Valsartan Amlodipine Randomized Trial

UMIN ID: C000000074

Registered date:23/08/2005

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Hypertension
• Date of first enrollment: 2004/07/01
• Target sample size: 3000
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Valsartan
Amlodipine

Outcome(s)

• Primary Outcome: 1.All death2.Sudden death: death of endogenous origin within 24 h after acute onset3.Cerebrovascular events: new occurrence or recurrence of a stroke or transient ischemia attack4.Cardiac events: new occurrence or recurrence of acute myocardial infarction or pectoris, new occurrence of aggravation of heart failure5.Vascular events: new occurrence or recurrence of dissecting aneurysm of aorta. hospitalization due to arteriosclerotic occlusion of peripheral artery6.Renal dysfunction: doubling of serum creatinine, end stage renal disease
• Secondary Outcome: 1.Effect on left ventricular hypertrophy (assessment by echocardiography or electrocadiogram) and left systoloic and diastolic function by echocardiography2.Effect on renal function (assessment by albuminuria or urinary albumin/creatinine ratio, serum creatinine)3.Effect on cardiac sympathetic activity (assessment by MIBG cardiac imaging)4.Effect on blood neurohormonal level5.Effect on blood pressure at home

Key inclusion & exclusion criteria

• Age minimum: 30years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: 1.Secondary hypertension 2.Severe valvular disease or congenital heart disease requiring operative treatment 3.Hypertrophic or dilated cardiomyopaty 4.PTCA or CABG performed within 6 months 5.Stroke occurred within 3 months 6.Renal dysfunction (serum creatinine >=3mg/dl) 7.Hepatic dysfunction (AST and/or ALT >=100IU/l) 8.Electrolyte abnormality resistant to treatment 9.Severe ventricular arrythmia 10.Severe cerebrovascular disease 11.Pregnancy, possible pregnancy 12.Active cancer 13.Contraindication for valsartan or amlodipine 14.Not suitable to the clinical trial as judged by a physician

Related Information

• Primary Sponsor: Dept. Cardiovascular Science and Medicine