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UMIN-CTR Clinical Trial |
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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 |
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 |
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Condition | ||
Condition | Hypertensive outpatiens | |
Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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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 |
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Target sample size | 600 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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Organization | apan Morning Surge-1 study group | ||||||
Division name | Division of Cardiovascular Medicine, Jichi Medical University School of Medicine | ||||||
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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 |
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Co-sponsor | |
Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | |
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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 |
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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 | |
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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 |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry |
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Date trial data considered complete |
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Date analysis concluded |
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Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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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 |