UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A Study on the Effects of Chronotherapy of Hypertension with Olmesartan on Blood-pressure Variability, Sympathetic Function, and Renal Function in Patients with Type 2 Diabetes Mellitus and Hypertension
Title of the study (Brief title)	J-CORRECT
Region	Japan

Condition
Condition	Patients with type 2 DM and hypertension.
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The objectives of this voluntary clinical study are to compare changes in home blood pressure and the effect of olmesartan on sympathetic function and renal function when administered in the morning versus before bedtime to patients with type 2 DM and hypertension.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Phase IV

Assessment
Primary outcomes	(i) Changes in home blood pressure from before to after administration in the morning or before bedtime (early-morning, nighttime, and before bedtime blood pressure and heart rate) and the effect of the time of administration of olmesartan on Na excretion (ii) Effect of morning and pre-bedtime administration on blood-pressure variability (ME difference, mean ME, and day-by-day blood pressure variability)
Key secondary outcomes	(i) Changes in outpatient blood pressure and heart rate from before to after administration (ii) Effect on the sympathetic nervous system: Changes in cortisol levels (iii) Effect on renal function: Changes in urinary albumin and RAAS-related enzyme levels (iv) Effect on cardiac function: Changes in BNP, NT-ProBNP, and hs-cTnT levels (v) Effect on glucose metabolism: Changes in HbA1c and adiponectin levels (vi) Effect on the anti-inflammatory process: Changes in hs-CRP level (vii) Evaluation of safety such as adverse events other than the primary endpoints

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	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	The morning olmesartan groups of patients with type 2 DM and hypertension n=100
Interventions/Control_2	The pre-bedtime olmesartan groups of patients with type 2 DM and hypertension n=100
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	30 years-old <
Age-upper limit	85 years-old >
Gender	Male and Female
Key inclusion criteria	1)Age:>30 to <85 years 2)Gender: Male or female 3)Patients with type 2 DM and hypertension with outpatient blood pressure of >= 130/80 mmHg despite treatment with ARBs (candesartan, losartan, valsartan, telmisartan, irbesartan, and/or azilsartan) other than olmesartan at the usual or maximum dose for at least 12 weeks in the morning
Key exclusion criteria	Patients who meet any of the following criteria will not be included in the study: 1)Patients with secondary or malignant hypertension 2)Patients with severe heart failure (NYHA Class III or higher) 3)Patients with nephrotic syndrome (or serum creatinine [Cr] >= 3.0 mg/dL) 4)Patients with serious liver or biliary diseases 5)Patients with a history of cardiovascular (myocardial infarction) or cerebral events (cerebral infarction) 6)Patients with endocrine disease 7)Patients with any malignancy 8)Patients determined by the investigator to be not suitable for other reasons
Target sample size	200

Research contact person
Name of lead principal investigator	Kazuomi Kario
Organization	Jichi Medical University School of Medicine
Division name	Division of Cardiovascular Medicine, Department of Medicine
Address	3311-1 Yakushiji, Shimotsuke, Tochigi 329-0498, Japan.
TEL	0285-58-7344
Email	kkario@jichi.ac.jp

Public contact
Name of contact person	Yuichiro Yano
Organization	Jichi Medical University School of Medicine
Division name	Division of Cardiovascular Medicine, Department of Medicine
Address	3311-1 Yakushiji, Shimotsuke, Tochigi 329-0498, Japan.
TEL	0285-58-7344
Homepage URL
Email	yyano@jichi.jp

Sponsor
Institute	Division of Cardiovascular Medicine, Department of Medicine, Jichi Medical University School of Medicine
Institute
Department

Funding Source
Organization	This study was supported by a grant from Jichi Medical University School of Medicine.
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	自治医科大学附属病院（栃木県）、たまきクリニック（宮崎県）、えとう循環器科・内科クリニック（宮崎県）、横田内科（宮崎県）、 串間市民病院（宮崎県）

Other administrative information
Date of disclosure of the study information	2013 Year 05 Month 01 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2012 Year 10 Month 01 Day
Anticipated trial start date	2013 Year 05 Month 01 Day
Last follow-up date	2016 Year 09 Month 30 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	2013 Year 04 Month 04 Day
Last modified on	2017 Year 04 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011902