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NCT00856973 · ClinicalTrials.gov registry record · Phase 3

Safety & Efficacy Study of Study Drug (Eszopiclone) in Children and Adolescents With Attention-deficit/Hyperactivity Disorder - Associated Insomnia

A Phase 3 study, sponsored by Sumitomo Pharma America.

Completed
Registry status
Phase 3
Development phase
486
Enrollment target

NCT00856973 is a Phase 3 study that has completed, run by Sumitomo Pharma America. The registered enrollment target is 486 participants.

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The verdict

NCT00856973, a Phase 3 study, has completed, sponsored by Sumitomo Pharma America.

COMPLETED
Registry status
Phase 3
Development phase
486 participants
Enrollment target

Study Summary

A multi center, randomized study to evaluate the efficacy and safety of eszopiclone compared to placebo in children (6-11 years of age, inclusive) and adolescents (12-17 years of age, inclusive) with attention deficit/hyperactivity disorder (ADHD) associated insomnia.

Interventions

  • DRUG Placebo
  • DRUG eszopiclone

Trial Details

FieldValue
Enrollment Target 486 participants
Start Date 2009-05
Est. Completion 2011-07
Phase Phase 3

Sponsor

Sumitomo Pharma America

168 total trials

What the Registry Record Tells You About NCT00856973

The ClinicalTrials.gov registry entry for NCT00856973 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 486 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sumitomo Pharma America, which has 168 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT00856973 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00856973 about?

NCT00856973 is a clinical study titled "Safety & Efficacy Study of Study Drug (Eszopiclone) in Children and Adolescents With Attention-deficit/Hyperactivity Disorder - Associated Insomnia". A multi center, randomized study to evaluate the efficacy and safety of eszopiclone compared to placebo in children (6-11 years of age, inclusive) and adolescents (12-17 years of age, inclusive) with attention deficit/hyperactivity disorder (ADHD) associated insomnia.

What is the current status of trial NCT00856973?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 486 participants. The study started on 2009-05. Estimated completion is 2011-07.

What interventions are being tested in trial NCT00856973?

The interventions under investigation include: Placebo (DRUG), eszopiclone (DRUG).

Who is sponsoring clinical trial NCT00856973?

This trial is sponsored by Sumitomo Pharma America, which has 168 total clinical trials registered on ClinicalTrials.gov.

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.