UMIN-CTR Clinical Trial

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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