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NCT00110461 · ClinicalTrials.gov registry record · Phase 3

Aripiprazole in Children and Adolescents With Bipolar I Disorder

A Phase 3 study, sponsored by Otsuka Pharmaceutical Development & Commercialization.

Completed
Registry status
Phase 3
Development phase
296
Enrollment target

NCT00110461 is a Phase 3 study that has completed, run by Otsuka Pharmaceutical Development & Commercialization. The registered enrollment target is 296 participants.

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The verdict

NCT00110461, a Phase 3 study, has completed, sponsored by Otsuka Pharmaceutical Development & Commercialization.

COMPLETED
Registry status
Phase 3
Development phase
296 participants
Enrollment target

Study Summary

The purpose of this trial is to test the safety and efficacy of two doses of aripiprazole in child and adolescent patients with bipolar I disorder, manic or mixed episode with or without psychotic features.

Interventions

  • DRUG placebo
  • DRUG Aripiprazole

Trial Details

FieldValue
Enrollment Target 296 participants
Start Date 2005-03
Est. Completion 2007-02
Phase Phase 3

What the Registry Record Tells You About NCT00110461

The ClinicalTrials.gov registry entry for NCT00110461 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 296 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Otsuka Pharmaceutical Development & Commercialization, which has 221 total studies on file at ClinicalTrials.gov.

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

NCT00110461 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00110461 about?

NCT00110461 is a clinical study titled "Aripiprazole in Children and Adolescents With Bipolar I Disorder". The purpose of this trial is to test the safety and efficacy of two doses of aripiprazole in child and adolescent patients with bipolar I disorder, manic or mixed episode with or without psychotic features.

What is the current status of trial NCT00110461?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 296 participants. The study started on 2005-03. Estimated completion is 2007-02.

What interventions are being tested in trial NCT00110461?

The interventions under investigation include: placebo (DRUG), Aripiprazole (DRUG).

Who is sponsoring clinical trial NCT00110461?

This trial is sponsored by Otsuka Pharmaceutical Development & Commercialization, which has 221 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.