Back to resultsOne-Year Safety and Tolerability Study of Azilsartan Medoxomil in Participants With Essential Hypertension
Primary Purpose
Hypertension
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Azilsartan medoxomil with or without add-on chlorthalidone
Azilsartan medoxomil with or without add-on hydrochlorothiazide
Sponsored by
About this trial
This is an interventional treatment trial for Hypertension focused on measuring Essential Hypertension, Cardiovascular Disease, High Blood Pressure, Drug Therapy
Eligibility Criteria
Inclusion Criteria
- Diastolic blood pressure greater than or equal to 95 mm Hg and less than or equal to 119 mm Hg. For diabetic subjects and subjects with chronic kidney disease, diastolic blood pressure must be greater than or equal to 85 mm Hg and less than or equal to109 mm Hg).
- Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating.
- Clinical laboratory evaluations within the reference range for or deemed not clinically significant by the investigator.
Exclusion Criteria
- Systolic blood pressure greater than 185 mm Hg.
- Expected to take angiotensin II receptor blockers other than the study drug.
- Taking more than 2 antihypertensive agents.
- Hypersensitive to angiotensin II receptor blockers, thiazide-type diuretics or sulfonamide-derived compounds.
- Recent history of major cardiovascular event.
- History of moderate to severe heart failure or hypertensive encephalopathy.
- Clinically significant cardiac conduction defects.
- Secondary hypertension of any etiology.
- Known or suspected unilateral or bilateral renal artery stenosis.
- Severe renal dysfunction or disease.
- History of drug abuse or a history of 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..
- Uncontrolled diabetes mellitus.
- Alanine aminotransferase level of greater than 2.5 times the upper limit of normal, active liver disease, or jaundice.
- Serum potassium level of greater than the upper limit of normal.
- Currently is participating in another investigational study or has participated in an investigational study within 30 days prior to enrollment.
- Any other serious disease or condition.
- Randomized in a previous azilsartan medoxomil study.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Azilsartan Medoxomil
Arm Description
Outcomes
Primary Outcome Measures
Number of Participants Reporting One or More Treatment-emergent Adverse Events From Day 1 Through End of the Study - Cohort 1.
Treatment-emergent adverse events are defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 14 days after the last dose of study drug, or if a serious adverse event, within 30 days after the last dose of study drug.
Number of Participants Reporting One or More Treatment-emergent Adverse Events From Day 1 Through End of the Study - Cohort 2.
Treatment-emergent adverse events are defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 14 days after the last dose of study drug, or if a serious adverse event, within 30 days after the last dose of study drug.
Secondary Outcome Measures
Change From Baseline in Sitting Clinic Systolic Blood Pressure - Cohort 1.
The change between sitting clinic systolic blood pressure measured at each week assessed relative to the baseline measurement. Mean calculated by using the average (arithmetic mean) of 3 measurements performed at each visit.
Change From Baseline in Sitting Clinic Systolic Blood Pressure - Cohort 2
The change between sitting clinic systolic blood pressure measured at each week assessed relative to the baseline measurement. Mean calculated by using the average (arithmetic mean) of 3 measurements performed at each visit.
Change From Baseline in Sitting Clinic Diastolic Blood Pressure - Cohort 1.
The change between sitting clinic diastolic blood pressure measured at each week assessed relative to the baseline measurement. Mean calculated by using the average (arithmetic mean) of 3 measurements performed at each visit.
Change From Baseline in Sitting Clinic Diastolic Blood Pressure - Cohort 2.
