An Efficacy and Safety Study of Azilsartan Medoxomil Compared to Valsartan and Olmesartan in Participants With Essential Hypertension.
A Double-Blind, Randomized, Placebo-Controlled, 5-Arm Titration Study to Evaluate the Efficacy and Safety of TAK-491 When Compared With Valsartan and Olmesartan in Subjects With Essential Hypertension
2 other identifiers
interventional
1,291
6 countries
131
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of azilsartan medoxomil, once daily (QD), compared to placebo, valsartan 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 Apr 2008
131 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
April 1, 2008
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
August 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2009
CompletedResults Posted
Study results publicly available
April 19, 2011
CompletedApril 19, 2011
March 1, 2011
1.3 years
June 10, 2008
March 24, 2011
March 24, 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 40 mg QD
EXPERIMENTALAzilsartan Medoxomil 80 mg QD
EXPERIMENTALValsartan 320 mg QD
ACTIVE COMPARATOROlmesartan 40 mg QD
ACTIVE COMPARATORPlacebo QD
PLACEBO COMPARATORInterventions
Azilsartan medoxomil 20 mg, tablets and matching placebo comparator orally once daily for two weeks. Increased to azilsartan medoxomil 40 mg tablets and matching placebo comparator orally, once daily for up to four weeks.
Valsartan 160 mg, tablets, and matching placebo comparator orally, once daily for two weeks. Increased to Valsartan 320 mg, tablets, and matching placebo comparator, orally, once daily for up to four weeks.
Olmesartan 20 mg, tablets and matching placebo comparator, orally, once daily for two weeks. Increased to Olmesartan 40 mg, tablets and matching placebo comparator, orally, once daily for up to four weeks.
Eligibility Criteria
You may qualify if:
- Essential hypertension (sitting systolic blood pressure between 150 and 180 mm Hg, inclusive, at Day -1 and 24-hour mean systolic blood pressure between 130 and 170 mm Hg, inclusive, at Day 1).
- Capable of understanding and complying with protocol requirements.
- 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 Screening Day 21 visit. If the participant is on amlodipine prior to Screening, the participant is willing to discontinue this medication at Screening Day -28.
You may not qualify if:
- Sitting diastolic blood pressure greater than 114 mm Hg at Day -1 (day prior to Randomization).
- Baseline 24-hour ambulatory blood pressure monitor reading of insufficient quality.
- Taking or expected to take an excluded medication as described in the Excluded Medications.
- Hypersensitive to angiotensin II receptor blockers.
- 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.
- Hemodynamically significant left ventricular outflow obstruction due to aortic valvular disease.
- Secondary hypertension of any etiology.
- Noncompliant (less than 70% or greater than 130%) with study medication during run-in period.
- Moderate to severe renal dysfunction or disease.
- 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 participants with basal cell or stage I squamous cell carcinoma of the skin).
- Type 1 or poorly-controlled type 2 diabetes mellitus (glycosylate hemoglobin greater than 8.0%) at Screening.
- Hyperkalemia as defined by the central laboratory normal reference range at Screening.
