Status:
COMPLETED
9 Week Extension Study of Asenapine and Olanzapine in Treatment of Mania (P07007)(COMPLETED)
Lead Sponsor:
Organon and Co
Collaborating Sponsors:
Pfizer
Conditions:
Bipolar Disorder
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Bipolar disorder is characterized by mood swings that range from high (manic) to low (depressed) states. Sometimes, symptoms of both depression and mania are present (mixed episodes). Asenapine is an ...
Eligibility Criteria
Inclusion
- Have completed an asenapine 3-week study for the treatment of an acute manic or mixed episode and not had a major protocol violation.in the short term study (A7501004 or A7501005) that they completed.
Exclusion
- Patients with unstable medical conditions or clinically significant laboratory abnormalities.
Key Trial Info
Start Date :
January 7 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 28 2006
Estimated Enrollment :
504 Patients enrolled
Trial Details
Trial ID
NCT00143182
Start Date
January 7 2005
End Date
June 28 2006
Last Update
August 15 2024
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