Valsartan Amlodipine Randomized Trial

Valsartan Amlodipine Randomized Trial - VART trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-C000000074

Enrollment

3000

Registered

2005-08-23

Start date

2004-07-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Interventions

Valsartan Amlodipine

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. 30 years old or older 2. Patients newly diagnosed hypertension (SBP>=140mmHg or DBP>=90mmHg in a sitting position at clinic) or treated with hypertensive drugs

Exclusion criteria

Exclusion 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

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

Japan

Contacts

Public ContactYoichi Kuwabara

Chiba University Dept. Cardiovascular Science and Medicine

yoichik-cib@umin.ac.jp043-222-7171

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026