Primary Hypertension
Conditions
Interventions
Test group:three compound omeprazole/amlodipine/hydrochlorothiazide tablets 20/5/12.5mg+two compound placebo
Control group:Two compound omeprazole/hydrochlorothiazide tablets 20/12.5mg+three compound placebo
Sponsors
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Subjects will be eligible for study participation if they meet the following criteria: 1. No gender limit, aged between 18 and 75 years old (including both ends); 2. Voluntarily sign an informed consent form to participate in this study, understand the study, be willing to follow the protocol, and be willing to complete all experimental procedures; 3. Before entering the run-in period, one of the following conditions must be met for msDBP: ? For patients who have not received treatment (including patients with primary hypertension who have not used any antihypertensive drugs or have been newly diagnosed within 4 weeks before the first administration), the average sitting diastolic blood pressure (msDBP) in the examination room should be = 100 mmHg; ? Primary hypertension patients who receive stable antihypertensive drug treatment (at least 4 weeks) before the first administration meet the following criteria for average sitting blood pressure in the consultation room before entering the induction period: monotherapy with msDBP = 95 mmHg, or combination therapy with two drugs with msDBP = 90 mmHg, or triple therapy with 70 mmHg = msDBP<90 mmHg. 4. Randomization criteria: msDBP = 90 mmHg [patients with diabetes or chronic kidney disease (creatinine clearance = 30 mL/min and = 60 mL/min) msDBP = 80 mmHg]; 5. Female subjects were screened and randomly tested negative for blood pregnancy and did not breastfeed; 6. Male and female participants of childbearing age voluntarily adopt effective contraceptive measures during the study period and within 6 months after the last administration
Exclusion criteria
Exclusion criteria: Subjects meeting any of the following criteria should not be enrolled in this study: 1. History or evidence of secondary hypertension, including but not limited to: renal parenchymal hypertension, renal vascular hypertension (unilateral or bilateral renal artery stenosis), aortic constriction, primary aldosteronism, Cushing's disease, pheochromocytoma, polycystic kidney disease, and drug-induced hypertension; 2. Subjects diagnosed by the researcher as intractable hypertension who cannot control their blood pressure to the target level after receiving tolerable and sufficient doses of three antihypertensive drugs (including one thiazide diuretic) for at least 4 weeks of treatment; Or subjects who require at least 4 medications to achieve blood pressure standards; 3. Before screening or randomization, msDBP = 110 mmHg or msSBP = 180 mmHg; 4. During the first two rounds of examination room blood pressure measurement before the introduction period, the change in mean sitting systolic blood pressure (SeSBP) of the subjects was = 20 mmHg or the change in mean sitting diastolic blood pressure (SeDBP) was = 10 mmHg; 5. There may be situations that may promote the occurrence of hypotension, such as malnutrition, insufficient blood volume, etc; 6. Complication with the following cardiovascular and cerebrovascular diseases: a) Cardiac disease: Screening for myocardial infarction, heart failure (NYHA grade III or IV), unstable angina, or coronary artery bypass grafting or percutaneous coronary intervention within 6 months prior to the visit; Hypertrophic obstructive cardiomyopathy; Significant narrowing of the heart valve; Severe arrhythmia with clinical significance (such as ventricular tachycardia, sick sinus syndrome, third degree atrioventricular block, atrial fibrillation or flutter, etc.); b) Cerebrovascular diseases: Screening for cerebral infarction, cerebral hemorrhage, and transient ischemic attacks that occurred within the first 6 months; c) Vascular disease: Arteriosclerotic occlusive disease with intermittent claudication symptoms; 7. Uncontrolled type 1 or type 2 diabetes (e.g., glycosylated hemoglobin>8%); 8. Patients with a history of malignant tumors within the past 5 years, except for patients with completely cured skin basal cell carcinoma, skin squamous cell carcinoma, melanoma in situ, and cervical carcinoma in situ, and/or any malignant tumor patients who have been cured without disease or have been disease-free for at least 5 years; 9. During the experiment, systemic glucocorticoid therapy is required ß blocker therapy or antidepressant therapy; 10. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) = 3 upper limit of normal (ULN) or total bilirubin = 1.5 x upper limit of normal (ULN); 11. Serum creatinine = 1.5 x Upper Limit of Normal (ULN), or creatinine clearance rate (based on Cockcroft Gault formula) is5.5 mmol/L) or hypokalemia (blood potassium<3.5 mmol/L); Hyponatremia (blood sodium<130 mmol/L); Hyperuricemia (male = 420 umol/L, female = 360 umol/L); 13. Suffering from gastrointestinal diseases that affect drug absorption, distribution, metabolism, and excretion, or having undergone relevant surgical procedures; 14. Subjects with or suspected history of alcohol or drug abuse; 15. Allergy to any component of the experimental drug; 16. The medication adherence during the introduction period is greater than 120% or less than 80%; 17.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Group randomization grouping until the end of the double-blind treatment period of 8 weeks, changes in mean sitting diastolic blood pressure (msDBP) ; | — |
Secondary
| Measure | Time frame |
|---|---|
| Group randomization grouping until the end of the double-blind treatment period of 8 weeks, changes in mean sitting diastolic blood pressure (msSBP) ;Changes in msDBP and msSBP from randomization to the end of a double-blind treatment period of 4 weeks;At the end of the fourth and eighth weeks of the double-blind treatment period, the percentage of subjects [msSBP/msDBP<140/90 mmHg or patients with diabetes and chronic kidney disease (creatinine clearance = 30 mL/min and = 60 mL/min) msSBP/msDBP<130/80 mmHg] who reached the target blood pressure; | — |
Countries
China
Contacts
Public ContactJiguang Wang
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Outcome results
None listed