Unique ID issued by UMIN | C000000074 |
---|---|
Receipt number | R000000124 |
Scientific Title | Valsartan Amlodipine Randomized Trial |
Date of disclosure of the study information | 2005/08/23 |
Last modified on | 2005/08/23 18:59:48 |
Valsartan Amlodipine Randomized Trial
VART trial
Valsartan Amlodipine Randomized Trial
VART trial
Japan |
Hypertension
Medicine in general | Cardiology |
Others
NO
To determine the optimal anti-hyperteisive treatmet suitable for Japanese, we designed and are conducting a prospective randomized clinical open-label trial, The Valsartan Amlodipine Randomized Trial (VART), which compares the treatment with a calcium channel blocker, amlodipine, and an angiotensin 2receptor blocker (ARB), valsartan.
Safety,Efficacy
Confirmatory
Pragmatic
Not applicable
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
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
Interventional
Parallel
Randomized
Individual
Open -but assessor(s) are blinded
Active
NO
YES
Institution is not considered as adjustment factor.
NO
Central registration
2
Treatment
Medicine |
Valsartan
Amlodipine
30 | years-old | <= |
Not applicable |
Male and Female
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
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
3000
1st name | |
Middle name | |
Last name | Yoichi Kuwabara |
Chiba University
Dept. Cardiovascular Science and Medicine
043-222-7171
1st name | |
Middle name | |
Last name | Yoichi Kuwabara |
Chiba University
Dept. Cardiovascular Science and Medicine
043-222-7171
http://www.vart-reserch.com
yoichik-cib@umin.ac.jp
Dept. Cardiovascular Science and Medicine
Self funding
NO
2005 | Year | 08 | Month | 23 | Day |
Unpublished
Preinitiation
2004 | Year | 07 | Month | 01 | Day |
2004 | Year | 07 | Month | 01 | Day |
2008 | Year | 12 | Month | 01 | Day |
2005 | Year | 08 | Month | 23 | Day |
2005 | Year | 08 | Month | 23 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000124
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |