Efficacy and Safety of Azilsartan Medoxomil, Once Daily (QD), Co-Administered With Amlodipine in Participants With Essential Hypertension
Condition: Hypertension
MeSH terms: Hypertension; Essential Hypertension
Intervention: Azilsartan Medoxomil and amlodipine; Azilsartan Medoxomil and amlodipine; Amlodipine
Intervention description: Azilsartan Medoxomil 40 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.; Azilsartan Medoxomil 80 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.; Azilsartan medoxomil placebo-matching tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
Intervention MeSH terms: Amlodipine; 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: 566.0
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 efficacy and safety of azilsartan medoxomil,
      once daily (QD), co-administered with amlodipine in treating individuals with essential
      hypertension, compared to treatment with amlodipine alone.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Has essential hypertension and 24-hour mean systolic blood pressure greater than or
             equal to 140 mm Hg and less than or equal to 180 mm Hg.

          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. Has clinical laboratory evaluations 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. Is willing to discontinue current antihypertensive medications.

        Exclusion Criteria:

          1. Has sitting trough clinic diastolic blood pressure greater than 119 mm Hg.

          2. Has a baseline 24 hour ambulatory blood pressure monitoring reading of insufficient
             quality.

          3. The subject is hypersensitive to angiotensin II receptor blockers or calcium channel
             blockers.

          4. Has a recent history of myocardial infarction, heart failure, unstable angina,
             coronary artery bypass graft, percutaneous coronary intervention, hypertensive
             encephalopathy, cerebrovascular accident, or transient ischemic attack.

          5. Has clinically significant cardiac conduction defects.

          6. Has hemodynamically significant left ventricular outflow obstruction due to aortic
             valvular disease.

          7. Has secondary hypertension of any etiology

          8. Is non-compliant with study medication during placebo run-in period.

          9. Has severe renal dysfunction or disease.

         10. Has known or suspected unilateral or bilateral renal artery stenosis.

         11. Has a history of drug abuse or a history of alcohol abuse within the past 2 years.

         12. Has a previous history of cancer that has not been in remission for at least 5 years
             prior to the first dose of study drug.

         13. Has type 1 or poorly controlled type 2 diabetes mellitus.

         14. Has hyperkalemia as defined by the central laboratory normal reference range,

         15. Has an alanine aminotransferase level of greater than 2.5 times the upper limit of
             normal, active liver disease or jaundice.

         16. Has an upper arm circumference less than 24 cm or greater than 42 cm.

         17. Works night (3rd) shift.

         18. Currently participating in another investigational study or has participated in an
             investigational study within 30 days prior to randomization.

         19. Has any other serious disease or condition that would compromise subject safety or
             make it difficult to successfully manage and follow the subject according to the
             protocol.

         20. Has been randomized in a previous TAK-491 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.