Mild to moderate essential hypertension
Conditions
Interventions
S086 tablet 240mg group:S086 tablet (240mg/tablet, 1 tablet/time, 1 time/day) +S086 placebo tablet (1 tablet/time, 1 time/day) + Olmesartan Medoxomil placebo tablet (1 tablet/time, 1 time/day),oral, Q
S086 tablet 480mg group: S086 tablet (240mg/tablet, 2 tablets/time, 1 time/day) + Olmesartan Medoxomil placebo tablet (1 tablet/time, 1 time/day), oral, QD, taken for 12 weeks.
Positive control group:S086 placebo tablet (2 tablets/time, 1 time/day) + Olmesartan Medoxomil tablet (20mg/tablet, 1 tablet/time, 1 time/day), oral, QD, taken for 12 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 18-75 years, male or female; 2.Patients diagnosed with essential hypertension who have not received treatment or are receiving antihypertensive drugs (monotherapy or combination therapy of two drugs, or 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) msSBP >= 150 mmHg and =150 and <180 mmHg at the end of the induction visit; 5.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 and hypertensive encephalopathy; 2. History of angioedema, drug-related or other causes; 3. Hypertension combined with the following diseases: acute coronary syndrome, myocardial infarction, percutaneous coronary intervention, stroke within 12 months; NYHA class II-IV heart failure, large aneurysm or dissecting aneurysm, grade II The above atrioventricular block, sick sinus syndrome, bradycardia (heart rate 5.5 mmoL/L or 2.5 x upper limit of normal (ULN); serum creatinine > 1.5 x ULN; any clinically significant laboratory abnormality that the investigator believes may interfere with the evaluation of the efficacy and/or safety data of this study; 5. Human immunodeficiency virus (HIV), hepatitis C (HCV) or Treponema pallidum (TP) antibody positive, or hepatitis B surface antigen (HBsAg) positive and HBV DNA >= 1000 U/mL; 6. Type 1 diabetes and type 2 diabetes with poor blood sugar control (HbAlc > 8.0%); 7. Obesity, body mass index BMI>30kg/m^2 (BMI=weight (kg)/height^2 (m^2)); 8. Active malignant tumor, or a history of malignant tumor within 5 years before screening (except for basal cell carcinoma of the skin or carcinoma in situ of the cervix that has been radically removed); 9. Patients undergoing 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, ulcers or gastrointestinal bleeding; 11. Known or suspected allergy to S086, sacubitril valsartan sodium or olmesartan medoxomil and related drugs (ARB, ACEI and renin inhibitors); 12. Use of other antihypertensive drugs, antianginal drugs (except trimetazidine and nicorandil), glucocorticoids (except topical or inhaled glucocorticoids) during the lead-in period ), estrogens, licorice, monoamine oxidase inhibitors, SGLT-2 inhibitors, digitalis drugs, potassium supplements and other chemicals, biological products, traditional Chinese medicines or natural medicines that researchers consider unsuitable for taking; 13. Female subjects who are pregnant, breastfeeding or have a positive pregnancy test; or subjects or their partners who cannot guarantee effective contraception during the trial (acceptable contraceptive methods: true abstinence; intrauterine device; barrier Or the partner has undergone sterilization. Unacceptable contraceptive methods: cycle abstinence, such as contraception based on calendar, ovulation, symptom temperature); 14. History of drug abuse or alcohol abuse within 6 months before screening (alcohol abuse is defined as drinking 14 units of alcohol per week: 1 unit = 285mL of beer, or 25mL of spirits, or 100mL of wine); 15. Those who have participated in any drug clinical trials and took research drugs within 3 months before screening, or who participated in any medical device clinical trials and used medical devices; 16. Those who participated in other clinical trials of S086 and took the study drug in the
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change of msSBP; | — |
Secondary
| Measure | Time frame |
|---|---|
| The change of msSBP compares to the baseline.;The change of msDBP compares to the baseline.;The change of MAP compares to the baseline.;The antihypertensive efficiency : The proportion of effective antihypertensive subject amount in each group subject total amount. Patients who responded to treatment are those with normal blood pressure (systolic/diastolic 20;Rate of reaching the standard of blood pressure reduction: The proportion of the amount of subjects who met the standard of treatment in each group subject total amount. Patient up to standard after treatment means blood pressure reaching normal( SBP/DBP < 140/90 mmHg).;24h ABPM: 24h mean systolic and diastolic blood pressure changes from baseline at the end of 12th/52nd week; Changes from baseline in mean systolic and diastolic blood pressure during the day and night at the end of 12th/52nd week.; | — |
Countries
China
Contacts
Public ContactWang Jiguang
Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Outcome results
None listed