Efficacy and Safety of Azilsartan Medoxomil Plus Chlorthalidone in Participants With Moderate to Severe Hypertension

PHASE3CompletedINTERVENTIONAL
Enrollment

1,085

Participants

Timeline

Start Date

March 31, 2009

Primary Completion Date

June 30, 2010

Study Completion Date

June 30, 2010

Conditions
Essential Hypertension
Interventions
DRUG

Azilsartan medoxomil and chlorthalidone

"Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg, tablets, orally, and olmesartan medoxomil-hydrochlorothiazide placebo tablets once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to azilsartan medoxomil 40 mg and chlorthalidone 25 mg, tablets, orally, once daily for the remaining 4 weeks."

DRUG

Azilsartan medoxomil and chlorthalidone

"Azilsartan medoxomil 40 mg and chlorthalidone 12.5, mg, tablets, orally, and olmesartan medoxomil-hydrochlorothiazide placebo tablets once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to azilsartan medoxomil 80 mg and chlorthalidone 25 mg, tablets, orally, once daily for the remaining 4 weeks."

DRUG

Olmesartan medoxomil-hydrochlorothiazide

"Olmesartan medoxomil 20 mg/hydrochlorothiazide 12.5 mg, tablets, orally, and Azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to olmesartan medoxomil 40 mg/hydrochlorothiazide 25 mg, tablets, orally, once daily for the remaining 4 weeks."

Trial Locations (80)

Unknown

Birmingham

Haleyville

Hueytown

Jasper

Tallassee

Green Valley

Phoenix

Long Beach

National City

Roseville

San Francisco

San Jose

Newark

Clearwater

Jacksonville

Jupiter

Miami

Ocala

Pembroke Pines

Plant City

Tallahassee

Arlington Heights

Chicago

Gurnee

Avon

Wichita

Louisville

Auburn

Baltimore

Brockton

Haverhill

North Dartmouth

Bingham Farms

Stevensville

Olive Branch

Kansas City

New York

Burlington

Charlotte

Hickory

Shelby

Akron

Cleveland

Columbus

Marion

Middleburg Heights

Willoughby Hills

Norman

Bensalem

Erie

Reading

Cranston

Cumberland

North Charleston

Jackson

Kingsport

Milan

Austin

Corpus Christi

Dallas

Houston

San Antonio

Salt Lake City

Arlington

Burke

Charlottesville

Manassas

Lakewood

Port Orchard

Menomonee Falls

Temuco

La Serena

Osorno

Viña del Mar

Santiago

Chihuahua City

Tijuana

León

Guadalajara

San Luis Potosí City

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Takeda

INDUSTRY