UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Assessment of time of day of blood pressure-lowering treatment by home blood pressure monitor in Japanese diabetic patients with hypertension
Title of the study (Brief title)	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	Masafumi Matsuda
Organization	Saitama Medical Center, Saitama Medical University
Division name	Dept. of Endocrinology and Diabetes
Address	1981 Kamoda, Kawagoe-shi, Saitama-ken, Japan
TEL	+81-49-228-3564
Email	matsudam-ind@umn.ac.jp

Public contact
Name of contact person	Masafumi Matsuda
Organization	Saitama Medical Center, Saitama Medical University
Division name	Dept. of Endocrinology and Diabetes
Address	1981 Kamoda, Kawagoe-shi, Saitama-ken
TEL	049-228-3564
Homepage URL
Email	bp@glucose-clamp.com

Sponsor
Institute	Dept. of Endocrinology and Diabetes, Saitama Medical Center, Saitama Medical University
Institute
Department

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)

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

Progress
Recruitment status	Main results already published
Date of protocol fixation	2012 Year 07 Month 15 Day
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

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000009825