Safety and Tolerability of Azilsartan Medoxomil Plus Chlorthalidone Compared to Olmesartan Medoxomil Plus Hydrochlorothiazide in Participants With Essential Hypertension

Exclusion Criteria

• •Has a mean clinic diastolic blood pressure (sitting, trough) greater than 119 mm Hg on Day 1.
• •Has secondary hypertension of any etiology (eg, renovascular disease, pheochromocytoma, Cushing's syndrome).
• •Has a recent history (within the last 6 months) of myocardial infarction, heart failure, unstable angina, coronary artery bypass graft, percutaneous coronary intervention, hypertensive encephalopathy, cerebrovascular accident or transient ischemic attack.
• •Has clinically significant cardiac conduction defects (ie, third-degree atrioventricular block, sick sinus syndrome).
• •Has hemodynamically significant left ventricular outflow obstruction due to aortic valvular disease.
• •Has severe renal dysfunction or disease.
• •Has known or suspected unilateral or bilateral renal artery stenosis.
• •Has a history of cancer that has not been in remission for at least 5 years prior to the first dose of study drug.
• •Has poorly-controlled type 1 or 2 diabetes mellitus at Screening.
• •Has hypokalemia or hyperkalemia at Screening.
• •Has an alanine aminotransferase or aspartate aminotransferase level of greater than 2.5 times the upper limit of normal, active liver disease, or jaundice at Screening.
• •Has any other known serious disease or condition that would compromise safety, might affect life expectancy, or make it difficult to successfully manage and follow according to the protocol.
• •Has known hypersensitivity to angiotensin II receptor blockers or thiazide-type diuretics or other sulfonamide-derived compounds.
• •Has been randomized/enrolled in a previous azilsartan or azilsartan medoxomil plus chlorthalidone study.
• •Currently is participating in another investigational study or has received any investigational compound within 30 days prior to Screening.
• •Has a history of drug abuse or a history of alcohol abuse within the past 2 years.
• •Is taking or expected to take any excluded medication, including:
• •* Antihypertensive medications must be discontinued completely by Day -14, except antihypertensive medications used in the open-label treatment period in accordance with the titration-to-target blood pressure titration.
• •* Angiotensin II receptor blockers or thiazide-type diuretics other than study medication.
• •* Over-the-counter products not permitted by investigator.