NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
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
Health condition(s) or Problem(s) studiedEssential hypertension
Date of first enrollment2001/04/01
Target sample size4000
Countries of recruitmentJapan
Study typeInterventional
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 OutcomePrimary 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 OutcomeSecondary endpoints were deaths from any causes other than the primary endpoints, and any problems in safety.

Key inclusion & exclusion criteria

Age minimum65years-old
Age maximum85years-old
GenderMale and Female
Include criteriaThe 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.
Exclude criteriaPatients 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

Contact

public contact
Name Masao Ishii
Address 1625-1-2553 Bukko-cho, Hodogaya-ku, Yokohama Japan
Telephone 045-332-7268
E-mail 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
E-mail
Affiliation The Yokohama Seamen's Insurance Hospital/Yokohama City University Department of Internal Medicne