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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 Oct 21, 2026, 11:01 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, Crossover Study to Determine the Safety and Efficacy 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 assess the efficacy and safety of Ramelteon, once daily (QD), 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

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
Oct 2002 (Type not available)
Primary completion
Jul 2003 (Actual)
Completion
Jul 2003 (Actual)
Last update posted
Feb 28, 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 28, 2012 · Synced Oct 21, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00671294 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →