Mild to moderate essential hypertension
Conditions
Interventions
S086 tablets 120mg group:S086 tablets (2 tablets/time) + S086 mimetic tablets (6 tablets/time) + Olmesartan ester mimetic tablets (1 tablet/time), oral, QD, for 8 weeks.
S086 tablets 240mg group:S086 tablets (4 tablets/time) + S086 mimetic tablets (4 tablets/time) + Olmesartan ester mimetic tablets (1 tablet/time), oral, QD, for 8 weeks.
S086 tablets 480mg group:S086 tablets (8 tablets/time) + Olmesartan ester mimetic tablets (1 tablet/time), oral, QD, for 8 weeks.
Positive group:Olmesartan ester tablets (1 tablet/time) + S086 mimetic tablets (8 tablets/time), oral, QD, for 8 weeks.
Placebo group:S086 mimetic tablets (8 tablets/time) + Olmesartan ester mimetic tablets (1 tablet/time), oral, QD, for 8 weeks.
Sponsors
Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 75 years male and female; 2. Patients diagnosed with essential hypertension who have not received treatment or are receiving antihypertensive drugs (monotherapy or combination therapy of two drugs, including a compound containing two drug components); 3. Untreated patients (newly diagnosed essential hypertension or those with a history of hypertension but not taking any antihypertensive drugs for at least 4 weeks prior to screening) must have a msSBP > 150 mmHg and < 180 mmHg at screening (Visit 1) and before randomization (Visit 4); 4. Patients who are receiving antihypertensive medication (antihypertensive medication within 4 weeks before screening) must meet the criteria of msSBP 140 to 180 mmHg at the end of the washout period (Visit 2), msSBP 150 to 180 mmHg at the time of randomization (Visit 4); 5. The msSBP difference between the randomization (Visit 4) and the end of the washout period (Visit 2) must be <15 mmHg; 6. Participate in the trial voluntarily and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. Severe hypertension (msSBP >=180 mmHg, and/or msDBP >=110 mmHg); malignant hypertension, hypertensive emergency, hypertensive crisis, hypertensive encephalopathy, etc.; 2. History of angioedema due to drug-related or other causes; 3. History or diagnosis of secondary hypertension, including but not limited to the following: renal parenchymal hypertension, renal vascular hypertension (unilateral or bilateral renal artery stenosis), aortic stenosis, primary aldosteronism, Cushing's syndrome, pheochromocytoma, cystic nephropathy, and drug-induced hypertension; 4. Hypertension with the following lesions: acute coronary syndrome, myocardial infarction, percutaneous coronary intervention, cerebrovascular accident within 6 months; NYHA class II-IV heart failure, large or dissecting aneurysm, atrioventricular block above degree II, sick sinus syndrome, bradycardia (heart rate 5.5 mmol/L; blood ALT and/or AST > 2.5 ULN; serum creatinine > 1.5 ULN; and any clinically significant laboratory abnormalities that the investigators believe may interfere with the evaluation of efficacy and/or safety data of this study; 6. T1DM and poorly controlled T2MD (HbAlc 30 kg/m^2 (BMI = weight (kg)/height^2 (m^2)); 8. Patients with malignant tumors; 9. Patients undergoing hemodialysis or strict salt restriction therapy; 10. Gastrointestinal lesions or gastrointestinal surgery may affect drug absorption or excretion, such as gastroenterectomy, active gastrointestinal inflammation, ulceration, or gastrointestinal bleeding; 11. Known or suspected allergy to S086, sakubatrovalsartan sodium or olmesartan ester and related drugs (ARB, ACEI and renin inhibitors); 12. Use of various antihypertensive drugs, antianginal drugs (trimetazidine excepted), digitalis drugs, glucocorticoids (topical glucocorticoids excepted), estrogens, potassium supplement drugs and other chemicals, biological products, traditional Chinese medicine or natural drugs that investigators consider not suitable for use in the lead-in period; 13. Female subjects who are pregnant, breast-feeding, or have a positive pregnancy test; or those whose partners are unable to guarantee effective contraception during the trial (acceptable forms of contraception: true abstinence; intrauterine devices; barrier contraceptives; or partners undergoing sterilization procedures). Unacceptable contraceptive methods: periodic abstinence, such as contraception based on calendar, ovulation, symptomatic body temperature; or having a family planning program within 6 months after the end of the trial; 14. History of drug abuse or alcohol abuse within 6 months prior to screening (alcoholism is defined as drinking 14 units of alcohol per week: 1 unit = 285 mL of beer, or 25 mL of spirits, or 100 mL of wine); 15. Participate in any other clinical trials such as drugs or medical devices within 3 months before screening, or participate in any other clinical trials such as drugs or medical devices during the planned trial or within 3 months after the end of the trial; 16. Previous participation in other S086 clinical trials; 17. Drug compliance in the lead-in period is 120%; 18. The investigator considers any other reason that may affect the efficacy and/or safety evaluation of this study that is not s
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| msSBP average; | — |
Secondary
| Measure | Time frame |
|---|---|
| msDBP average;MAP average;Blood pressure reduction effective rate;Blood pressure reduction compliance rate;24h ambulatory blood pressure monitoring; | — |
Countries
China
Contacts
Public ContactJiguang Wang
Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Outcome results
None listed