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Completed Phase 3 Interventional

Safety and Efficacy of Ramelteon in Elderly Subjects With Chronic Insomnia

ClinicalTrials.gov ID: NCT00671255

Public ClinicalTrials.gov record NCT00671255. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 20, 2026, 3:27 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase III, Randomized, Double-Blind, Placebo-Controlled, Outpatient, Safety and Efficacy Study of TAK-375 in Elderly Subjects With Chronic Insomnia

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This purpose of this study is to evaluate the safety and effectiveness of Ramelteon, once daily (QD), in elderly participants with chronic insomnia.

Study identification

NCT ID
NCT00671255
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Takeda
Industry
Enrollment
829 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
65 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Dec 2002 (Type not available)
Primary completion
Jan 2004 (Actual)
Completion
Jan 2004 (Actual)
Last update posted
Feb 28, 2012

2002 – 2004

United States locations

U.S. sites
102
U.S. states
35
U.S. cities
102
Facility City State ZIP Site status
Not listed Columbiana Alabama — —
Not listed Mobile Alabama — —
Not listed Muscle Shoals Alabama — —
Not listed Tallahassee Alabama — —
Not listed Phoenix Arizona — —
Not listed Scottsdale Arizona — —
Not listed Tempe Arizona — —
Not listed Hot Springs Arkansas — —
Not listed Little Rock Arkansas — —
Not listed Anaheim California — —
Not listed Encinitas California — —
Not listed Irvine California — —
Not listed La Jolla California — —
Not listed La Mesa California — —
Not listed Los Angeles California — —
Not listed Murrieta California — —
Not listed Northridge California — —
Not listed Oakland California — —
Not listed Redlands California — —
Not listed Riverside California — —
Not listed Rosemead California — —
Not listed San Diego California — —
Not listed Spring Valley California — —
Not listed Vista California — —
Not listed Colorado Springs Colorado — —
Not listed Denver Colorado — —
Not listed Clearwater Florida — —
Not listed DeLand Florida — —
Not listed Hollywood Florida — —
Not listed Jacksonville Florida — —
Not listed Kissimmee Florida — —
Not listed Longwood Florida — —
Not listed Pembroke Pines Florida — —
Not listed Pinellas Park Florida — —
Not listed Safety Harbor Florida — —
Not listed St. Petersburg Florida — —
Not listed Tampa Florida — —
Not listed Vero Beach Florida — —
Not listed West Palm Beach Florida — —
Not listed Winter Park Florida — —
Not listed Atlanta Georgia — —
Not listed Blairsville Georgia — —
Not listed Macon Georgia — —
Not listed Chciago Illinois — —
Not listed Northfield Illinois — —
Not listed Evansville Indiana — —
Not listed Shawnee Mission Kansas — —
Not listed Wichita Kansas — —
Not listed Louisville Kentucky — —
Not listed Murray Kentucky — —
Not listed New Orleans Louisiana — —
Not listed Bethesda Maryland — —
Not listed Belmont Massachusetts — —
Not listed Brockton Massachusetts — —
Not listed Newton Massachusetts — —
Not listed Detroit Michigan — —
Not listed Hattiesburg Mississippi — —
Not listed Kansas City Missouri — —
Not listed St Louis Missouri — —
Not listed Lincoln Nebraska — —
Not listed Las Vegas Nevada — —
Not listed Brick New Jersey — —
Not listed Edison New Jersey — —
Not listed Toms River New Jersey — —
Not listed Albuquerque New Mexico — —
Not listed Great Neck New York — —
Not listed Manlius New York — —
Not listed Mineola New York — —
Not listed Williamsville New York — —
Not listed Cary North Carolina — —
Not listed Greensboro North Carolina — —
Not listed Hickory North Carolina — —
Not listed Raleigh North Carolina — —
Not listed Salisbury North Carolina — —
Not listed Winston-Salem North Carolina — —
Not listed Beachwood Ohio — —
Not listed Canfield Ohio — —
Not listed Cincinnati Ohio — —
Not listed Toledo Ohio — —
Not listed Oklahoma City Oklahoma — —
Not listed Tulsa Oklahoma — —
Not listed Eugene Oregon — —
Not listed Portland Oregon — —
Not listed Jenkintown Pennsylvania — —
Not listed Reading Pennsylvania — —
Not listed Scotland Pennsylvania — —
Not listed Warwick Rhode Island — —
Not listed Anderson South Carolina — —
Not listed Greer South Carolina — —
Not listed Mt. Pleasant South Carolina — —
Not listed Fayetteville Tennessee — —
Not listed Johnson City Tennessee — —
Not listed Dallas Texas — —
Not listed Fort Worth Texas — —
Not listed Houston Texas — —
Not listed San Antonio Texas — —
Not listed Salt Lake City Utah — —
Not listed Norfolk Virginia — —
Not listed Bellevue Washington — —
Not listed Gig Harbor Washington — —
Not listed Madison Wisconsin — —
Not listed New Berlin Wisconsin — —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 13 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00671255, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Feb 28, 2012 · Synced Oct 20, 2026

Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.

Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00671255 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →