Effect of Febuxostat on Blood Pressure

Exclusion Criteria

• •1. The participant has received any investigational compound within 30 days, or within 5 half-lives of the compound (whichever is longer) prior to the Screening Visit.
• •2. The participant has received febuxostat or any urate-lowering therapy (ULT) in a previous clinical study or as a therapeutic agent.
• •3. The participant has gout, history of gout, or gout flares.
• •4. The participant has secondary hyperuricemia (HPU) (e.g., due to myeloproliferative disorder, or organ transplant).
• •5. The participant has known secondary hypertension of any etiology (e.g., renovascular disease, primary hyperaldosteronism, Cushing syndrome).
• •6. The participant has a history, within the 6 months prior to screening, of myocardial infarction, heart failure, unstable angina, coronary artery bypass graft, or percutaneous coronary intervention.
• •7. The participant has an irregular cardiac rhythm (e.g., atrial fibrillation, multifocal premature atrial contractions) which leads to difficulty with interpretation of ambulatory blood pressure monitoring (ABPM).
• •8. The participant has a history of congestive heart failure, hypertensive encephalopathy, cerebrovascular accident, or transient ischemic attack.
• •9. The participant has type 1 or poorly controlled type 2 diabetes mellitus (glycosylated hemoglobin \[HbA1c\] \>8.0%) at Screening.
• •10. The participant has a history of infection with hepatitis B, hepatitis C, or human immunodeficiency virus.
• •11. The participant has an average clinic SBP \>165 mm Hg or DBP \>105 mm Hg at 1 or more visits during the Placebo Run-in Period.
• •12. The participant's average clinic SBP or DBP measurement that increases or decreases by \>10 mm Hg between Placebo Run-in visits (Day -14 to Day -7, or Day -7 to Day -1, or Day -14 to Day -1).
• •13. The participant is an immediate family member, study site employee, or is in a dependent relationship with a study site employee who is involved in conduct of this study (e.g., spouse, parent, child, sibling) or may consent under duress.
• •14. The participant has an alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) values greater than 2.0 times the upper limit of normal (ULN).
• •15. The participant has a significant medical condition and/or conditions that would interfere with the treatment, safety or compliance with the protocol.
• •16. The participant has a history of alcoholism or illicit drug abuse within 5 years prior to the Screening Visit or is currently consuming \>14 alcoholic drinks per week.
• •17. The participant has a known hypersensitivity or allergies to febuxostat or any components of the formulations of this compound.
• •18. The participant is taking or expected to take a medication as described in the excluded medication section.
• •19. The participant has a history of cancer that has not been in remission for at least 5 years prior to the first dose of study drug. This criterion does not apply to those participants with successfully resected basal cell or stage I squamous cell carcinoma of the skin.
• •20. The participant's estimated glomerular filtration rate (eGFR) is \<30 mL/min/1.73m3, where eGFR is calculated by the Central Laboratory using the Modification of Diet in Renal Disease (MDRD) formula at the Day -21 Screening Visit.
• •21. The participant is noncompliant (\<80% or \>120%) with study medication during Placebo Run-In Period.
• •22. The participant has an upper arm circumference less than 24 cm or greater than 42 cm.
• •23. The participant's work shift includes any hour between 11 PM (2300) to 7 AM (0700).
• •24. The participant has a baseline 24-hour ABPM reading of insufficient quality (as described in Appendix F of the protocol).