Hypertensive
Conditions
Interventions
MN-08 tablet high dose group:MN-08 tablet
MN-08 tablet low dose group:MN-08 tablet
Sponsors
The First Affiliated Hospital of Jinan University(Guangzhou Overseas Chinese Hospital)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. At the time of signing the informed consent form, subjects should be between 18 and 65 years of age (including borderline values). 2. Essential hypertension was diagnosed according to the diagnostic criteria of the Chinese Guidelines for the prevention and treatment of Hypertension (2018 revision), classified as grade 1 hypertension or grade 2 hypertension, and the mean sitting diastolic blood pressure measured in the office during the screening period and the baseline period was between 90 mmHg and 109 mmHg (including boundary values). 3. Patients with newly diagnosed hypertension, or patients with a history of hypertension who are not taking any antihypertensive medication, or who have been taking antihypertensive medication for at least 2 weeks prior to baseline and still do not have an acceptable blood pressure. 4. BMI should be between 18 and 28 kg/m2 (including borderline values). 5. Male or female subjects are required to agree to use a suitable method of contraception, of which: Male subjects: agree to use a reliable method of contraception from the time of signing the informed consent form until 30 days after the last dose. Female subjects: should fulfil at least one of the following conditions: Women not of childbearing age; Females of childbearing potential who are not pregnant or breastfeeding, have a negative blood pregnancy test at Screening and/or Baseline, and agree to use reliable contraception from the time they sign the Informed Consent Form until 30 days after their last dose. 6. Be able to sign an informed consent form, including compliance with the requirements and limitations outlined in the informed consent form and in this programme.
Exclusion criteria
Exclusion criteria: 1. Diagnosis of severe hypertension, defined as mean seated systolic blood pressure = 180 mmHg and/or mean seated diastolic blood pressure = 110 mmHg; 2. Orthostatic hypotension: a reduction in upright systolic blood pressure of =20 mmHg or diastolic blood pressure of =10 mmHg in the sitting position compared to the sitting position, measured in the clinic during the screening or baseline period,accompanied by vertigo, amaurosis, and syncope. Or the head-up tilt test (optional) was performed during the screening period, and the subjects showed positive orthostatic hypotension. During the screening period, either orthostatic blood pressure test or head-up tilt test was completed. 3. Diagnosis of secondary hypertension, including but not limited to Cushing's syndrome, primary aldosteronism, pheochromocytoma, and drug-induced hypertension. 4.Heart failure (NYHA class III and IV), acute coronary syndrome, percutaneous coronary intervention, coronary artery bypass grafting, or other cardiac diseases that the investigator considered might affect the safety of the subjects within 6 months before screening. 5.Severe cerebrovascular disease within 6 months before screening, such as stroke, transient ischemic attack, hypertensive encephalopathy, cerebral hemorrhage, etc. 6. Screening for autoimmune diseases that can affect the circulatory system, such as systemic lupus erythematosus and antiphospholipid antibody syndrome. 7. Patients with gastrointestinal disorders that may affect drug absorption, as judged by the investigator at screening. 8. Poor glycemic control, with a glycated hemoglobin A1c (HbA1c) >9.0% at screening (one retest was allowed if slightly above 9.0% (<9.5%)). 9. Severe renal insufficiency: blood urea nitrogen and/or serum creatinine =3.0 times the upper limit of normal during the screening period, or other known severe renal insufficiency. 10. Severe liver damage: ALT, AST or alkaline phosphatase =3.0 times the upper limit of normal during the screening period, or other known liver diseases such as active hepatitis, cirrhosis, liver failure, etc. 11. Those who are using the following medications during the screening period and cannot be discontinued during the trial: nitrates, PDE5 inhibitors, alpha-blockers, and riociguat. 12.Participation in another drug clinical trial (defined as enrollment and receipt of the trial drug) within 3 months before screening. 13.Alcohol abuse in the 3 months prior to screening (more than 14 units of alcohol per week, 1 unit =360 mL of beer or 45 mL of 40% spirits or 150 mL of wine) 14.History of drug use within 3 months prior to screening. 15.Subjects required to work night shifts (subjects were allowed a maximum of two night shifts per week, but no night shifts were allowed during the 3 days before each visit or during visits requiring recording of ambulatory blood-pressure monitoring). 16.Other circumstances deemed inappropriate by the investigator to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison of the value of change in clinic-measured mean seated diastolic blood pressure relative to baseline in each test group; | — |
Secondary
| Measure | Time frame |
|---|---|
| Comparison of the value of change in clinic-measured mean seated systolic blood pressure relative to baseline in each test group;Comparison of the value of change in clinic-measured mean seated diastolic blood pressure relative to baseline in each test group;Comparison of effective rates 1 and compliance rates 2 of clinic-measured mean seated diastolic blood pressure in each test group;Comparison of clinic-measured mean seated systolic blood pressure effective rate 3 and compliance rate4 in each trial group;Comparison of mean daytime blood pressure, mean nighttime blood pressure, maximum blood pressure, minimum blood pressure, and change from baseline in the test groups; | — |
Countries
China
Contacts
Public ContactShaorong Wu
The First Affiliated Hospital of Jinan University(Guangzhou Overseas Chinese Hospital)
Outcome results
None listed