drugset / Trial / NCT03951207
Rosuvastatin/Amlodipine vs Atorvastatin/Amlodipine in Hypertension Patient With Dyslipidemia
RandomizedParallel-groupOpen-labelTreatment
Summary
This study is to Compare the Efficacy and Safety of Rosuvastatin/Amlodipine Combination Therapy Versus Atorvastatin/Amlodipine Combination Therapy in Hypertension patient with Dyslipidemia
Timeline
- Start
- 2019-05-30
- Primary completion
- 2021-09-29
- Completion
- 2021-09-29
Outcome
Met primary endpoint
paper FAS]: -7.08%, 95% CI: -11.79 to -2.38, p = .0034 PMID 37584254 ↗
paper RSV 10 mg/AML 5 mg and the RSV 20 mg/AML 5 mg more effectively reduced LDL-C compared with the ATV 20 mg /AML 5 mg PMID 37584254 ↗
Publications
- Park CM, Jung HW. Predictors of Significant High-Sensitivity C-Reactive Protein Reduction After Use of Rosuvastatin/Amlodipine and Atorvastatin/Amlodipine-Subgroup Analysis in Randomized Controlled Trials. J Clin Med. 2025 May 12;14(10):3363. doi: 10.3390/jcm14103363.
- Jung HW, Kim CY, Hong SP, Bae HJ, Choi JY, Ryu JK, Lee JB, Lee KH, Han KR, Yang DH, Park CG, Yu GW, Rhee MY, Park SJ, Hyon MS, Shin JH, Hong BK, Jin HY, Lee SY, Seol SH, Lee SR, Kim SY, Lee KJ, Cho EJ, Nam CW, Park TH, Kim U, Kim KS. Randomized, multicenter, parallel, open, phase 4 study to compare the efficacy and safety of rosuvastatin/amlodipine polypill versus atorvastatin/amlodipine polypill in hypertension patient with dyslipidemia. J Clin Hypertens (Greenwich). 2023 Sep;25(9):828-844. doi: 10.1111/jch.14715. Epub 2023 Aug 16.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Amlodipine | Other / unclassified | 5 mg | — |
| Comparator | Atorvastatin | Small molecule | 20 mg | — |
| Subject | Rosuvastatin | Small molecule | 10 mg | — |
| Subject | Rosuvastatin | Small molecule | 20 mg | — |