Hypertention
Conditions
Interventions
Experimental group1:Compound preparation simulation tablet 1 tablet/d+Amlodipine 5mg/d
Experimental group2:Compound preparation 1 tablet /d+ Amlodipine analog tablet 1 tablet /d
Experimental group3:Compound preparation simulation tablet 1 tablet /d+ Alisartan 240mg/d
Experimental group4:Compound preparation 1 tablet /d+Alisartan analog tablet 1 tablet /d
Sponsors
Beijing Chaoyang Hospital of Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 70 years (including 18 years old and 70 years old), and the gender is not limited; 2.18.5kg/m^2= 130/80 mmHg; 7. Subjects (including partners) are willing to take effective contraceptive measures voluntarily from screening to 6 months after the last study drug administration; 8. The drug compliance before randomization of the double-blind treatment is 80% to 120% (including the boundary value); 9. Understand and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. Secondary hypertension (renal essential hypertension, Cushing's syndrome, primary aldosteronism, pheochromocytoma, drug-induced hypertension, etc.); 2. Mean sitting blood pressure (SBP) >= 180 mmHg and/or DBP >= 110mmHg, or patients with acute or subacute hypertension; 3. Allergy to CCB or ARB drugs, and intolerance to amlodipine or alisartan ester; 4. Two or more antihypertensive drugs (including compound preparations) were taken at the same time within 2 months before screening;Other antihypertensive agents other than amlodipine besylate or alisartan ester were used during the preceding 1 month of monotherapy for hypertension; 5. Nearly six months have heart failure (NYHA heart function New York heart association class for III and IV), acute coronary syndrome and percutaneous coronary intervention or other serious heart disease [such as cardiac shock, heart valve disease, II ~ III degree atrioventricular block, bradycardia (heart rate = 11mmol/L); 12. Renal artery stenosis or severe renal insufficiency (Cr > 1.5 times normal upper limit); 13 blood potassium > 5.5mmol/L; 14. Patients with active viral hepatitis (including hepatitis B and C), other severe liver disease or liver insufficiency (ALT or AST > 2.5 times normal upper limit and TBIL > 2 times normal upper limit); 15. Positive for AIDS antibody or treponema pallidum specific antibody; 16. Blood donation or massive blood loss (> 400mL) within 3 months before screening, or clinically diagnosed inadequate blood volume; 17. Female subjects are lactating or serum-positive during the screening period or during the trial; 18. History of substance abuse or alcohol abuse in the 6 months prior to screening (14 units of alcohol per week: 1 unit = 285mL beer, or 25mL spirits, or 100mL wine); 19. Participated in clinical trials of other drugs or devices within 3 months prior to screening; 20. Patients deemed unsuitable for clinical trials by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in mean systolic blood pressure when sitting from baseline; | — |
Countries
China
Contacts
Public ContactDong Shaohong
Shenzhen People's Hospital
Outcome results
None listed