Efficacy and Safety of Azilsartan Medoxomil Combined With Chlorthalidone in Participants With Moderate to Severe Hypertension

Exclusion Criteria

• •1. Has a mean sitting clinic diastolic blood pressure greater than 119 mm Hg on the day prior to randomization.
• •2. Has a baseline 24-hour ambulatory blood pressure measurement reading of insufficient quality.
• •3. Has works a night (third) shift (defined as 11 PM \[2300\] to 7 AM \[0700\]).
• •4. Has an upper arm circumference less than 24 cm or greater than 42 cm.
• •5. Has is noncompliant with study medication during the placebo run-in period.
• •6. Has secondary hypertension of any etiology.
• •7. Has recent history of myocardial infarction, heart failure, unstable angina, coronary artery bypass graft, percutaneous coronary intervention, hypertensive encephalopathy, cerebrovascular accident, or transient ischemic attack.
• •8. Has clinically significant cardiac conduction defects.
• •9. Has hemodynamically significant left ventricular outflow obstruction due to aortic valvular disease.
• •10. Has severe renal dysfunction or disease.
• •11. Has known or suspected unilateral or bilateral renal artery stenosis.
• •12. Has a history of cancer that has not been in remission for at least 5 years prior to the first dose of study drug.
• •13. Has poorly controlled type 1 or type 2 diabetes mellitus at Screening.
• •14. Has hypokalemia or hyperkalemia.
• •15. Has an alanine aminotransferase or aspartate aminotransferase level of greater than 2.5 times the upper limit of normal, active liver disease, or jaundice.
• •16. 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 Has according to the protocol.
• •17. Has known hypersensitivity to angiotensin II receptor blockers, thiazide-type diuretics or other sulfonamide-derived compounds.
• •18. Has been randomized in a previous azilsartan medoxomil study.
• •19. Is currently participating in another investigational study or is receiving or has received any investigational compound within 30 days prior to Screening.
• •20. Has a history of drug abuse or a history of alcohol abuse within the past 2 years.