Unique ID issued by UMIN | UMIN000001021 |
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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 |
The Japanese Trial to Assess Optimal Systolic Blood Pressure in Elderly Hypertensive Patients (JATOS)
JATOS Study
The Japanese Trial to Assess Optimal Systolic Blood Pressure in Elderly Hypertensive Patients (JATOS)
JATOS Study
Japan |
Essential hypertension
Cardiology | Geriatrics |
Others
NO
Comparison of the effect of strict treatment and that of mild treatment in elderly hypertensive patients
Efficacy
Exploratory
Pragmatic
Not applicable
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).
Secondary endpoints were deaths from any causes other than the primary endpoints, and any problems in safety.
Interventional
Parallel
Randomized
Individual
Open -but assessor(s) are blinded
Dose comparison
NO
NO
Institution is not considered as adjustment factor.
NO
Central registration
2
Treatment
Medicine |
A strict treatment to maintain systolic blood pressure below 140 mmHg.
A mild treatment to maintain systolic blood presure 140 mmHg or higher but below 160 mmHg.
65 | years-old | <= |
85 | years-old | >= |
Male and Female
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.
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.
4000
1st name | |
Middle name | |
Last name | Masao Ishii |
The Yokohama Seamen's Insurance Hospital/Yokohama City University
Department of Internal Medicne
43-1, Kamadai-cho, Hodogaya-ku, Yokohama/3-9 Fukuura, Kanazawa-ku, Yokohama
045-331-1251
1st name | |
Middle name | |
Last name | Masao Ishii |
JATOS Study Group
Home of the corespondent person
1625-1-2553 Bukko-cho, Hodogaya-ku, Yokohama
045-332-7268
http://japha.umin.jp/jatos/index.htm
mishii@dc4.so-net.ne.jp
JATOS Study Group
Shionogi & CO., Ltd.
Profit organization
Japan
NO
2008 | Year | 02 | Month | 15 | Day |
Partially published
Completed
2001 | Year | 04 | Month | 07 | Day |
2001 | Year | 04 | Month | 01 | Day |
2004 | Year | 12 | Month | 01 | Day |
2005 | Year | 10 | Month | 01 | Day |
2005 | Year | 11 | Month | 01 | Day |
2005 | Year | 12 | Month | 01 | Day |
2008 | Year | 02 | Month | 07 | Day |
2008 | Year | 03 | Month | 17 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001224
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