UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The importance of home blood pressure in patients with diabetes.
Title of the study (Brief title)	home blood pressure in patients with diabetes.
Region	Japan

Condition
Condition	diabetes mellitus
Classification by specialty	Medicine in general Cardiology Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of the present study is to provide an innovative thrapeutic means for the prevention and treatment of microvascular and macrovascular complications in patients with diabetes mellitus.
Basic objectives2	Others
Basic objectives -Others	The aim of the present study is to compare the effects on home blood pressure and home blood pressure variability of combination therapy of olmesartan combined with azelnidipine or trichlormethiazide in patients with type 2 diabetes mellitus using home blood pressure telemonitoring system.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	home blood pressure and home blood pressure variability at least 28 days after randomization or switching drugs.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit
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	olmesartan 20mg and azelnidipine 16mg, olmesartan 20mg and trichlormethiazide 1mg for more than 6 weeks each We used HBP data at least 28 days after randomization or switching drugs.
Interventions/Control_2	olmesartan 20mg and trichlormethiazide 1mg, olmesartan 20mg and azelnidipine 16mg for more than 6 weeks each We used HBP data at least 28 days after randomization or switching drugs.
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	40 years-old <=
Age-upper limit	80 years-old >
Gender	Male and Female
Key inclusion criteria	Inclusion criteria were as follows: 40-80 years, type 2 diabetes mellitus, hypertension with the use of RAS inhibitors, RAS inhibitors and CCBs, or RAS inhibitors and diuretics.
Key exclusion criteria	Exclusion criteria were as follows: secondary hypertension or malignant hypertension, history of cerebrovascular accident, myocardial infarction or hospitalization for angina pectoris within 6 months before evaluation for study entry, advanced liver or renal dysfunction (serum creatinine equal to or more than 2.0mg/dl or current treatment by dialysis), atrial fibrillation or severe arrhythmia, prescribed 3 and over antihypertensive drugs, prescribed other class of antihypertensive drugs than study drugs (that is, RAS inhibitors, CCBs or diuretics), history of side effects from study drugs, life-threatening condition like malignant tumor or not suited to be a study patients as judged by a physician in charge.
Target sample size	50

Research contact person
Name of lead principal investigator	Michiaki Fukui
Organization	Kyoto Prefectural University of Medicine, Graduate School of Medical Science
Division name	Department of Endocrinology and Metabolism
Address	465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan
TEL	075-251-5505
Email	michiaki@koto.kpu-m.ac.jp

Public contact
Name of contact person	Emi Ushigome
Organization	Kyoto Prefectural University of Medicine, Graduate School of Medical Science
Division name	Department of Endocrinology and Metabolism
Address	465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan
TEL	075-251-5505
Homepage URL
Email	emis@koto.kpu-m.ac.jp

Sponsor
Institute	Kyoto Prefectural University of Medicine, Graduate School of Medical Science
Institute
Department

Funding Source
Organization	Emi Ushigome received grant support from Japanese Study Group for Physiology and Management of Blood Pressure and Astellas Foundation for Research on Metabolic Disorders.
Organization
Division
Category of Funding Organization	Other
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	2015 Year 08 Month 07 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 04 Month 01 Day
Anticipated trial start date	2014 Year 04 Month 01 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	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 08 Month 07 Day
Last modified on	2016 Year 08 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000020409