Efficacy and Safety of Azilsartan Medoxomil in Participants With Essential Hypertension
A Phase 3, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of TAK-491 in Subjects With Essential Hypertension
2 other identifiers
interventional
1,275
3 countries
85
Brief Summary
The purpose of this study is to determine the safety and efficacy of azilsartan medoxomil, once daily (QD), compared to placebo and olmesartan in participants with essential hypertension.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 hypertension
Started Jun 2007
85 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2007
CompletedFirst Submitted
Initial submission to the registry
June 10, 2008
CompletedFirst Posted
Study publicly available on registry
June 12, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2008
CompletedResults Posted
Study results publicly available
April 19, 2011
CompletedJuly 29, 2011
July 1, 2011
1.3 years
June 10, 2008
March 24, 2011
July 27, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline in the 24-hour Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.
The change in 24-hour mean systolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-hour mean is the average of all measurements recorded for 24 hours after dosing.
Baseline and Week 6.
Secondary Outcomes (14)
Change From Baseline in Mean Trough Clinic Sitting Systolic Blood Pressure
Baseline and Week 6.
Change From Baseline in the 24-hour Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.
Baseline and Week 6.
Change From Baseline in Mean Trough Clinic Sitting Diastolic Blood Pressure
Baseline and Week 6.
Change From Baseline in Daytime (6am to 10 pm) Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.
Baseline and Week 6.
Change From Baseline in Daytime (6am to 10 pm) Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.
Baseline and Week 6.
- +9 more secondary outcomes
Study Arms (5)
Azilsartan Medoxomil 20 mg QD
EXPERIMENTALAzilsartan Medoxomil 40 mg QD
EXPERIMENTALAzilsartan Medoxomil 80 mg QD
EXPERIMENTALOlmesartan 40 mg QD
ACTIVE COMPARATORPlacebo QD
PLACEBO COMPARATORInterventions
Azilsartan medoxomil 20 mg, tablets, azilsartan medoxomil 40 mg placebo-matching tablets, azilsartan medoxomil 80 mg placebo-matching tablets and olmesartan 40 mg placebo-matching tablets, orally, for up to 6 weeks.
Olmesartan 40 mg, tablets, azilsartan medoxomil 20 mg placebo-matching tablets, azilsartan medoxomil 40 mg placebo-matching tablets and azilsartan medoxomil 80 mg placebo-matching tablets, orally, once daily for up to 6 weeks.
Azilsartan medoxomil 20 mg placebo-matching tablets, azilsartan medoxomil 40 mg placebo-matching tablets, azilsartan medoxomil 80 mg placebo-matching tablets, and olmesartan 40 mg placebo- matching tablets, orally, once daily for up to 6 weeks.
Eligibility Criteria
You may qualify if:
- Has essential hypertension (defined as sitting trough clinic systolic blood pressure between 150 and 180 mm Hg, inclusive at Day minus 1) and 24-hour mean systolic blood pressure greater than or equal to 130 mm Hg and less than or equal to 170 mm Hg at Day 1).
- 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.
- The subject is willing to discontinue current antihypertensive medications at the Screening Day minus 21 visit. If the subject is on amlodipine prior to screening, the subject is willing to discontinue this medication at Screening Day minus 28.
You may not qualify if:
- Sitting trough clinic diastolic blood pressure greater than 114 mm Hg at Day minus 1.
- Baseline 24-hour ambulatory blood pressure monitor reading of insufficient quality.
- History of myocardial infarction, heart failure, unstable angina, coronary artery bypass graft, percutaneous coronary intervention, hypertensive encephalopathy, cerebrovascular accident, or transient ischemic attack.
- Clinically significant cardiac conduction defects (eg, third degree atrioventricular block, left bundle branch block, sick sinus syndrome, atrial fibrillation or atrial flutter).
- Hemodynamically significant left ventricular outflow obstruction due to aortic valvular disease.
- Secondary hypertension of any etiology.
- Is noncompliant (less than 70% or greater than 130%) with study medication during Placebo Run-In Period.
- Severe renal dysfunction or disease (based on calculated creatinine clearance less than 30 mL/min/1.73 m2) at Screening.
- Known or suspected unilateral or bilateral renal artery stenosis.
- History of drug abuse (defined as illicit drug use) or a history of alcohol abuse (defined as regular or daily consumption of more than 2 alcoholic drinks per day) within the past 2 years.
- 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 apply to those subjects with basal cell or stage I squamous cell carcinoma of the skin).
- Type 1 or poorly controlled type 2 diabetes mellitus (glycosylated hemoglobin greater than 8.0%) at Screening.
- Alanine aminotransferase level greater than 2.5 times the upper limit of normal, active liver disease, or jaundice at Screening.
