Azilsartan Medoxomil in the Treatment of Essential Hypertension and Type 2 Diabetes in Asia

Inclusion Criteria:

1. In the opinion of the investigator, the participant is capable of understanding andcomplying with protocol requirements.

2. The participant or, when applicable, the participant's legally acceptablerepresentative signs and dates a written, informed consent form and any requiredprivacy authorization prior to the initiation of any study procedures.

3. Has type 2 diabetes mellitus (T2DM) with essential hypertension.

4. T2DM participants are either treated by stable life style intervention or by oralantidiabetic drugs (OADs) that are stable, including no dose adjustment within 12weeks before baseline.

5. Is male or female and aged 18 to 75 years, inclusive.

6. Uncontrolled hypertension (systolic blood pressure ≥140 mmHg to <180 mmHg, ordiastolic blood pressure ≥85 mmHg and <110 mmHg at screening and baseline.

7. Has screening glycosylated hemoglobin (HbA1C) <9.5%.

8. Female participants must be either of non-childbearing potential, ie, surgicallysterilized (defined as having undergone hysterectomy and/or bilateral oophorectomyand/or bilateral salpingectomy; tubal ligation alone is not considered sufficient) orone year after the last menstrual period; or, if of childbearing potential andparticipant is sexually active with a nonsterilized male partner, must agree to useroutinely adequate contraception from signing of informed consent throughout theduration of study.

Exclusion Criteria:

1. Has systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg despiteconcurrent treatment with three antihypertensive medications from different classes atadequate doses including a diuretic.

2. Has type 1 or poorly controlled type 2 diabetes mellitus, defined as HbA1c ≥9.5% atscreening.

3. Is treated with OADs has not been on stable treatment including no dose change oftheir OADs for at least 12 weeks prior to baseline.

4. Has been previously treated with azilsartan medoxomil (AZM) or azilsartan.

5. Has secondary hypertension of any etiology (eg, renovascular disease,pheochromocytoma, Cushing's syndrome).

6. Has congestive heart failure (New York Heart Association class III or IV), clinicallyrelevant cardiac arrhythmias (as determined by the investigator's clinical judgment ona participant-by-participant basis), severe obstructive coronary artery disease.

7. Has participated in a clinical trial including interventional and observationalstudies, or received any investigational compound currently or 30 days prior toscreening.

8. Has severe renal impairment (based on estimated glomerular filtration rate [GFR] <30mL/min/1.73m^2) at Screening.

9. Has hyperkalemia defined as serum potassium >5.0 mEq/L.

10. Has an alanine aminotransferase (ALT) level of greater than 2.5 times the upper limitof normal, active liver disease, or jaundice at screening.

11. Has any clinically relevant disease (eg malignancy, neurological, hepaticabnormalities) and/or significant abnormal laboratory findings (past or present),which, in the opinion of the investigator, may put the participant at risk because ofparticipation in the study.

12. Is taking prohibited medications including lithium and aliskiren (refer to Edarbi®product insert).

13. Has known hypersensitivity to any excipients or angiotensin converting enzymeinhibitor (ACEIs)/ angiotensin receptor blockers (ARBs).

14. Has prior angioedema due to an ACE inhibitor or ARB.

15. Breast feeding or pregnant women or women who are intending to become pregnant before,during or within 1 month after participating in the study; or intending to donate ovaduring such time period, or refusal to submit to a urine test to rule out pregnancyprior to enrolment and at end of study.

16. Have a history of alcohol abuse, drug abuse or illegal drug addiction within the 6months prior to signing the informed consent.

17. Is an immediate family member, study site employee, or is in a dependent relationshipwith a study site employee who is involved in conduct of this study (eg, spouse,parent, child, sibling) or may consent under duress.