Efficacy of Ramelteon in Subjects With Chronic Insomnia

PHASE3CompletedINTERVENTIONAL
Enrollment

1,213

Participants

Timeline

Start Date

February 28, 2003

Primary Completion Date

September 30, 2004

Study Completion Date

September 30, 2004

Conditions
Sleep Initiation and Maintenance Disorders
Interventions
DRUG

Ramelteon

Subjects 65 yrs of age and older will take Ramelteon 8 mg, tablets, orally, once nightly for up to one year.

DRUG

Ramelteon

Subjects between 18 and 64 years of age will take Ramelteon 16 mg, tablets, orally, once nightly for up to one year.

Trial Locations (122)

Unknown

Birmingham

Mobile

Phoenix

Tempe

Hot Springs

Little Rock

Anaheim

Burbank

Cerritos

Irvine

La Jolla

La Mesa

Lafayette

Murrieta

Newport Beach

Northridge

Redlands

Riverside

San Diego

San Francisco

Santa Monica

Boulder

Colorado Springs

Denver

Pueblo

Wheat Ridge

Wilmington

Brandon

Clearwater

DeLand

Edgewater

Fort Lauderdale

Largo

Miami

Naples

New Smyrna Beach

Ocala

Safety Harbor

St. Petersburg

Stuart

Tampa

Winter Park

Atlanta

Austell

Blairsville

Macon

Boise

Chicago

Elk Grove Village

Libertyville

Skokie

Evansville

Fort Wayne

Shawnee Mission

Florence

Louisville

Paducah

New Orleans

Shreveport

Baltimore

Bryan Pogue

Chevy Chase

Frederick

Prince Frederick

Rockville

Newton

Ann Arbor

Troy

Minneapolis

Hattiesburg

City of Saint Peters

St Louis

Wentzville

Billings

Lincoln

Las Vegas

Clementon

Lawrenceville

Newark

Toma River

Brooklyn

Kingston

Lake Success

Rochester

White Plains

Williamsville

Cary

Raleigh

Salisbury

Wilmington

Winston-Salem

Beachwood

Cincinnati

Columbus

Dublin

Toledo

Oklahoma City

Eugene

Portland

Bala-Cynwyd

Duncansville

Jenkintown

Lafayette Hill

Philadelphia

Warwick

Anderson

Columbia

Greer

Bristol

Cordova

Austin

Houston

Plano

San Antonio

Salt Lake City

Charlottesville

Fairfax

Oakland

Seattle

Tacoma

Milwaukee

Wauwatosa

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Takeda

INDUSTRY