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Completed Phase 3 Interventional

Safety and Efficacy of Ramelteon in Elderly Subjects With Chronic Insomnia.

ClinicalTrials.gov ID: NCT00671294

Public ClinicalTrials.gov record NCT00671294. 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 Jun 25, 2026, 8:14 PM 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, Crossover Study to Determine the Safety and Efficacy of TAK-375 in Elderly Subjects With Chronic Insomnia.

Study identification

NCT ID
NCT00671294
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Takeda
Industry
Enrollment
100 participants

Conditions and interventions

Interventions

  • Ramelteon and Placebo (9 possible combinations total) Drug

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
Sep 30, 2002
Primary completion
Jun 30, 2003
Completion
Jun 30, 2003
Last update posted
Feb 27, 2012

2002 – 2003

United States locations

U.S. sites
18
U.S. states
11
U.S. cities
18
Facility City State ZIP Site status
Not listed Hot Springs Arkansas
Not listed Irvine California
Not listed Palm Springs California
Not listed San Diego California
Not listed Brandon Florida
Not listed Miami Florida
Not listed Naples Florida
Not listed Pembroke Pines Florida
Not listed St. Petersburg Florida
Not listed Atlanta Georgia
Not listed Overland Park Kansas
Not listed Crestview Hills Kentucky
Not listed Troy Michigan
Not listed St Louis Missouri
Not listed Winston-Salem North Carolina
Not listed Cincinnati Ohio
Not listed Toledo Ohio
Not listed Houston Texas

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

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00671294, 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 Jun 25, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00671294 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →