A multicenter, randomized, and double-blind phase IV clinical trial to compare the efficacy and safety of fixed-dose combinations of amlodipine orotate/valsartan 5/160 mg versus valsartan/hydrochlorothiazide 160/12.5 mg in patients with essential hypertension uncontrolled by valsartan 160 mg monotherapy
In: Medicine, Jg. 97 (2018-09-15), Heft 37
Online
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Zugriff:
Background: To determine whether the effectiveness and safety of fixed-dose combinations (FDCs) of amlodipine orotate/valsartan (AML/VAL) 5/160 mg are noninferior to those of valsartan/hydrochlorothiazide (VAL/HCTZ) 160/12.5 mg in hypertensive patients with inadequate response to valsartan 160 mg monotherapy. Methods: This 8-week, active-controlled, parallel-group, fixed-dose, multicenter, double-blind randomized controlled, and noninferiority trial was conducted at 17 cardiovascular centers in the Republic of Korea. Eligible patients had mean sitting diastolic blood pressure (msDBP) ≥90 mm Hg despite monotherapy with valsartan 160 mg for 4 weeks. Patients were randomly assigned to treatment with AML/VAL 5/160 mg FDC (AML/VAL) group or VAL/HCTZ 160/12.5 mg FDC (VAL/HCTZ) group once daily for 8 weeks. A total of 238 patients were enrolled (AML/VAL group, n = 121; VAL/HCTZ group, n = 117), of whom 228 completed the study. Results: At 8 weeks after randomization, msDBP was significantly decreased in both groups (−9.44 ± 0.69 mm Hg in the AML/VAL group and −7.47 ± 0.71 mm Hg in the VAL/HCTZ group, both P
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A multicenter, randomized, and double-blind phase IV clinical trial to compare the efficacy and safety of fixed-dose combinations of amlodipine orotate/valsartan 5/160 mg versus valsartan/hydrochlorothiazide 160/12.5 mg in patients with essential hypertension uncontrolled by valsartan 160 mg monotherapy
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Autor/in / Beteiligte Person: | Sang Wook Lim ; Kyoo Rok Han ; Min Su Hyon ; Sang Ho Jo ; Nae Hee Lee ; Kwang Soo Cha ; Ahn, Taehoon ; Sang Wook Kim ; Doo Il Kim ; Chang, Kiyuk ; Kim, Yongcheol ; Kim, Weon ; Kwan, Jun ; Chi Young Shim ; Ahn, Youngkeun ; Moo Yong Rhee ; Sung Yun Lee |
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Zeitschrift: | Medicine, Jg. 97 (2018-09-15), Heft 37 |
Veröffentlichung: | 2018 |
Medientyp: | unknown |
ISSN: | 1536-5964 (print) |
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