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Completed Phase 3 Interventional

Study of Efficacy of Ramelteon in Adults With Chronic Insomnia

ClinicalTrials.gov ID: NCT00671125

Public ClinicalTrials.gov record NCT00671125. 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 28, 2026, 11:50 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, PSG Plus Outpatient Study to Determine the Safety and Efficacy 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 the treatment of chronic insomnia using polysomnography and subjective measures of sleep

Study identification

NCT ID
NCT00671125
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Takeda
Industry
Enrollment
405 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
Jan 2003 (Type not available)
Primary completion
Sep 2003 (Actual)
Completion
Sep 2003 (Actual)
Last update posted
Nov 12, 2012

2003

United States locations

U.S. sites
25
U.S. states
19
U.S. cities
25
Facility City State ZIP Site status
Not listed Birmingham Alabama — —
Not listed Scottsdale Arizona — —
Not listed Hot Springs Arkansas — —
Not listed Anaheim California — —
Not listed Oakland California — —
Not listed San Diego California — —
Not listed San Francisco California — —
Not listed Santa Monica California — —
Not listed Miami Florida — —
Not listed Pembroke Pines Florida — —
Not listed Atlanta Georgia — —
Not listed Chicago Illinois — —
Not listed Overland Park Kansas — —
Not listed Crestview Hills Kentucky — —
Not listed Chevy Chase Maryland — —
Not listed Newton Massachusetts — —
Not listed Troy Michigan — —
Not listed Lincoln Nebraska — —
Not listed Las Vegas Nevada — —
Not listed New York New York — —
Not listed Winston-Salem North Carolina — —
Not listed Cincinnati Ohio — —
Not listed Lafayette Hill Pennsylvania — —
Not listed Austin Texas — —
Not listed Plano 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 NCT00671125, 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 12, 2012 · Synced Oct 28, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00671125 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →