Efficacy and Safety of Azilsartan Medoxomil in Participants With Essential Hypertension
Condition: Hypertension
MeSH terms: Hypertension; Essential Hypertension
Intervention: Azilsartan medoxomil and olmesartan; Azilsartan medoxomil and olmesartan; Azilsartan medoxomil and olmesartan; Olmesartan; Placebo
Intervention description: Azilsartan medoxomil 20 mg, tablets, azilsartan medoxomil 40 mg placebo-matching tablets, azilsartan medoxomil 80 mg placebo-matching tablets and olmesartan 40 mg placebo-matching tablets, orally, for up to 6 weeks.; Azilsartan medoxomil 40 mg, tablets, azilsartan medoxomil 20 mg placebo-matching tablets, azilsartan medoxomil 80 mg placebo-matching tablets and olmesartan 40 mg placebo-matching tablets, orally, for up to 6 weeks.; Azilsartan medoxomil 80 mg, tablets, azilsartan medoxomil 20 mg placebo-matching tablets, azilsartan medoxomil 40 mg placebo-matching tablets and olmesartan 40 mg placebo-matching tablets, orally, once daily for up to 6 weeks.; Olmesartan 40 mg, tablets, azilsartan medoxomil 20 mg placebo-matching tablets, azilsartan medoxomil 40 mg placebo-matching tablets and azilsartan medoxomil 80 mg placebo-matching tablets, orally, once daily for up to 6 weeks.; Azilsartan medoxomil 20 mg placebo-matching tablets, azilsartan medoxomil 40 mg placebo-matching tablets, azilsartan medoxomil 80 mg placebo-matching tablets, and olmesartan 40 mg placebo- matching tablets, orally, once daily for up to 6 weeks.
Intervention MeSH terms: Olmesartan; Olmesartan Medoxomil; 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: 1275.0
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 safety and efficacy of azilsartan medoxomil,
      once daily (QD), compared to placebo and olmesartan in participants with essential
      hypertension.
    

Eligibility criteria:

        Inclusion Criteria

          1. Has essential hypertension (defined as sitting trough clinic systolic blood pressure
             between 150 and 180 mm Hg, inclusive at Day minus 1) and 24-hour mean systolic blood
             pressure greater than or equal to 130 mm Hg and less than or equal to 170 mm Hg at Day
             1).

          2. Females 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.

          3. Clinical laboratory evaluations (including clinical chemistry, hematology, and
             complete urinalysis) within the reference range for the testing laboratory or the
             results are deemed not clinically significant for inclusion into this study by the
             investigator.

          4. The subject is willing to discontinue current antihypertensive medications at the
             Screening Day minus 21 visit. If the subject is on amlodipine prior to screening, the
             subject is willing to discontinue this medication at Screening Day minus 28.

        Exclusion Criteria

          1. Sitting trough clinic diastolic blood pressure greater than 114 mm Hg at Day minus 1.

          2. Baseline 24-hour ambulatory blood pressure monitor reading of insufficient quality.

          3. History of myocardial infarction, heart failure, unstable angina, coronary artery
             bypass graft, percutaneous coronary intervention, hypertensive encephalopathy,
             cerebrovascular accident, or transient ischemic attack.

          4. Clinically significant cardiac conduction defects (eg, third degree atrioventricular
             block, left bundle branch block, sick sinus syndrome, atrial fibrillation or atrial
             flutter).

          5. Hemodynamically significant left ventricular outflow obstruction due to aortic
             valvular disease.

          6. Secondary hypertension of any etiology.

          7. Is noncompliant (less than 70% or greater than 130%) with study medication during
             Placebo Run-In Period.

          8. Severe renal dysfunction or disease (based on calculated creatinine clearance less
             than 30 mL/min/1.73 m2) at Screening.

          9. Known or suspected unilateral or bilateral renal artery stenosis.

         10. History of drug abuse (defined as illicit drug use) or a history of alcohol abuse
             (defined as regular or daily consumption of more than 2 alcoholic drinks per day)
             within the past 2 years.

         11. 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 subjects with basal
             cell or stage I squamous cell carcinoma of the skin).

         12. Type 1 or poorly controlled type 2 diabetes mellitus (glycosylated hemoglobin greater
             than 8.0%) at Screening.

         13. Alanine aminotransferase level greater than 2.5 times the upper limit of normal,
             active liver disease, or jaundice at Screening.

         14. Hyperkalemia (defined as serum potassium greater than the upper limit of normal per
             the central laboratory) at Screening.

         15. Upper arm circumference less than 24 cm or greater than 42 cm.

         16. Works night (3rd) shift (defined as 11 PM to 7 AM).

         17. Currently participating in another investigational study or has participated in an
             investigational study within 30 days prior to Screening.

         18. Any other serious disease or condition at Screening (or Randomization) that would
             compromise subject safety, might affect life expectancy, or make it difficult to
             successfully manage and follow the subject according to the protocol.

         19. Randomized in a previous azilsartan medoxomil study.