Azilsartan Medoxomil in the Treatment of Essential Hypertension and Type 2 Diabetes in Asia
Condition: Essential Hypertension; Type 2 Diabetes Mellitus
MeSH terms: Hypertension; Essential Hypertension; Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Azilsartan Medoxomil
Intervention description: Azilsartan medoxomil tablets
Intervention MeSH terms: Azilsartan medoxomil
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 380.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Drug therapy

Summary:

      The purpose of this study is to evaluate the efficacy and safety of azilsartan medoxomil
      (AZM) in Asian adult participants with both essential hypertension and type 2 diabetes.
    

Eligibility criteria:

        Inclusion Criteria:

          1. In the opinion of the investigator, the participant is capable of understanding and
             complying with protocol requirements.

          2. The participant or, when applicable, the participant's legally acceptable
             representative signs and dates a written, informed consent form and any required
             privacy 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 oral
             antidiabetic drugs (OADs) that are stable, including no dose adjustment within 12
             weeks 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, or
             diastolic 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, surgically
             sterilized (defined as having undergone hysterectomy and/or bilateral oophorectomy
             and/or bilateral salpingectomy; tubal ligation alone is not considered sufficient) or
             one year after the last menstrual period; or, if of childbearing potential and
             participant is sexually active with a nonsterilized male partner, must agree to use
             routinely adequate contraception from signing of informed consent throughout the
             duration of study.

        Exclusion Criteria:

          1. Has systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg despite
             concurrent treatment with three antihypertensive medications from different classes at
             adequate doses including a diuretic.

          2. Has type 1 or poorly controlled type 2 diabetes mellitus, defined as HbA1c ≥9.5% at
             screening.

          3. Is treated with OADs has not been on stable treatment including no dose change of
             their 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), clinically
             relevant cardiac arrhythmias (as determined by the investigator's clinical judgment on
             a participant-by-participant basis), severe obstructive coronary artery disease.

          7. Has participated in a clinical trial including interventional and observational
             studies, or received any investigational compound currently or 30 days prior to
             screening.

          8. Has severe renal impairment (based on estimated glomerular filtration rate [GFR] <30
             mL/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 limit
             of normal, active liver disease, or jaundice at screening.

         11. Has any clinically relevant disease (eg malignancy, neurological, hepatic
             abnormalities) and/or significant abnormal laboratory findings (past or present),
             which, in the opinion of the investigator, may put the participant at risk because of
             participation 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 enzyme
             inhibitor (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 ova
             during such time period, or refusal to submit to a urine test to rule out pregnancy
             prior to enrolment and at end of study.

         16. Have a history of alcohol abuse, drug abuse or illegal drug addiction within the 6
             months prior to signing the informed consent.

         17. 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 (eg, spouse,
             parent, child, sibling) or may consent under duress.