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

StatusCompleted
PhasePhase 3
Started

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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 sites
    v100
  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 3
    v97
  5. Results first posted: Jan 25, 2010v96 Show 4 more changesShow less
    • Primary endpoints: 1 to 13
    • Study sites: 5 to 55
    • Eligibility criteria expanded, about 38 words
    • Secondary endpoints: 2 to 8
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 23
    v93
  4. Secondary endpoints: 4 to 2v92
  5. Enrollment target: 330 to 300
    • Study sites: 23 to 24
    v91
  6. Trial status: Active, Not Recruiting to Completed
    • Enrollment target: estimated 300 to confirmed 330
    v90
  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
  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 sites
    v59
  21. Study sites revised (48)v58
  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
  27. Re-verified, no change to tracked fieldsv52
  28. Primary completion date: Jun 2009
    • Study completion date: Oct 2009 to Jun 2009
    v51
  • 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
(from sponsor)		 Autistic Disorder, Behavioral Symptoms
Related terms Autistic Disorder, Behavioral Symptoms, Problem Behavior
Enrollment 330 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov