title: A Randomized, Double-blind, Multicenter, Phase III Study to Evaluate the Efficacy and Safety of Fimasartan/Amlodipine Combined Therapy Versus Fimasartan Monotherapy in Patients With Essential Hypertension Unresponsive to Fimasartan Monotherapy.
abstract: The goal of this study was to evaluate whether the blood pressure-lowering efficacy of fimasartan/amlodipine combination therapy was superior to that of fimasartan monotherapy after 8 weeks of treatment in patients with hypertension who had failed to respond adequately to fimasartan monotherapy.
  
  
  
  This trial was a randomized, double-blind, multicenter, Phase III clinical study. Patients who failed to respond after 4 weeks of treatment with 60 mg daily of fimasartan (sitting systolic blood pressure [SiSBP]) ≥140 mm Hg) were randomized to receive either daily fimasartan 60 mg or fimasartan/amlodipine 60 mg/10 mg. The primary efficacy end point was the change in SiSBP from baseline to week 8. Secondary end points included the change in SiSBP from baseline to week 4, the changes in sitting diastolic blood pressure from baseline to weeks 4 and 8, and the response rate (SiSBP <140 mm Hg or decrease in SiSBP ≥20 mm Hg) or control rate (SiSBP <140 mm Hg) at week 8. Treatment-emergent adverse events were also assessed.
  
  
  
  Of 143 patients randomized to treatment, 137 patients who had available efficacy data were analyzed. The mean age of patients was 59.1 (8.9) years, and 100 (73.0%) were male. Baseline SiSBP and sitting diastolic blood pressure were 150.6 (9.2) mm Hg and 91.7 (8.6) mm Hg, respectively. In the fimasartan/amlodipine combination group, a greater reduction in SiSBP from baseline to week 8 was observed compared with the fimasartan group (7.8 [13.3] mm Hg in the fimasartan group vs 20.5 [14.6] mm Hg in the fimasartan/amlodipine group; P < 0.0001). This reduction was observed after 4 weeks. The mean SiSBP changes from baseline to week 4 were 8.1 (15.8) mm Hg in the fimasartan group and 20.1 (14.7) mm Hg in the fimasartan/amlodipine group (P < 0.0001). At week 8, the response rate was significantly higher in the fimasartan/amlodipine (82.1%) group than in the fimasartan (32.9%) group (P < 0.0001). The control rate at week 8 was also higher in the fimasartan/amlodipine (79.1%) group than in the fimasartan (31.4%) group (P < 0.0001). Adverse drug reactions were observed in 9 patients (6.3%), with no significant differences between treatment groups. There were no serious adverse events associated with the study drugs.
  
  
  
  Fimasartan/amlodipine combination therapy exhibited superior efficacy in reducing blood pressure, with no increase in adverse drug reactions, compared with fimasartan monotherapy. ClinicalTrials.gov identifier: NCT02152306.
authors: Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Republic of Korea.
authors: Kwang-Il
authors: KI
authors: Kim
authors: Division of Cardiology, Gachon University Gil Medical Center, Incheon, Republic of Korea.
authors: Mi-Seung
authors: MS
authors: Shin
authors: Department of Internal Medicine, Bucheon St. Mary׳s Hospital, College of Medicine, The Catholic University of Koreau, Bucheon, Republic of Korea.
authors: Sang-Hyun
authors: SH
authors: Ihm
authors: Division of Cardiology, Department of Internal Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.
authors: Ho-Joong
authors: HJ
authors: Youn
authors: Division of Cardiology, Department of Medicine Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.
authors: Ki-Chul
authors: KC
authors: Sung
authors: Department of Internal Medicine, Kyungpook National University Hospital, Daegu, Republic of Korea.
authors: Shung Chull
authors: SC
authors: Chae
authors: Department of Internal Medicine, Dongsan Medical Center, Keimyung University, Daegu, Republic of Korea.
authors: Chang-Wook
authors: CW
authors: Nam
authors: Department of Internal Medicine, Korea University Guro Hospital, Seoul, Republic of Korea.
authors: Hong Seog
authors: HS
authors: Seo
authors: Division of Cardiology, Korea University College of Medicine, Seoul, Republic of Korea.
authors: Seong-Mi
authors: SM
authors: Park
authors: Cardiovascular Center, Dongguk University Ilsan Hospital, Goyang, Republic of Korea.
authors: Moo-Yong
authors: MY
authors: Rhee
authors: Department of Cardiology, Dong-A University Hospital, Busan, Republic of Korea.
authors: Moo Hyun
authors: MH
authors: Kim
authors: Department of Cardiology, Pusan National University Hospital, Busan, Republic of Korea.
authors: Kwang Soo
authors: KS
authors: Cha
authors: Department of Internal Medicine, Seoul National University Hospital, Seoul, Republic of Korea.
authors: Yong-Jin
authors: YJ
authors: Kim
authors: Division of Cardiology, Asan Medical Center, University of Ulsan, Seoul, Republic of Korea.
authors: Jae-Joong
authors: JJ
authors: Kim
authors: Department of Internal Medicine, Pusan National University Yangsan Hospital, Yangsan, Republic of Korea.
authors: Kook Jin
authors: KJ
authors: Chun
authors: Division of Cardiology, Wonju Severance Christian Hospital, Wonju, Republic of Korea.
authors: Byung-Su
authors: BS
authors: Yoo
authors: Division of Cardiology, Yonsei Cardiovascular Hospital, Yonsei Health System, Seoul, Republic of Korea.
authors: Sungha
authors: S
authors: Park
authors: Department of Cardiology, Ulsan University Hospital, University of Ulsan College of Medicine,Ulsan, Republic of Korea.
authors: Eun-Seok
authors: ES
authors: Shin
authors: Department of Internal Medicine, Inje University Busan Paik Hospital, Busan, Republic of Korea.
authors: Dong-Soo
authors: DS
authors: Kim
authors: Department of Internal Medicine, Haeundae Paik Hospital, Busan, Republic of Korea.
authors: Doo
authors: D
authors: Il Kim
authors: Department of Cardiology, Chonnam National University Hospital, Gwangju, Republic of Korea.
authors: Kye Hun
authors: KH
authors: Kim
authors: Department of Internal Medicine, Jeju National University Hospital, Jeju, Republic of Korea.
authors: Seung-Jae
authors: SJ
authors: Joo
authors: Department of Internal Medicine, Chungnam National University Hospital, Daejeon, Republic of Korea.
authors: Jin-Ok
authors: JO
authors: Jeong
authors: Division of Cardiology, Hanyang University Hospital, Seoul, Republic of Korea.
authors: Jinho
authors: J
authors: Shin
authors: Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Republic of Korea. Electronic address: cheolkim@snu.ac.kr.
authors: Cheol Ho
authors: CH
authors: Kim
mesh_terms: D000368:Aged; D017311:Amlodipine / Q000008:administration & dosage*; D000959:Antihypertensive Agents / Q000008:administration & dosage*; D001713:Biphenyl Compounds / Q000008:administration & dosage*; D001794:Blood Pressure / Q000187:drug effects; D004311:Double-Blind Method; D000075222:Essential Hypertension; D005260:Female; D006801:Humans; D006973:Hypertension / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D011743:Pyrimidines / Q000008:administration & dosage*; D013777:Tetrazoles / Q000008:administration & dosage*
chemical_list: D000959:Antihypertensive Agents; D001713:Biphenyl Compounds; D011743:Pyrimidines; D013777:Tetrazoles; D017311:Amlodipine; C558933:fimasartan
keywords: amlodipine; angiotensin II type 1 receptor blockers; antihypertensive; blood pressure; combination; fimasartan