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

StatusCompleted
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 100 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Primary and study completion dates: Jun 2009 to Jun 1, 2009 Start date: Sep 2006 to Sep 1, 2006 · Site details revised at 3 of 55 sitesv100 Show all 3 changesShow less
    • Start date: Sep 2006 to Sep 1, 2006
    • Site details revised at 3 of 55 sites
  2. Lead sponsor: Bristol-Myers Squibb to Otsuka Pharmaceutical Development & Commercialization, Inc.v99
  3. Re-verified, no change to tracked fieldsv98
  4. Primary endpoints revised (13) Eligibility criteria expanded, about 7 words · Secondary endpoints reordered · Study arms: 1 to 3v97 Show all 4 changesShow less
    • Eligibility criteria expanded, about 7 words
    • Secondary endpoints reordered
    • Study arms: 1 to 3

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  5. Results first posted: Jan 25, 2010 Primary endpoints: 1 to 13 · Study sites: 5 to 55 · Eligibility criteria expanded, about 38 words · 1 morev96 Show all 5 changesShow less
    • Primary endpoints: 1 to 13
    • Study sites: 5 to 55
    • Eligibility criteria expanded, about 38 words
    • Secondary endpoints: 2 to 8

    See this version in full on ClinicalTrials.gov ↗

Show 45 earlier versionsHide 45 earlier versions
  1. Study sites: 23 to 5v95
  2. Re-verified, no change to tracked fieldsv94
  3. Enrollment target: estimated 300 to confirmed 330 Study sites: 24 to 23v93 Show all 2 changesShow less
    • Study sites: 24 to 23
  4. Secondary endpoints: 4 to 2v92 Show moreShow less

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  5. Enrollment target: 330 to 300 Study sites: 23 to 24v91 Show all 2 changesShow less
    • Study sites: 23 to 24
  6. Trial status: Active, Not Recruiting to Completed Enrollment target: estimated 300 to confirmed 330v90 Show all 2 changesShow less
    • Enrollment target: estimated 300 to confirmed 330
  7. Site details revised at 1 of 23 sitesv89
  8. 9 versions Re-verified since Apr 22, 2009, no change to tracked fieldsv80-v88
  9. Study sites: 27 to 23v79
  10. 2 versions Re-verified since Mar 6, 2009, no change to tracked fieldsv77-v78
  11. Study sites: 41 to 27v76
  12. 6 versions Re-verified since Dec 8, 2008, no change to tracked fieldsv70-v75
  13. Study sites: 44 to 41v69
  14. Study sites: 46 to 44v68
  15. 2 versions Re-verified since Oct 10, 2008, no change to tracked fieldsv66-v67
  16. Study sites: 48 to 46v65
  17. Re-verified, no change to tracked fieldsv64
  18. Study sites revised (48)v63 Show moreShow less

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  19. 3 versions Re-verified since Jun 27, 2008, no change to tracked fieldsv60-v62
  20. Trial status: Recruiting to Active, Not Recruiting Site details revised at 48 of 48 sitesv59 Show all 2 changesShow less
    • Site details revised at 48 of 48 sites
  21. Study sites revised (48)v58 Show moreShow less

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  22. Site details revised at 36 of 48 sitesv57
  23. Re-verified, no change to tracked fieldsv56
  24. Site contacts updated at 1 of 48 sitesv55
  25. Study sites: 55 to 48v54
  26. Study sites revised (55)v53 Show moreShow less

    See this version in full on ClinicalTrials.gov ↗

  27. Re-verified, no change to tracked fieldsv52
  28. Primary completion date: Jun 2009 Completion date: Oct 2009 to Jun 2009v51 Show all 2 changesShow less
    • Completion date: Oct 2009 to Jun 2009
  • 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 provide long-term safety data for patients who are taking aripiprazole for up to 1 year. Most patients enrolled in this study will have participated in a short-term study with aripiprazole (CN138-178 \[NCT00332241\] or CN138-179 \[NCT00337571\]).
Trial Details
NCT Number NCT00365859
Lead Sponsor Otsuka Pharmaceutical Development & Commercialization, Inc.
Collaborators: Otsuka America Pharmaceutical
Conditions Autistic Disorder, Behavioral Symptoms
Enrollment 330 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov