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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001021
Receipt No. 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

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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
Institute JATOS Study Group
Institute
Department

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
URL(English) https://upload.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


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