UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Investigation about treatment of midnight hypertension in diabetes
Title of the study (Brief title)	Investigation about treatment of midnight hypertension in diabetes
Region	Japan

Condition
Condition	hypertension in diabetes
Classification by specialty	Cardiology Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To clarify the best combination of Ca antagonist and ARB in the treatment of hypertensive diabetes patients using ambulatory blood pressure monitoring
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	comparison of the anti-hypertensive effect through the 24 hrs
Key secondary outcomes	change in urinary albumin excretion ratio

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	4
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	olmesartan 20 mg +amlodipine 5mg once daily
Interventions/Control_2	olmesartan 20 mg + azelnidipine 16 mg once daily
Interventions/Control_3	candesartan 8 mg or varsartan 80 mg + amlodipine 5mg once daily
Interventions/Control_4	candesartan 8 mg or varsartan 80 mg + azelnidipine 16 mg once daily
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	79 years-old >
Gender	Male and Female
Key inclusion criteria	diabetes patient having midnight hypertension
Key exclusion criteria	1) drug allergy to ARB or Ca antagonist 2) pregnant women or possible pregnant women 3) using anti-fugal drug or HIV protease inhibitor 4) bilateral renal artery stenosis or unilateral renal artery stenosis of remnant kidny
Target sample size	40

Research contact person
Name of lead principal investigator	Kazuhiko sakaguchi
Organization	Department od Internal Medicine, Kobe University Graduate School of Medicine
Division name	Division of diabetes, metabolism and Endocrinology
Address	7-5-1 Kusunoki-cho, Chuo-ku, Kobe
TEL	078-382-5861
Email	kzhkskgc@med.kobe-u.ac.jp

Public contact
Name of contact person	Kazuhiko sakaguchi
Organization	Department od Internal Medicine, Kobe University Graduate School of Medicine
Division name	Division of diabetes, metabolism and Endocrinology
Address	7-5-1 Kusunoki-cho, Chuo-ku, Kobe
TEL	078-382-5861
Homepage URL
Email	kzhkskgc@med.kobe-u.ac.jp

Sponsor
Institute	Division of diabetes, metabolism and Endocrinology Department od Internal Medicine, Kobe University Graduate School of Medicine
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	none
Name of secondary funｄer(s)	none

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	2009 Year 09 Month 15 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2009 Year 06 Month 03 Day
Anticipated trial start date	2009 Year 09 Month 01 Day
Last follow-up date	2013 Year 07 Month 15 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2009 Year 07 Month 15 Day
Last modified on	2017 Year 04 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000002712