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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000002567
Receipt No. 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

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Basic information
Public title Home blood pressure measurement with Olmesartan Naive patients to Establish Standard Target blood pressure Study
Acronym Home blood pressure measurement with Olmesartan Naive patients to Establish Standard Target blood pressure Study
Scientific Title Home blood pressure measurement with Olmesartan Naive patients to Establish Standard Target blood pressure Study
Scientific Title:Acronym Home blood pressure measurement with Olmesartan Naive patients to Establish Standard Target blood pressure Study
Region
Japan

Condition
Condition Essential Hypertension
Classification by specialty
Medicine in general Cardiology Endocrinology and Metabolism
Nephrology Psychosomatic Internal Medicine Geriatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 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.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes 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.
Key secondary outcomes (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.

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria (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.
Key exclusion criteria (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.
Target sample size 20000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shimada Kazuyuki
Organization Shin-Oyama City Hospital
Division name No
Zip code
Address 1-1-5 Wakagicho, Oyama, Tochigi 323-0028, Japan.
TEL +81-285-21-3800
Email kazuyuki@hospital.oyama.tochigi.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shuichi Chikada
Organization DAIICHI SANKYO COMPANY, LIMITED
Division name Medical Affairs Department
Zip code
Address 3-5-1, Nihonbashi Honcho, Chuo-ku, Tokyo 103-8426, Japan
TEL +81-3-6225-1044
Homepage URL
Email chikada.shuichi.ic@daiichisankyo.co.jp

Sponsor
Institute DAIICHI SANKYO COMPANY, LIMITED
Institute
Department

Funding Source
Organization DAIICHI SANKYO COMPANY, LIMITED
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2009 Year 09 Month 30 Day

Related information
URL releasing protocol http://www.ncbi.nlm.nih.gov/pubmed/23096234
Publication of results Published

Result
URL related to results and publications http://www.ncbi.nlm.nih.gov/pubmed/25156169
Number of participants that the trial has enrolled
Results
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.
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Main results already published
Date of protocol fixation
2009 Year 08 Month 10 Day
Date of IRB
Anticipated trial start date
2009 Year 10 Month 01 Day
Last follow-up date
2012 Year 09 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information 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.

Management information
Registered date
2009 Year 09 Month 30 Day
Last modified on
2015 Year 02 Month 04 Day


Link to view the page
URL(English) https://upload.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


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