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

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

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.

Sponsors & Collaborators

• The Second Affiliated Hospital of Chongqing Medical University

  collaborator OTHER

• Nanchong Central Hospital

  collaborator OTHER_GOV

• The People's Hospital of Leshan

  collaborator OTHER

• The Affiliated Traditional Chinese Medicine Hospital Of Southwest Medical University

  collaborator UNKNOWN

• Chengdu First People's Hospital

  collaborator OTHER

• Mianyang People's Hospital

  collaborator UNKNOWN

• Guan'an People's Hospital

  collaborator UNKNOWN

• Meishan Traditional Chinese Medicine Hospital

  collaborator OTHER

• Qijiang District People's Hospital

  collaborator UNKNOWN

• Meishan People's Hospital

  collaborator UNKNOWN

• The First People's Hospital of Guangyuan

  collaborator UNKNOWN

• Dazhou Central Hospital

  collaborator OTHER

• Sichuan Academy of Medical Sciences

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-08-01

Primary Completion

2025-04-10

Completion

2025-04-10

Countries

• China

Study Locations