos | |
| United Kingdom | |
| Imperial Clinical Trials Unit | Not yet recruiting |
| 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:
| Responsible Party: | Imperial College London |
| ClinicalTrials.gov Identifier: | NCT01669928 History of Changes |
| Other Study ID Numbers: | CRO1749 |
| Study First Received: | July 2, 2012 |
| Last Updated: | August 17, 2012 |
| Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Additional relevant MeSH terms:
|
Hypertension Vascular Diseases Cardiovascular Diseases Angiotensin II Angiotensin-Converting Enzyme Inhibitors Antihypertensive Agents Calcium Channel Blockers Vasodilator Agents Angiotensin Receptor Antagonists |
Vasoconstrictor Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Membrane Transport Modulators |
ClinicalTrials.gov processed this record on May 19, 2013