UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008748 |
|---|---|
| Receipt number | R000009825 |
| Scientific Title | Assessment of time of day of blood pressure-lowering treatment by home blood pressure monitor in Japanese diabetic patients with hypertension |
| Date of disclosure of the study information | 2012/08/22 |
| Last modified on | 2017/02/24 09:31:01 |
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Basic information
Public title
Assessment of time of day of blood pressure-lowering treatment by home blood pressure monitor in Japanese diabetic patients with hypertension
Acronym
TODBP study
Scientific Title
Assessment of time of day of blood pressure-lowering treatment by home blood pressure monitor in Japanese diabetic patients with hypertension
Scientific Title:Acronym
TODBP study
Region
| Japan |
Condition
Condition
diabetes mellitus, hypertension
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess better time (after breakfast or bedtime) to take anti-hypertensive agents in a day, the difference of home blood pressure monitoring results will be compared in Japanese type 2 diabetic patients with hypertension.
Basic objectives2
Others
Basic objectives -Others
To assess the effect of time to take anti-hypertensive agents on drug adherence.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Average blood pressure with standard deviation of home blood pressure monitoring
Key secondary outcomes
Frequency of missing to take medications, and self-comfortless
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
taking anti-hypertensive drugs after the breakfast
Interventions/Control_2
taking anti-hypertensive drugs at bedtime
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
| 18 | years-old | <= |
Age-upper limit
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
diabetic patients with hypertension
Key exclusion criteria
1) those who are taking diuretics
2) when a doctor dicide not to be enrolled
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masafumi Matsuda |
Organization
Saitama Medical Center, Saitama Medical University
Division name
Dept. of Endocrinology and Diabetes
Zip code
Address
1981 Kamoda, Kawagoe-shi, Saitama-ken, Japan
TEL
+81-49-228-3564
matsudam-ind@umn.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masafumi Matsuda |
Organization
Saitama Medical Center, Saitama Medical University
Division name
Dept. of Endocrinology and Diabetes
Zip code
Address
1981 Kamoda, Kawagoe-shi, Saitama-ken
TEL
049-228-3564
Homepage URL
bp@glucose-clamp.com
Sponsor or person
Institute
Dept. of Endocrinology and Diabetes, Saitama Medical Center, Saitama Medical University
Institute
Department
Personal name
Funding Source
Organization
Dept. of Endocrinology and Diabetes, Saitama Medical Center, Saitama Medical University
Organization
Division
Category of Funding Organization
Self funding
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
埼玉医科大学総合医療センター
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 08 | Month | 22 | Day |
Related information
URL releasing protocol
Publication of results
Partially 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
Main results already published
Date of protocol fixation
| 2012 | Year | 07 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 07 | Month | 15 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 08 | Month | 22 | Day |
Last modified on
| 2017 | Year | 02 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009825
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
