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

Schizophrenia Clinical Trial

Official title:

A Phase II Study to Test PK Tolerability in Children and Adolescents

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00102479
• Other study ID #: 31-03-238
• Status: Completed
• Phase: Phase 2
• First received: January 29, 2005
• Last updated: April 13, 2006
• Start date: July 2004
• Est. completion date: July 2005

Study information

• Verified date: April 2006
• Source: Otsuka Pharmaceutical Development & Commercialization, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: July 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 10 Years to 17 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• History of mental retardation

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Mania
• Schizophrenia

Intervention

Drug:
• Aripiprazole

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Otsuka Pharmaceutical Development & Commercialization, Inc.