A Safety and Tolerability Study of Azilsartan Medoxomil in Participants With Essential Hypertension
Condition: Hypertension
MeSH terms: Hypertension; Essential Hypertension
Intervention: Azilsartan medoxomil; Azilsartan medoxomil, with or without chlorthalidone and other non-angiotensin II receptor blocker antihypertensive medications.; Placebo
Intervention description: All subjects initiated azilsartan medoxomil 40 mg, tablets, orally, once daily for four weeks, force-titrated to 80 mg, tablets, orally, once daily. After Week 8, chlorthalidone, 25 mg, tablets, orally, once daily as needed and other antihypertensive medications as needed to achieve target blood pressure (defined as <140/90 mm Hg for participants without diabetes or chronic kidney disease (CKD) and <130/80 mm Hg for participants with diabetes or CKD) for up to 26 weeks.
Study medication could have been up-titrated only after the subject had been at the previous dose level for a minimum of 2 weeks. Study medication could only have been up- or down-titrated by 1 dose level per scheduled or unscheduled visit.; Azilsartan medoxomil at the final dose received during the open-label phase: (20 mg, 40 mg or 80 mg), tablets, orally, once daily with or without chlorthalidone 25 mg, tablets, orally once daily and other non-ARB antihypertensive medications (if currently taking), for 6 weeks/Week 32.; Azilsartan medoxomil placebo-matching tablets, orally, once daily with or without chlorthalidone 25 mg or other non-ARB antihypertensive (if currently taking), tablets, orally, once daily for 6 weeks/Week 32.
Intervention MeSH terms: Antihypertensive Agents; Chlorthalidone; 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: 418.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Essential Hypertension; Cardiovascular Disease; High Blood Pressure; Drug Therapy

Summary:

      The purpose of this study is to determine the long term safety and tolerability of azilsartan
      medoxomil, once daily (QD), in participants with Essential Hypertension.
    

Eligibility criteria:

        Inclusion Criteria

          1. Has essential hypertension (diastolic blood pressure ≥ 95mm Hg and ≤ 119 mm Hg. For
             participants with diabetes or chronic kidney disease diastolic blood pressure must be
             ≥ 85 mm Hg and ≤ to 109 mm Hg.

          2. Female participant is not of childbearing potential (eg, sterilized, postmenopausal).

          3. Female participants of childbearing potential who are sexually active must agree to
             use adequate contraception, and can neither be pregnant nor lactating from Screening
             throughout the duration of the study.

          4. Clinical laboratory evaluations (including clinical chemistry, hematology, and
             complete urinalysis) are within the reference range for the testing laboratory unless
             the results are deemed not clinically significant for inclusion into this study by the
             investigator.

        Exclusion Criteria

          1. Systolic blood pressure greater than 185 mm Hg.

          2. Is required to take or intends to continue taking any disallowed medication, any
             prescription medication, herbal treatment or over-the counter medication that may
             interfere with evaluation of the study medication, including:

          3. Is hypersensitive to AII receptor blockers.

          4. Recent history (within the last 6 months) of myocardial infarction, unstable angina,
             coronary artery bypass graft, percutaneous coronary intervention, cerebrovascular
             accident, or transient ischemic attack.

          5. History of moderate to severe heart failure or hypertensive encephalopathy.

          6. Has clinically significant cardiac conduction defects (eg, third-degree
             atrioventricular block, sick sinus syndrome).

          7. Has secondary hypertension of any etiology.

          8. Known or suspected unilateral or bilateral renal artery stenosis.

          9. Has severe renal dysfunction or disease (based on calculated creatinine clearance < 30
             mL/min/1.73 m2) at Screening.