drugset / Trial / NCT06501651
Sacubitril/Valsartan Treats Patients With Essential Hypertension and Type 2 Diabetic Nephropathy
Phase 4
Not yet recruiting
297 enrolled
Sichuan Academy of Medical Sciences
Chengdu First People's Hospital · collabDazhou Central Hospital · collabGuan'an People's Hospital · collabMeishan People's Hospital · collabMeishan Traditional Chinese Medicine Hospital · collabMianyang People's Hospital · collabNanchong Central Hospital · collabQijiang District People's Hospital · collabThe Affiliated Traditional Chinese Medicine Hospital Of Southwest Medical University · collabThe First People's Hospital of Guangyuan · collabThe People's Hospital of Leshan · collabThe Second Affiliated Hospital of Chongqing Medical University · collab
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2024-08-01
- Primary completion
- 2025-04-10
- Completion
- 2025-04-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Sacubitril | Small molecule | — | — |
| Subject | Valsartan | Small molecule | 80 mg | — |
| Subject | Valsartan | Small molecule | 160 mg | — |