UMIN-CTR Clinical Trial

Unique ID issued by UMIN C000000319
Receipt number R000000412
Scientific Title The Effect of Losartan and Amlodipine on Left Ventricular Diastolic Function in Patients With Mild-to-Moderate Hypertension
Date of disclosure of the study information 2006/02/01
Last modified on 2011/02/01 09:56:55

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Basic information

Public title

The Effect of Losartan and Amlodipine on Left Ventricular Diastolic Function in Patients With Mild-to-Moderate Hypertension

Acronym

J-ELAN

Scientific Title

The Effect of Losartan and Amlodipine on Left Ventricular Diastolic Function in Patients With Mild-to-Moderate Hypertension

Scientific Title:Acronym

J-ELAN

Region

Japan


Condition

Condition

Hypertensive heart disease

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

to assess the effects of losartan and amlodipine on LV diastolic function in hypertensive patients with LV diastolic dysfunction in absence of systolic dysfunction

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase

Phase IV


Assessment

Primary outcomes

LV diastolic function

Key secondary outcomes

carotid artery atherosclerosis
BNP
PIIIP
CITP
high sensitivity C-reactive protein


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


Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

treatment with angiotensin II type 1 receptor blocker

Interventions/Control_2

treatment with calcium channel blocker

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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

•Mild to moderate hypertension (systolic blood pressure with 140 mmHg or over and with 200 mmHg or less, diastolic blood pressure with 90 mmHg or over and with 110 mmHg or less,
•Presence of LV hypertrophy (a ratio of LV mass to body surface area (LV mass index) with 120 g/m2 or over in men and with 105 g/m2 or over in women, or LV wall thickness > 11 mm.
•LV diastolic dysfunction (a ratio of peak early to late diastolic filling velocities (E/A) < 1.0 or > 1.5, an E-wave deceleration time <160 msec or >280 msec, isovolumic relaxation time <60 msec or > 105 msec)
•LV ejection fraction with 50% or over

Key exclusion criteria

•History of a life-threatening adverse event induced by ARB or CCB
•Pregnant woman
•Serious liver dysfunction (aspartate aminotransferase or alanine aminotransferase more than 10 times of normal upper limit)
•Serum creatinine > 1.8 mg/dl, known bilateral renal artery stenosis, single kidney, renal sclerosis
•Secondary hypertension, malignant hypertension, hypertensive encephalopathy
•Cardiovascular or cerebrovascular accidents within the last 6 months
•Patients with angina pectoris who need CCB or beta-blocker
•Significant aortic stenosis (peak transaortic valve pressure gradient > 20 mmHg)
•Important aortic or mitral regurgitation in the investigators opinion
•Patients with other diseases which affect the serum levels of carboxy-terminal telopeptide of collagen type I (CITP) and carboxy-terminal of procollagen type III (PIIIP)
•Prescription of ACEI or ARB within 5 months
•Prescription of beta-blocker or CCB within 4 weeks

Target sample size

300


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Masatsugu Hori

Organization

Osaka University Graduate School of Medicine

Division name

Department of Cardiovascular Medicine

Zip code


Address

2-2 Yamadaoka, Suita 565-0871, Japan

TEL

06-6879-5111

Email



Public contact

Name of contact person

1st name
Middle name
Last name Kazuhiro Yamamoto

Organization

Osaka University Graduate School of Medicine

Division name

Department of Cardiovascular Medicine

Zip code


Address

2-2 Yamadaoka, Suita 565-0871, Japan

TEL

06-6879-5111

Homepage URL

http://poppy.ac/j-elan/

Email

kazuhiro@medone.med.osaka-u.ac.jp


Sponsor or person

Institute

J-ELAN study group

Institute

Department

Personal name



Funding Source

Organization

Osaka Heart Club

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Japan


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

2006 Year 02 Month 01 Day


Related information

URL releasing protocol

http://poppy.ac/j-elan/

Publication of results

Published


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results

Under the similar reduction of blood pressure, losartan is likely effective in protecting the progression of atherosclerosis of the carotid artery compared to amlodipine. Losartan may improve LV diastolic function, and amlodipine may attenuate LV hypertrophy; however this study cannot make consecutive remarks about the superiority of either treatment regimen in the effects on cardiac function and geometry.

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

Completed

Date of protocol fixation

2004 Year 12 Month 27 Day

Date of IRB


Anticipated trial start date

2005 Year 03 Month 01 Day

Last follow-up date

2009 Year 07 Month 01 Day

Date of closure to data entry

2009 Year 08 Month 01 Day

Date trial data considered complete

2009 Year 10 Month 01 Day

Date analysis concluded

2010 Year 03 Month 01 Day


Other

Other related information

Yamamoto K, Ozaki H, Takayasu K, Akehi N, Fukui S, Sakai A, Kodama M, Shimonagata T, Kobayashi H, Ota M, Horiguchi Y, Ebisuno S, Katsube Y, Yamazaki T, Ohtsu H, Hori M. The Effect of losartan and amlodipine on left ventricular diastolic function and atherosclerosis in Japanese patients with mild-to-moderate hypertension -J-ELAN study- Hypertens Res (in press)


Management information

Registered date

2006 Year 02 Month 01 Day

Last modified on

2011 Year 02 Month 01 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000412


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name