Study of Aripiprazole in the Treatment of Children and Adolescents With Autistic Disorder (AD).

StatusCompleted
PhasePhase 3
Started

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Record History

The 50 most recent of 65 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Primary and study completion dates: Apr 2008 to Apr 1, 2008
    • Start date: Jun 2006 to Jun 1, 2006
    • Study title revised
    v65
  2. Lead sponsor: Bristol-Myers Squibb to Otsuka Pharmaceutical Development & Commercialization, Inc.v64
  3. Publications: details revised at 1 of 4 entriesv63
  4. Re-verified, no change to tracked fieldsv62
  5. Results first posted: Jul 23, 2009
    • Primary endpoint revised
    • Secondary endpoints: 4 to 7
    v61
Show 45 earlier versionsHide 45 earlier versions
  1. Enrollment target: 164 to 98v60
  2. 2 versions Re-verified since Jun 27, 2008, no change to tracked fieldsv58-v59
  3. Trial status: Active, Not Recruiting to Completed
    • Enrollment target: estimated 200 to confirmed 164
    v57
  4. Enrollment target: 100 to 200
    • Study sites: 11 to 9
    • Primary and study completion dates: Jun 2008 to Apr 2008
    v56
  5. Study sites: 16 to 11v55
  6. Re-verified, no change to tracked fieldsv54
  7. Study sites: 19 to 16v53
  8. Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 20 to 19
    • Primary completion date: Jun 2008
    • Study completion date: Oct 2008 to Jun 2008
    v52
  9. Site contacts updated at 2 of 20 sitesv51
  10. Site contacts updated at 4 of 20 sitesv50
  11. 2 versions Re-verified since Jan 8, 2008, no change to tracked fieldsv48-v49
  12. Interventions: Aripiprazole (Drug) to Aripiprazole (Drug), Placebo (Drug)
    • Study arms: 0 to 2
    v47
  13. Site details revised at 1 of 20 sitesv46
  14. Re-verified, no change to tracked fieldsv45
  15. Study completion date: Oct 2008v44
  16. 11 versions Re-verified since Jul 31, 2007, no change to tracked fieldsv33-v43
  17. Trial status: Active, Not Recruiting to Recruiting
    • Site details revised at 20 of 20 sites
    v32
  18. Trial status: Recruiting to Active, Not Recruiting
    • Study sites revised (20)
    v31
  19. 2 versions Re-verified since May 30, 2007, no change to tracked fieldsv29-v30
  20. Secondary endpoints: details revised at 4 of 4 entriesv28
  21. Study sites revised (20)v27
  22. Re-verified, no change to tracked fieldsv26
  23. Study sites revised (20)v25
  24. Study sites revised (20)v24
  25. Study sites revised (20)v23
  26. Study sites: 22 to 20v22
  27. Site details revised at 4 of 22 sitesv21
  28. Eligibility criteria shortened, about 15 wordsv20
  29. Study sites: 21 to 22v19
  30. Study sites: 20 to 21v18
  31. Site details revised at 2 of 20 sitesv17
  32. Site details revised at 1 of 20 sitesv16
  • 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.
This study will compare the effectiveness (how well the drug works) of aripiprazole, flexibly dosed with a placebo, in reducing serious behavioral problems in children and adolescents with a diagnosis of autistic disorder (AD).
Trial Details
NCT Number NCT00332241
Lead Sponsor Otsuka Pharmaceutical Development & Commercialization, Inc.
Collaborators: Otsuka America Pharmaceutical
Conditions
(from sponsor)		 Autistic Disorder
Related terms Autistic Disorder, Problem Behavior
Enrollment 98 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov