Essential hypertension
Conditions
Interventions
experimental group:S086 tablet 240mg + amlodipine 5mg
control group:S086 240mg
Sponsors
Peking University First Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged between 18 and 75 years old, no gender restrictions. 2. Diagnosed with primary hypertension; 3. During the screening process, meeting any one of the following criteria is sufficient (A, B, and C follow Route 1; D follows Route 2): A. Patients who have not received any treatment (recently diagnosed primary hypertension or those with a history of hypertension but did not take any antihypertensive drugs for at least 4 weeks before the screening), must have an average sitting office systolic blood pressure (msSBP) of >= 150 mmHg and = 140 mmHg and = 140 mmHg and = 140 mmHg and = 140 mmHg and = 130/80 mmHg. (Subjects who do not meet inclusion criterion 6 can still participate in the above non-ABPM studies.);
Exclusion criteria
Exclusion criteria: 1. Severe hypertension (mean systolic blood pressure >= 180 mmHg, and/or mean diastolic blood pressure >= 110 mmHg); malignant hypertension, hypertensive emergencies, hypertensive crises and hypertensive encephalopathy, etc. 2. There is a history or diagnostic basis of secondary hypertension, including but not limited to the following conditions: renal parenchymal hypertension, renal vascular hypertension (unilateral or bilateral renal artery stenosis), aortic stenosis, primary aldosteronism, Cushing's syndrome, pheochromocytoma, polycystic kidney disease, and drug-induced hypertension, etc. 3. Those who took three or more types of antihypertensive drugs simultaneously within the past 1 month (including compound preparations containing more than three antihypertensive ingredients). 4. There is a history of angioedema, caused by medication, other factors, or other reasons. 5. Hypertension combined with the following conditions: Acute coronary syndrome, myocardial infarction, percutaneous coronary intervention, stroke within 12 months; NYHA class II-IV heart failure, large aneurysm or dissecting aortic aneurysm, second-degree or higher atrioventricular block, sick sinus syndrome, bradycardia (heart rate 5.5 mmoL/L or 2.5 times the upper limit of normal (ULN); serum creatinine > 1.5 times the ULN; any clinically significant laboratory abnormalities that the investigator believes may interfere with the evaluation of the efficacy and/or safety data of this study. 7. Those who are positive for antibodies to human immunodeficiency virus (HIV), hepatitis C virus (HCV), or Treponema pallidum (TP), or who are positive for hepatitis B surface antigen (HBsAg) and have HBV DNA >= 1000 IU/mL; 8. Type 1 diabetes and type 2 diabetes with poor blood sugar control (HbAlc > 8.0%); 9. Excessive obesity, with a body mass index (BMI) greater than 30 kg/m^2 (BMI = weight (kg) / height² (m²)); 10. Patients with active malignant tumors, or those with a history of malignant tumors within the previous 5 years (excluding skin basal cell carcinomas that have been surgically removed or cervical carcinoma in situ); 11. Patients undergoing hemodialysis or those undergoing strict salt restriction therapy; 12. Gastrointestinal disorders or post-gastrointestinal surgeries may affect drug absorption or excretion, such as gastrointestinal resection, active gastrointestinal inflammation, ulcers or gastrointestinal bleeding; 13. Known or suspected allergy to S086 or similar drugs such as sacubitril/valsartan sodium and related drugs (ARB, ACEI and renin inhibitors); 14. During the introduction period, the following types of antihypertensive drugs, anti-angina drugs (except for trimetazidine and nicorandil), glucocorticoids (except for those used topically or in inhalation), estrogens, licorice, monoamine oxidase inhibitors, SGLT-2 inhibitors, digitalis drugs, potassium-sparing drugs, and other chemical drugs, biological products, traditional Chinese medicines or natural medicines that the researchers consider unsuitable for use were also used. 15. Women who are currently pregnant, brea
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change in mean sitting systolic blood pressure (msSBP) in the clinic at the 12th week compared with the baseline.; | — |
Secondary
| Measure | Time frame |
|---|---|
| The average change in systolic blood pressure in the examination room sitting position from the baseline at the 4th and 8th weeks;The changes in mean arterial pressure (MAP) at the 4th, 8th, and 12th weeks compared to the baseline;The changes in average sitting diastolic blood pressure (msDBP) in the examination room from the 4th;The effective rate of blood pressure reduction at the 4th, 8th, and 12th weeks;The rate of achieving blood pressure control by the end of the 4th, 8th, and 12th weeks; | — |
Countries
China
Contacts
Public ContactJianping Li
Peking University First Hospital
Outcome results
None listed