The change between sitting clinic diastolic blood pressure measured at each week assessed relative to the baseline measurement. Mean calculated by using the average (arithmetic mean) of 3 measurements performed at each visit.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00695955
Brief Title
One-Year Safety and Tolerability Study of Azilsartan Medoxomil in Participants With Essential Hypertension
Official Title
A One-Year Phase 3, Open-Label Study to Evaluate the Safety and Tolerability of TAK-491 in Subjects With Essential Hypertension
Study Type
Interventional
2. Study Status
Record Verification Date
March 2011
Overall Recruitment Status
Completed
Study Start Date
June 2007 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
May 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Takeda
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This purpose of this study is to evaluate the long-term safety and tolerability of azilsartan medoxomil in individuals 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 measures are not implemented. According to the World Health Organization, hypertension is the most common attributable cause of preventable death in developed nations, as uncontrolled hypertension greatly increases the risk of cardiovascular disease, cerebrovascular disease, and renal failure. Despite the availability of antihypertensive treatments, hypertension remains inadequately controlled; only about one-third of patients continue to maintain control successfully.
Takeda Global Research and Development is developing TAK-491 (azilsartan medoxomil) for the treatment of essential hypertension. This study is being conducted to demonstrate the long-term safety and tolerability of azilsartan medoxomil in individuals with essential hypertension.
Study participation is anticipated to be approximately 1 year and 1.5 months, and participants will be required to return to the clinic for 10 study visits.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
Keywords
Essential Hypertension, Cardiovascular Disease, High Blood Pressure, Drug Therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
669 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Azilsartan Medoxomil
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Azilsartan medoxomil with or without add-on chlorthalidone
Other Intervention Name(s)
TAK-491, Edarbi
Intervention Description
Azilsartan medoxomil 40 mg, tablets, orally, once daily for four weeks; increased to azilsartan medoxomil 80 mg, tablets, orally, once daily for remainder of 56-week treatment period, if tolerated. Additional antihypertensive medications added, beginning with chlorthalidone 25 mg, once-daily, if target blood pressure not achieved.
Intervention Type
Drug
Intervention Name(s)
Azilsartan medoxomil with or without add-on hydrochlorothiazide
Other Intervention Name(s)
TAK-491, Edarbi
Intervention Description
Azilsartan medoxomil 40 mg, tablets, orally, once daily for four weeks; increased to azilsartan medoxomil 80 mg, tablets, orally, once daily for remainder of 56-week treatment period, if tolerated. Additional antihypertensive medications added, beginning with hydrochlorothiazide 12.5 to 25 mg, once-daily, if target blood pressure not achieved.
Primary Outcome Measure Information:
Title
Number of Participants Reporting One or More Treatment-emergent Adverse Events From Day 1 Through End of the Study - Cohort 1.
Description
Treatment-emergent adverse events are defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 14 days after the last dose of study drug, or if a serious adverse event, within 30 days after the last dose of study drug.
Time Frame
56 weeks.
Title
Number of Participants Reporting One or More Treatment-emergent Adverse Events From Day 1 Through End of the Study - Cohort 2.
Description
Treatment-emergent adverse events are defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 14 days after the last dose of study drug, or if a serious adverse event, within 30 days after the last dose of study drug.
Time Frame
56 weeks.
Secondary Outcome Measure Information:
Title
Change From Baseline in Sitting Clinic Systolic Blood Pressure - Cohort 1.
Description
The change between sitting clinic systolic blood pressure measured at each week assessed relative to the baseline measurement. Mean calculated by using the average (arithmetic mean) of 3 measurements performed at each visit.
Time Frame
52 weeks
Title
Change From Baseline in Sitting Clinic Systolic Blood Pressure - Cohort 2
Description
The change between sitting clinic systolic blood pressure measured at each week assessed relative to the baseline measurement. Mean calculated by using the average (arithmetic mean) of 3 measurements performed at each visit.
Time Frame
52 weeks
Title
Change From Baseline in Sitting Clinic Diastolic Blood Pressure - Cohort 1.
Description
The change between sitting clinic diastolic blood pressure measured at each week assessed relative to the baseline measurement. Mean calculated by using the average (arithmetic mean) of 3 measurements performed at each visit.
Time Frame
52 weeks.
Title
Change From Baseline in Sitting Clinic Diastolic Blood Pressure - Cohort 2.
Description
The change between sitting clinic diastolic blood pressure measured at each week assessed relative to the baseline measurement. Mean calculated by using the average (arithmetic mean) of 3 measurements performed at each visit.
Time Frame
52 weeks.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria
Diastolic blood pressure greater than or equal to 95 mm Hg and less than or equal to 119 mm Hg. For diabetic subjects and subjects with chronic kidney disease, diastolic blood pressure must be greater than or equal to 85 mm Hg and less than or equal to109 mm Hg).
Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating.
Clinical laboratory evaluations within the reference range for or deemed not clinically significant by the investigator.
Exclusion Criteria
Systolic blood pressure greater than 185 mm Hg.
Expected to take angiotensin II receptor blockers other than the study drug.
Taking more than 2 antihypertensive agents.
Hypersensitive to angiotensin II receptor blockers, thiazide-type diuretics or sulfonamide-derived compounds.
Recent history of major cardiovascular event.
History of moderate to severe heart failure or hypertensive encephalopathy.
Clinically significant cardiac conduction defects.
Secondary hypertension of any etiology.
Known or suspected unilateral or bilateral renal artery stenosis.
Severe renal dysfunction or disease.
History of drug abuse or a history of 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..
Uncontrolled diabetes mellitus.
Alanine aminotransferase level of greater than 2.5 times the upper limit of normal, active liver disease, or jaundice.
Serum potassium level of greater than the upper limit of normal.
Currently is participating in another investigational study or has participated in an investigational study within 30 days prior to enrollment.
Any other serious disease or condition.
Randomized in a previous azilsartan medoxomil study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Executive Medical Director Clinical Science
Organizational Affiliation
Takeda
Official's Role
Study Director
Facility Information:
City
Ozark
State/Province
Alabama
Country
United States
City
Tallassee
State/Province
Alabama
Country
United States
City
Long Beach
State/Province
California
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United States
City
Santa Rosa
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California
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United States
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Spring Valley
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California
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United States
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Colorado Springs
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Colorado
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United States
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Trumbull
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Connecticut
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United States
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Waterbury
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Connecticut
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United States
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Fort Lauderdale
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Florida
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United States
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Hollywood
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Florida
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United States
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Jacksonville
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Florida
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Miami
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Florida
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United States
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Pembroke Pines
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Florida
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Pinellas Park
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Florida
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United States
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Atlanta
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Georgia
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United States
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Augusta
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Georgia
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United States
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Brooklyn Center
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Minnesota
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United States
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Olive Branch
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Mississippi
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United States
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Rochester
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New York
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United States
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Charlotte
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North Carolina
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United States
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Raleigh
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North Carolina
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United States
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Salisbury
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North Carolina
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United States
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Winston-Salem
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North Carolina
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United States
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Akron
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Ohio
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United States
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Cincinnati
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Ohio
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United States
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Mogadore
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Ohio
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United States
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Springdale
State/Province
Ohio
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United States
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Oklahoma City
State/Province
Oklahoma
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United States
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Philadelphia
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Pennsylvania
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United States
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Anderson
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South Carolina
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United States
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Mt. Pleasant
State/Province
South Carolina
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United States
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Simpsonville
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South Carolina
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United States
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Bristol
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Tennessee
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United States
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Nashville
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Tennessee
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United States
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Arlington
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Texas
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United States
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Austin
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Texas
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United States
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North Richland Hills
State/Province
Texas
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United States
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Salt Lake City
State/Province
Utah
Country
United States
City
Norfolk
State/Province
Virginia
Country
United States
City
San Bernardo
State/Province
Santiago
Country
Chile
City
Tijuana
State/Province
BC
Country
Mexico
12. IPD Sharing Statement
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One-Year Safety and Tolerability Study of Azilsartan Medoxomil in Participants With Essential Hypertension
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