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

This study has been completed.
Sponsor:
Information provided by:
Takeda
ClinicalTrials.gov Identifier:
NCT00695955
First received: June 10, 2008
Last updated: March 24, 2011
Last verified: March 2011
  Purpose

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


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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Masking: 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

Resource links provided by NLM:


Further study details as provided by Takeda:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: Yes ]
    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. [ Time Frame: 56 weeks. ] [ Designated as safety issue: Yes ]
    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. [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    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. [ Time Frame: 52 weeks. ] [ Designated as safety issue: No ]
    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. [ Time Frame: 52 weeks. ] [ Designated as safety issue: No ]
    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.


Enrollment: 669
Study Start Date: June 2007
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00695955

  Show 41 Study Locations
Sponsors and Collaborators
Takeda
Investigators
Study Director: Executive Medical Director Clinical Science Takeda
  More Information

Additional Information:
No publications provided

Responsible Party: Sr. VP, Clinical Science, Takeda Global Research & Development Center, Inc.
ClinicalTrials.gov Identifier: NCT00695955     History of Changes
Other Study ID Numbers: 01-05-TL-491-006, U1111-1113-8874
Study First Received: June 10, 2008
Results First Received: March 24, 2011
Last Updated: March 24, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Takeda:
Essential Hypertension
Cardiovascular Disease
High Blood Pressure
Drug Therapy

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Hydrochlorothiazide
Chlorthalidone
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 02, 2014