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A Switch Study of BMS-337039 in Schizophrenic Out-patients

StatusCompleted
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 54 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Primary and study completion dates: Apr 2007 to Apr 1, 2007 Start date: Jun 2005 to Jun 1, 2005 · Secondary endpoints: details revised at 1 of 1 entry · Site details revised at 8 of 72 sitesv54 Show all 4 changesShow less
    • Start date: Jun 2005 to Jun 1, 2005
    • Secondary endpoints: details revised at 1 of 1 entry
    • Site details revised at 8 of 72 sites
  2. Lead sponsor: Bristol-Myers Squibb to Otsuka Pharmaceutical Development & Commercialization, Inc.v53
  3. Primary and study completion dates: Apr 2007v52
  4. Re-verified, no change to tracked fieldsv51
  5. Interventions: Aripiprazole (Drug) to Aripiprazole (Drug), Aripiprazole (Drug) Study arms: 0 to 2v50 Show all 2 changesShow less
    • Study arms: 0 to 2
Show 45 earlier versionsHide 45 earlier versions
  1. 2 versions Re-verified since Dec 20, 2007, no change to tracked fieldsv48-v49
  2. Trial status: Active, Not Recruiting to Completedv47
  3. 2 versions Re-verified since Jul 31, 2007, no change to tracked fieldsv45-v46
  4. Trial status: Recruiting to Active, Not Recruiting Study sites: 83 to 72v44 Show all 2 changesShow less
    • Study sites: 83 to 72
  5. Site details revised at 1 of 83 sitesv43
  6. Site details revised at 1 of 83 sitesv42
  7. Site details revised at 1 of 83 sitesv41
  8. Site details revised at 1 of 83 sitesv40
  9. Site details revised at 3 of 83 sitesv39
  10. Site details revised at 1 of 83 sitesv38
  11. Site details revised at 1 of 83 sitesv37
  12. Site details revised at 1 of 83 sitesv36
  13. Site details revised at 3 of 83 sitesv35
  14. Site details revised at 1 of 83 sitesv34
  15. Site details revised at 1 of 83 sitesv33
  16. Site details revised at 3 of 83 sitesv32
  17. Site details revised at 2 of 83 sitesv31
  18. Study sites: 81 to 83v30
  19. Site details revised at 1 of 81 sitesv29
  20. Site details revised at 3 of 81 sitesv28
  21. Site details revised at 1 of 81 sitesv27
  22. Study sites: 83 to 81v26
  23. Study sites: 84 to 83v25
  24. Enrollment target: 500 to 450 Site details revised at 5 of 84 sitesv24 Show all 2 changesShow less
    • Site details revised at 5 of 84 sites
  25. Site details revised at 1 of 84 sitesv23
  26. Site details revised at 1 of 84 sitesv22
  27. Site details revised at 1 of 84 sitesv21
  28. Study sites: 82 to 84v20
  29. Site details revised at 3 of 82 sitesv19
  30. Site details revised at 2 of 82 sitesv18
  31. Study sites: 80 to 82v17
  32. Site details revised at 7 of 80 sitesv16
  33. Study sites: 77 to 80v15
  34. Site details revised at 2 of 77 sitesv14
  35. Study sites: 76 to 77v13
  36. Study sites: 78 to 76v12
  37. Site details revised at 1 of 78 sites Study title shortened, about 2 wordsv11 Show all 2 changesShow less
    • Study title shortened, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  38. Study sites: 80 to 78v10
  39. Study sites: 82 to 80v9
  40. Study sites: 80 to 82v8
  41. Site details revised at 1 of 80 sitesv7
  42. Study sites: 77 to 80v6
  43. Study sites: 76 to 77v5
  • 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.
The purpose of this clinical research study is to evaluate the safety and tolerability of two switching strategies from risperidone to aripiprazole over a period of 12 weeks in out-patients who are treated in a general psychiatric practice setting and who are currently experiencing efficacy and/or safety/tolerability issues while on risperidone.
Trial Details
NCT Number NCT00232687
Lead Sponsor Otsuka Pharmaceutical Development & Commercialization, Inc.
Collaborators: Otsuka America Pharmaceutical
Conditions Schizophrenia
Enrollment 450 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov