UMIN ID: UMIN000001021
Registered date:15/02/2008
The Japanese Trial to Assess Optimal Systolic Blood Pressure in Elderly Hypertensive Patients (JATOS)
Basic Information
Recruitment status | Complete: follow-up complete |
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Health condition(s) or Problem(s) studied | Essential hypertension |
Date of first enrollment | 2001/04/01 |
Target sample size | 4000 |
Countries of recruitment | Japan |
Study type | Interventional |
Intervention(s) | 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. |
Outcome(s)
Primary Outcome | 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). |
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Secondary Outcome | Secondary endpoints were deaths from any causes other than the primary endpoints, and any problems in safety. |
Key inclusion & exclusion criteria
Age minimum | 65years-old |
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Age maximum | 85years-old |
Gender | Male and Female |
Include criteria | |
Exclude 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. |
Related Information
Primary Sponsor | JATOS Study Group |
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Secondary Sponsor | |
Source(s) of Monetary Support | Shionogi & CO., Ltd. |
Secondary ID(s) |
Contact
public contact | |
Name | Masao Ishii |
Address | 1625-1-2553 Bukko-cho, Hodogaya-ku, Yokohama Japan |
Telephone | 045-332-7268 |
mishii@dc4.so-net.ne.jp | |
Affiliation | JATOS Study Group Home of the corespondent person |
scientific contact | |
Name | Masao Ishii |
Address | 43-1, Kamadai-cho, Hodogaya-ku, Yokohama/3-9 Fukuura, Kanazawa-ku, Yokohama Japan |
Telephone | 045-331-1251 |
Affiliation | The Yokohama Seamen's Insurance Hospital/Yokohama City University Department of Internal Medicne |