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| Name | Class |
|---|---|
| Aristotle University Of Thessaloniki | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Evening medication | Active Comparator | Anti hypertensive medication in the evening (between 18.00 and 23.00) |
|
| Morning medication | Active Comparator | Antihypertensive medication in the morning(between 06.00 and 11.00) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in 24 Hour Systolic Blood Pressure | Changes in 24 hour systolic Blood Pressure using ABPM | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Day-time ABPM Systolic BP | 6 months | |
| Mean Day-time ABPM Diastolic BP | 6 months | |
| Μean Night Time ABPM Systolic BP |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Neil Poulter, MRCS LRCP MBBS MRCP MSc FRCP | Imperial College London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aristotle University of Thessaloniki | Thessaloniki | Greece | ||||
| Imperial Clinical Trials Unit |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 7656688 | Background | Lemmer B. Clinical chronopharmacology: the importance of time in drug treatment. Ciba Found Symp. 1995;183:235-47; discussion 247-53. doi: 10.1002/9780470514597.ch13. | |
| 9739478 | Background | Bruguerolle B. Chronopharmacokinetics. Current status. Clin Pharmacokinet. 1998 Aug;35(2):83-94. doi: 10.2165/00003088-199835020-00001. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Morning Medication, Then Evening | Antihypertensive medication in the morning (between 06.00 and 11.00) for 6 months, then cross over to antihypertensive medication in the evening (between 18.00 and 23.00) for 6 months. 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. |
| FG001 | Evening Medication, Then Morning | Anti hypertensive medication in the evening (between 18.00 and 23.00) for 6 months, then cross over to antihypertensive medication in the morning (between 06.00 and 11.00) for 6 months, 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention |
|
| ||||||||||||||||||
| Second Intervention |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Morning Medication, Then Evening | Antihypertensive medication in the morning (between 06.00 and 11.00) for 6 months, then cross over to antihypertensive medication in the evening (between 18.00 and 23.00) for 6 months. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Changes in 24 Hour Systolic Blood Pressure | Changes in 24 hour systolic Blood Pressure using ABPM | Total of 8 withdrawals / drop outs | Posted | Mean | Standard Deviation | mm Hg | 6 months |
|
2 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Morning Medication | Antihypertensive medication in the morning (between 06.00 and 11.00) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chest pain | General disorders | MedDRA (10.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Professor Neil Poulter | Imperial College London | +44 20 7594 3446 | n.poulter@imperial.ac.uk |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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|
|
| 6 months |
| Μean Night Time ABPM Diastolic BP | 6 months |
| Mean Clinic - Systolic BP | This measure was assessed at a clinic. | 6 months |
| Mean Clinic - Diastolic BP | This measure was assessed at a clinic. | 6 months |
| Self Reported Side Effects | Serious Adverse Events reported during the trial | 12 months |
| Quality of Life Score | Quality of Life Score via questionnaire - EQ-5D-5L Score scale is 0-100, 100 optimal health state. | 6 months |
| London |
| W2 1LA |
| United Kingdom |
| 20226988 | Background | Rothwell PM, Howard SC, Dolan E, O'Brien E, Dobson JE, Dahlof 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. |
| 20571367 | Background | 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. |
| 20854139 | Background | Hermida RC, Ayala DE, Mojon A, Fernandez 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. |
| 10639539 | Background | 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. doi: 10.1056/NEJM200001203420301. |
| 9576134 | Background | 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. doi: 10.1161/01.hyp.31.5.1190. |
| 30354703 | Derived | Poulter NR, Savopoulos C, Anjum A, Apostolopoulou M, Chapman N, Cross M, Falaschetti E, Fotiadis S, James RM, Kanellos I, Szigeti M, Thom S, Sever P, Thompson D, Hatzitolios AI. Randomized Crossover Trial of the Impact of Morning or Evening Dosing of Antihypertensive Agents on 24-Hour Ambulatory Blood Pressure. Hypertension. 2018 Oct;72(4):870-873. doi: 10.1161/HYPERTENSIONAHA.118.11101. |
| NOT COMPLETED |
|
| BG001 | Evening Medication, Then Morning | Anti hypertensive medication in the evening (between 18.00 and 23.00) for 6 months, then cross over to antihypertensive medication in the morning (between 06.00 and 11.00) for 6 months, 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Secondary | Mean Day-time ABPM Systolic BP | Total of 8 withdrawals / drop outs | Posted | Mean | Standard Deviation | mm Hg | 6 months |
|
|
|
| Secondary | Mean Day-time ABPM Diastolic BP | Total of 8 withdrawals / drop outs | Posted | Mean | Standard Deviation | mm Hg | 6 months |
|
|
|
| Secondary | Μean Night Time ABPM Systolic BP | Total of 8 withdrawals / drop outs | Posted | Mean | Standard Error | mm Hg | 6 months |
|
|
|
| Secondary | Μean Night Time ABPM Diastolic BP | Total of 8 withdrawals / drop outs | Posted | Mean | Standard Deviation | mm Hg | 6 months |
|
|
|
| Secondary | Mean Clinic - Systolic BP | This measure was assessed at a clinic. | Total of 8 withdrawals / drop outs | Posted | Mean | Standard Deviation | mm Hg | 6 months |
|
|
|
| Secondary | Mean Clinic - Diastolic BP | This measure was assessed at a clinic. | Total of 8 withdrawals / drop outs | Posted | Mean | Standard Deviation | mm Hg | 6 months |
|
|
|
| Secondary | Self Reported Side Effects | Serious Adverse Events reported during the trial | Posted | Number | Serious Adverse Events | 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. | Total of 8 withdrawals / drop outs | Posted | Mean | Standard Deviation | Score out of 100 | 6 months |
|
|
|
| 0 |
| 95 |
| 0 |
| 95 |
| 0 |
| 97 |
| EG001 | Evening Medication | Anti hypertensive medication in the evening (between 18.00 and 23.00) | 0 | 97 | 3 | 97 | 0 | 95 |
| Planned admission for ERCP with stent. | Surgical and medical procedures | MedDRA (10.0) | Systematic Assessment |
|
| Syncope episode | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
|
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