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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000309
Receipt No. R000000399
Scientific Title Japan Morning Surge -1 study
Date of disclosure of the study information 2006/01/20
Last modified on 2006/01/19

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Basic information
Public title Japan Morning Surge -1 study
Acronym JMS1 study
Scientific Title Japan Morning Surge -1 study
Scientific Title:Acronym JMS1 study
Region
Japan

Condition
Condition Hypertensive outpatiens
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Morning blood pressure is reported to be more closely related to hypertensive organ damage such as left ventricular mass index, microalbuminuria and silent cerebral infarcts, than blood pressure at other times of the day. Morning blood pressure may play an important role in pathogenesis of hypertensive target organ damage. Increased sympathetic nerve activity is reported to be one of the mechanisms of morning hypertension; however, there are no available data that show whether strict home blood pressure control, especially in the morning period can reduce target organ damage.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Brain natriuretic peptide (BNP)
Urinary albumin excretion /creatinine ratio (UAR)
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification NO
Dynamic allocation NO
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 Doxazosin
Interventions/Control_2 Doxazosin, beta 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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1.Hypertensive outpatients with uncontrolled morning systolic BP (>135 mmHg) and antihypertensive medication status for 3 months.
Key exclusion criteria 1. History of heart failure
2. Orthostatic hypotension
3. Dementia
4. Malignancy
5. Chronic inflammatory disease
6. Users of alfa blocker or beta blocker.
7. Atrial fibrillation.
8. Judged inappropriate for this study by the physicians
Target sample size 600

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuomi Kario
Organization Jichi Medical University School of Medicine
Division name Division of Cardiovascular Medicine
Zip code
Address 3311-1, Yakushiji, Shimotsuke, Tochigi, Japan
TEL 0285-58-7344
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization apan Morning Surge-1 study group
Division name Division of Cardiovascular Medicine, Jichi Medical University School of Medicine
Zip code
Address
TEL
Homepage URL
Email

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

Funding Source
Organization The Japan Heart Foundation
Organization
Division
Category of Funding Organization Non profit foundation
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
2006 Year 01 Month 20 Day

Related information
URL releasing protocol
Publication of results Published

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
2003 Year 06 Month 30 Day
Date of IRB
Anticipated trial start date
2003 Year 08 Month 01 Day
Last follow-up date
2005 Year 08 Month 01 Day
Date of closure to data entry
2005 Year 09 Month 01 Day
Date trial data considered complete
2005 Year 10 Month 01 Day
Date analysis concluded
2006 Year 01 Month 01 Day

Other
Other related information

Management information
Registered date
2006 Year 01 Month 19 Day
Last modified on
2006 Year 01 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000399

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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