hypertension
Conditions
Interventions
Group A:1 tablet of Levamlodipine Besilate Tablets (2.5mg) and 1 tablet of Levamlodipine Bisoprolol Tablets placebo,Phase 1, taken daily in the morning
Group B:1 tablet of Levamlodipine Besilate Tablets placebo and 1 tablet of Levamlodipine Bisoprolol Tablets(2.5mg/2.5mg) , Phase 1 and 2, taken daily in the morning
Group C :1 tablet of Levamlodipine Besilate Tablets placebo and 1 tablet of Levamlodipine Bisoprolol Tablets(2.5mg/5mg) , Phase 1 and 2, taken daily in the morning
Group D :1 tablet of Bisoprolol Fumarate Tablets (5mg) and 1 tablet of Levamlodipine Bisoprolol Tablets placebo,Phase 1, taken daily in the morning
Group E :1 tablet of Bisoprolol Fumarate Tablets placebo and 1 tablet of Levamlodipine Bisoprolol Tablets(2.5mg/5mg) ,Phase 1 and 2, taken daily in the morning
Sponsors
Peking University First Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Phase 1 Queue 1 1. Age range from 18 to 75 years old (including 18 and 75), regardless of gender; 2. According to the diagnostic criteria of the "Chinese Guidelines for the Prevention and Treatment of Hypertension" (revised in 2018), patients diagnosed with primary hypertension: (1) For subjects who have not received treatment (newly diagnosed primary hypertension or have a history of hypertension but have not taken any antihypertensive drugs for at least 4 weeks before screening), sitting DBP = 95mmHg; (2) Subjects who continuously take other antihypertensive drugs for = 4 weeks should stop taking the antihypertensive drugs according to the researcher's judgment; (3) Subjects who received stable and continuous antihypertensive treatment with levamlodipine besilate tablets (2.5mg) for = 4 weeks and had a sitting DBP of = 90mmHg. 3. Voluntarily sign the ICF before participating in the experiment; When the double-blind treatment period is randomized, the average sitting blood pressure of the subjects is sitting DBP = 90mmHg. Queue 2 1. Age range from 18 to 75 years old (including 18 and 75), regardless of gender; 2. According to the diagnostic criteria of the "Chinese Guidelines for the Prevention and Treatment of Hypertension" (revised in 2018), patients diagnosed with primary hypertension: (1) For subjects who have not received treatment (newly diagnosed primary hypertension or have a history of hypertension but have not taken any antihypertensive drugs for at least 4 weeks before screening), sitting DBP = 95mmHg; (2) Subjects who continuously take other antihypertensive drugs for = 4 weeks should stop taking the antihypertensive drugs according to the researcher's judgment; (3) Subjects who received stable and continuous antihypertensive treatment with bisoprolol fumarate tablets (5mg) for = 4 weeks and had a sitting DBP of = 90mmHg. 3. Voluntarily sign the ICF before participating in the experiment; When the double-blind treatment period is randomized, the average sitting blood pressure of the subjects is sitting DBP = 90mmHg. Phase 2 This stage of the study was a long-term safety follow-up for the compound group of participants in the first phase, with queue 1 consisting of compound group participants (Group B and Group C) who continued their medication follow-up; Queue 2 consists of compound group subjects (Group E) who participated in the first stage and will continue to receive medication follow-up.
Exclusion criteria
Exclusion criteria: Phase 1 1. Known or suspected patients with refractory hypertension, hypertensive emergencies, secondary hypertension (such as primary aldosteronism, pheochromocytoma, Cushing syndrome, renal hypertension, etc.), and white coat hypertension; 2. The blood pressure measurement value in the consultation room, sitting DBP = 110mmHg, or sitting SBP = 180mmHg; 3. Known history of orthostatic hypotension or frequent occurrence of hypotension after taking antihypertensive drugs; 4. Patients who need to take antihypertensive drugs other than the investigational drug during the trial period; 5. Plan or combine the use of other non antihypertensive drugs that may affect blood pressure during the trial period; Note: Participants are allowed to use local (such as eye, intra-articular, nasal) and inhaled corticosteroids for treatment (with extremely low systemic absorption); Allowing short-term (= 3 days) use of glucocorticoids for preventive treatment (such as contrast agent allergies) or for the treatment of non autoimmune diseases (such as delayed hypersensitivity reactions caused by contact allergens). 6. During the trial, planned or combined use of drugs that may have an impact on the metabolism of levamlodipine besilate tablets and/or bisoprolol fumarate tablets, such as potent or moderate inducers of CYP3A and potent or moderate inhibitors; 7. Previous or current combined history or impact of any of the following major diseases: (1) Screening subjects with severe cerebrovascular diseases or accidents within the previous 6 months, such as hypertensive encephalopathy, cerebrovascular injury, cerebral hemorrhage, transient ischemic attack, etc; (2) Within the past 6 months, there has been heart failure (NYHA grade III and IV), acute coronary syndrome, percutaneous coronary intervention, coronary artery bypass grafting, or other serious heart disease [such as cardiogenic shock, moderate or above heart valve disease, second to third degree atrioventricular block, bradycardia (heart rate<60 beats/min), or other serious arrhythmias]; (3) Individuals who have already installed pacemakers before screening; (4) Subjects with known cerebrovascular malformations, cerebral aneurysms, large aneurysms or dissecting aneurysms, or cardiac surgery; (5) Suffering from obstructive sleep apnea hypopnea syndrome and judged by researchers to require or be receiving mechanical ventilation treatment; (6) Subjects with severe or malignant retinal lesions, where severe lesions are defined as a combination of retinal hemorrhage, small arterial aneurysms, flocculent plaques, hard exudates, or a combination of these symptoms, while malignant lesions are defined as a combination of severe retinal lesions and optic disc edema; (7) Subjects with a history of malignant tumors (excluding non metastatic basal cell or squamous cell carcinoma of the skin and cervical cancer in situ that have been diagnosed with malignant tumors within the past 5 years, are currently stable and have received appropriate treatment or resection); (8) Patients with known contraindications to levamlodipine or bisoprolol, such as severe bronchial asthma, severe chronic obstructive pulmonary disease, advanced peripheral arterial obstructive disease, Raynaud's syndrome, metabolic acidosis, psoriasis, etc; (9) Subjects who have a history of gastrointestinal surgery that may significantly alter drug absorption, distribution, metabolism, and excretion, or have severe gastrointestinal diseases or difficulty s
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The changes of DBP relative to baseline were compared among different groups at the 8th week of treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| The changes of SBP relative to baseline were compared among different groups at the 2nd, 4th and 8th week of treatment;The changes of DBP relative to baseline were compared among different groups at the 2nd and 4th week of treatment.;The blood pressure lowering rate was compared among different groups at the 2nd, 4th and 8th week of treatment;The effective rates of blood pressure lowering were compared among different groups at the 2nd, 4th and 8th week of treatment;The changes of mean DBP and mean SBP of ambulatory blood pressure monitoring (ABPM) at week 8 were compared between groups;Diurnal and nighttime DBP, diurnal and nighttime SBP were compared among different groups and at the 8th week of treatment; | — |
Countries
China
Contacts
Public ContactYong Huo ;Wei Ma
Peking University First Hospital
Outcome results
None listed