Efficacy and Tolerability of Once-Daily Oral Fimasartan 20 to 240 mg/d in Korean Patients with Hypertension: Findings from Two Phase II, Randomized, Double-Blind, Placebo-Controlled Studies

• Published in: Clinical therapeutics 2012-06, Vol.34 (6), p.1273-1289
• Main Authors: Lee, Howard, MD, PhD, Yang, Han-Mo, MD, Lee, Hae-Young, MD, Kim, Jae-Joong, MD, PhD, Choi, Dong-Ju, MD, PhD, Seung, Ki-Bae, MD, PhD, Jeon, Eun-Seok, MD, PhD, Ha, Jong-Won, MD, PhD, Rim, Se-Joong, MD, PhD, Park, Jeong Bae, MD, PhD, Shin, Joon-Han, MD, Oh, Byung-Hee, MD
• Format: Article
• Language: English
• Subjects: 24-hour ambulatory blood pressure monitoring; Administration, Oral; Adult; Aged; angiotensin II receptor blocker; Angiotensin Receptor Antagonists - administration & dosage; Angiotensin Receptor Antagonists - adverse effects; Angiotensin Receptor Antagonists - therapeutic use; Antihypertensive Agents - administration & dosage; Antihypertensive Agents - adverse effects; Antihypertensive Agents - therapeutic use; Arterial hypertension. Arterial hypotension; Biological and medical sciences; Biphenyl Compounds - administration & dosage; Biphenyl Compounds - adverse effects; Biphenyl Compounds - therapeutic use; Blood and lymphatic vessels; Blood pressure; Blood Pressure Monitoring, Ambulatory; Cardiology. Vascular system; Double-Blind Method; Drug therapy; efficacy; essential hypertension; Female; fimasartan; Heart attacks; Humans; Hypertension; Hypertension - drug therapy; Internal Medicine; Korea; Male; Medical Education; Medical sciences; Middle Aged; Older people; Pharmacology. Drug treatments; Placebos; Pyrimidines - administration & dosage; Pyrimidines - adverse effects; Pyrimidines - therapeutic use; Studies; Tetrazoles - administration & dosage; Tetrazoles - adverse effects; Tetrazoles - therapeutic use; tolerability
• ISSN: 0149-2918; 1879-114X
• DOI: 10.1016/j.clinthera.2012.04.021

Abstract Background Fimasartan is a selective angiotensin II receptor blocker developed for once-daily dosing. Objectives To meet the regulatory requirements for approval of an antihypertensive treatment in Korea, this pair of studies was conducted to evaluate the efficacy and tolerability of fimasartan, to determine its dose-response relationship and minimum effective dose, and to characterize its blood pressure (BP)-reduction profile over the dosing interval. Methods These 2 Phase II, randomized, double-blind, placebo-controlled, parallel-group, and dose-response studies enrolled male or nonchildbearing female Korean patients aged 18 to 65 years (study 1) or 18 to 70 years (study 2) with essential hypertension (sitting diastolic BP [DBP] 95–