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

NCT ID: NCT00695955

Last Updated: 2011-04-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 669 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-06-30
• Study Completion Date: 2010-05-31

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.

Conditions

Hypertension

Study Design

• Allocation Method: NON_RANDOMIZED
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Azilsartan Medoxomil

Group Type: EXPERIMENTAL

Azilsartan medoxomil with or without add-on chlorthalidone

Intervention Type: 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.

Azilsartan medoxomil with or without add-on hydrochlorothiazide

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

TAK-491; Edarbi; TAK-491; Edarbi

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Takeda

INDUSTRY

Sponsor Role: lead

Responsible Party

Takeda Global Research & Development Center, Inc.

Principal Investigators

Executive Medical Director Clinical Science

Role: STUDY_DIRECTOR

Takeda

Locations

Ozark, Alabama, United States

Tallassee, Alabama, United States

Long Beach, California, United States

Santa Rosa, California, United States

Spring Valley, California, United States

Colorado Springs, Colorado, United States

Trumbull, Connecticut, United States

Waterbury, Connecticut, United States

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

Atlanta, Georgia, United States

Augusta, Georgia, United States

Brooklyn Center, Minnesota, United States

Olive Branch, Mississippi, United States

Rochester, New York, United States

Charlotte, North Carolina, United States

Raleigh, North Carolina, United States

Salisbury, North Carolina, United States

Winston-Salem, North Carolina, United States

Akron, Ohio, United States

Cincinnati, Ohio, United States

Mogadore, Ohio, United States

Springdale, Ohio, United States

Oklahoma City, Oklahoma, United States

Philadelphia, Pennsylvania, United States

Anderson, South Carolina, United States

Mt. Pleasant, South Carolina, United States

Simpsonville, South Carolina, United States

Bristol, Tennessee, United States

Nashville, Tennessee, United States

Arlington, Texas, United States

Austin, Texas, United States

North Richland Hills, Texas, United States

Salt Lake City, Utah, United States

Norfolk, Virginia, United States

San Bernardo, Santiago Metropolitan, Chile

Tijuana, Estado de Baja California, Mexico

Countries

United States; Chile; Mexico

Other Identifiers

U1111-1113-8874

Identifier Type: REGISTRY

Identifier Source: secondary_id

01-05-TL-491-006

Identifier Type: -

Identifier Source: org_study_id