Azilsartan Medoxomil (TAK-491) Compared to Placebo in Korean Adults With Hypertension
Condition: Hypertension
MeSH terms: Hypertension
Intervention: Azilsartan medoxomil; Azilsartan medoxomil placebo
Intervention description: Azilsartan medoxomil tablets; Azilsartan medoxomil placebo-matching tablets
Intervention MeSH terms: Azilsartan medoxomil
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 328.0
Sex: All
Minimum age: 19 Years
Healthy volunteers: No
Keywords: Drug therapy

Summary:

      The purpose of this study is to compare the antihypertensive effect of azilsartan medoxomil
      versus placebo in Korean adults with essential hypertension.
    

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. Is treated with antihypertensive therapy and has a post-washout mean sitting clinic
             systolic blood pressure (SBP) ≥150 and ≤180 mm Hg on Day 1; or the patient has not
             received antihypertensive treatment within 28 days prior to Screening and has a mean
             sitting clinic SBP ≥150 and ≤180 mm Hg at the Screening Visit and on Day 1.

          4. Is male or female aged ≥19 years.

          5. A female of childbearing potential who is sexually active with a nonsterilized male
             partner agrees to routinely use adequate contraception from signing of the informed
             consent through 30 days after last study drug dose.

          6. Is willing to discontinue current antihypertensive medications on Day -21. If on
             amlodipine or chlorthalidone prior to Screening, the participant is willing to
             discontinue this medication on Day -28.

        Exclusion Criteria:

          1. Has received any investigational compound within 30 days prior to the first dose of
             study medication.

          2. Has received TAK-491 in a previous clinical study or as a therapeutic agent.

          3. 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.

          4. Has sitting trough clinic diastolic blood pressure (DBP) greater than 114 mm Hg at Day
             1 (after placebo run-in).

          5. Has a history of hypersensitivity to TAK-491 (azilsartan medoxomil), any of its
             excipients, or other angiotensin-converting enzyme (ARBs).

          6. Has a history of myocardial infarction, heart failure, unstable angina, coronary
             artery bypass graft, percutaneous coronary intervention, hypertensive encephalopathy,
             cerebrovascular accident, or transient ischemic attack.

          7. Has clinically significant cardiac conduction defects (e.g., 3rd degree
             atrioventricular block, left bundle branch block, sick sinus syndrome, atrial
             fibrillation, or flutter).

          8. Has hemodynamically significant left ventricular outflow obstruction due to aortic
             valvular disease and hypertrophic obstructive cardiomyopathy (HOCM).

          9. Has secondary hypertension of any etiology (e.g., renovascular disease,
             pheochromocytoma, Cushing syndrome).

         10. Is noncompliant (less than 70% or greater than 130%) with study medication during
             placebo run-in period.

         11. Has severe renal dysfunction or disease (confirmed by calculated creatinine clearance
             <30 mL/min/1.73m^2) at Screening.

         12. Has known or suspected unilateral or bilateral renal artery stenosis.

         13. Has a history of drug or alcohol abuse within the past 2 years.

         14. 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 patients with
             basal cell or stage I squamous cell carcinoma of the skin.)

         15. Has type 1 or poorly controlled type 2 diabetes mellitus (hemoglobin A1c [HbA1c]>8.0%)
             at Screening.

         16. Has an alanine aminotransferase (ALT) level greater than 2.5 times the upper limit of
             normal, active liver disease, or jaundice at Screening.

         17. Has hyperkalemia (defined as serum potassium greater than the upper limit of normal
             per the central laboratory) at Screening.

         18. Has any other serious disease or condition at screening or randomization that would
             compromise participant safety, might affect life expectancy, or make it difficult to
             successfully manage and follow the participant according to the protocol.

         19. Is required to take excluded medications.

         20. If female, is pregnant or lactating or intending to become pregnant before, during, or
             within 30 days after participating in this study; or intending to donate ova during
             such time period.