This study aims to compare the efficacy and safety of Sacubitril/Valsartan versus Valsartan in patients with essential hypertension and type 2 diabetic nephropathy over a 12-week treatment period, including two treatment groups, with a total of 297 eligible subjects randomly assigned in a 2:1 ratio to either the experimental group or the control group.Subjects will participate in the study through two phases: the screening period and the follow-up period.The primary outcome measure is the change in systolic blood pressure from baseline after 12 weeks of treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
297
Sacubitril/Valsartan is a novel antihypertensive medication composed of an angiotensin II receptor blocker (ARB) Valsartan and a neprilysin inhibitor Sacubitril in a 1:1 molar co-crystal form. Sacubitril is a prodrug that, once ingested, is metabolized by esterases into its active form, which inhibits neprilysin activity. Neprilysin has various substrates, including natriuretic peptides and angiotensin II (Ang II). By inhibiting neprilysin, the levels of natriuretic peptides that have antihypertensive and organ-protective effects are increased. The other component, Valsartan, effectively inhibits the Ang II type 1 receptor (AT1R), providing additional antihypertensive and organ-protective effects. The co-crystal structure ensures that Sacubitril and Valsartan have similar absorption and elimination rates, thereby synchronizing their pharmacological effects.
Valsartan, effectively inhibits the Ang II type 1 receptor (AT1R), providing both antihypertensive and organ-protective effects.
Sichuan Academy of Medical Sciences · Sichuan Provincial People's Hospital
Chengdu, Sichuan, China
Reduction in 24-hour ambulatory systolic blood pressure(SBP)
The comparison of the reduction in 24-hour ambulatory systolic blood pressure from baseline between the two groups
Time frame: From enrollment to the end of treatment at 12 weeks
Reduction in 24-hour ambulatory diastolic blood pressure(DBP)
The comparison of the reduction in 24-hour ambulatory diastolic blood pressure from baseline between the two groups
Time frame: From enrollment to the end of treatment at 12 weeks
Changes in daytime and nighttime ambulatory blood pressure
The comparison of the changes in daytime and nighttime ambulatory blood pressure between the two groups. (The mean daytime blood pressure is defined as the average of hourly measurements taken between 6:00 and 22:00, and the mean nighttime is defined as the average of hourly measurements taken between 22:00 and 6:00.)
Time frame: From enrollment to the end of treatment at 12 weeks
Rate of dipper blood pressure restoration
The comparison of the proportion of subjects in each group who achieve a dipper blood pressure pattern, defined as a nighttime blood pressure reduction of 10-20% in both systolic and diastolic blood pressure.
Time frame: From enrollment to the end of treatment at 12 weeks
Rate of blood pressure achievement
The comparison of the proportion of subjects in each group who achieve blood pressure targets (SBP \< 130 mmHg and DBP \< 80 mmHg)
Time frame: From enrollment to the end of treatment at 12 weeks
Rate of hypertension treatment response
The comparison of the proportion of subjects in each group who achieve hypertension treatment response, defined as: SBP \< 140 mmHg and/or a reduction from baseline of ≥ 20 mmHg; DBP \< 90 mmHg and/or a reduction from baseline of ≥ 10 mmHg; both of them
Time frame: From enrollment to the end of treatment at 12 weeks
Improvement in diabetes condition
Comparison of reductions in fasting plasma glucose (FPG) and glycated hemoglobin (HbA1c) between the two groups
Time frame: From enrollment to the end of treatment at 12 weeks
Improvement in Renal Function
The comparison of reductions in serum creatinine, urine albumin/creatinine ratio, and blood urea nitrogen between the two groups
Time frame: From enrollment to the end of treatment at 12 weeks
Medication utilization
The comparison of dose escalation proportions and the proportion of subjects requiring adjunctive nifedipine controlled-release tablets between the two groups
Time frame: From enrollment to the end of treatment at 12 weeks
Safety assessments
Safety assessments included monitoring of all adverse events (AEs), serious AEs (SAEs), and regular monitoring of vital signs and clinical laboratory tests.
Time frame: From enrollment to the end of treatment at 12 weeks
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