Efficacy and Safety of Azilsartan Medoxomil and Chlorthalidone Compared to Olmesartan Medoxomil and Hydrochlorothiazide in Participants With Moderate to Severe Hypertension.

PHASE3CompletedINTERVENTIONAL
Enrollment

1,071

Participants

Timeline

Start Date

January 31, 2010

Primary Completion Date

October 31, 2010

Study Completion Date

November 30, 2010

Conditions
Essential Hypertension
Interventions
DRUG

Azilsartan medoxomil and chlorthalidone

"Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks."

DRUG

Azilsartan medoxomil and chlorthalidone

"Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to azilsartan medoxomil 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks."

DRUG

Olmesartan medoxomil and hydrochlorothiazide

"Olmesartan medoxomil 20 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily and azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to olmesartan medoxomil 40 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to olmesartan medoxomil 40 mg and hydrochlorothiazide 25 mg combination tablets, orally, once daily for the next 4 weeks."

Trial Locations (94)

Unknown

Gulf Shores

Litchfield Park

Mesa

Scottsdale

Tucson

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Carmichael

Greenbrae

Irvine

Paramount

Sacramento

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Wildomar

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Aventura

Clearwater

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Fort Lauderdale

Miami

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Plant City

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Roswell

Suwanee

Chicago

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Naperville

Avon

Indianapolis

Valparaiso

Crestview Hills

Lexington

Auburn

Brockton

Hyannis

West Yarmouth

Ann Arbor

City of Saint Peters

St Louis

Henderson

Margate City

Wildwood Crest

Albuquerque

Glens Falls

Boiling Springs

Raleigh

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Cincinnati

Columbus

Willoughby Hills

Oklahoma City

Yukon

Ashland

Portland

Bensalem

Feasterville

Lansdale

Pittsburgh

Reading

Tipton

Cranston

Cumberland

Mt. Pleasant

Simpsonville

Beaumont

Dallas

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North Richland Hills

San Antonio

Magna

Manassas

Lakewood

Port Orchard

Madison

Menomonee Falls

Abbotsford

Powell River

Mount Pearl

Halifax

London

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Sarnia

Vaughan

Whitby

Woodstock

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Takeda

INDUSTRY