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

NCT00365859 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 330

Last updated 2013-12-02

Study results available
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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 \[NCT00337571\]).

Conditions

  • Autistic Disorder
  • Behavioral Symptoms

Interventions

DRUG

Aripiprazole

Tablets, Oral, 2, 5, 10, or 15 mg, once daily, 52 weeks

Sponsors & Collaborators

  • Otsuka America Pharmaceutical

    collaborator INDUSTRY

  • Otsuka Pharmaceutical Development & Commercialization, Inc.

    lead INDUSTRY

Principal Investigators

  • Bristol-Myers Squibb · Bristol-Myers Squibb

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-09-30
Primary Completion
2009-06-30
Completion
2009-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00365859 on ClinicalTrials.gov