Efficacy and Safety Comparison of Azilsartan Medoxomil to Valsartan in Participants With Essential Hypertension
A Double-Blind, Randomized, Parallel-Group Study to Compare the Efficacy and Safety of TAK-491 With Valsartan in Subjects With Essential Hypertension
2 other identifiers
interventional
984
4 countries
88
Brief Summary
The purpose of this study is to compare the efficacy and safety of TAK-491 (azilsartan medoxomil), once daily (QD), to valsartan 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 Dec 2007
Typical duration for phase_3 hypertension
88 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2007
CompletedFirst Submitted
Initial submission to the registry
December 27, 2007
CompletedFirst Posted
Study publicly available on registry
January 11, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2010
CompletedResults Posted
Study results publicly available
April 19, 2011
CompletedFebruary 2, 2012
January 1, 2012
1.8 years
December 27, 2007
March 24, 2011
January 31, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline in 24-hour Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.
The change in 24-hour mean systolic blood pressure measured at week 24 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 24.
Secondary Outcomes (14)
Change From Baseline in Mean Trough Clinic Sitting Systolic Blood Pressure.
Baseline and Week 24.
Change From Baseline in the 24-hour Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.
Baseline and Week 24.
Change From Baseline in Mean Trough Clinic Sitting Diastolic Blood Pressure
Baseline and Week 24.
Change From Baseline in Daytime (6am to 10 pm) Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.
Baseline and Week 24.
Change From Baseline in Daytime (6am to 10 pm) Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.
Baseline and Week 24.
- +9 more secondary outcomes
Study Arms (3)
Azilsartan Medoxomil 40 mg QD
EXPERIMENTALAzilsartan Medoxomil 80 mg QD
EXPERIMENTALValsartan 320 mg QD
ACTIVE COMPARATORInterventions
Azilsartan Medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 40 mg, tablets, orally, once daily for up to 22 weeks.
Valsartan 80 mg, tablets, orally, once daily for 2 weeks; titrated to 320 mg, tablets, orally, once daily for up to 22 weeks.
Eligibility Criteria
You may qualify if:
- 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 between 130 and 170 mm Hg inclusive 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.
- 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.
- The subject has a baseline 24-hour ambulatory blood pressure monitor reading of insufficient quality.
- 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.
- Hypersensitive to angiotensin II receptor blockers.
- Recent history (within the last 6 months) 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, 3rd degree atrioventricular block, left bundle branch block, sick sinus syndrome, atrial fibrillation or flutter).
- Hemodynamically significant left ventricular outflow obstruction due to aortic valvular disease.
- Secondary hypertension of any etiology.
- Non-compliant (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 per min/1.73m2) at Screening.
- Known or suspected unilateral or bilateral renal artery stenosis.
- History of drug or alcohol abuse within the past 2 years.
- Previous 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 1 squamous cell carcinoma of the skin).
- Type 1 or poorly controlled type 2 diabetes mellitus (glycosylated hemoglobin greater than 8.0%) at Screening.
- Hyperkalemia as defined by the central laboratory normal reference range at Screening.
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takedalead
Study Sites (88)
Unknown Facility
Huntsville, Alabama, United States
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Glendale, Arizona, United States
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Phoenix, Arizona, United States
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Scottsdale, Arizona, United States
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Tuscon, Arizona, United States
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Beverly Hills, California, United States
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Burbank, California, United States
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La Jolla, California, United States
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Long Beach, California, United States
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Los Angeles, California, United States
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Paramount, California, United States
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San Diego, California, United States
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Santa Monica, California, United States
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Spring Valley, California, United States
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Tustin, California, United States
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Vista, California, United States
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Westlake Village, California, United States
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Ridgefield, Connecticut, United States
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Newark, Delaware, United States
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Washington D.C., District of Columbia, United States
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DeLand, Florida, United States
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Fort Lauderdale, Florida, United States
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Hollywood, Florida, United States
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Inverness, Florida, United States
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Jacksonville, Florida, United States
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Boise, Idaho, United States
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Chicago, Illinois, United States
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Gurnee, Illinois, United States
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Morton, Illinois, United States
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Park Ridge, Illinois, United States
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Avon, Indiana, United States
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Bloomington, Indiana, United States
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Crestview Hills, Kentucky, United States
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Baltimore, Maryland, United States
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Columbia, Maryland, United States
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Brockton, Massachusetts, United States
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West Yarmouth, Massachusetts, United States
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Ann Arbor, Michigan, United States
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City of Saint Peters, Missouri, United States
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Florissant, Missouri, United States
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Kansas City, Missouri, United States
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Washington, Missouri, United States
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Wentzville, Missouri, United States
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Charlotte, North Carolina, United States
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Salisbury, North Carolina, United States
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Shelby, North Carolina, United States
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Cincinnati, Ohio, United States
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Delaware, Ohio, United States
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Mogadore, Ohio, United States
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Willoughby Hills, Ohio, United States
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Zanesville, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Eugene, Oregon, United States
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Portland, Oregon, United States
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Bridgeville, Pennsylvania, United States
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Downingtown, Pennsylvania, United States
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Jenkintown, Pennsylvania, United States
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Lansdale, Pennsylvania, United States
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Charleston, South Carolina, United States
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Spartanburg, South Carolina, United States
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Kingsport, Tennessee, United States
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Austin, Texas, United States
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Dallas, Texas, United States
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Fort Worth, Texas, United States
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Houston, Texas, United States
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Pearland, Texas, United States
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Rosenberg, Texas, United States
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San Antonio, Texas, United States
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Riverton, Utah, United States
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Salt Lake City, Utah, United States
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West Jordan, Utah, United States
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Arlington, Virginia, United States
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Burke, Virginia, United States
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Norfolk, Virginia, United States
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Lakewood, Washington, United States
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Port Richard, Washington, United States
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Menomonee Falls, Wisconsin, United States
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Santiago, Chile
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Temuco, Chile
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Cabo San Lucas, Mexico
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Colonia Escandón, Mexico
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Culiacán, Mexico
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Mexico City, Mexico
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Monterrey Nuevo Leon, Mexico
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Morelia, Mexico
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Querétaro, Mexico
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Chiclayo, Peru
Unknown Facility
Lima, Peru
Related Publications (1)
Sica D, White WB, Weber MA, Bakris GL, Perez A, Cao C, Handley A, Kupfer S. Comparison of the novel angiotensin II receptor blocker azilsartan medoxomil vs valsartan by ambulatory blood pressure monitoring. J Clin Hypertens (Greenwich). 2011 Jul;13(7):467-72. doi: 10.1111/j.1751-7176.2011.00482.x. Epub 2011 Jun 20.
PMID: 21762358RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
For the Non-Serious Adverse Event Table, the total number of participants affected is based on the AEs with ≥5% in each phase, calculated separately.
Results Point of Contact
- Title
- Sr. VP, Clinical Science
- Organization
- Takeda Global Research and Development Center, Inc.
Study Officials
- STUDY DIRECTOR
Executive Medical Director Clinical Science
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
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 27, 2007
First Posted
January 11, 2008
Study Start
December 1, 2007
Primary Completion
September 1, 2009
Study Completion
March 1, 2010
Last Updated
February 2, 2012
Results First Posted
April 19, 2011
Record last verified: 2012-01