UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000001139
Receipt number R000001383
Scientific Title Japan Morning Surge-Total Organ Protection: JMS-TOP Study
Date of disclosure of the study information 2008/04/29
Last modified on 2018/09/05 12:19:16

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Basic information

Public title

Japan Morning Surge-Total Organ Protection: JMS-TOP Study

Acronym

JMS-TOP Study

Scientific Title

Japan Morning Surge-Total Organ Protection: JMS-TOP Study

Scientific Title:Acronym

JMS-TOP Study

Region

Japan


Condition

Condition

Hypertension

Classification by specialty

Medicine in general Cardiology Endocrinology and Metabolism
Nephrology Geriatrics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To compare the efficacy of evening versus morning administration of angiotensin II receptor blocker (Candesartan) on home blood pressure and hypertensive target organ damage

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

Reduction of home morning blood pressure
Improvements of hypertensive target organ damage measured as urinary albumin excretion ratio and brain-type natriuretic peptide

Key secondary outcomes

Changes in 24-hr blood pressure
Changes in left ventricular hypertrophy(electrocardiogram and echocardiography), left ventricular diastolic function, carotid intima-media thickness, pulse wave velocity, augmentation index and baroreflex sensitivity


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

YES

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Evening administration of angiotensin II receptor blocker (Candesartan)

Interventions/Control_2

Morning administration of angiotensin II receptor blocker (Candesartan)

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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Hypertensive patients with morning and/or evening home systolic blood pressure at least 135 mmHg

Key exclusion criteria

1) Recent history (within 6 months) of ischemic heart disease, stroke (excluding transient ischemic attack), aortic dissection, and peripheral arterial disease.
2) History of admission due to heart failure
3) On hemodialysis
4) Chronic inflammatory disease (cancer, collagen disease)
5) Subjects who are difficult to get informed consent
6) Subjects who are unable to visit to hospitals/clinics
7) History of adverse effect with candesartan, and contraindications of candesartan
8) Atrial fibrillation
9) Bilateral renal arterial stenosis

Target sample size

450


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kazuomi Kario

Organization

Jichi Medical University

Division name

Division of Cardiovascular Medicine

Zip code


Address

Yakushiji 3311-1, Shimotsuke, Tochigi, Japan

TEL

0285-44-2111

Email

kkario@jichi.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Satoshi Hoshide, Joji Ishikawa

Organization

JMS-TOP study coordinator

Division name

Division of Cardiovascular Medicine, Department of Medicine, Jichi Medical University School of Medi

Zip code


Address

Yakushiji 3311-1, Shimotsuke, Tochigi 320-0498, Japan

TEL

0285-44-2130

Homepage URL


Email

saikimi@jichi.ac.jp


Sponsor or person

Institute

Division of Cardiovascular Medicine, Department of Medicine, Jichi Medical University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Japan Heart Foundation

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

2008 Year 04 Month 29 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

Completed

Date of protocol fixation

2005 Year 04 Month 01 Day

Date of IRB


Anticipated trial start date

2005 Year 04 Month 01 Day

Last follow-up date

2008 Year 12 Month 01 Day

Date of closure to data entry

2009 Year 06 Month 01 Day

Date trial data considered complete

2009 Year 09 Month 01 Day

Date analysis concluded



Other

Other related information



Management information

Registered date

2008 Year 04 Month 29 Day

Last modified on

2018 Year 09 Month 05 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001383


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name