A Safety and Tolerability Study of Azilsartan Medoxomil in Participants With Essential Hypertension

PHASE3CompletedINTERVENTIONAL
Enrollment

418

Participants

Timeline

Start Date

June 30, 2007

Primary Completion Date

April 30, 2009

Study Completion Date

April 30, 2009

Conditions
Hypertension
Interventions
DRUG

Azilsartan medoxomil

"All subjects initiated azilsartan medoxomil 40 mg, tablets, orally, once daily for four weeks, force-titrated to 80 mg, tablets, orally, once daily. After Week 8, chlorthalidone, 25 mg, tablets, orally, once daily as needed and other antihypertensive medications as needed to achieve target blood pressure (defined as \<140/90 mm Hg for participants without diabetes or chronic kidney disease (CKD) and \<130/80 mm Hg for participants with diabetes or CKD) for up to 26 weeks.~Study medication could have been up-titrated only after the subject had been at the previous dose level for a minimum of 2 weeks. Study medication could only have been up- or down-titrated by 1 dose level per scheduled or unscheduled visit."

DRUG

Azilsartan medoxomil, with or without chlorthalidone and other non-angiotensin II receptor blocker antihypertensive medications.

Azilsartan medoxomil at the final dose received during the open-label phase: (20 mg, 40 mg or 80 mg), tablets, orally, once daily with or without chlorthalidone 25 mg, tablets, orally once daily and other non-ARB antihypertensive medications (if currently taking), for 6 weeks/Week 32.

DRUG

Placebo

Azilsartan medoxomil placebo-matching tablets, orally, once daily with or without chlorthalidone 25 mg or other non-ARB antihypertensive (if currently taking), tablets, orally, once daily for 6 weeks/Week 32.

Trial Locations (45)

Unknown

Huntsville

Chandler

Mesa

Tempe

Los Gatos

Sacramento

Tustin

Westlake Village

Colorado Springs

Wheat Ridge

Melbourne

Pembroke Pines

Augusta

South Bend

Auburn

Marlborough

Chelsea

St Louis

Trenton

Rochester

Burlington

Wilmington

Cleveland

Columbus

Oklahoma City

Carlisle

Philadelphia

Mt. Pleasant

San Antonio

Norfolk

Lakewood

Renton

Madison

Berazategui

Pilar

Córdoba

Salta

León

Guadalajara

Cuernavaca

Rosario

Tampico

Durango

Mexico City

Puebla City

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Takeda

INDUSTRY