title: Azilsartan in Patients With Mild to Moderate Hypertension Using Clinic and Ambulatory Blood Pressure Measurements.
abstract: This was a phase 2, multicenter, randomized, parallel-group, double-blind dose-ranging study. Hypertensive adults (n=555) received one of five doses of azilsartan (AZL; 2.5, 5, 10, 20, 40 mg), olmesartan medoxomil (OLM) 20 mg, or placebo once daily. The primary endpoint was change in trough clinic diastolic blood pressure (DBP) at week 8. Compared with placebo, all AZL doses (except 2.5 mg) provided statistically and clinically significant reductions in DBP and systolic blood pressure (SBP) based on both clinic blood pressure (BP) and 24-hour ambulatory BP monitoring (ABPM). AZL 40 mg was statistically superior vs OLM. Clinic BP was associated with a pronounced placebo effect (-6 mm Hg), whereas this was negligible with ABPM (±0.5 mm Hg). Adverse event frequency was similar in the AZL and placebo groups. Based on these and other findings, subsequent trials investigated the commercial AZL medoxomil tablet at doses 20 to 80 mg/d using 24-hour ABPM.
authors.affiliation: Takeda Development Center Americas, Inc., Deerfield, IL.
authors.forename: Alfonso
authors.initials: A
authors.lastname: Perez
authors.affiliation: Takeda Development Center Americas, Inc., Deerfield, IL.
authors.forename: Charlie
authors.initials: C
authors.lastname: Cao
mesh_terms: D000328:Adult; D000368:Aged; D000959:Antihypertensive Agents / Q000008:administration & dosage* / Q000627:therapeutic use; D001562:Benzimidazoles / Q000008:administration & dosage* / Q000627:therapeutic use; D001795:Blood Pressure Determination; D018660:Blood Pressure Monitoring, Ambulatory; D004309:Double Bind Interaction; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D006973:Hypertension / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D000068557:Olmesartan Medoxomil / Q000008:administration & dosage* / Q000627:therapeutic use; D010069:Oxadiazoles / Q000008:administration & dosage* / Q000627:therapeutic use; D016896:Treatment Outcome
chemical_list: D000959:Antihypertensive Agents; D001562:Benzimidazoles; D010069:Oxadiazoles; D000068557:Olmesartan Medoxomil; C521273:azilsartan