UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study on quality use of angiotensin II receptor blockers -Comparison between valsartan and olmesartan-
Title of the study (Brief title)	Chronotherapy of ARBs
Region	Japan

Condition
Condition	hypertension
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To clarify the optimizing dosing-time of valsartan and olmesartan in improving the circadian rhythm of blood pressure and in preventing from the progression of organ damage in patients with nocturnal hypertension
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Phase IV

Assessment
Primary outcomes	# Decrease rate of nocturnal blood pressure # Change in the fall of blood pressure during night-time # Changes in urine albumin level and serum cystatin C concentration
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is considered as a block.
Blocking	YES
Concealment	No need to know

Intervention
No. of arms	4
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Once daily of valsartan (40-160mg/day) at morning for 4 months
Interventions/Control_2	Once daily of valsartan (40-160mg/day) at evening for 4 months
Interventions/Control_3	Once daily of olmesartan medoxomil (10-40mg/day) at morning for 4 months
Interventions/Control_4	Once daily of olmesartan medoxomil (10-40mg/day) at evening for 4 months
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	I. Men and women aged 20 or over II. Taking once daily of valsartan (40-160 mg/day) at morning III. More than two months without any change in treatment, including valsartan IV. Need not be considered additional changes and anti-hypertensive drugs V. If any other diseases complicated, it has been either stable disease, treatment details (drug and its usage) need not be expected to change VI. Been obtained in written informed consent to participate in this study
Key exclusion criteria	I. Have an anamnesis to the drug II. Pregnant or potentially pregnant women III. Severe renal impairment (more than twice the standard value of serum creatinine, including the case in hemodialysis) IV. Have been diagnosed with secondary hypertension V. Shift workers and night workers (Have an irregular rhythm of life-style) VI.Judged inappropriate to participate in this study by a doctor
Target sample size	150

Research contact person
Name of lead principal investigator	Akio Fujimura
Organization	Jichi Medical University
Division name	Clinical Pharmacology
Address	3311-1 Yakushiji, Shimotsuke, Tochigi
TEL	0285-58-7388
Email	akiofuji@jichi.ac.jp

Public contact
Name of contact person	Kentaro Ushijima
Organization	Jichi Medical University
Division name	Clinical Pharmacology
Address	3311-1 Yakushiji, Shimotsuke, Tochigi
TEL	0285-58-7388
Homepage URL
Email	ushijima-kentarou@umin.ac.jp

Sponsor
Institute	Division of Clinical Pharmacology, Department of Pharmacology, Jichi Medical University
Institute
Department

Funding Source
Organization	Japanese research Foundation of For Clinical Pharmacology
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization	Japan

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）、金沢循環器病院（石川県）、舩木・上野病院（石川県）、松永循環器病院（大分県）、笠岡第一病院（岡山県）、小林病院（埼玉県）、国際医療福祉大学病院（栃木県）

Other administrative information
Date of disclosure of the study information	2010 Year 06 Month 18 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2010 Year 06 Month 18 Day
Anticipated trial start date	2010 Year 06 Month 18 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	Published
URL releasing results	https://www.ncbi.nlm.nih.gov/pubmed/25704020
Results
Other related information

Management information
Registered date	2010 Year 06 Month 18 Day
Last modified on	2017 Year 11 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004541