Mild to Moderate Hypertension
Conditions
Interventions
S086 group:S086
S086 placebo:S086 placebo
Olmesartan Medoxomil Tablets:Olmesartan Medoxomil Tablets
Sponsors
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. aged between 18-75 years; 2. Patients with mild-to-moderate hypertension, untreated or currently taking antihypertensive therapy(Combination therapy with a single drug or two drugs includes a combination of two drugs); 3. Untreated patients (newly diagnosed with essential hypertension or having a history of hypertension but have not been taking any antihypertensive drugs for at least 4 weeks prior to Visit 1) must have an msSBP 150 mmHg to 180 mmHg at both Visit 1 and Visit 4; 4. Treated patients (using antihypertensive treatments within 4 weeks prior to Visit 1 must have an msSBP 150 mmHg to 180 mmHg at the randomization visit 4 and msSBP 140 mmHg to 180 mmHg at the visit immediately proceeding Visit 2; 5. Patients must have an absolute difference of <=15 mmHg in msSBP between Visit 201 and the immediately preceding visit; 6. Volunteer to participate in the trial and sign informed consent.
Exclusion criteria
Exclusion criteria: 1. Severe hypertension (msDBP >=110 mmHg and/or msSBP >=180 mmHg); 2. History of angioedema, drug-related or otherwise; 3. History or evidence of a secondary form of hypertension, including but not limited to any of the following: renal parenchymal hypertension, renovascular hypertension (unilateral or bilateral renal artery stenosis), coarctation of the aorta, primary hyperaldosteronism, Cushing's disease, pheochromocytoma, polycystic kidney disease, and drug-induced hypertension; 4. Hypertension complicated with the following diseases: acute coronary syndrome, myocardial infarction, percutaneous coronary intervention, cerebrovascular accident within 6 months; NYHA class II-IV heart failure, large artery aneurysm or dissecting aneurysm, atrioventricular block above II degree, sick sinus syndrome, bradycardia (heart rate 5.5mmol/l; serum ALT and / or ast >2.5 ULN; serum creatinine >1.5 ULN; any clinically significant laboratory abnormalities that the researchers believe may interfere with the evaluation of the efficacy and / or safety data of this study; 6. Type 1 diabetes and type 2 diabetes with poor glycemic control (HbAlc >=8%); 7. Overweight, BMI > 30kg / m^2 (BMI = weight(kg)/height^2 (m^2)); 8. Cancer patients; 9. Patients with hemodialysis or strict salt restriction therapy; 10. Gastrointestinal lesions or gastrointestinal surgery may affect drug absorption or excretion, such as gastrointestinal resection, active gastrointestinal inflammation, ulcer or gastrointestinal bleeding; 11. Known or suspected to be allergic to s086, sakubatrovalsartan sodium or olmesartan axetil and related drugs (ARB, ACEI and renin inhibitors); 12. In the lead-in period, all kinds of antihypertensive drugs, anti angina drugs (except trimetazidine), digitalis drugs, glucocorticoids (except local glucocorticoids), estrogen, potassium supplement drugs and other chemicals, biological products, traditional Chinese medicine or natural drugs considered unsuitable by the researchers were used in the lead-in period; 13. Female subjects who are in pregnancy, lactation, or pregnancy test positive; or during the trial period, the subjects or their partners cannot guarantee effective contraception (acceptable contraceptive methods: real abstinence; intrauterine device; barrier contraceptive; or partner underwent sterilization. Methods of contraception not accepted: periodic abstinence, such as contraception according to calendar, ovulation and symptomatic body temperature; or those who have birth planning within 6 months after the end of the trial; and; 14. There was a history of drug abuse or alcoholism within 6 months before screening (alcoholism was defined as drinking 14 units of alcohol per week: 1 unit = 285ml beer, 25ml spirits, or 100ml wine); 15. Participated in any other clinical trials of drugs or medical devices within 3 months before screening, or participated in other clinical trials of drugs or medical devices during the planned trial or within 3 months after the end of the trial; 16. Participated in other clinical trials of s086 in the past; 17. The medication compliance in the lead-in period was less than 80% or > 120%; 18. The researcher thinks that any other reasons that may affect the efficacy and / or safety evaluation of this study are not suitable for pa
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| systolic blood pressure; | — |
Secondary
| Measure | Time frame |
|---|---|
| diastolic blood pressure;mean arterial pressure;Antihypertensive efficiency;Rate of reaching the standard of decompression;24-h ambulatory blood pressure monitoring; | — |
Countries
China
Contacts
Public ContactXiaoping Chen
West China Hospital, Sichuan University
Outcome results
None listed