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NCT00671086 · ClinicalTrials.gov registry record · Phase 3

Efficacy of Ramelteon in Subjects With Chronic Insomnia

A Phase 3 study of Sleep Initiation and Maintenance Disorders, sponsored by Takeda.

Completed
Registry status
Phase 3
Development phase
1,213
Enrollment target
20
Study locations

NCT00671086 is a Phase 3 study of Sleep Initiation and Maintenance Disorders that has completed, run by Takeda. The registered enrollment target is 1,213 participants, above the 226-participant average among 19 other Sleep Initiation and Maintenance Disorders trials with a reported enrollment target (437% higher). The trial reports 20 study locations across 4 states.

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The verdict

NCT00671086, a Phase 3 study of Sleep Initiation and Maintenance Disorders, has completed, sponsored by Takeda.

COMPLETED
Registry status
Phase 3
Development phase
1,213 participants
Enrollment target
20
Study locations

Study Summary

The purpose of this study is to determine the long-term safety of Ramelteon, once daily (QD), in subjects with chronic insomnia.

Interventions

  • DRUG Ramelteon

Study Locations (20)

California

  • - Anaheim
  • - Burbank
  • - Cerritos
  • - Irvine
  • - La Jolla
  • - La Mesa
  • - Lafayette
  • - Murrieta
  • - Newport Beach
  • - Northridge
  • - Redlands
  • - Riverside
  • - San Diego
  • - San Francisco

Alabama

  • - Birmingham
  • - Mobile

Arizona

  • - Phoenix
  • - Tempe

Arkansas

  • - Hot Springs
  • - Little Rock

Trial Details

FieldValue
Enrollment Target 1,213 participants
Start Date 2003-02
Est. Completion 2004-09
Phase Phase 3

Sponsor

Takeda

408 total trials

What the Registry Record Tells You About NCT00671086

The ClinicalTrials.gov registry entry for NCT00671086 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,213 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 226-participant average among 19 other Sleep Initiation and Maintenance Disorders trials with a reported enrollment target (437% higher). The listed sponsor is Takeda, which has 408 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Sleep Initiation and Maintenance Disorders appearing as the primary indexed condition, and to 1 intervention - of which Ramelteon is the first listed.

NCT00671086 reports 20 study locations spanning 4 distinct geographic areas - top geographies include California, Alabama, Arizona.

Frequently Asked Questions

What is clinical trial NCT00671086 about?

NCT00671086 is a clinical study titled "Efficacy of Ramelteon in Subjects With Chronic Insomnia". The purpose of this study is to determine the long-term safety of Ramelteon, once daily (QD), in subjects with chronic insomnia.

What is the current status of trial NCT00671086?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,213 participants. The study started on 2003-02. Estimated completion is 2004-09.

What conditions does trial NCT00671086 study?

This clinical trial studies the following conditions: Sleep Initiation and Maintenance Disorders.

What interventions are being tested in trial NCT00671086?

The interventions under investigation include: Ramelteon (DRUG).

Who is sponsoring clinical trial NCT00671086?

This trial is sponsored by Takeda, which has 408 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00671086 being conducted?

This trial has 20 study locations across Alabama, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.