Efficacy and Safety of Azilsartan Medoxomil, Once Daily (QD), Co-Administered With Amlodipine in Participants With Essential Hypertension

• Status: Completed
• Trial end date: 2009-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Takeda
• Treatments: Amlodipine; Azilsartan medoxomil

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.