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

This study has been completed.
Information provided by:
Otsuka Pharmaceutical Development & Commercialization, Inc. Identifier:
First received: January 29, 2005
Last updated: April 13, 2006
Last verified: April 2006
The purpose of this trial is to assess the safety, tolerability and pharmacokinetics of aripiprazole tablets following oral administration to children and adolescents.

Condition Intervention Phase
Schizophrenia Mania Drug: Aripiprazole Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study to Test PK Tolerability in Children and Adolescents

Resource links provided by NLM:

Further study details as provided by Otsuka Pharmaceutical Development & Commercialization, Inc.:

Study Start Date: July 2004
Estimated Study Completion Date: July 2005

Ages Eligible for Study:   10 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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No Contacts or Locations Provided
  More Information

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00102479     History of Changes
Other Study ID Numbers: 31-03-238
Study First Received: January 29, 2005
Last Updated: April 13, 2006

Keywords provided by Otsuka Pharmaceutical Development & Commercialization, Inc.:
acute mania in pediatric populations

Additional relevant MeSH terms:
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs processed this record on August 23, 2017