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

NCT00695955 | Completed Phase 3 Results

• 2 other identifiers: 01-05-TL-491-006U1111-1113-8874
• Study Type: interventional
• Target: 669
• Locations: 3 countries
• Sites: 41

Brief Summary

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

Conditions

Hypertension

Keywords

Essential Hypertension; Cardiovascular Disease; High Blood Pressure; Drug Therapy

Outcome Measures

Primary Outcomes (2)

• 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.

  56 weeks.

• 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.

  56 weeks.

Secondary Outcomes (4)

• Change From Baseline in Sitting Clinic Systolic Blood Pressure - Cohort 1.

  52 weeks

• Change From Baseline in Sitting Clinic Systolic Blood Pressure - Cohort 2

  52 weeks

• Change From Baseline in Sitting Clinic Diastolic Blood Pressure - Cohort 1.

  52 weeks.

• Change From Baseline in Sitting Clinic Diastolic Blood Pressure - Cohort 2.

  52 weeks.

Study Arms (1)

Azilsartan Medoxomil

EXPERIMENTAL

Drug: Azilsartan medoxomil with or without add-on chlorthalidone; Drug: Azilsartan medoxomil with or without add-on hydrochlorothiazide

Interventions

Azilsartan medoxomil with or without add-on chlorthalidone DRUG

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.

Also known as: TAK-491, Edarbi

Azilsartan Medoxomil

Azilsartan medoxomil with or without add-on hydrochlorothiazide DRUG

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.

Also known as: TAK-491, Edarbi

Azilsartan Medoxomil

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Takeda: lead

Study Sites (41)

Unknown Facility

Ozark, Alabama, United States

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Tallassee, Alabama, United States

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Long Beach, California, United States

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Santa Rosa, California, United States

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Spring Valley, California, United States

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Colorado Springs, Colorado, United States

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Trumbull, Connecticut, United States

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Waterbury, Connecticut, United States

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Fort Lauderdale, Florida, United States

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Hollywood, Florida, United States

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Jacksonville, Florida, United States

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Miami, Florida, United States

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Pembroke Pines, Florida, United States

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Pinellas Park, Florida, United States

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Atlanta, Georgia, United States

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Augusta, Georgia, United States

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Brooklyn Center, Minnesota, United States

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Olive Branch, Mississippi, United States

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Rochester, 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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Salisbury, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Akron, Ohio, United States

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Cincinnati, Ohio, United States

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Mogadore, Ohio, United States

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Springdale, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Philadelphia, Pennsylvania, United States

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Anderson, South Carolina, United States

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Mt. Pleasant, South Carolina, United States

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Simpsonville, South Carolina, United States

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Bristol, Tennessee, United States

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Nashville, Tennessee, United States

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Arlington, Texas, United States

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Austin, Texas, United States

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North Richland Hills, Texas, United States

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Salt Lake City, Utah, United States

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Norfolk, Virginia, United States

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San Bernardo, Santiago Metropolitan, Chile

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Tijuana, Estado de Baja California, Mexico

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MeSH Terms

Conditions

Hypertension; Essential Hypertension; Cardiovascular Diseases

Interventions

azilsartan medoxomil; azilsartan

Condition Hierarchy (Ancestors)

Vascular Diseases

Results Point of Contact

• Title: Sr. VP, Clinical Science
• Organization: Takeda Global Research and Development Center, Inc.

clinicaltrialregistry@tpna.com

800-778-2860

Study Officials

• Executive Medical Director Clinical Science

  Takeda

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 10, 2008
• First Posted: June 12, 2008
• Study Start: June 1, 2007
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: April 19, 2011
• Results First Posted: April 19, 2011

Record last verified: 2011-03

Locations

CL (1); US (39); ME (1)