Safety and Efficacy of Azilsartan Medoxomil in Participants With Mild to Moderate Hypertension
Condition: Hypertension
MeSH terms: Hypertension
Intervention: Azilsartan Medoxomil; Azilsartan Medoxomil; Azilsartan Medoxomil; Azilsartan Medoxomil; Azilsartan Medoxomil; Olmesartan; Placebo
Intervention description: Azilsartan medoxomil 5 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.; Azilsartan medoxomil 10 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.; Azilsartan medoxomil 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.; Azilsartan medoxomil 40 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.; Azilsartan medoxomil 80 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.; Olmesartan 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.; Matching placebo tablets, orally, once daily for up to 8 weeks.
Intervention MeSH terms: Olmesartan; Azilsartan medoxomil
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 449.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: hypertension; blood pressure; diastolic blood pressure; drug therapy

Summary:

      The purpose of this study is to evaluate the safety, efficacy, and tolerability of azilsartan
      medoxomil, once daily (QD), in individuals with hypertension.
    

Eligibility criteria:

        Inclusion Criteria

          1. Mild to moderate uncomplicated essential hypertension.

          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. Must be in good health as determined by a physician.

          4. The subject has clinical laboratory evaluations within the reference range for the
             testing laboratory unless the results are deemed not clinically significant by the
             investigator or sponsor.

          5. The subject is willing to discontinue current antihypertensive medications at
             Screening Day minus 21.

        Exclusion Criteria

          1. Diastolic blood pressure less than 95 or greater than 114 mmHg at Placebo Run-in Day
             minus 14 or Randomization visit, or systolic blood pressure greater than 180 mm Hg.

          2. Decrease of more than or equal to 8 mm Hg in clinic diastolic blood pressure between
             Placebo Run-in Day minus 14 and Randomization visit.

          3. Has taken within 7 days prior to placebo run-in, or is expected to take medications
             known to affect blood pressure and 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, including:

          4. Hypersensitive to angiotensin II receptor blockers.

          5. History of an acute myocardial infarction within 12 months prior to Screening, history
             of coronary revascularization within 6 months prior to Screening, or any history of
             heart failure, post-myocardial infarction angina, hypertensive encephalopathy,
             cerebrovascular accident, or transient ischemic attack.

          6. Clinically significant cardiac conduction defects (eg, 3rd degree atrioventricular
             block, left bundle branch block, atrial fibrillation or flutter).

          7. Secondary hypertension of any etiology.

          8. Upper arm circumference less than 24 or greater than 42 cm.

          9. Works night (3rd) shift (defined as 11pm to 7am).

         10. Non-compliant (less than 80%) with study medication during Placebo Run-in period.

         11. Significant, moderate to severe renal dysfunction (confirmed by serum creatinine of
             greater than 2 mg per dl or disease (including renal artery stenosis or known
             nephrotic proteinuria).

         12. History of drug abuse (defined as illicit drug use) or a history of alcohol abuse
             (defined as regular or daily consumption of more than 4 alcoholic drinks per day)
             within the past 2 years.

         13. Previous 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 include those subjects with
             basal cell or Stage 1 squamous cell carcinoma of the skin).

         14. Type 1 or uncontrolled type 2 diabetes mellitus (confirmed by glycosylated hemoglobin
             greater than 9.5%).

         15. Alanine transaminase level of greater than 2.5 times the upper limit of normal, active
             liver disease, or jaundice.

         16. Currently is participating in another investigational study or has participated in an
             investigational study within 30 days prior to randomization.

         17. 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.