Essential hypertension
Conditions
Interventions
TY-0201R group:A single TY-0201R 8 mg transdermal patch once daily and a single oral 5 mg placebo tablet once daily, administered orally in the morning.
Oral formulation group:A single TY-0201R 8 mg transdermal placebo patch administered once daily, and a single 5 mg oral tablet administered orally once daily in the morning.
ABPM subjects:Fifty subjects will be selected from the TY-0201R group and the oral formulation group as ABPM subjects. Dose, dosage and timing of the study drug shall follow the TY-0201R group and the
Sponsors
Peking University People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: Chinese patients with essential hypertension (grade I or II) who meet all of the following inclusion criteria and none of the exclusion criteria. (1) Blood pressure values 1) A sitting diastolic blood pressure of 90-109 mmHg (including 90, 109 mmHg) and a sitting systolic blood pressure of 140-179 mmHg (including 140 and 179 mmHg) measured on Visit 1. A sitting diastolic blood pressure of 95-109 mmHg (including 95, 109 mmHg) measured on Visit 2 and a sitting systolic blood pressure of 140-179 mmHg (including 140, 179 mmHg). 2) Patients with a variation in sitting diastolic blood pressure of 10 mmHg or less as measured during Visit 1 and Visit 2. (2) Patients whose age on the date of signing the informed consent is between 18 and 70 years old. (3) Patients who have received a detailed explanation of the purpose, content and anticipated adverse effects of the trial, and who have fully understood the contents before participating in the trial, and who voluntarily have given their written consent to participate in the trial. (4) Patients who are able to comply with the requirements for management of subjects. Criteria for selecting patients for ABPM measurements. Patients who agree to participate in the ABPM study, who meet the selection and none of the exclusion criteria and have a 24-hour mean ABPM of =130/80 mmHg measured during the screening period. If the ABPM blood pressure measured during the screening period does not meet the above criterion, participation in the ABPM study will be terminated, but the patient may continue with other observations and tests in this clinical trial.
Exclusion criteria
Exclusion criteria: (1) Patients with suspected secondary hypertension (renal parenchymal hypertension, hypertension caused by renal artery stenosis and other vascular diseases, hypertension caused by obstructive sleep apnea syndrome, primary aldosteronism and other endocrine hypertension, drug-induced hypertension, monogenic inherited hypertension, etc.) (2) Patients with current complications or history of malignant hypertension (3) Patients whose sitting systolic blood pressure was 180 mmHg or more or sitting diastolic blood pressure was 110 mmHg or more as measured during the observation period (4) Patients with a compliance rate of less than 80 % during the observation period (5) Patients whose sitting pulse rate measured during Visit 1 or Visit 2 is less than 60 beats/min (6) Patients with the following medical history related to heart disease: 1) Angina pectoris 2) Myocardial infarction within 6 months prior to obtaining informed consent 3) Coronary revascularization [percutaneous coronary angioplasty (PTCA) within 6 months prior to obtaining informed consent] ), coronary artery bypass grafting (CABG), etc.] 4) Heart failure (NYHA cardiac function category II or higher) 5) Severe arrhythmia including atrial fibrillation, atrioventricular block (grade II, III), sinoatrial block, sick sinus syndrome (7) Patients with the following medical history related to other diseases: 1) Pheochromocytoma 2) History of cerebrovascular disorder (cerebral hemorrhage, cerebral infarction, transient ischemic attack, subarachnoid hemorrhage, etc.) (excluding asymptomatic cases) 3) History of obvious syncope 4) Diabetic ketoacidosis, metabolic acidosis 5) Thyrotoxicosis 6) Reactive hypoglycemia or functional hypoglycemia, poorly controlled diabetes (HbA1c [NGSP] 7.9% or more) 7) Hepatic and renal dysfunction [Criteria] Hepatic dysfunction: AST (GOT) or ALT (GPT) 2.5 times or more the upper limit of the reference value. Renal dysfunction: creatinine 1.5 times or more the upper limit of the reference value 8) Bronchial asthma or convulsions 9) Raynaud's syndrome, peripheral arterial occlusive disease 10) Psoriasis or history of psoriasis 11) Malignant tumor (within 5 years prior to obtaining informed consent) or suspicion thereof (8) Patients who cannot stop taking antihypertensive drugs from the day after Visit 0 (9) Patients who are pregnant, breastfeeding, may become pregnant, or wish to become pregnant during the study period (10) Patients with poor skin condition at the application site or patients who have experienced clinically problematic dermatitis due to topical preparations (11) Patients with a history of hypersensitivity to bisoprolol or other ß-blockers (12) Patients who participated in a clinical trial and received the investigational drug within 3 months prior to obtaining informed consent (13) Patients, who in the opinion of the principal investigator or sub-investigator, are otherwise judged to be ineligible for the clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in seated diastolic blood pressure from pre-treatment value until after 8 weeks of administration in the treatment phase; | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in seated diastolic blood pressure from pre-treatment value until after 4 weeks of administration in the treatment phase;Change in seated systolic blood pressure from pre-treatment value until after 4 and 8 weeks of administration in the treatment phase;Change in seated pulse rate from pre-treatment values until after 4 and 8 weeks of administration in the treatment phase;Antihypertensive efficacy rate after 8 weeks of administration in the treatment-phase;Antihypertensive achievement rate after 8 weeks of administration in the treatment-phase ;Changes in systolic blood pressure, diastolic blood pressure, and pulse rate (24-hour average, daytime average, nighttime average, early morning average) by ABPM;Changes in systolic and diastolic blood pressure at trough and peak times and trough/peak (T/P) ratio by ABPM;Rate of adverse events and side effects observed during the treatment and follow-up periods; | — |
Countries
China
Contacts
Public ContactHongyi Wang
Peking University People's Hospital
Outcome results
None listed