UMIN-CTR Clinical Trial

Public title

Azilsartan Circadian and Sleep pressure the 1st study

Acronym

ACS1

Scientific Title

Azilsartan Circadian and Sleep pressure the 1st study

Scientific Title:Acronym

ACS1

Region

Japan

Condition

Grade I or Grade II essential hypertension patients

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To determine the efficacy of Azilsartan 20 mg versus Amlodipine 5 mg oral administration once per day for 8 weeks in patients with grade I or grade II essential hypertension.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

Change in nocturnal systolic blood pressure level*
-Change at the end of a treatment period (Week8) from the beginning point of an observation period
* : -- nocturnal systolic blood pressure level: -- the mean value of systolic arterial pressure during night (during sleeping)

Key secondary outcomes

(1) Efficacy:
I. Change in the absolute value in difference with targeted value** (15%) of nocturnal systolic blood pressure fall*
II. Change in nocturnal diastolic blood pressure level
III. Change in 24-hour mean systolic blood pressure level
IV. Change in 24-hour mean diastolic blood pressure level
V. Change in urinary micro albumin excretion
VI. Change in N-terminal pro-B-type natriuretic peptide (NT-proBNP)
VII. Change in high-sensitivity cardiac troponin T (hs-cTnT)
VIII. Change in fasting glucose
IX. Change in insulin resistance index***

*: Rate of nocturnal blood pressure fall: calculated as (awake SBP-sleep SBP)/awake SBP
**: The targeted value has been set as the median of the dipping rate, normal type of nocturnal blood pressure variation, rate of nocturnal blood pressure fall(10-20%)
***: Insulin resistance index = fasting insulin level x fasting glucoselevel /405

(2) safeties:
Adverse event
-For SAS, count the onset rate of adverse events in term from the start of treatment period (Week0) to the end (Week8) in each group

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is not considered as adjustment factor.

Blocking

YES

Concealment

Central registration

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Azilsartan
Single dose of 20 mg/day in oral administration
Treatment duration: 8 weeks

Interventions/Control_2

Amlodipine
Single dose of 5 mg/day in oral administration
Treatment duration: 8 weeks

Interventions/Control_3

Interventions/Control_4

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. Grade I or 2 essential hypertension
II. The sitting systolic blood pressure is in term of 140-179 mmHg, or sitting diastolic blood pressure is in term of 90-109 mmHg at the both two time points at the beginning of the observation period and at the beginning of a treatment period (Week0).
III. 20 years old or older at the time of the informed consent
IV. Able to give written informed consent before participating in the research
V. Therapeutic category during the observation period: Ambulatory

Key exclusion criteria

A. Secondary hypertension, grade III hypertension (sitting systolic blood pressure greater than or equal to 180mmHg or sitting diastolic blood pressure greater than or equal to 110mmHg), malignant hypertension
B. More than 2 kinds of hypotensive agents for treatment on the hypertension
C. History of taking following within 2 weeks before start of the observation period
When subject taking any of the following at the time of informed consent is included, stop to take the medicine for determined period after the informed consent.
a. Hypotensive agents
b. Antianginal agents
c. Antiarrhythmic agents (except single time use of the lidocaine hydrochloride formulation for anesthesia)
d. Digitalis products
D. Less than 130mmHg of mean 24-hour systolic blood pressure and less than 80mmHg of mean 24-hour diastolic blood pressure at the start of the observation period.
E. History of following circulatory-related diseases or symptoms within 24 weeks before start of the observation period
a. Cardiac disease: Myocardial infarction, coronary artery revascularization
b. Cerebrovascular disease: cerebral infarction, cerebral hemorrhage, transient ischemic attack
c. Progressive hypertensive retinopathy: hemorrhage, exudation, or papilledema
F. History or complication with the following circulatory-related diseases
Valvular stenosis, Atrial fibrillation, pharmacotherapy-required angina, congestion heart failure, or cardiac arrhythma, or arteriosclerosis obliterans with symptoms of intermittent claudication et al
G. Day/night reversal
H. History of hypersensitivity or allergy to Azilsartan, Amlodipine, or related drugs
I. Participant in any other clinical research
J. Pregnant, possible to pregnancy, or lactating woman
K. Mal-control of blood pressure during informed consent to taking hypotensive agent
L. Symptoms or abnormalities require the withdrawal as soon as possible during informed consent to taking hypotensive agent
M. Any those the investigator or other researchers consider as unsuitable

Target sample size

700

Name of lead principal investigator

1st name
Middle name
Last name	Kazuomi Kario

Organization

ACS Society

Division name

Jichi Medical University School of Medicine, Internal Medicine, Department of Cardiology

Zip code

Address

3311-1 Yakushiji, Shimotsuke, Tochigi

TEL

0285-58-7538

Email

Name of contact person

1st name
Middle name
Last name	Naoyuki Takano

Organization

Sogo Rinsho Medefi Co., Ltd

Division name

Business promotion department Assistant general manager

Zip code

Address

KDX Building 9th Floor, 3-2-7, Nishi-shinjuku, Shinjuku-ku, Tokyo

TEL

03-6901-6079

Homepage URL

Email

ACS1@sogo-medefi.jp

Institute

ACS Society

Institute

Department

Personal name

Organization

Takeda Pharmaceutical Company Ltd

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan

Co-sponsor

Sogo Rinsho Medefi Co., Ltd
Asklep Co., Ltd
Linical Co., Ltd.

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

Date of disclosure of the study information

2012

Year

12

Month

18

Day

URL releasing protocol

Publication of results

Published

URL related to results and publications

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

Main results already published

Date of protocol fixation

2012

Year

10

Month

12

Day

Date of IRB

Anticipated trial start date

2012

Year

12

Month

22

Day

Last follow-up date

2013

Year

11

Month

28

Day

Date of closure to data entry

2013

Year

12

Month

20

Day

Date trial data considered complete

2013

Year

12

Month

20

Day

Date analysis concluded

2014

Year

08

Month

31

Day

Other related information

Registered date

2012

Year

12

Month

18

Day

Last modified on

2015

Year

09

Month

30

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011237