UMIN-CTR Clinical Trial

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

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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 or person

Institute

DAIICHI SANKYO COMPANY, LIMITED

Institute

Department

Personal name



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

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