Moderate to severe essential hypertension
Conditions
Interventions
QR12000 Compound tablets 75 mg:Take 1 tablets orally daily
QR12000 Compound tablets 150 mg:Take 1 tablets orally daily
NA:Take 1 tablets orally daily
Sponsors
Peking University First Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) Be able to understand and be willing to strictly abide by the clinical trial protocol to complete this trial, and have signed the informed consent form. 2) Age: 18 to 75 years old (including both upper and lower limits), body mass index <=30 kg/m ², gender not limited. 3) Diagnosed with moderate to severe essential hypertension: For patients first diagnosed with essential hypertension or those with a history of hypertension but not taking any antihypertensive drugs in the 4 weeks prior to screening, the sitting systolic blood pressure at V1 and V4 (random/start treatment) visits was between 160mmHg and msSBP<190mmHg. For patients with a history of hypertension who have been taking antihypertensive drugs regularly for 4 weeks or more before screening and whose blood pressure has not yet reached the target, During the V1 visit, the sitting systolic blood pressure should meet the criteria of 150mmHg<=msSBP<180mmHg (taking one antihypertensive drug within 4 weeks of the screening period) or 140mmHg<=msSBP<170mmHg (taking 2 within 4 weeks of the screening period) One type (including two single prescriptions or compound preparations composed of two drugs) or more antihypertensive drugs, and during the V4 visit, the systolic blood pressure in the sitting position should be 160mmHg<=msSBP<190mmHg. The absolute difference in the sitting systolic blood pressure of the subjects during the V4 visit from that during the previous visit (V3) did not exceed 20mmHg. 4) The subjects and their sexual partners are willing to have no plans for having children from two weeks before screening to one month after completing the last medication prescribed in this study, and voluntarily take effective contraceptive measures and have no plans for sperm or egg donation.
Exclusion criteria
Exclusion criteria: 1) Patients who have been previously diagnosed or suspected of secondary hypertension (including but not limited to the following causes: primary aldosteronism, pheochromocytoma, Cushing's syndrome, renal hypertension, aortic stenosis, drug-induced hypertension, etc.). 2) Patients with prior peripheral arterial occlusive disease and Raynaud's disease syndrome. 3) Patients with prior hyperthyroidism. 4) Patients with a history of orthostatic hypotension in the past or frequent hypotension after taking antihypertensive drugs. 5) Patients with a history of angioneuroedema caused by drugs or other reasons in the past. 6) Patients with severe cerebrovascular diseases within 1 year prior to screening, such as hypertensive encephalopathy, cerebrovascular injury, cerebral hemorrhage, transient ischemic attack, large artery atherosclerotic cerebral infarction, etc. 7) Patients with a history of any of the following severe cardiovascular diseases within 1 year prior to screening, such as: chronic heart failure (New York Heart Association [NYHA] Class III and IV), acute coronary syndrome, cardiogenic shock, arrhythmias requiring intervention (including but not limited to atrioventricular block above grade II, sick sinus syndrome, bradycardia (heart rate =8% within 1 month prior to screening, or fasting blood glucose >11.1mmol/L at screening). 12) Patients with a history of severe autoimmune diseases, severe hematopoietic diseases, or severe chronic inflammatory diseases requiring long-term anti-inflammatory therapy (except for those who only take = 100mg of low-dose aspirin per day). 13) Patients who need to be treated with three or more drugs in combination within 6 months prior to screening for severe depression, anxiety disorders, and severe sleep disorders. 14) Clinically significant laboratory abnormalities, including but not limited to: serum potassium >5.5 mmoL/L or 2.5× upper limit of normal (ULN), serum creatinine >1.5×ULN; Any clinically significant laboratory abnormality that, in the opinion of the investigator, may interfere with the efficacy and/or safety data evaluation of this study. 15) Those who have been allergic to the test drug, the positive control drug and the drugs similar to the test drug and the positive control drug (i.e., drugs containing azilsartan, valsartan or sacubitril, such as mesartan potassium, valsartan, sacubitril valsartan sodium, etc.) or related excipients. 16)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in office msSBP/msDBP; | — |
Secondary
| Measure | Time frame |
|---|---|
| Frequency and severity of AEs and SAEs;Change from baseline in daytime and nighttime maSBP/ma;Laboratory tests (blood routine, blood biochemistry, urine routine and coagulation function);Change from baseline in maSBP/maDBP;Blood pressure attainment rate,;Antihypertensive effective rate; | — |
Countries
China
Contacts
Public ContactJianping Li
Peking University First Hospital
Outcome results
None listed