Efficacy and Safety of Azilsartan Medoxomil Co-Administered With Chlorthalidone in Participants With Essential Hypertension
A Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of TAK-491 When Co-administered With Chlorthalidone in Subjects With Essential Hypertension
2 other identifiers
interventional
551
1 country
46
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of azilsartan medoxomil, once daily (QD), co-administered with chlorthalidone in treating individuals with essential hypertension, compared to treatment with chlorthalidone alone.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 hypertension
Started Sep 2007
46 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
September 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
March 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2009
CompletedResults Posted
Study results publicly available
April 19, 2011
CompletedApril 19, 2011
March 1, 2011
1.5 years
December 27, 2007
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 (3)
Azilsartan Medoxomil 40 mg QD and Chlorthalidone 25 mg QD
EXPERIMENTALAzilsartan Medoxomil 80 mg QD and Chlorthalidone 25 mg QD
EXPERIMENTALChlorthalidone 25 mg QD
ACTIVE COMPARATORInterventions
Azilsartan medoxomil 40 mg, tablets, orally, once daily; azilsartan medoxomil 80 mg placebo-matching tablets, orally, once daily; and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
Chlorthalidone 25 mg, tablets, orally, once daily; azilsartan medoxomil 80 mg placebo-matching tablets, orally, once daily and azilsartan medoxomil 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 160 and 190 mm Hg inclusive at Day minus 1 and 24-hour mean systolic blood pressure greater than or equal to 140 mm Hg and ≤ 180 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.
- 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:
- Has sitting trough clinic diastolic blood pressure greater than 119 mmHg at Day minus 1.
- 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.
- 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 (for example, 3rd degree atrioventricular block, left bundle branch block, sick sinus syndrome, atrial fibrillation).
- Hemodynamically significant left ventricular outflow obstruction due to aortic valvular disease.
- The subject has secondary hypertension of any etiology.
- Non-compliant (less than 70% or greater than 130%) with study medication
- during the 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.
- 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%).
- Hypo- or hyperkalemia (defined as serum potassium outside of the normal reference range of the central laboratory).
- +7 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takedalead
Study Sites (46)
Unknown Facility
Huntsville, Alabama, United States
Unknown Facility
Montgomery, Alabama, United States
Unknown Facility
Buena Park, California, United States
Unknown Facility
Huntington Beach, California, United States
Unknown Facility
Long Beach, California, United States
Unknown Facility
Mission Viejo, California, United States
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Roseville, California, United States
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Sacramento, California, United States
Unknown Facility
Westlake Village, California, United States
Unknown Facility
Coral Gables, Florida, United States
Unknown Facility
DeLand, Florida, United States
Unknown Facility
Fort Lauderdale, Florida, United States
Unknown Facility
Hollywood, Florida, United States
Unknown Facility
Miami, Florida, United States
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Auburn, Maine, United States
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Bingham Farms, Michigan, United States
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Troy, Michigan, United States
Unknown Facility
Charlotte, North Carolina, United States
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Huntersville, North Carolina, United States
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Shelby, North Carolina, United States
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Akron, Ohio, United States
Unknown Facility
Centerville, Ohio, United States
Unknown Facility
Cincinnati, Ohio, United States
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Willoughby Hills, Ohio, United States
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Zanesville, Ohio, United States
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Norman, Oklahoma, 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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Tualatin, Oregon, United States
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Bensalem, Pennsylvania, United States
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Feasterville, Pennsylvania, United States
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Cranston, Rhode Island, United States
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Simpsonville, South Carolina, United States
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Kingsport, Tennessee, United States
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Corpus Christi, Texas, United States
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Houston, Texas, United States
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Pearland, Texas, United States
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San Antonio, Texas, United States
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Salt Lake City, Utah, United States
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Arlington, Virginia, United States
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Burke, Virginia, United States
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Richmond, Virginia, United States
Unknown Facility
Lakewood, Washington, United States
Unknown Facility
Olympia, Washington, United States
Unknown Facility
Port Orchard, Washington, United States
Related Publications (1)
Weber MA, Sever P, Juhasz A, Roberts A, Cao C. A randomized trial of the efficacy and safety of azilsartan medoxomil combined with chlorthalidone. J Renin Angiotensin Aldosterone Syst. 2018 Jul-Sep;19(3):1470320318795000. doi: 10.1177/1470320318795000.
PMID: 30175930DERIVED
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
December 27, 2007
First Posted
January 11, 2008
Study Start
September 1, 2007
Primary Completion
March 1, 2009
Study Completion
March 1, 2009
Last Updated
April 19, 2011
Results First Posted
April 19, 2011
Record last verified: 2011-03