Unique ID issued by UMIN | UMIN000002567 |
---|---|
Receipt number | R000003122 |
Scientific Title | Home blood pressure measurement with Olmesartan Naive patients to Establish Standard Target blood pressure Study |
Date of disclosure of the study information | 2009/09/30 |
Last modified on | 2015/02/04 11:40:18 |
Home blood pressure measurement with Olmesartan Naive patients to Establish Standard Target blood pressure Study
Home blood pressure measurement with Olmesartan Naive patients to Establish Standard Target blood pressure Study
Home blood pressure measurement with Olmesartan Naive patients to Establish Standard Target blood pressure Study
Home blood pressure measurement with Olmesartan Naive patients to Establish Standard Target blood pressure Study
Japan |
Essential Hypertension
Medicine in general | Cardiology | Endocrinology and Metabolism |
Nephrology | Psychosomatic Internal Medicine | Geriatrics |
Others
NO
To investigate the relation between blood pressure measured either at home (early morning and before bedtime) or in physician's office and incidence of cardiovascular events in olmesartan medoxomil (OLM)-naive hypertensive patients given OLM for a 2-year follow-up period.
In addition, to investigate the relation between the first or second daily measurement of home blood pressure level, or the average calculated thereof, and the incidence rate of cardiovascular events.
Furthermore, to assess stably lasting blood pressure-lowering effects of OLM.
Efficacy
Confirmatory
Pragmatic
Time from start of treatment to first occurrence of major cardiovascular events*.
* Major cardiovascular events defined as composite of cerebral infarction, intracerebral hemorrhage, subarachnoid hemorrhage, stroke of unknown type, myocardial infarction, coronary revascularization procedures for angina pectoris, or sudden death.
(1)Time from start of treatment to first occurrence of major events*.
*Major events include major cardiovascular events, hospital admissions for angina pectoris or heart failure, aortic dissection, arteriosclerosis obliterans, end-stage renal disease, doubling of the serum creatinine concentration, and all-cause death.
(2) Change in blood pressure levels.
(3) Adverse events.
Observational
Not applicable |
Not applicable |
Male and Female
(1)OLM-naive patients with essential hypertension.
(2)Ambulatory outpatients who are able to visit the physician's office without any assistant or helper.
(3)Patients from whom written informed consent was obtained.
(4)Patients whose blood pressure levels could be measured in physician's office at least once within 28 days before starting OLM administration.
(5)Patients whose early morning blood pressure levels could be measured by arm-cuff blood pressure monitor at home at least twice on different days within 28 days prior to administration of OLM.
(1)Patients with prior myocardial infarction, cerebral infarction, cerebral hemorrhage, subarachnoid hemorrhage, and stroke of unknown type (however, patients with TIA are eligible for inclusion) within the previous 6 months.
(2)Patients undergoing coronary intervention surgery such as percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG), and the like and those who had been hospitalized due to heart failure within the previous 6 months.
(3)Patients scheduled to undergo coronary intervention surgery such as PCI, CABG, or the like when OLM is started to administer.
(4)Patients with persistent or sustained atrial fibrillation.
(5)Patients with history of or concurrent cardiac diseases such as congenital heart diseases, rheumatic heart disease, and moderate-to-severe valvular heart disease.
(6)Patients with unstable angina pectoris or severe arrhythmia.
(7)Pregnant or possibly pregnant patients.
(8)Patients deemed inadequate for long-term monitoring (e.g. those under treatment for severe hepatic or renal dysfunction (patients undergoing kidney dialysis are not eligible), malignant neoplasm, and the like) as determined by physician.
20000
1st name | |
Middle name | |
Last name | Shimada Kazuyuki |
Shin-Oyama City Hospital
No
1-1-5 Wakagicho, Oyama, Tochigi 323-0028, Japan.
+81-285-21-3800
kazuyuki@hospital.oyama.tochigi.jp
1st name | |
Middle name | |
Last name | Shuichi Chikada |
DAIICHI SANKYO COMPANY, LIMITED
Medical Affairs Department
3-5-1, Nihonbashi Honcho, Chuo-ku, Tokyo 103-8426, Japan
+81-3-6225-1044
chikada.shuichi.ic@daiichisankyo.co.jp
DAIICHI SANKYO COMPANY, LIMITED
DAIICHI SANKYO COMPANY, LIMITED
Profit organization
Japan
NO
2009 | Year | 09 | Month | 30 | Day |
http://www.ncbi.nlm.nih.gov/pubmed/23096234
Published
http://www.ncbi.nlm.nih.gov/pubmed/25156169
A prospective observational study of 21 591 outpatients with essential hypertension (mean age, 64.9 years; women, 50.6%) enrolled between 2009 and 2010 at clinics and hospitals in Japan. After a mean follow-up period of 2.02 years, cardiovascular events occurred in 280 patients (incidence, 6.46/1000 patient years). The risk for the primary end point was significantly higher in patients with on-treatment morning home blood pressure >145 to 155 mmHg (hazard ratio, 1.83; 95% confidence interval, 1.12-2.99) and >155 mmHg (hazard ratio, 5.03; 95% confidence interval, 3.05-8.31) than <125 mmHg, and with on-treatment clinic blood pressure >150 to 160 mmHg (hazard ratio, 1.69; 95% confidence interval, 1.10-2.60) and >160 mmHg (hazard ratio, 4.38; 95% confidence interval, 2.84-6.75) than <130 mmHg. Morning home blood pressure associated with minimum risk was 124 mmHg by spline regression analysis. Cardiovascular risk was increased in patients with morning home blood pressure >145 mmHg and clinic blood pressure <130 mmHg (hazard ratio, 2.47; 95% confidence interval, 1.20-5.08) compared to morning home blood pressure <125 mmHg and clinic blood pressure <130 mmHg.
In conclusion, it is essential to control morning home blood pressure to <145 mmHg, even in patients with controlled clinic blood pressure.
Main results already published
2009 | Year | 08 | Month | 10 | Day |
2009 | Year | 10 | Month | 01 | Day |
2012 | Year | 09 | Month | 01 | Day |
In this prospective observational study designed to investigate the relation between blood pressure levels measured either at home (early morning and before bedtime) or in physician's office and incidence of cardiovascular events, data were collected by Patient Registration Center System.
2009 | Year | 09 | Month | 30 | Day |
2015 | Year | 02 | Month | 04 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003122
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |