Dataset Information
Efficacy and safety of azilsartan medoxomil, an angiotensin receptor blocker, in Korean patients with essential hypertension.
Ontology highlight
ABSTRACT: Background
This was a phase 3, randomized, double-blind, placebo-controlled study.Methods
Adult Korean patients with essential hypertension and a baseline mean sitting clinic systolic blood pressure (scSBP) ≥150 and ≤180 mmHg were randomized to 6-week treatment with placebo (n = 65), azilsartan medoxomil (AZL-M) 40 mg (n = 132), or AZL-M 80 mg (n = 131). The primary endpoint was the change from baseline to week 6 in trough scSBP.Results
The least-squares mean (standard error) change from baseline in trough scSBP in the placebo, AZL-M 40-mg, and 80-mg groups at week 6 were - 8.8 (2.00), - 22.1 (1.41), and - 23.7 (1.40) mmHg, respectively (p < 0.001 for AZL-M 40 and 80 mg vs placebo). No clinically meaningful heterogeneity in efficacy was observed between subgroups (age, sex, diabetes status) and the overall population. Treatments were well tolerated and adverse events were similar between groups.Conclusions
Results of this study confirm a positive benefit-risk profile of AZL-M for essential hypertension in Korean adults.Trial registration
Clinicaltrial.gov; identifier number: NCT02203916. Registered July 28, 2014 (retrospectively registered).
SUBMITTER: Juhasz A
PROVIDER: S-EPMC5804062 | biostudies-literature | 2018
REPOSITORIES: biostudies-literature
Publications
Efficacy and safety of azilsartan medoxomil, an angiotensin receptor blocker, in Korean patients with essential hypertension.
Clinical hypertension 20180207
<h4>Background</h4>This was a phase 3, randomized, double-blind, placebo-controlled study.<h4>Methods</h4>Adult Korean patients with essential hypertension and a baseline mean sitting clinic systolic blood pressure (scSBP) ≥150 and ≤180 mmHg were randomized to 6-week treatment with placebo (<i>n</i> = 65), azilsartan medoxomil (AZL-M) 40 mg (<i>n</i> = 132), or AZL-M 80 mg (<i>n</i> = 131). The primary endpoint was the change from baseline to week 6 in trough scSBP.<h4>Results</h4>The least-squa ...[more]