Safety and Efficacy of Ramelteon in Elderly Subjects With Chronic Insomnia

PHASE3CompletedINTERVENTIONAL
Enrollment

829

Participants

Timeline

Start Date

December 31, 2002

Primary Completion Date

January 31, 2004

Study Completion Date

January 31, 2004

Conditions
Chronic Insomnia
Interventions
DRUG

Ramelteon

Ramelteon 4 mg, tablets, orally, once daily for up to 5 weeks.

DRUG

Ramelteon

Ramelteon 8 mg, tablets, orally, once daily for up to 5 weeks.

DRUG

Placebo

Ramelteon placebo-matching, tablets, orally, each night for up to 35 consecutive days.

Trial Locations (115)

Unknown

Columbiana

Mobile

Muscle Shoals

Tallahassee

Phoenix

Scottsdale

Tempe

Hot Springs

Little Rock

Anaheim

Encinitas

Irvine

La Jolla

La Mesa

Los Angeles

Murrieta

Northridge

Oakland

Redlands

Riverside

Rosemead

San Diego

Spring Valley

Vista

Colorado Springs

Denver

Clearwater

DeLand

Hollywood

Jacksonville

Kissimmee

Longwood

Pembroke Pines

Pinellas Park

Safety Harbor

St. Petersburg

Tampa

Vero Beach

West Palm Beach

Winter Park

Atlanta

Blairsville

Macon

Chciago

Northfield

Evansville

Shawnee Mission

Wichita

Louisville

Murray

New Orleans

Bethesda

Belmont

Brockton

Newton

Detroit

Hattiesburg

Kansas City

St Louis

Lincoln

Las Vegas

Brick

Edison

Toms River

Albuquerque

Great Neck

Manlius

Mineola

Williamsville

Cary

Greensboro

Hickory

Raleigh

Salisbury

Winston-Salem

Beachwood

Canfield

Cincinnati

Toledo

Oklahoma City

Tulsa

Eugene

Portland

Jenkintown

Reading

Scotland

Warwick

Anderson

Greer

Mt. Pleasant

Fayetteville

Johnson City

Dallas

Fort Worth

Houston

San Antonio

Salt Lake City

Norfolk

Bellevue

Gig Harbor

Madison

New Berlin

Calgary

Edmonton

Medicine Hat

North Vancouver

Winnipeg

St. John's

Corunna

London

North Bay

Sarnia

Toronto

Parkdale

Montreal

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Takeda

INDUSTRY