Clinical trial NCT00695955: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Keywords: Essential Hypertension
Cardiovascular Disease
High Blood Pressure
Drug Therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2008-06-12
Enrollment: 669
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Number of Participants Reporting One or More Treatment-emergent Adverse Events From Day 1 Through End of the Study - Cohort 1.
timeFrame: 56 weeks.
measure: Number of Participants Reporting One or More Treatment-emergent Adverse Events From Day 1 Through End of the Study - Cohort 2.
timeFrame: 56 weeks.
Secondary outcomes:
measure: Change From Baseline in Sitting Clinic Systolic Blood Pressure - Cohort 1.
timeFrame: 52 weeks
measure: Change From Baseline in Sitting Clinic Systolic Blood Pressure - Cohort 2
timeFrame: 52 weeks
measure: Change From Baseline in Sitting Clinic Diastolic Blood Pressure - Cohort 1.
timeFrame: 52 weeks.
measure: Change From Baseline in Sitting Clinic Diastolic Blood Pressure - Cohort 2.
timeFrame: 52 weeks.
Other outcomes:
Locations:
city: Ozark
country: United States
state: Alabama
city: Tallassee
country: United States
state: Alabama
city: Long Beach
country: United States
state: California
city: Santa Rosa
country: United States
state: California
city: Spring Valley
country: United States
state: California
city: Colorado Springs
country: United States
state: Colorado
city: Trumbull
country: United States
state: Connecticut
city: Waterbury
country: United States
state: Connecticut
city: Fort Lauderdale
country: United States
state: Florida
city: Hollywood
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Pembroke Pines
country: United States
state: Florida
city: Pinellas Park
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Augusta
country: United States
state: Georgia
city: Brooklyn Center
country: United States
state: Minnesota
city: Olive Branch
country: United States
state: Mississippi
city: Rochester
country: United States
state: New York
city: Charlotte
country: United States
state: North Carolina
city: Raleigh
country: United States
state: North Carolina
city: Salisbury
country: United States
state: North Carolina
city: Winston-Salem
country: United States
state: North Carolina
city: Akron
country: United States
state: Ohio
city: Cincinnati
country: United States
state: Ohio
city: Mogadore
country: United States
state: Ohio
city: Springdale
country: United States
state: Ohio
city: Oklahoma City
country: United States
state: Oklahoma
city: Philadelphia
country: United States
state: Pennsylvania
city: Anderson
country: United States
state: South Carolina
city: Mt. Pleasant
country: United States
state: South Carolina
city: Simpsonville
country: United States
state: South Carolina
city: Bristol
country: United States
state: Tennessee
city: Nashville
country: United States
state: Tennessee
city: Arlington
country: United States
state: Texas
city: Austin
country: United States
state: Texas
city: North Richland Hills
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: Norfolk
country: United States
state: Virginia
city: San Bernardo
country: Chile
state: Santiago
city: Tijuana
country: Mexico
state: BC
Study officials:
affiliation: Takeda
name: Executive Medical Director Clinical Science
role: STUDY_DIRECTOR
References: