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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.


ABSTRACT: 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?

SUBMITTER: Ahn Y 

PROVIDER: S-EPMC6156014 | biostudies-literature | 2018 Sep

REPOSITORIES: biostudies-literature

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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.

Ahn Youngkeun Y   Kim Yongcheol Y   Chang Kiyuk K   Kim Weon W   Rhee Moo-Yong MY   Cha Kwang Soo KS   Hyon Min Su MS   Shim Chi Young CY   Lee Sung Yun SY   Kim Doo Il DI   Kim Sang Wook SW   Lim Sang-Wook SW   Han Kyoo-Rok KR   Jo Sang-Ho SH   Lee Nae-Hee NH   Kwan Jun J   Ahn Taehoon T  

Medicine 20180901 37


<h4>Background</h4>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.<h4>Methods</h4>This 8-week, active-controlled, parallel-group, fixed-dose, multicenter, double-blind randomized controlled, and noninferiority trial was conducted at 17 cardiovascula  ...[more]

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