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

StatusCompleted
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 70 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Primary and study completion dates: Jun 2008 to Jun 1, 2008
    • Start date: Jun 2006 to Jun 1, 2006
    • Site details revised at 1 of 31 sites
    v70
  2. Lead sponsor: Bristol-Myers Squibb to Otsuka Pharmaceutical Development & Commercialization, Inc.v69
  3. Publications: details revised at 1 of 3 entriesv68
  4. Re-verified, no change to tracked fieldsv67
  5. Results first posted: Jul 23, 2009
    • Primary endpoint revised
    • Secondary endpoints: 5 to 7
    v66
Show 45 earlier versionsHide 45 earlier versions
  1. Enrollment target: estimated 440 to confirmed 218v65
  2. Re-verified, no change to tracked fieldsv64
  3. Trial status: Active, Not Recruiting to Completedv63
  4. 4 versions Re-verified since May 14, 2008, no change to tracked fieldsv59-v62
  5. Enrollment target: 220 to 440
    • Study sites: 32 to 31
    v58
  6. Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 38 to 32
    v57
  7. Re-verified, no change to tracked fieldsv56
  8. Primary completion date: Jun 2008
    • Study completion date: Oct 2008 to Jun 2008
    v55
  9. Site details revised at 32 of 38 sitesv54
  10. Re-verified, no change to tracked fieldsv53
  11. Site contacts updated at 2 of 38 sitesv52
  12. Study sites revised (38)v51
  13. Re-verified, no change to tracked fieldsv50
  14. Interventions: Aripiprazole (Drug) to Aripiprazole (Drug), Placebo (Drug)
    • Study arms: 0 to 4
    v49
  15. Study sites: 37 to 38v48
  16. Re-verified, no change to tracked fieldsv47
  17. Study completion date: Oct 2008v46
  18. Site details revised at 1 of 37 sitesv45
  19. Study sites: 35 to 37v44
  20. Re-verified, no change to tracked fieldsv43
  21. Study sites: 34 to 35v42
  22. 8 versions Re-verified since Jul 31, 2007, no change to tracked fieldsv34-v41
  23. Trial status: Active, Not Recruiting to Recruiting
    • Study sites revised (34)
    v33
  24. Trial status: Recruiting to Active, Not Recruiting
    • Study sites revised (34)
    v32
  25. Re-verified, no change to tracked fieldsv31
  26. Study sites: 33 to 34v30
  27. Secondary endpoints: details revised at 5 of 5 entriesv29
  28. Study sites revised (33)v28
  29. Re-verified, no change to tracked fieldsv27
  30. Study sites revised (33)v26
  31. Site details revised at 2 of 33 sitesv25
  32. Study sites: 35 to 33v24
  33. Study sites: 36 to 35v23
  34. Study sites: 37 to 36v22
  35. Eligibility criteria shortened, about 36 wordsv21
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • 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 with placebo (fixed dose) in reducing serious behavioral problems in children and adolescents with a diagnosis of autistic disorder (AD).
Trial Details
NCT Number NCT00337571
Lead Sponsor Otsuka Pharmaceutical Development & Commercialization, Inc.
Collaborators: Otsuka America Pharmaceutical
Conditions
(from sponsor)		 Behavioral Symptoms, Autistic Disorder
Related terms Autistic Disorder, Behavioral Symptoms
Enrollment 218 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov