Mild to Moderate Essential Hypertension and Type 2 Diabetic Nephropathy
Conditions
Interventions
Experimental:Dosage regimen of the experimental group
Comparator:Dosage regimen of the Comparative group
Sponsors
Sichuan Provincial People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Age 18 years or older, no gender restriction; 2.Diagnosed with mild to moderate primary hypertension (140 = 1 glucose control medication regimens (which may include long-acting insulin) for at least 12 weeks before screening, with a stable treatment regimen (i.e., the same medication and dosage) for at least 28 days before screening, and maintaining this regimen during the study. At the investigator’s discretion, the dose of supplemental short-acting insulin can be adjusted as needed to achieve adequate glucose control; b) HbA1c level = 8 hours) plasma glucose level 13.3 mmol/ L, the investigator may repeat the test to determine eligibility); 4.Urine albumin/creatinine ratio (UACR) >= 30 mg/g in two measurements taken on separate days or eGFR < 60 mL/min/1.73 m²; 5.Non-pregnant or fertile patients (male or female) using reliable contraception; 6.Female patients with potential for pregnancy must have a negative pregnancy test at screening; 7.Subjects must voluntarily agree to comply strictly with the study protocol requirements and sign a written informed consent form.
Exclusion criteria
Exclusion criteria: 1.Presence of severe hypertension, malignant hypertension, hypertensive emergencies, or hypertensive crises; 2.History or evidence of secondary hypertension within 12 months before screening, including but not limited to any of the following: renovascular hypertension, renal parenchymal hypertension, unilateral or bilateral renal artery stenosis, coarctation of the aorta, primary aldosteronism, Cushing‘s disease, pheochromocytoma, polycystic kidney disease, and drug-induced hypertension; 3.History of angioedema (drug-related or other causes) within 12 months before screening; 4.Presence of diabetic ketoacidosis; 5.History or evidence of secondary diabetes within 12 months before screening, including but not limited to any of the following: endocrine disorders causing carbohydrate metabolism disorders, pancreatogenic diabetes, hepatogenic diabetes, nephrogenic diabetes, etc.; 6.History of malignancy in any organ system (excluding localized basal cell carcinoma of the skin); 7.History of acute stroke, lacunar infarction, or dementia within 6 months before screening; 8.History of coronary artery bypass graft surgery or any percutaneous coronary intervention (PCI) within 6 months before screening; 9.Previously diagnosed or currently diagnosed heart failure (NYHA Class III- IV) or clinically significant valvular heart disease; 10.History or current diagnosis of cardiac abnormalities: (1) second or third- degree atrioventricular block without a pacemaker; (2) clinically significant arrhythmias, including atrial fibrillation with a ventricular rate >= 120 bpm; (3) family history of long QT syndrome or torsades de pointes ventricular tachycardia; 11.Chronic kidney disease stage 4 or higher (eGFR 5.5 mmol/L or 3 times the upper limit of normal; 13.History of allergy to antihypertensive drugs such as ARBs, Angiotensin- Converting Enzyme (ACE) inhibitors, or renin inhibitors; 14.Clear history of intolerance to drugs similar to the study medication (e.g., ACE inhibitors, ARBs); 15.Use of traditional Chinese or Western medicines that could affect the study's efficacy during the study period (see appendix for list); 16.Any surgery or medical condition that significantly alters the absorption, distribution, metabolism, or excretion of any medication, including but not limited to the following: clinically significant gastrointestinal surgery within 12 months before the screening (e.g., gastrectomy, gastrointestinal anastomosis, bowel resection, gastric bypass, gastroenterostomy, or gastric banding), current active inflammatory bowel disease or history of active inflammatory bowel disease; 17.Pregnant or breastfeeding women, or patients of childbearing potential unwilling or unable to use effective contraception during the study period; 18.Participation in another clinical study using any investigational drug or observational study within 30 days before screening; 19.Other conditions that, in the investigator’s judgment, may affect the conduct of the clinical study or the determination of study results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The comparison of the reduction in 24-hour ambulatory systolic blood pressure from baseline between the two groups; | — |
Secondary
| Measure | Time frame |
|---|---|
| The comparison of the reduction in 24-hour ambulatory diastolic blood pressure from baseline between the two groups;Changes in daytime and nighttime ambulatory blood pressure;Rate of dipper blood pressure restoration;24-hour, daytime, and nighttime blood pressure load values;Rate of blood pressure achievement;Rate of hypertension treatment response;Improvement in diabetes condition;Improvement in Renal Function;Medication utilization;Safety assessments; | — |
Countries
China
Contacts
Public ContactWenjie Tian
Sichuan Provincial People's Hospital
Outcome results
None listed