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NCT00365859 · ClinicalTrials.gov registry record · Phase 3

Study of Aripiprazole in the Treatment of Serious Behavioral Problems in Children and Adolescents With Autistic Disorder (AD)

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

Completed
Registry status
Phase 3
Development phase
330
Enrollment target

NCT00365859 is a Phase 3 study that has completed, run by Otsuka Pharmaceutical Development & Commercialization. The registered enrollment target is 330 participants.

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The verdict

NCT00365859, a Phase 3 study, has completed, sponsored by Otsuka Pharmaceutical Development & Commercialization.

COMPLETED
Registry status
Phase 3
Development phase
330 participants
Enrollment target

Study Summary

This study will provide long-term safety data for patients who are taking aripiprazole for up to 1 year. Most patients enrolled in this study will have participated in a short-term study with aripiprazole (CN138-178 \[NCT00332241\] or CN138-179 \[NCT00337571\]).

Interventions

  • DRUG Aripiprazole

Trial Details

FieldValue
Enrollment Target 330 participants
Start Date 2006-09
Est. Completion 2009-06
Phase Phase 3

What the Registry Record Tells You About NCT00365859

The ClinicalTrials.gov registry entry for NCT00365859 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 330 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 1 intervention - of which Aripiprazole is the first listed.

NCT00365859 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00365859 about?

NCT00365859 is a clinical study titled "Study of Aripiprazole in the Treatment of Serious Behavioral Problems in Children and Adolescents With Autistic Disorder (AD)". This study will provide long-term safety data for patients who are taking aripiprazole for up to 1 year. Most patients enrolled in this study will have participated in a short-term study with aripiprazole (CN138-178 \[NCT00332241\] or CN138-179 \[NCT00337571\]).

What is the current status of trial NCT00365859?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 330 participants. The study started on 2006-09. Estimated completion is 2009-06.

What interventions are being tested in trial NCT00365859?

The interventions under investigation include: Aripiprazole (DRUG).

Who is sponsoring clinical trial NCT00365859?

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.