UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000309 |
|---|---|
| Receipt number | R000000399 |
| Scientific Title | Japan Morning Surge -1 study |
| Date of disclosure of the study information | 2006/01/20 |
| Last modified on | 2006/01/19 19:00:57 |
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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
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
Sponsor or person
Institute
Division of Cardiovascular Medicine, Jichi Medical University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.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 | |
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| Registered date | File name |
