title: A Randomized, Double-blind, Candesartan-controlled, Parallel Group Comparison Clinical Trial to Evaluate the Antihypertensive Efficacy and Safety of Fimasartan in Patients with Mild to Moderate Essential Hypertension.
abstract: A new antihypertensive drug that selectively blocks angiotensin II receptor type 1, fimasartan, has a potent and rapidly acting antihypertensive effect. We investigated the antihypertensive effects of fimasartan 60 and 120 mg and its safety in comparison to 8 mg of candesartan.
  
  
  
  This clinical trial is a multicenter, randomized, double-blind, active comparator, and parallel group study. Three hundred sixty-two individuals were screened, and 290 patients aged 19 to 75 years with mild to moderate hypertension (diastolic blood pressure [DBP], 90-110 mm Hg) were randomly assigned to 60 to 120 mg/d of fimasartan or 8 mg/d of candesartan after a 2-week placebo run-in period. Treatments were administered for 12 weeks without dosage adjustment. The primary end point was the differences in DBP changes at week 12.
  
  
  
  After 12 weeks of treatment, DBP and systolic blood pressure (SBP) decreased significantly in all 3 groups. The decrease in DBP at week 12 was larger but not statistically significant in the fimasartan 60 mg compared with the candesartan 8 mg group with a mean (SD) difference of 1.72 (8.32) mm Hg (95% CI, -0.71 to 4.15 mm Hg; P = 0.17). The lower margin of the CI (-0.71 mm Hg) exceeded the noninferiority margin (-3.5 mm Hg). The DBP-lowering effect of fimasartan 120 mg was also nonsignificantly larger than candesartan 8 mg (difference, 1.58 [8.27] mm Hg; P = 0.20). The decrease in SBP was also nonsignificantly larger in the fimasartan 60 mg group compared with the candesartan 8 mg group (difference, 3.50 [12.63] mm Hg; P = .06). The SBP-lowering effect of fimasartan 120 mg was statistically larger than candesartan 8 mg (difference, 4.98 [13.99] mm Hg; P = .02). Response rate (DBP <90 mm Hg or DBP lowering >10 mm Hg at week 12) was also nonsignificantly greater in both fimasartan groups (Fimasartan 60 mg, 81%; fimasartan 120 mg, 72%; candesartan 8 mg, 71%). The safety profile of the fimasartan 60 mg and 120 mg was similar to candesartan 8 mg, with a slightly higher, but statistically not significant, incidence of hepatic enzyme elevation in fimasartan 120 mg.
  
  
  
  The antihypertensive effect of fimasartan, a newly available angiotensin II receptor type 1 blocker, is comparable, although not superior, to candesartan with a good safety profile. ClinicalTrials.gov identifier: NCT01135212.
authors.affiliation: Kyungpook National University School of Medicine, Daegu, Republic of Korea.
authors.forename: Jang Hoon
authors.initials: JH
authors.lastname: Lee
authors.affiliation: Kyungpook National University School of Medicine, Daegu, Republic of Korea.
authors.forename: Dong Heon
authors.initials: DH
authors.lastname: Yang
authors.affiliation: Gyeongsang National University School of Medicine, Jinju, Republic of Korea.
authors.forename: Jin Yong
authors.initials: JY
authors.lastname: Hwang
authors.affiliation: Keimyung University Dongsan Medical Center, Daegu, Republic of Korea.
authors.forename: Seung Ho
authors.initials: SH
authors.lastname: Hur
authors.affiliation: Kosin University Gospel Hospital, Busan, Republic of Korea.
authors.forename: Tae Joon
authors.initials: TJ
authors.lastname: Cha
authors.affiliation: Daegu Catholic University Hospital, Daegu, Republic of Korea.
authors.forename: Ki-Sik
authors.initials: KS
authors.lastname: Kim
authors.affiliation: Donga University Hospital, Busan, Republic of Korea.
authors.forename: Moo Hyun
authors.initials: MH
authors.lastname: Kim
authors.affiliation: Pusan National University Yangsan Hospital, Yangsan, Republic of Korea.
authors.forename: Kook Jin
authors.initials: KJ
authors.lastname: Chun
authors.affiliation: Pusan University Hospital, Busan, Republic of Korea.
authors.forename: Gwang Soo
authors.initials: GS
authors.lastname: Cha
authors.affiliation: Yeungnam University Medical Center, Daegu, Republic of Korea.
authors.forename: Geu Ru
authors.initials: GR
authors.lastname: Hong
authors.affiliation: Ulsan University Hospital, Ulsan, Republic of Korea.
authors.forename: Sang Gon
authors.initials: SG
authors.lastname: Lee
authors.affiliation: Inje University Pusan Paik Hospital, Busan, Republic of Korea.
authors.forename: Dong Soo
authors.initials: DS
authors.lastname: Kim
authors.affiliation: Inje University Haeundae Baik Hospital, Busan, Republic of Korea.
authors.forename: Doo Il
authors.initials: DI
authors.lastname: Kim
authors.affiliation: Kyungpook National University School of Medicine, Daegu, Republic of Korea. Electronic address: scchae@knu.ac.kr.
authors.forename: Shung Chull
authors.initials: SC
authors.lastname: Chae
mesh_terms: D000328:Adult; D000368:Aged; D047228:Angiotensin II Type 1 Receptor Blockers / Q000009:adverse effects / Q000627:therapeutic use*; D000959:Antihypertensive Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001562:Benzimidazoles / Q000009:adverse effects / Q000627:therapeutic use*; D001713:Biphenyl Compounds / Q000009:adverse effects / Q000627:therapeutic use*; D001794:Blood Pressure / Q000187:drug effects; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D000075222:Essential Hypertension; D005260:Female; D006801:Humans; D006973:Hypertension / Q000188:drug therapy* / Q000503:physiopathology; D008297:Male; D008875:Middle Aged; D011743:Pyrimidines / Q000009:adverse effects / Q000627:therapeutic use*; D013777:Tetrazoles / Q000009:adverse effects / Q000627:therapeutic use*; D055815:Young Adult
chemical_list: D047228:Angiotensin II Type 1 Receptor Blockers; D000959:Antihypertensive Agents; D001562:Benzimidazoles; D001713:Biphenyl Compounds; D011743:Pyrimidines; D013777:Tetrazoles; C558933:fimasartan; C081643:candesartan
keywords: angiotensin receptor blocker; candesartan; fimasartan; hypertension