Status:
COMPLETED
A Safety and Tolerability Study of Azilsartan Medoxomil in Participants With Essential Hypertension
Lead Sponsor:
Takeda
Conditions:
Hypertension
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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.
Detailed Description
Hypertension affects approximately 50 million individuals in the United States. As the population ages, the prevalence of hypertension will continue to increase if broad and effective preventive measu...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- 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.
- Female participant is not of childbearing potential (eg, sterilized, postmenopausal).
- 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.
- 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
- Systolic blood pressure greater than 185 mm Hg.
- 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:
- Is hypersensitive to AII receptor blockers.
- 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.
- History of moderate to severe heart failure or hypertensive encephalopathy.
- Has clinically significant cardiac conduction defects (eg, third-degree atrioventricular block, sick sinus syndrome).
- Has secondary hypertension of any etiology.
- Known or suspected unilateral or bilateral renal artery stenosis.
- Has severe renal dysfunction or disease (based on calculated creatinine clearance \< 30 mL/min/1.73 m2) at Screening.
Exclusion
Key Trial Info
Start Date :
June 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2009
Estimated Enrollment :
418 Patients enrolled
Trial Details
Trial ID
NCT00696384
Start Date
June 1 2007
End Date
April 1 2009
Last Update
January 4 2012
Active Locations (45)
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1
Huntsville, Alabama, United States
2
Chandler, Arizona, United States
3
Mesa, Arizona, United States
4
Tempe, Arizona, United States