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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 Sep 5, 2026, 2:30 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
Nov 30, 2002
Primary completion
Dec 31, 2003
Completion
Dec 31, 2003
Last update posted
Feb 27, 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 27, 2012 · Synced Sep 5, 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 protocol, eligibility criteria, and contact information for NCT00671255 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →