NCT06501651

Sacubitril/Valsartan Treats Patients With Essential Hypertension and Type 2 Diabetic Nephropathy

A Prospective, Randomized, Controlled, Multicenter Study of Sacubitril/Valsartan in the Treatment of Patients With Mild to Moderate Essential Hypertension and Type 2 Diabetic Nephropathy: The Hyper-Save Study

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 297 (estimated)
• Sponsor: Sichuan Academy of Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Essential Hypertension
• Type 2 Diabetes
• Nephropathy

Interventions

Type	Name	Description
DRUG	Sacubitril/Valsartan	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.
DRUG	Valsartan	Valsartan, effectively inhibits the Ang II type 1 receptor (AT1R), providing both antihypertensive and organ-protective effects.

Timeline

• Start date: 2024-08-01
• Primary completion: 2025-04-10
• Completion: 2025-04-10
• First posted: 2024-07-15
• Last updated: 2024-07-15

Locations

1 site across 1 country: China