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Completed Phase 3 Interventional

Efficacy of Ramelteon in Subjects With Chronic Insomnia

ClinicalTrials.gov ID: NCT00671086

Public ClinicalTrials.gov record NCT00671086. 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 22, 2026, 7:19 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 3, Open-label, Fixed-dose Study to Determine the Safety of Long-term Administration of TAK-375 in Subjects 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 long-term safety of Ramelteon, once daily (QD), in subjects with chronic insomnia.

Study identification

NCT ID
NCT00671086
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Takeda
Industry
Enrollment
1,213 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 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
Feb 2003 (Type not available)
Primary completion
Sep 2004 (Actual)
Completion
Sep 2004 (Actual)
Last update posted
Feb 28, 2012

2003 – 2004

United States locations

U.S. sites
122
U.S. states
38
U.S. cities
122
Facility City State ZIP Site status
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Not listed Bryan Pogue Maryland — —
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Not listed Clementon New Jersey — —
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Not listed Toma River New Jersey — —
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Not listed Kingston New York — —
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Not listed Rochester New York — —
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Not listed Cary North Carolina — —
Not listed Raleigh North Carolina — —
Not listed Salisbury North Carolina — —
Not listed Wilmington North Carolina — —
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Not listed Beachwood Ohio — —
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Not listed Jenkintown Pennsylvania — —
Not listed Lafayette Hill Pennsylvania — —
Not listed Philadelphia Pennsylvania — —
Not listed Warwick Rhode Island — —
Not listed Anderson South Carolina — —
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Not listed Greer South Carolina — —
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Not listed Charlottesville Virginia — —
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Not listed Oakland Washington — —
Not listed Seattle Washington — —
Not listed Tacoma Washington — —
Not listed Milwaukee Wisconsin — —
Not listed Wauwatosa Wisconsin — —

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 NCT00671086, 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 22, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00671086 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →