Essential hypertension
Conditions
Interventions
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.
Sponsors
JATOS Study Group
Eligibility
Sex/Gender
All
Inclusion criteria
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.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Secondary endpoints were deaths from any causes other than the primary endpoints, and any problems in safety. | — |
Countries
Japan
Contacts
Public ContactMasao Ishii
JATOS Study Group Home of the corespondent person
Outcome results
None listed