High blood pressure
Conditions
Interventions
Group 1:Oral MT-1207 tablet (1 tablet/time) bid + mt-1207 placebo (1 tablet/time) bid + amlodipine besylate analog tablet (1 tablet/time) qd for 8 weeks.
Group 2:Oral MT-1207 tablets (2 tablets/time) bid + amlodipine besylate analog tablets (1 tablet/time) qd for 8 weeks.
Group 3:Oral MT-1207 placebo (2 tablets/time) bid + amlodipine besylate (1 tablet/time) qd for 8 weeks.
Group 4:Oral mt-1207 placebo (2 tablets/time) bid + amlodipine besylate analog tablet (1 tablet/time) qd for 8 weeks.
Sponsors
Ruijin Hospital Affiliated to Medical College of Shanghai Jiaotong University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Sign the informed consent form before the test, and fully understand the content, process and possible adverse reactions of the test; be able to complete the study in accordance with the requirements of the test plan; 2. Subjects (and their partners) are willing to voluntarily take effective contraceptive measures within 6 months from screening to the last study drug administration; 3. Age 18-75 years old (including 18 and 75 years old), gender is not limited; 4. Body mass index (BMI=weight (kg)/height2 (m2)): 18-35 kg/m2 (including critical value); 5. Patients diagnosed with essential hypertension who have not received treatment or are receiving antihypertensive drugs; 6. Patients who have not received treatment (have not taken antihypertensive drugs or have not used any antihypertensive drugs within 4 weeks before screening), or patients who are receiving antihypertensive drugs (have taken antihypertensive drugs within 4 weeks before screening) , at the end of the 4-week lead-in period (Day-1), msSBP was between 150 mmHg-180 mmHg (excluding 180 mmHg).
Exclusion criteria
Exclusion criteria: 1. Severe essential hypertension (sitting systolic blood pressure >= 180 mmHg and/or sitting diastolic blood pressure >= 110 mmHg), malignant hypertension, hypertensive emergency, hypertensive crisis and hypertensive encephalopathy, etc.; 2. There is a history or diagnosis of secondary hypertension, including but not limited to the following conditions: renal parenchymal hypertension, renovascular hypertension (unilateral or bilateral renal artery stenosis), aortic coarctation, primary Hyperaldosteronism, Cushing's syndrome, pheochromocytoma, cystic kidney disease, and drug-related hypertension; 3. Hypertension combined with the following diseases: acute myocardial infarction, stroke, transient ischemic attack within 6 months; dissecting aneurysm, angina pectoris, II-IV grade (NYHA grade) heart failure history, atrioventricular conduction above degree II Blockade, sick sinus syndrome, bradycardia (heart rate 5.5 mmoL/L; blood ALT and/or AST > 2.5 x upper limit of normal (ULN); blood creatinine > 1.5 x ULN; the investigator believes any clinically significant laboratory abnormalities that may interfere with the efficacy and/or safety evaluation of this study; 6. Type 1 diabetes and poorly controlled type 2 diabetes (HbAlc >= 8%); 7. Gastrointestinal lesions or gastrointestinal surgery may affect drug absorption or excretion, such as gastrointestinal resection, active gastrointestinal inflammation, ulcer or gastrointestinal bleeding; 8. Known or suspected hypersensitivity to MT-1207 tablets or amlodipine besylate tablets and related drugs (ARB, ACEI and renin inhibitors); 9. The use of other antihypertensive drugs, antianginal drugs (except trimetazidine), digitalis drugs, glucocorticoids (except topical glucocorticoids), estrogen, etc. Hormones, potassium supplements, and other chemicals, biological products, traditional Chinese medicines or natural medicines considered unsuitable by researchers; 10. History of drug abuse or alcoholism within 6 months before screening (alcoholism is defined as drinking 14 units of alcohol per week: 1 unit = 285 mL of beer, or 25 mL of spirits, or 100 mL of wine); 11. Patients with malignant tumors; 12. Patients undergoing hemodialysis or strict salt restriction; 13. Participated in other clinical trials within 30 days before the trial; 14. Medication compliance during the lead-in period 120%; 15. Female subjects are breastfeeding or have positive serum pregnancy results during the screening period or test; 16. Other reasons that the investigator thinks it is inappropriate to participate in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in mean sitting systolic blood pressure (msSBP); | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in daytime and nighttime mean systolic blood pressure;Mean arterial pressure;Average 24-hour systolic/diastolic blood pressure;Diastolic blood pressure change from baseline; | — |
Countries
China
Contacts
Public ContactWang Peng
Liaoning Green Biological Pharmaceutical Group Co. Ltd.
Outcome results
None listed