UMIN-CTR Clinical Trial

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

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Basic information

Public title

Valsartan Amlodipine Randomized Trial

Acronym

VART trial

Scientific Title

Valsartan Amlodipine Randomized Trial

Scientific Title:Acronym

VART trial

Region

Japan


Condition

Condition

Hypertension

Classification by specialty

Medicine in general Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

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.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

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

Key secondary outcomes

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


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -but assessor(s) are blinded

Control

Active

Stratification

NO

Dynamic allocation

YES

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Valsartan

Interventions/Control_2

Amlodipine

Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

30 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key 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

Key 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

Target sample size

3000


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yoichi Kuwabara

Organization

Chiba University

Division name

Dept. Cardiovascular Science and Medicine

Zip code


Address

TEL

043-222-7171

Email



Public contact

Name of contact person

1st name
Middle name
Last name Yoichi Kuwabara

Organization

Chiba University

Division name

Dept. Cardiovascular Science and Medicine

Zip code


Address

TEL

043-222-7171

Homepage URL

http://www.vart-reserch.com

Email

yoichik-cib@umin.ac.jp


Sponsor or person

Institute

Dept. Cardiovascular Science and Medicine

Institute

Department

Personal name



Funding Source

Organization

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2005 Year 08 Month 23 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Preinitiation

Date of protocol fixation

2004 Year 07 Month 01 Day

Date of IRB


Anticipated trial start date

2004 Year 07 Month 01 Day

Last follow-up date

2008 Year 12 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2005 Year 08 Month 23 Day

Last modified on

2005 Year 08 Month 23 Day



Link to view the page

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