A Therapeutic Exploratory Clinical Study to Evaluate the Antihypertensive Efficacy of Fimasartan (BR-A-657•K) During 24 Hours in Patients With Mild to Moderate Essential Hypertension

Phase 2 Completed 92 enrolled Boryung Pharmaceutical Co., Ltd Catholic Medical Center · collab Chonnam National University Hospital · collab Inje University · collab Kyungpook National University Hospital · collab Seoul National University Hospital · collab

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to evaluate the antihypertensive efficacy and safety of Fimasartan (BR-A-657•K) during 24 hours by dose in patients with mild to moderate essential hypertension.

Timeline

Start: 2008-12
Primary completion: 2009-08
Completion: 2009-08

Outcome

Met primary endpoint

registry analysis (other test); Fimasartan 1-ITT vs Fimasartan 2-ITT vs Valsartan: Control-ITT; p <0.05; ANOVA NCT00922441 ↗

Publications

Lee H, Kim KS, Chae SC, Jeong MH, Kim DS, Oh BH. Ambulatory blood pressure response to once-daily fimasartan: an 8-week, multicenter, randomized, double-blind, active-comparator, parallel-group study in Korean patients with mild to moderate essential hypertension. Clin Ther. 2013 Sep;35(9):1337-49. doi: 10.1016/j.clinthera.2013.06.021. Epub 2013 Aug 7.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Fimasartan	Small molecule	60 mg	Oral
Subject	Fimasartan	Small molecule	120 mg	Oral
Comparator	Valsartan	Unknown	80 mg	Oral