A Study to Evaluate the Efficacy and Safety of BR1015 Combination Therapy

Phase 3 Completed 248 enrolled Boryung Pharmaceutical Co., Ltd

RandomizedParallel-groupDouble-blindTreatment

Summary

The objective of this clinical trial is to evaluate the efficacy and safety of BR1015 Combination therapy group in comparison with Fimasartan monotherapy group at Week 8 for essential hypertension patients who do not adequately responded by Fimasartan 30 mg

Timeline

Start: 2022-11-09
Primary completion: 2024-12-02
Completion: 2024-12-02

Outcome

Met primary endpoint

paper At week 8, the least square mean reduction in SiSBP was greater with FMS/IND SR than with FMS (-17.9 vs -7.4 mmHg, P<0.0001). PMID 42163997 ↗

Publications

Youn JC, Lee SY, Yu CW, Sung KC, Shin J, Oh JH, Na JO, Kim DH, Cho EJ, Yoon HJ, Lee CJ, Lee HC, Lee HY, Sohn IS, Lee KS, Kim DI, Choi WG, Chung WJ, Lee EM, Choi SH, Choi S, Kang TS, Ihm SH. Efficacy and Safety of Fimasartan/Indapamide Combination Therapy versus Fimasartan Monotherapy in Patients with Essential Hypertension Inadequately Responding to Fimasartan 30 mg (FINEDUO): A Randomized, Double-Blind, Multicenter, Phase III Study. Drug Des Devel Ther. 2026 May 15;20:578736. doi: 10.2147/DDDT.S578736. eCollection 2026.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Fimasartan	Small molecule	60 mg	—
Subject	Indapamide	Small molecule	1.5 mg	—