- Hyperkalemia (defined as serum potassium greater than the upper limit of normal per the central laboratory) at Screening.
- Upper arm circumference less than 24 cm or greater than 42 cm.
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takedalead
Study Sites (85)
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Birmingham, Alabama, United States
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Huntsville, Alabama, United States
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Mesa, Arizona, United States
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Phoenix, Arizona, United States
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Tempe, Arizona, United States
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Little Rock, Arkansas, United States
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Tempe, Arkansas, United States
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Beverly Hills, California, United States
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Carmichael, California, United States
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Fountain Valley, California, United States
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Long Beach, California, United States
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Los Gatos, California, United States
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Orangevale, California, United States
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Sacramento, California, United States
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Santa Ana, California, United States
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Spring Valley, California, United States
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Tustin, California, United States
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Westlake Village, California, United States
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Colorado Springs, Colorado, United States
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Farmington, Connecticut, United States
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Hollywood, Florida, United States
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Jacksonville, Florida, United States
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Jupiter, Florida, United States
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Melbourne, Florida, United States
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Miami, Florida, United States
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Naples, Florida, United States
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Ocala, Florida, United States
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Pembroke Pines, Florida, United States
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Sarasota, Florida, United States
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St. Petersburg, Florida, United States
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Augusta, Georgia, United States
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Lawrenceville, Georgia, United States
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Chicago, Illinois, United States
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Melrose Park, Illinois, United States
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Naperville, Illinois, United States
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Round Lake Beach, Illinois, United States
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Valparaiso, Indiana, United States
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Wichita, Kansas, United States
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Erlanger, Kentucky, United States
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Lexington, Kentucky, United States
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Auburn, Maine, United States
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West Yarmouth, Massachusetts, United States
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Benzonia, Michigan, United States
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Chelsea, Michigan, United States
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Omaha, Nebraska, United States
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Trenton, New Jersey, United States
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Wildwood Crest, New Jersey, United States
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Albuquerque, New Mexico, United States
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Brooklyn, New York, United States
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Orangevale, New York, United States
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Rochester, New York, United States
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Burlington, North Carolina, United States
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Charlotte, North Carolina, United States
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Raleigh, North Carolina, United States
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Salisbury, North Carolina, United States
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Statesville, North Carolina, United States
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Wilmington, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Kettering, Ohio, United States
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Lyndhurst, Ohio, United States
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Marion, Ohio, United States
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Norman, Oklahoma, United States
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Oklahoma City, Oklahoma, United States
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Altoona, Pennsylvania, United States
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Reading, Pennsylvania, United States
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Mt. Pleasant, South Carolina, United States
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Simpsonville, South Carolina, United States
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Taylors, South Carolina, United States
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Nashville, Tennessee, United States
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New Tazewell, Tennessee, United States
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Dallas, Texas, United States
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Houston, Texas, United States
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Lake Jackson, Texas, United States
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North Richland Hills, Texas, United States
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San Antonio, Texas, United States
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Draper, Utah, United States
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Burke, Virginia, United States
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Norfolk, Virginia, United States
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Tacoma, Washington, United States
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Madison, Wisconsin, United States
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Provincia de Buenos Aires, Argentina
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Provincia de Cordoba, Argentina
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Aguascalientes, Mexico
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Mexico City, Mexico
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San Luis Potosà City, Mexico
Related Publications (2)
White WB, Weber MA, Sica D, Bakris GL, Perez A, Cao C, Kupfer S. Effects of the angiotensin receptor blocker azilsartan medoxomil versus olmesartan and valsartan on ambulatory and clinic blood pressure in patients with stages 1 and 2 hypertension. Hypertension. 2011 Mar;57(3):413-20. doi: 10.1161/HYPERTENSIONAHA.110.163402. Epub 2011 Jan 31.
PMID: 21282560RESULTBakris GL, Sica D, Weber M, White WB, Roberts A, Perez A, Cao C, Kupfer S. The comparative effects of azilsartan medoxomil and olmesartan on ambulatory and clinic blood pressure. J Clin Hypertens (Greenwich). 2011 Feb;13(2):81-8. doi: 10.1111/j.1751-7176.2010.00425.x.
PMID: 21272195RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Sr. VP, Clinical Science
- Organization
- Takeda Global Research and Development Center, Inc.
Study Officials
- STUDY DIRECTOR
VP Clinical Science Strategy
Takeda
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
June 10, 2008
First Posted
June 12, 2008
Study Start
June 1, 2007
Primary Completion
October 1, 2008
Study Completion
October 1, 2008
Last Updated
July 29, 2011
Results First Posted
April 19, 2011
Record last verified: 2011-07