A Safety and Tolerability Study of Azilsartan Medoxomil 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 determine the long term safety and tolerability of azilsartan medoxomil, once daily (QD), in participants with Essential Hypertension.

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

Details

• Lead Sponsor: Takeda
• Treatments: Antihypertensive Agents; Azilsartan medoxomil; Chlorthalidone

Criteria

Inclusion Criteria

1. Has essential hypertension (diastolic blood pressure ≥ 95mm Hg and ≤ 119 mm Hg. For participants with diabetes or chronic kidney disease diastolic blood pressure must be ≥ 85 mm Hg and ≤ to 109 mm Hg.

2. Female participant is not of childbearing potential (eg, sterilized, postmenopausal).

3. Female participants 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.

4. Clinical laboratory evaluations (including clinical chemistry, hematology, and complete urinalysis) are within the reference range for the testing laboratory unless the results are deemed not clinically significant for inclusion into this study by the investigator.

Exclusion Criteria

1. Systolic blood pressure greater than 185 mm Hg.

2. Is required to take or intends to continue taking any disallowed medication, any prescription medication, herbal treatment or over-the counter medication that may interfere with evaluation of the study medication, including:

3. Is hypersensitive to AII receptor blockers.

4. Recent history (within the last 6 months) of myocardial infarction, unstable angina, coronary artery bypass graft, percutaneous coronary intervention, cerebrovascular accident, or transient ischemic attack.

5. History of moderate to severe heart failure or hypertensive encephalopathy.

6. Has clinically significant cardiac conduction defects (eg, third-degree atrioventricular block, sick sinus syndrome).

7. Has secondary hypertension of any etiology.

8. Known or suspected unilateral or bilateral renal artery stenosis.

9. Has severe renal dysfunction or disease (based on calculated creatinine clearance < 30 mL/min/1.73 m2) at Screening.