Hypertension Clinical Trial
— HARMONYOfficial title:
Hellenic Anglo Research Into Morning Or Evening Antihypertensive Drug deliverY Trial
NCT number | NCT01669928 |
Other study ID # | CRO1749 |
Secondary ID | |
Status | Completed |
Phase | Phase 4 |
First received | |
Last updated | |
Start date | April 2012 |
Est. completion date | July 2015 |
Verified date | March 2021 |
Source | Imperial College London |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 103 |
Est. completion date | July 2015 |
Est. primary completion date | July 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Greece | Aristotle University of Thessaloniki | Thessaloniki | |
United Kingdom | Imperial Clinical Trials Unit | London |
Lead Sponsor | Collaborator |
---|---|
Imperial College London | Aristotle University Of Thessaloniki |
Greece, United Kingdom,
Bruguerolle B. Chronopharmacokinetics. Current status. Clin Pharmacokinet. 1998 Aug;35(2):83-94. Review. — View Citation
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. — View Citation
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. — View Citation
Lemmer B. Clinical chronopharmacology: the importance of time in drug treatment. Ciba Found Symp. 1995;183:235-47; discussion 247-53. Review. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes in 24 Hour Systolic Blood Pressure | Changes in 24 hour systolic Blood Pressure using ABPM | 6 months | |
Secondary | Mean Day-time ABPM Systolic BP | 6 months | ||
Secondary | Mean Day-time ABPM Diastolic BP | 6 months | ||
Secondary | ?ean Night Time ABPM Systolic BP | 6 months | ||
Secondary | ?ean Night Time ABPM Diastolic BP | 6 months | ||
Secondary | Mean Clinic - Systolic BP | This measure was assessed at a clinic. | 6 months | |
Secondary | Mean Clinic - Diastolic BP | This measure was assessed at a clinic. | 6 months | |
Secondary | Self Reported Side Effects | Serious Adverse Events reported during the trial | 12 months | |
Secondary | Quality of Life Score | Quality of Life Score via questionnaire - EQ-5D-5L Score scale is 0-100, 100 optimal health state. | 6 months |
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