Status:
COMPLETED
6-Month Extension Trial of Asenapine With Olanzapine in Negative Symptom Patients Who Completed the Protocol 25543 (25544)(P05777)
Lead Sponsor:
Organon and Co
Conditions:
Schizophrenia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This is an extension study to further test the efficacy and safety of asenapine compared with a marketed agent (olanzapine) in the treatment of patients with persistent negative symptoms of schizop...
Eligibility Criteria
Inclusion
- Continue to meet all demographic and procedural
- inclusion criteria of the 25543 trial (NCT 00212836; P05817) to enter into
- this extension trial.
- Have demonstrated an acceptable
- degree of compliance and completed the 25543
- trial, and would benefit from continued treatment
- according to the investigator.
Exclusion
- Have an uncontrolled, unstable clinically significant
- medical condition.
- Have been judged to be medically
- noncompliant in the management of their disease.
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2008
Estimated Enrollment :
306 Patients enrolled
Trial Details
Trial ID
NCT00265343
Start Date
December 1 2005
End Date
January 1 2008
Last Update
February 9 2022
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