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

StatusCompleted
PhasePhase 1
Started

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Record History

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  1. Phase: Phase 2 to Phase 1v5 Show 7 more changesShow less
    • Results first posted: Jun 22, 2026
    • Enrollment target: 21
    • Primary completion date: Jul 1, 2005
    • Study completion date: Jul 2005 to Jul 1, 2005
    • Start date: Jul 2004 to Jul 1, 2004
    • Eligibility criteria expanded, about 399 words
    • Study arms: 0 to 3
  2. Study Status, Contacts/Locationsv4
  3. Re-verified, no change to tracked fieldsv3
  4. Trial status: Recruiting to Completed
    • Site details revised at 3 of 3 sites
    v2
  5. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The purpose of this trial is to assess the safety, tolerability and pharmacokinetics of aripiprazole tablets following oral administration to children and adolescents.
Trial Details
NCT Number NCT00102479
Lead Sponsor Otsuka Pharmaceutical Development & Commercialization, Inc.
Conditions
(from sponsor)		 Schizophrenia, Mania
Related terms Mania, Schizophrenia
Enrollment 21 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov