UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Investigation of effective treatment of nocturnal hypertension in diabetes
Title of the study (Brief title)	Treatment of nocternal hypertension in diabetes with new blood pressure measureing method
Region	Japan

Condition
Condition	Nocturnal hypertension in type 2 DM
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Effects on noucurnal hypertension with changing ARB and CCB to losartan/ hydrochlorothiazide in type 2 diabetes
Basic objectives2	Others
Basic objectives -Others	effects on metabolic parameter
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Phase IV

Assessment
Primary outcomes	Change in nocturnal blood pressure level after 12 weeks of treatment
Key secondary outcomes	change in blood pressure level on an outpatient basis after 4,8 weeks of treatment change after12 weeks about HbA1c, fasting bllod glucose level, urine alubimin excretion, Urine Na, Crine K, renin, aldsterone, BNP, serum K, serum Na, serum UA, serum Creatinine, eGFR, LDL-C, TG, HDL-C

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Losartan / hydrochlorothiazide group
Interventions/Control_2	ARB and CCB group
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Hypertensive diabetic patients, who have been treated with ARB and Carcium channnel blocker for more than 4weeks, but not reached systolic blood pressure to 150 mmHg and /or diastolic blood pressure to 100 mmHg 2) aged more than 20 years 3) men and women 4) patients who fully understand the study procedures explained to them using explanatory notes and have given written informed consent to patients in the study
Key exclusion criteria	1) patients with secondary hypertension 2) patients with liver dysfunction (GPT over three times the normal value) 3) patients with renal failure (serum creatinine over 2.0 mg/dL) 4) patients with bilareral renal artery stenosis 5) pregnant or possible pregnant women 6) patients with a history of hypersensitivity to Losartan or thiazide
Target sample size	50

Research contact person
Name of lead principal investigator	kazuhiko sakaguchi
Organization	Kobe University Graduate School of Medicine
Division name	Division of deabetes, metabolism and endocrinology
Address	7-5-1, Kusunoki-Cho, Chuo-Ku, Kobe, 650-0017 Japan
TEL	078-382-5861
Email	kzhkskgc@med.kobe-u.ac.jp

Public contact
Name of contact person	kazuhiko sakaguchi
Organization	Kobe University Graduate School of Medicine
Division name	Division of deabetes, metabolism and endocrinology
Address	7-5-1, Kusunoki-Cho, Chuo-Ku, Kobe, 650-0017 Japan
TEL	078-382-5861
Homepage URL
Email	kzhkskgc@med.kobe-u.ac.jp

Sponsor
Institute	Kobe University Graduate School of Medicine Division of deabetes, metabolism and endocrinology
Institute
Department

Funding Source
Organization	Division of deabetes, metabolism and endocrinology Kobe University Graduate School of Medicine
Organization
Division
Category of Funding Organization
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

Other administrative information
Date of disclosure of the study information	2009 Year 07 Month 01 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2009 Year 05 Month 15 Day
Anticipated trial start date	2009 Year 07 Month 01 Day
Last follow-up date	2011 Year 03 Month 01 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 03 Month 26 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=R000002176