UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000001021
Receipt number R000001224
Scientific Title The Japanese Trial to Assess Optimal Systolic Blood Pressure in Elderly Hypertensive Patients (JATOS)
Date of disclosure of the study information 2008/02/15
Last modified on 2008/03/17 10:18:30

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Basic information

Public title

The Japanese Trial to Assess Optimal Systolic Blood Pressure in Elderly Hypertensive Patients (JATOS)

Acronym

JATOS Study

Scientific Title

The Japanese Trial to Assess Optimal Systolic Blood Pressure in Elderly Hypertensive Patients (JATOS)

Scientific Title:Acronym

JATOS Study

Region

Japan


Condition

Condition

Essential hypertension

Classification by specialty

Cardiology Geriatrics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Comparison of the effect of strict treatment and that of mild treatment in elderly hypertensive patients

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Primary endpoints were cerebrovascular disease (cerebral hemorrhage, cerebral infarction, transient ischemic attack, subarachnoid hemorrhage, and other types of cerebrovascular disease), cardiac disease (myocardial infarction, angina pectoris requiring hospitalization, and heart failure), vascular disease (dissecting aneurysms of the aorta and occlusive arterial disease), and renal failure (acute or chronic renal failure; doubling of the serum concentration of creatinine to a value of 1.5 mg/dl or higher).

Key secondary outcomes

Secondary endpoints were deaths from any causes other than the primary endpoints, and any problems in safety.


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -but assessor(s) are blinded

Control

Dose comparison

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

A strict treatment to maintain systolic blood pressure below 140 mmHg.

Interventions/Control_2

A mild treatment to maintain systolic blood presure 140 mmHg or higher but below 160 mmHg.

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

65 years-old <=

Age-upper limit

85 years-old >=

Gender

Male and Female

Key inclusion criteria

The subjects were male or female outpatients 65 to 85 years of age with essential hypertension who persistently had a systolic blood pressure of 160 mmHg or higher during a run-in period, while receiving no antihypertensive drugs or while receiving the same drug(s) for at least 4 weeks.

Key exclusion criteria

Patients were excluded if they had been receiving efonidipine or had any of the following conditions: a diastolic BP of 120 mmHg or above, secondary hypertension, recent stroke (less than 6 months previously) or signs and symptoms of stroke, a recent myocardial infarction or coronary angioplasty (less than 6 months previously), or angina pectoris requiring hospitalization, congestive heart failure of NYHA class II or higher, persistent arrhythmias such as atrial fibrillation, dissecting aneurysm of the aorta or occlusive arterial disease, hypertensive retinopathy, serum aspartate aminotransferase or serum alanine aminotransferase levels more than double the respective upper limits of normal, poorly controlled diabetes mellitus (fasting blood sugar of 200 mg/dl or higher or HbA1c of 8% or higher), renal dysfunction (serum creatinine of 1.5 mg/dl or higher), or malignant disease or collagen disease. Patients considered unsuitable as subjects were also excluded.

Target sample size

4000


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Masao Ishii

Organization

The Yokohama Seamen's Insurance Hospital/Yokohama City University

Division name

Department of Internal Medicne

Zip code


Address

43-1, Kamadai-cho, Hodogaya-ku, Yokohama/3-9 Fukuura, Kanazawa-ku, Yokohama

TEL

045-331-1251

Email



Public contact

Name of contact person

1st name
Middle name
Last name Masao Ishii

Organization

JATOS Study Group

Division name

Home of the corespondent person

Zip code


Address

1625-1-2553 Bukko-cho, Hodogaya-ku, Yokohama

TEL

045-332-7268

Homepage URL

http://japha.umin.jp/jatos/index.htm

Email

mishii@dc4.so-net.ne.jp


Sponsor or person

Institute

JATOS Study Group

Institute

Department

Personal name



Funding Source

Organization

Shionogi & CO., Ltd.

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

2008 Year 02 Month 15 Day


Related information

URL releasing protocol


Publication of results

Partially published


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


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

Completed

Date of protocol fixation

2001 Year 04 Month 07 Day

Date of IRB


Anticipated trial start date

2001 Year 04 Month 01 Day

Last follow-up date

2004 Year 12 Month 01 Day

Date of closure to data entry

2005 Year 10 Month 01 Day

Date trial data considered complete

2005 Year 11 Month 01 Day

Date analysis concluded

2005 Year 12 Month 01 Day


Other

Other related information



Management information

Registered date

2008 Year 02 Month 07 Day

Last modified on

2008 Year 03 Month 17 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001224


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name