drugset / Trial / NCT03246555
Fimasartan in the Senior Subjects
RandomizedParallel-groupTriple-blindTreatment
Summary
The objective of this study is to confirm the noninferiority of the blood pressure lowering effect of fimasartan and evaluate its safety compared to perindopril in the elderly with essential hypertension.
Timeline
- Start
- 2016-07-15
- Primary completion
- 2019-08-19
- Completion
- 2019-12-09
Publications
- Lee HY, Kim KI, Ihm SH, Rhee MY, Sohn IS, Park S, Jeon ES, Song JM, Pyun WB, Sung KC, Kim MH, Kim SH, Kim SY, Kim SJ, Kim EJ, Shin J, Lee SY, Chun KJ, Jeong JO, Chae SC, Yoo KD, Choi YJ, Park YH, Kim CH. A Randomized, Double-blind, Active-controlled, Two Parallel-Group, Optional Titration, Multicenter, Phase IIIb Study to Evaluate the Efficacy and Safety of Fimasartan Versus Perindopril Monotherapy With and Without a Diuretic Combination in Elderly Patients With Essential Hypertension. Clin Ther. 2021 Oct;43(10):1746-1756. doi: 10.1016/j.clinthera.2021.08.003. Epub 2021 Sep 7.
- Kang MG, Kim KI, Ihm SH, Rhee MY, Sohn IS, Lee HY, Park S, Jeon ES, Song JM, Pyun WB, Sung KC, Kim MH, Kim SH, Kim SY, Kim SJ, Kim EJ, Shin J, Lee SY, Chun KJ, Jeong JO, Chae SC, Yoo KD, Choi YJ, Park YH, Kim CH. Fimasartan versus perindopril with and without diuretics in the treatment of elderly patients with essential hypertension (Fimasartan in the Senior Subjects (FITNESS)): study protocol for a randomized controlled trial. Trials. 2019 Jul 1;20(1):389. doi: 10.1186/s13063-019-3466-5.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Fimasartan | Small molecule | 30 mg | — |
| Subject | Fimasartan | Small molecule | 60 mg | — |
| Subject | Hydrochlorothiazide | Unknown | 12.5 mg | — |
| Comparator | Indapamide | Small molecule | 1.25 mg | — |
| Comparator | Perindopril | Small molecule | 2.5 mg | — |
| Comparator | Perindopril | Small molecule | 5 mg | — |
Indications
No indication recorded.