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takedalead
Study Sites (131)
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Alabaster, Alabama, United States
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Ozark, Alabama, United States
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Green Valley, Arizona, United States
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Litchfield Park, Arizona, United States
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Mesa, Arizona, United States
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Tempe, Arizona, United States
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Carmichael, California, United States
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Chula Vista, California, United States
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Lincoln, California, United States
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Mission Viejo, California, United States
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National City, California, United States
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Pasadena, California, United States
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Riverside, California, United States
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Sacramento, California, United States
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San Diego, California, United States
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San Dimas, California, United States
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San Francisco, California, United States
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San Ramon, California, United States
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Santa Ana, California, United States
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Vista, California, United States
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Colorado Springs, Colorado, United States
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Denver, Colorado, United States
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Littleton, Colorado, United States
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Longmont, Colorado, United States
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Cape Coral, Florida, United States
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Clearwater, Florida, United States
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Largo, Florida, United States
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Miami, Florida, United States
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New Port Richey, Florida, United States
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New Smyrna Beach, Florida, United States
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Palm Harbor, Florida, United States
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Tallahassee, Florida, United States
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Dunwoody, Georgia, United States
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Roswell, Georgia, United States
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Arlington Heights, Illinois, United States
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Belleville, Illinois, United States
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Champaign, Illinois, United States
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Chicago, Illinois, United States
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Peoria, Illinois, United States
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Vernon Hills, Illinois, United States
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Evansville, Indiana, United States
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Indianapolis, Indiana, United States
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Terre Haute, Indiana, United States
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Kansas City, Kansas, United States
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Overland Park, Kansas, United States
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Shawnee, Kansas, United States
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Biddeford, Maine, United States
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Norwood, Maine, United States
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Baltimore, Maryland, United States
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Towson, Maryland, United States
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Brooklyn Center, Minnesota, United States
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Chesterfield, Missouri, United States
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Jefferson City, Missouri, United States
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Kansas City, Missouri, United States
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St Louis, Missouri, United States
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Billings, Montana, United States
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Las Vegas, Nevada, United States
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Margate City, New Jersey, United States
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Glens Falls, New York, United States
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Great Neck, New York, United States
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New Hyde Park, New York, United States
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New Windsor, New York, United States
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New York, New York, United States
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Charlotte, North Carolina, United States
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Raleigh, North Carolina, United States
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Columbus, Ohio, United States
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Norman, Oklahoma, United States
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Tulsa, Oklahoma, United States
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Yukon, Oklahoma, United States
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Ashland, Oregon, United States
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Eugene, Oregon, United States
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Medford, Oregon, United States
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Portland, Oregon, United States
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Pittsburgh, Pennsylvania, United States
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Tipton, Pennsylvania, United States
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Charleston, South Carolina, United States
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Murrells Inlet, South Carolina, United States
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North Charleston, South Carolina, United States
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Cleveland, Tennessee, United States
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Bedford, Texas, United States
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Dallas, Texas, United States
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Houston, Texas, United States
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Missouri City, Texas, United States
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San Antonio, Texas, United States
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Sugarland, Texas, United States
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Tacoma, Washington, United States
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Carlos Paz, Córdoba Province, Argentina
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Córdoba, Córdoba Province, Argentina
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Guaymayen, Mendoza Province, Argentina
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Bahía Blanca, Argentina
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Berazategui, Argentina
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Buenos Aires, Argentina
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Corrientes, Argentina
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Haedo Pcia. de Buenos Aires, Argentina
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La Plata, Argentina
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Ramos Mejía Pcia. de Buenos Aires, Argentina
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Rosario, Argentina
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Salta, Argentina
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San Miguel de Tucumán, Argentina
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San Salvador de Jujuy, Argentina
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Belo Horizonte, Brazil
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Campinas, Brazil
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Fortaleza, Brazil
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Goiaenia, Brazil
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Joildille, Brazil
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Porto Alegre, Brazil
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Rio Janeiro, Brazil
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São Paulo, Brazil
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Sorocava, Brazil
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Aguascalientes, Aguascalientes, Mexico
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Chihuahua City, Chihuahua, Mexico
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Tijuana, Estado de Baja California, Mexico
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León, Guanajuato, Mexico
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Guadalajara, Jalapa, Mexico
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Monterrey, Nuevo León, Mexico
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San Luis Potosí City, San Luis Potosí, Mexico
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Xalapa, Veracruz, Mexico
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Mexico City, Mexico
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Querètaro, Mexico
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Arequipa, Peru
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Cusco, Peru
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Huaura, Peru
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Ica, Peru
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Lima, Peru
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Trujillo, Peru
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Aguas Buenas, Puerto Rico
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Carolina, Puerto Rico
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Jardines de Loiza, Puerto Rico
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Orocovis, Puerto Rico
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Ponce, Puerto Rico
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San Juan, Puerto Rico
Related Publications (1)
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: 21282560RESULT
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
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
Study Record Dates
First Submitted
June 10, 2008
First Posted
June 12, 2008
Study Start
April 1, 2008
Primary Completion
August 1, 2009
Study Completion
August 1, 2009
Last Updated
April 19, 2011
Results First Posted
April 19, 2011
Record last verified: 2011-03