UMIN-CTR Clinical Trial

Public title

Study on quality use of angiotensin II receptor blockers -Comparison between valsartan and olmesartan-

Acronym

Chronotherapy of ARBs

Scientific Title

Study on quality use of angiotensin II receptor blockers -Comparison between valsartan and olmesartan-

Scientific Title:Acronym

Chronotherapy of ARBs

Region

Japan

Condition

hypertension

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

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

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

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

Name of lead principal investigator

1st name
Middle name
Last name	Akio Fujimura

Organization

Jichi Medical University

Division name

Clinical Pharmacology

Zip code

Address

3311-1 Yakushiji, Shimotsuke, Tochigi

TEL

0285-58-7388

Email

akiofuji@jichi.ac.jp

Name of contact person

1st name
Middle name
Last name	Kentaro Ushijima

Organization

Jichi Medical University

Division name

Clinical Pharmacology

Zip code

Address

3311-1 Yakushiji, Shimotsuke, Tochigi

TEL

0285-58-7388

Homepage URL

Email

ushijima-kentarou@umin.ac.jp

Institute

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

Institute

Department

Personal name

Organization

Japanese research Foundation of For Clinical Pharmacology

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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）

Date of disclosure of the study information

2010

Year

06

Month

18

Day

URL releasing protocol

Publication of results

Published

URL related to results and publications

https://www.ncbi.nlm.nih.gov/pubmed/25704020

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2010

Year

06

Month

18

Day

Date of IRB

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

Other related information

Registered date

2010

Year

06

Month

18

Day

Last modified on

2017

Year

11

Month

15

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004541