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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001139
Receipt No. 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

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

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
URL(English) https://upload.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


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