Efficacy and Safety of Azilsartan Medoxomil in African American Participants With Essential Hypertension
Condition: Hypertension
MeSH terms: Hypertension; Essential Hypertension
Intervention: Azilsartan medoxomil; Azilsartan medoxomil; Placebo
Intervention description: Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.; Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.; Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 6 weeks.
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: 413.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Blood pressure; blood pressure monitoring ambulatory; Drug Therapy

Summary:

      The purpose of this study is to evaluate the effectiveness and safety of azilsartan medoxomil
      compared to placebo, once daily (QD), in African-American participants with essential
      hypertension.
    

Eligibility criteria:

        Inclusion Criteria:

          1. The participant has essential hypertension (defined as sitting trough clinic systolic
             blood pressure between 150 and 180 mm Hg, inclusive at Day -1) and 24-hour mean
             systolic blood pressure 130-170 mm Hg, inclusive, 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 within the reference range for the testing laboratory
             unless the results are deemed not clinically significant for inclusion into this study
             by the investigator.

          4. Willing to discontinue current antihypertensive medication.

        Exclusion Criteria:

          1. Has sitting trough clinic diastolic blood pressure greater than 114 mm Hg.

          2. Baseline 24 hour ambulatory blood pressure monitor reading of insufficient quality.

          3. Hypersensitive to angiotensin II receptor blockers.

          4. History of myocardial infarction, heart failure, unstable angina, coronary artery
             bypass graft, percutaneous coronary intervention, hypertensive encephalopathy,
             cerebrovascular accident, or transient ischemic attack.

          5. Clinically significant cardiac conduction defects.

          6. Hemodynamically significant left ventricular outflow obstruction due to aortic
             valvular disease.

          7. Secondary hypertension of any etiology.

          8. Non-compliant with study medication during run-in period.

          9. Severe renal dysfunction or disease (based on calculated creatinine clearance less
             than 30 mL/min/1.73 m2) at Screening.

         10. Known or suspected unilateral or bilateral renal artery stenosis.

         11. History of drug abuse or a history of alcohol abuse within the past 2 years.

         12. Previous history of cancer that has not been in remission for at least 5 years prior
             to the first dose of study drug.

         13. Type 1 or poorly controlled type 2 diabetes mellitus.

         14. Alanine aminotransferase level of greater than 2.5 times the upper limit of normal,
             active liver disease, or jaundice.

         15. Hyperkalemia.

         16. Upper arm circumference less than 24 cm or greater than 42 cm.

         17. Works night (3rd) shift.

         18. Currently is participating in another investigational study or has participated in an
             investigational study within 30 days prior to randomization.

         19. 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.

         20. Randomized in a previous azilsartan medoxomil study.

         21. Is required to take or continues taking any disallowed medication, prescription
             medication, herbal treatment or over-the counter medication that may interfere with
             evaluation of the study medication.