UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009576 |
|---|---|
| Receipt number | R000011237 |
| Scientific Title | Azilsartan Circadian and Sleep pressure the 1st study |
| Date of disclosure of the study information | 2012/12/18 |
| Last modified on | 2015/09/30 18:55:46 |
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Basic information
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
Condition
Grade I or Grade II essential hypertension patients
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
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
Assessment
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
Base
Study type
Interventional
Study design
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
Intervention
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
Eligibility
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
Research contact person
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
Public contact
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
ACS1@sogo-medefi.jp
Sponsor or person
Institute
ACS Society
Institute
Department
Personal name
Funding Source
Organization
Takeda Pharmaceutical Company Ltd
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Sogo Rinsho Medefi Co., Ltd
Asklep Co., Ltd
Linical Co., Ltd.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2012 | Year | 12 | Month | 18 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
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
Progress
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
Other related information
Management 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
