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

Kwang il Kim, Mi Seung Shin, Sang Hyun Ihm, Ho Joong Youn, Ki Chul Sung, Shung Chull Chae, Chang Wook Nam, Hong Seog Seo, Seong-Mi Park, Moo Yong Rhee, Moo Hyun Kim, Kwang Soo Cha, Yong Jin Kim, Jae Joong Kim, Kook Jin Chun, Byung Su Yoo, Sungha Park, Eun Seok Shin, Dong Soo Kim, Doo Il KimKye Hun Kim, Seung Jae Joo, Jin Ok Jeong, Jinho Shin, Cheol Ho Kim

Research output: Contribution to journalArticle

4 Citations (Scopus)

Abstract

Purpose 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. Methods 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. Findings 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. Implications 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.

Original languageEnglish
Pages (from-to)2159-2170
Number of pages12
JournalClinical Therapeutics
Volume38
Issue number10
DOIs
Publication statusPublished - 2016 Oct 1

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Amlodipine
Blood Pressure
Safety
Therapeutics
fimasartan
Essential Hypertension
Drug-Related Side Effects and Adverse Reactions

Keywords

  • amlodipine
  • angiotensin II type 1 receptor blockers
  • antihypertensive
  • blood pressure
  • combination
  • fimasartan

ASJC Scopus subject areas

  • Pharmacology
  • Pharmacology (medical)

Cite this

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. / Kim, Kwang il; Shin, Mi Seung; Ihm, Sang Hyun; Youn, Ho Joong; Sung, Ki Chul; Chae, Shung Chull; Nam, Chang Wook; Seo, Hong Seog; Park, Seong-Mi; Rhee, Moo Yong; Kim, Moo Hyun; Cha, Kwang Soo; Kim, Yong Jin; Kim, Jae Joong; Chun, Kook Jin; Yoo, Byung Su; Park, Sungha; Shin, Eun Seok; Kim, Dong Soo; Il Kim, Doo; Kim, Kye Hun; Joo, Seung Jae; Jeong, Jin Ok; Shin, Jinho; Kim, Cheol Ho.

In: Clinical Therapeutics, Vol. 38, No. 10, 01.10.2016, p. 2159-2170.

Research output: Contribution to journalArticle

Kim, KI, Shin, MS, Ihm, SH, Youn, HJ, Sung, KC, Chae, SC, Nam, CW, Seo, HS, Park, S-M, Rhee, MY, Kim, MH, Cha, KS, Kim, YJ, Kim, JJ, Chun, KJ, Yoo, BS, Park, S, Shin, ES, Kim, DS, Il Kim, D, Kim, KH, Joo, SJ, Jeong, JO, Shin, J & Kim, CH 2016, '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', Clinical Therapeutics, vol. 38, no. 10, pp. 2159-2170. https://doi.org/10.1016/j.clinthera.2016.07.008
Kim, Kwang il ; Shin, Mi Seung ; Ihm, Sang Hyun ; Youn, Ho Joong ; Sung, Ki Chul ; Chae, Shung Chull ; Nam, Chang Wook ; Seo, Hong Seog ; Park, Seong-Mi ; Rhee, Moo Yong ; Kim, Moo Hyun ; Cha, Kwang Soo ; Kim, Yong Jin ; Kim, Jae Joong ; Chun, Kook Jin ; Yoo, Byung Su ; Park, Sungha ; Shin, Eun Seok ; Kim, Dong Soo ; Il Kim, Doo ; Kim, Kye Hun ; Joo, Seung Jae ; Jeong, Jin Ok ; Shin, Jinho ; Kim, Cheol Ho. / 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. In: Clinical Therapeutics. 2016 ; Vol. 38, No. 10. pp. 2159-2170.
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abstract = "Purpose 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. Methods 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. Findings 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. Implications 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.",
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author = "Kim, {Kwang il} and Shin, {Mi Seung} and Ihm, {Sang Hyun} and Youn, {Ho Joong} and Sung, {Ki Chul} and Chae, {Shung Chull} and Nam, {Chang Wook} and Seo, {Hong Seog} and Seong-Mi Park and Rhee, {Moo Yong} and Kim, {Moo Hyun} and Cha, {Kwang Soo} and Kim, {Yong Jin} and Kim, {Jae Joong} and Chun, {Kook Jin} and Yoo, {Byung Su} and Sungha Park and Shin, {Eun Seok} and Kim, {Dong Soo} and {Il Kim}, Doo and Kim, {Kye Hun} and Joo, {Seung Jae} and Jeong, {Jin Ok} and Jinho Shin and Kim, {Cheol Ho}",
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T1 - 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

AU - Kim, Kwang il

AU - Shin, Mi Seung

AU - Ihm, Sang Hyun

AU - Youn, Ho Joong

AU - Sung, Ki Chul

AU - Chae, Shung Chull

AU - Nam, Chang Wook

AU - Seo, Hong Seog

AU - Park, Seong-Mi

AU - Rhee, Moo Yong

AU - Kim, Moo Hyun

AU - Cha, Kwang Soo

AU - Kim, Yong Jin

AU - Kim, Jae Joong

AU - Chun, Kook Jin

AU - Yoo, Byung Su

AU - Park, Sungha

AU - Shin, Eun Seok

AU - Kim, Dong Soo

AU - Il Kim, Doo

AU - Kim, Kye Hun

AU - Joo, Seung Jae

AU - Jeong, Jin Ok

AU - Shin, Jinho

AU - Kim, Cheol Ho

PY - 2016/10/1

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N2 - Purpose 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. Methods 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. Findings 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. Implications 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.

AB - Purpose 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. Methods 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. Findings 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. Implications 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.

KW - amlodipine

KW - angiotensin II type 1 receptor blockers

KW - antihypertensive

KW - blood pressure

KW - combination

KW - fimasartan

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