Hypertension
Conditions
Interventions
Group A:1 tablet of Levamlodipine Besilate Tablets placebo+2 tablets of Bisoprolol Fumarate Tablets placebo, taken daily in the morning
Group B:1 tablet of Levamlodipine Besilate Tablets(2.5 mg)+2 tablets of Bisoprolol Fumarate Tablets placebo, taken daily in the morning
Group C:1 tablet of Levamlodipine Besilate Tablets placebo+2 tablets of Bisoprolol Fumarate Tablets(2.5 mg), taken daily in the morning
Group D:1 tablet of Levamlodipine Besilate Tablets(2.5 mg)+1 tablet of Bisoprolol Fumarate Tablets(2.5 mg)+1 tablet of Bisoprolol Fumarate Tablets placebo, taken daily in the morning
Group E:1 tablet of Levamlodipine Besilate Tablets(2.5 mg)+2 tablets of Bisoprolol Fumarate Tablets(2.5 mg), taken daily in the morning
Sponsors
Peking University People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: Only subjects who meet all of the following criteria can be enrolled in this study: 1. Age: 18 to 70 years old (inclusive), gender not limited. 2. Patients diagnosed with mild to moderate essential hypertension according to the diagnostic criteria of the "Chinese Guidelines for the Prevention and Treatment of Hypertension" (Revised Edition 2018); For newly diagnosed subjects or those who have not received antihypertensive drug treatment within one month: At the time of initial screening, the average sitting diastolic blood pressure (DBP) and systolic blood pressure (SBP) of the subjects (blood pressure measurement was conducted after sitting and resting for 5 minutes, with a total of 3 measurements, measured once every 2 minutes or more, and the average value was taken) met: 90mmHg <= DBP < 110mmHg; For subjects currently undergoing antihypertensive drug treatment (including those who have taken antihypertensive drugs within 30 days) : No limit is set on the average sitting blood pressure of the subjects during the initial screening. 3. From the start of screening to the end of the follow-up period, the subjects (applicable to both male and female subjects) must be willing to take effective contraceptive measures (except oral contraceptives that may affect blood pressure), or have already gone through menopause; 4. Voluntarily sign the ICF before participating in the trial. Inclusion criteria at the end of the placebo lead-in period/before randomization: After the placebo introduction period, subjects meeting the following criteria can be randomly assigned and officially enrolled: The average sitting blood pressure of the subjects (blood pressure measurement was conducted after sitting and resting for 5 minutes, with a total of 3 measurements, once every 2 minutes or more, and the average value was taken) was 95mmHg <= DBP < 110mmHg.
Exclusion criteria
Exclusion criteria: Exclusion criteria Subjects who meet any of the following criteria will not be eligible for this study: 1. Known or suspected secondary hypertension (such as primary aldosteronism, pheochromocytoma, Cushing's syndrome, renal hypertension, etc.); 2. During the screening visit, the blood pressure measurement values in the consultation room: DBP in the sitting position >= 110mmHg, or SBP in the sitting position >= 180mmHg (blood pressure measurement is conducted after sitting for 5 minutes of rest, with a total of 3 measurements, once every 2 minutes or more, and the average value is taken). 3. According to the researcher's judgment, it is suspected to be a patient with white coat hypertension. 4. There is a known history of orthostatic hypotension or frequent hypotension after taking antihypertensive drugs; 5. Patients who need to take other antihypertensive drugs other than the study drug during the trial period; 6. During the trial period, other non-antihypertensive drugs that may affect blood pressure are planned or used in combination; Note: The subjects are allowed to use local, ocular, intra-articular, intranasal and inhaled glucocorticoids for treatment (with extremely low systemic absorption). Short-term ( 11.1 mmol/L); Subjects with severe depression, anxiety disorders and severe sleep disorders who require long-term intervention treatment with multiple drugs; Subjects with severe or malignant retinopathy, where severe lesions are defined as retinal hemorrhage, small aneurysms, cotton-like spots, hard exudates, or a combination of these symptoms, while malignant lesions are defined as a combination of severe retinopathy and optic disc edema; Subjects with large aneurysms or dissecting aneurysms, who have undergone percutaneous transluminal coronary angioplasty or cardiac surgery; Patients with severe liver diseases or liver dysfunction, such as t
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| The change value of SBP in the sitting position relative to the baseline after treatment;Effective rate of blood pressure reduction;Safety evaluation; | — |
Primary
| Measure | Time frame |
|---|---|
| The change of DBP (bottom value) in sitting position from baseline after treatment; | — |
Countries
China
Contacts
Public ContactNingling Sun; Yuanyuan Chen
Peking University People's Hospital
Outcome results
None listed