Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT00277212 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

A Phase IV Study of the Safety and Efficacy of Aripiprazole in Combination With Lamotrigine in the Long-Term Maintenance Treatment of Patients With Bipolar I Disorder With A Recent Manic or Mixed Episode

StatusCompleted
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 136 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Primary and study completion dates: Jul 2009 to Jul 1, 2009
    • Start date: Dec 2005 to Dec 1, 2005
    v136
  2. Lead sponsor: Bristol-Myers Squibb to Otsuka Pharmaceutical Development & Commercialization, Inc.v135
  3. Secondary endpoints: details revised at 2 of 16 entriesv134
  4. Results first posted: Oct 20, 2010
    • Enrollment target: 349 to 1169
    • Primary endpoint revised
    • Secondary endpoints: 3 to 16
    v133
  5. 3 versions Re-verified since Apr 13, 2010, no change to tracked fieldsv130-v132
Show 43 earlier versionsHide 43 earlier versions
  1. Study sites revised (66)v129
  2. 2 versions Re-verified since Mar 4, 2010, no change to tracked fieldsv127-v128
  3. Study sites: 1 to 66v126
  4. 5 versions Re-verified since Nov 16, 2009, no change to tracked fieldsv121-v125
  5. Study sites: 2 to 1v120
  6. Study sites: 7 to 2v119
  7. Study sites: 9 to 7v118
  8. Study sites: 15 to 9v117
  9. Re-verified, no change to tracked fieldsv116
  10. Study sites: 14 to 15v115
  11. Trial status: Active, Not Recruiting to Completed
    • Enrollment target: estimated 350 to confirmed 349
    • Study sites: 13 to 14
    v114
  12. Study sites: 16 to 13v113
  13. Study sites: 15 to 16v112
  14. Study sites: 17 to 15v111
  15. 2 versions Re-verified since May 6, 2009, no change to tracked fieldsv109-v110
  16. Study sites: 19 to 17v108
  17. Study sites: 20 to 19v107
  18. Primary and study completion dates: Aug 2009 to Jul 2009v106
  19. Study sites: 21 to 20v105
  20. Study sites: 24 to 21v104
  21. Study sites: 25 to 24
    • Primary and study completion dates: Jul 2009 to Aug 2009
    v103
  22. Study sites: 26 to 25v102
  23. 3 versions Re-verified since Dec 22, 2008, no change to tracked fieldsv99-v101
  24. Study sites: 27 to 26v98
  25. Re-verified, no change to tracked fieldsv97
  26. Study sites: 29 to 27v96
  27. Re-verified, no change to tracked fieldsv95
  28. Study sites: 31 to 29v94
  29. Enrollment target: 1170 to 350
    • Study sites: 32 to 31
    v93
  30. Study sites: 34 to 32v92
  31. Study sites: 35 to 34v91
  32. Re-verified, no change to tracked fieldsv90
  33. Study sites: 39 to 35v89
  34. Re-verified, no change to tracked fieldsv88
  35. Study sites: 43 to 39v87
  • 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.
Efficacy of Aripiprazole in Combination with Lamotrigine in the Long-Term Maintenance Treatment of Bipolar I Disorder in Outpatients with Recent Manic or Mixed Episode
Trial Details
NCT Number NCT00277212
Lead Sponsor Otsuka Pharmaceutical Development & Commercialization, Inc.
Collaborators: Otsuka America Pharmaceutical
Conditions
(from sponsor)		 Bipolar Disorder
Related terms Bipolar Disorder
Enrollment 1,169 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov