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One-Year Safety and Tolerability Study of Azilsartan Medoxomil in Participants With Essential Hypertension

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00695955
Recruitment Status : Completed
First Posted : June 12, 2008
Results First Posted : April 19, 2011
Last Update Posted : April 19, 2011
Sponsor:
Information provided by:
Takeda

Brief Summary:
This purpose of this study is to evaluate the long-term safety and tolerability of azilsartan medoxomil in individuals with essential hypertension.

Condition or disease Intervention/treatment Phase
Hypertension Drug: Azilsartan medoxomil with or without add-on chlorthalidone Drug: Azilsartan medoxomil with or without add-on hydrochlorothiazide Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 669 participants
Allocation: Non-Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : June 2007
Actual Primary Completion Date : May 2010
Actual Study Completion Date : May 2010

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Azilsartan Medoxomil Drug: Azilsartan medoxomil with or without add-on chlorthalidone
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.
Other Names:
  • TAK-491
  • Edarbi

Drug: Azilsartan medoxomil with or without add-on hydrochlorothiazide
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.
Other Names:
  • TAK-491
  • Edarbi




Primary Outcome Measures :
  1. Number of Participants Reporting One or More Treatment-emergent Adverse Events From Day 1 Through End of the Study - Cohort 1. [ Time Frame: 56 weeks. ]
    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.

  2. Number of Participants Reporting One or More Treatment-emergent Adverse Events From Day 1 Through End of the Study - Cohort 2. [ Time Frame: 56 weeks. ]
    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 :
  1. Change From Baseline in Sitting Clinic Systolic Blood Pressure - Cohort 1. [ Time Frame: 52 weeks ]
    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.

  2. Change From Baseline in Sitting Clinic Systolic Blood Pressure - Cohort 2 [ Time Frame: 52 weeks ]
    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.

  3. Change From Baseline in Sitting Clinic Diastolic Blood Pressure - Cohort 1. [ Time Frame: 52 weeks. ]
    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.

  4. Change From Baseline in Sitting Clinic Diastolic Blood Pressure - Cohort 2. [ Time Frame: 52 weeks. ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  1. 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).
  2. Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating.
  3. Clinical laboratory evaluations within the reference range for or deemed not clinically significant by the investigator.

Exclusion Criteria

  1. Systolic blood pressure greater than 185 mm Hg.
  2. Expected to take angiotensin II receptor blockers other than the study drug.
  3. Taking more than 2 antihypertensive agents.
  4. Hypersensitive to angiotensin II receptor blockers, thiazide-type diuretics or sulfonamide-derived compounds.
  5. Recent history of major cardiovascular event.
  6. History of moderate to severe heart failure or hypertensive encephalopathy.
  7. Clinically significant cardiac conduction defects.
  8. Secondary hypertension of any etiology.
  9. Known or suspected unilateral or bilateral renal artery stenosis.
  10. Severe renal dysfunction or disease.
  11. History of drug abuse or a history of alcohol abuse within the past 2 years.
  12. Previous history of cancer that has not been in remission for at least 5 years prior to the first dose of study drug..
  13. Uncontrolled diabetes mellitus.
  14. Alanine aminotransferase level of greater than 2.5 times the upper limit of normal, active liver disease, or jaundice.
  15. Serum potassium level of greater than the upper limit of normal.
  16. Currently is participating in another investigational study or has participated in an investigational study within 30 days prior to enrollment.
  17. Any other serious disease or condition.
  18. Randomized in a previous azilsartan medoxomil study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00695955


Locations
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United States, Alabama
Ozark, Alabama, United States
Tallassee, Alabama, United States
United States, California
Long Beach, California, United States
Santa Rosa, California, United States
Spring Valley, California, United States
United States, Colorado
Colorado Springs, Colorado, United States
United States, Connecticut
Trumbull, Connecticut, United States
Waterbury, Connecticut, United States
United States, Florida
Fort Lauderdale, Florida, United States
Hollywood, Florida, United States
Jacksonville, Florida, United States
Miami, Florida, United States
Pembroke Pines, Florida, United States
Pinellas Park, Florida, United States
United States, Georgia
Atlanta, Georgia, United States
Augusta, Georgia, United States
United States, Minnesota
Brooklyn Center, Minnesota, United States
United States, Mississippi
Olive Branch, Mississippi, United States
United States, New York
Rochester, New York, United States
United States, North Carolina
Charlotte, North Carolina, United States
Raleigh, North Carolina, United States
Salisbury, North Carolina, United States
Winston-Salem, North Carolina, United States
United States, Ohio
Akron, Ohio, United States
Cincinnati, Ohio, United States
Mogadore, Ohio, United States
Springdale, Ohio, United States
United States, Oklahoma
Oklahoma City, Oklahoma, United States
United States, Pennsylvania
Philadelphia, Pennsylvania, United States
United States, South Carolina
Anderson, South Carolina, United States
Mt. Pleasant, South Carolina, United States
Simpsonville, South Carolina, United States
United States, Tennessee
Bristol, Tennessee, United States
Nashville, Tennessee, United States
United States, Texas
Arlington, Texas, United States
Austin, Texas, United States
North Richland Hills, Texas, United States
United States, Utah
Salt Lake City, Utah, United States
United States, Virginia
Norfolk, Virginia, United States
Chile
San Bernardo, Santiago, Chile
Mexico
Tijuana, BC, Mexico
Sponsors and Collaborators
Takeda
Investigators
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Study Director: Executive Medical Director Clinical Science Takeda

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Responsible Party: Sr. VP, Clinical Science, Takeda Global Research & Development Center, Inc.
ClinicalTrials.gov Identifier: NCT00695955    
Other Study ID Numbers: 01-05-TL-491-006
U1111-1113-8874 ( Registry Identifier: WHO )
First Posted: June 12, 2008    Key Record Dates
Results First Posted: April 19, 2011
Last Update Posted: April 19, 2011
Last Verified: March 2011
Keywords provided by Takeda:
Essential Hypertension
Cardiovascular Disease
High Blood Pressure
Drug Therapy
Additional relevant MeSH terms:
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Hypertension
Essential Hypertension
Vascular Diseases
Cardiovascular Diseases
Hydrochlorothiazide
Chlorthalidone
Azilsartan medoxomil
Antihypertensive Agents
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists