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

PHASE3CompletedINTERVENTIONAL
Enrollment

669

Participants

Timeline

Start Date

June 30, 2007

Primary Completion Date

May 31, 2010

Study Completion Date

May 31, 2010

Conditions
Hypertension
Interventions
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.

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.

Trial Locations (41)

Unknown

Ozark

Tallassee

Long Beach

Santa Rosa

Spring Valley

Colorado Springs

Trumbull

Waterbury

Fort Lauderdale

Hollywood

Jacksonville

Miami

Pembroke Pines

Pinellas Park

Atlanta

Augusta

Brooklyn Center

Olive Branch

Rochester

Charlotte

Raleigh

Salisbury

Winston-Salem

Akron

Cincinnati

Mogadore

Springdale

Oklahoma City

Philadelphia

Anderson

Mt. Pleasant

Simpsonville

Bristol

Nashville

Arlington

Austin

North Richland Hills

Salt Lake City

Norfolk

San Bernardo

Tijuana

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Takeda

INDUSTRY