Grade I or Grade II essential hypertension patients
Conditions
Interventions
Azilsartan Single dose of 20 mg/day in oral administration Treatment duration: 8 weeks
Amlodipine Single dose of 5 mg/day in oral administration Treatment duration: 8 weeks
Sponsors
ACS Society
Sogo Rinsho Medefi Co., Ltd Asklep Co., Ltd Linical Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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) | — |
Secondary
| Measure | Time frame |
|---|---|
| (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 | — |
Countries
Japan
Contacts
Public ContactNaoyuki Takano
Sogo Rinsho Medefi Co., Ltd Business promotion department Assistant general manager
Outcome results
None listed