One-Year Safety and Tolerability Study of Azilsartan Medoxomil in Participants With Essential Hypertension
Condition: Hypertension
MeSH terms: Hypertension; Essential Hypertension
Intervention: Azilsartan medoxomil with or without add-on chlorthalidone; Azilsartan medoxomil with or without add-on hydrochlorothiazide
Intervention description: Azilsartan medoxomil 40 mg, tablets, orally, once daily for four weeks; increased to azilsartan medoxomil 80 mg, tablets, orally, once daily for remainder of 56-week treatment period, if tolerated. Additional antihypertensive medications added, beginning with chlorthalidone 25 mg, once-daily, if target blood pressure not achieved.; Azilsartan medoxomil 40 mg, tablets, orally, once daily for four weeks; increased to azilsartan medoxomil 80 mg, tablets, orally, once daily for remainder of 56-week treatment period, if tolerated. Additional antihypertensive medications added, beginning with hydrochlorothiazide 12.5 to 25 mg, once-daily, if target blood pressure not achieved.
Intervention MeSH terms: Hydrochlorothiazide; Chlorthalidone; Azilsartan medoxomil
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Masking: None (Open Label)
Enrollment: 669.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Essential Hypertension; Cardiovascular Disease; High Blood Pressure; Drug Therapy

Summary:

      This purpose of this study is to evaluate the long-term safety and tolerability of azilsartan
      medoxomil in individuals with essential hypertension.
    

Eligibility criteria:

        Inclusion Criteria

          1. Diastolic blood pressure greater than or equal to 95 mm Hg and less than or equal to
             119 mm Hg. For diabetic subjects and subjects with chronic kidney disease, diastolic
             blood pressure must be greater than or equal to 85 mm Hg and less than or equal to109
             mm Hg).

          2. Females of childbearing potential who are sexually active must agree to use adequate
             contraception, and can neither be pregnant nor lactating.

          3. Clinical laboratory evaluations within the reference range for or deemed not
             clinically significant by the investigator.

        Exclusion Criteria

          1. Systolic blood pressure greater than 185 mm Hg.

          2. Expected to take angiotensin II receptor blockers other than the study drug.

          3. Taking more than 2 antihypertensive agents.

          4. Hypersensitive to angiotensin II receptor blockers, thiazide-type diuretics or
             sulfonamide-derived compounds.

          5. Recent history of major cardiovascular event.

          6. History of moderate to severe heart failure or hypertensive encephalopathy.

          7. Clinically significant cardiac conduction defects.

          8. Secondary hypertension of any etiology.

          9. Known or suspected unilateral or bilateral renal artery stenosis.

         10. Severe renal dysfunction or disease.

         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. Uncontrolled diabetes mellitus.

         14. Alanine aminotransferase level of greater than 2.5 times the upper limit of normal,
             active liver disease, or jaundice.

         15. Serum potassium level of greater than the upper limit of normal.

         16. Currently is participating in another investigational study or has participated in an
             investigational study within 30 days prior to enrollment.

         17. Any other serious disease or condition.

         18. Randomized in a previous azilsartan medoxomil study.