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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN C000000074
Receipt No. R000000124
Scientific Title Valsartan Amlodipine Randomized Trial
Date of disclosure of the study information 2005/08/23
Last modified on 2005/08/23

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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
Institute Dept. Cardiovascular Science and Medicine
Institute
Department

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
URL(English) https://upload.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


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