Status:

COMPLETED

Aripiprazole Pharmacokinetics (PK) and Tolerability Study in Children and Adolescents

Lead Sponsor:

Otsuka Pharmaceutical Development & Commercialization, Inc.

Conditions:

Schizophrenia

Mania

Eligibility:

All Genders

10-17 years

Phase:

PHASE2

Brief Summary

The purpose of this trial is to assess the safety, tolerability and pharmacokinetics of aripiprazole tablets following oral administration to children and adolescents.

Eligibility Criteria

Inclusion

  • Children and adolescents between 10-17 years, in good physical health, preferentially with a primary schizophrenia spectrum diagnosis or bipolar spectrum disorder

Exclusion

  • History of mental retardation
  • Any neurological disorder with the exception of Pervasive Developmental Disorder (PDD), Attention Deficit Hyperactivity Disorder (ADHD), and Tourette's Syndrome

Key Trial Info

Start Date :

July 1 2004

Trial Type :

INTERVENTIONAL

End Date :

July 1 2005

Estimated Enrollment :

Patients enrolled

Trial Details

Trial ID

NCT00102479

Start Date

July 1 2004

End Date

July 1 2005

Last Update

April 17 2006

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