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Completed Phase 3 Interventional

Ramelteon in Adults With Chronic Insomnia

ClinicalTrials.gov ID: NCT00671567

Public ClinicalTrials.gov record NCT00671567. 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, 5:36 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 Adults With Chronic Insomnia

Brief summary

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

The purpose of this study is to determine the safety and efficacy of Ramelteon, once daily (QD), in adult subjects with chronic insomnia.

Study identification

NCT ID
NCT00671567
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Takeda
Industry
Enrollment
848 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years to 64 Years
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
Sep 2003 (Actual)
Completion
Sep 2003 (Actual)
Last update posted
Nov 20, 2012

2002 – 2003

United States locations

U.S. sites
70
U.S. states
29
U.S. cities
70
Facility City State ZIP Site status
Not listed Birmingham Alabama — —
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Not listed Safety Harbor Florida — —
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Not listed Danville Indiana — —
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Not listed Bethesda Maryland — —
Not listed Brockton Massachusetts — —
Not listed Detroit Michigan — —
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Not listed St Louis Missouri — —
Not listed Lawrenceville New Jersey — —
Not listed Moorestown New Jersey — —
Not listed Albuquerque New Mexico — —
Not listed Mineola New York — —
Not listed Williamsville New York — —
Not listed Cary North Carolina — —
Not listed Raleigh North Carolina — —
Not listed Winston-Salem North Carolina — —
Not listed Beachwood Ohio — —
Not listed Cincinnati Ohio — —
Not listed Oklahoma City Oklahoma — —
Not listed Altoona Pennsylvania — —
Not listed Jenkintown Pennsylvania — —
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Not listed Sellersville Pennsylvania — —
Not listed Warwick Rhode Island — —
Not listed Mt. Pleasant South Carolina — —
Not listed Johnson City Tennessee — —
Not listed Dallas Texas — —
Not listed Houston Texas — —
Not listed San Antonio Texas — —
Not listed Salt Lake City Utah — —
Not listed Norfolk Virginia — —
Not listed Virginia Beach Virginia — —
Not listed Gig Harbor Washington — —

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 NCT00671567, 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 Nov 20, 2012 · Synced Oct 20, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00671567 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →