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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00102479
First Posted: January 31, 2005
Last Update Posted: April 17, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Otsuka Pharmaceutical Development & Commercialization, Inc.
  Purpose
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
  Eligibility

Information from the National Library of Medicine

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

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
No Contacts or Locations Provided
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00102479     History of Changes
Other Study ID Numbers: 31-03-238
First Submitted: January 29, 2005
First Posted: January 31, 2005
Last Update Posted: April 17, 2006
Last Verified: April 2006

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

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Aripiprazole
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs