6-Month Extension Trial of Asenapine With Olanzapine in Negative Symptoms Patients Who Completed the First 6- Month Trial (A7501014)(COMPLETED)(P05772)
NCT ID: NCT00174265
Last Updated: 2022-02-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
196 participants
INTERVENTIONAL
2005-07-31
2009-05-31
Brief Summary
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the efficacy and safety of Asenapine compared with a
marketed agent (olanzapine) in the treatment of patients with
persistent negative symptoms of schizophrenia.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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asenapine
asenapine
5-10 mg sublingually twice daily for 26 weeks
olanzapine
olanzapine
5-20 mg by mouth once daily for 26 weeks
Interventions
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asenapine
5-10 mg sublingually twice daily for 26 weeks
olanzapine
5-20 mg by mouth once daily for 26 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
this extension trial.
* Have demonstrated an acceptable degree of compliance
and completed the A7501013 trial, and would benefit
from continued treatment according to the investigator.
Exclusion Criteria
medical condition.
* Have been judged to be medically noncompliant in the
management of their disease.
18 Years
ALL
No
Sponsors
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Organon and Co
INDUSTRY
Responsible Party
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References
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Buchanan RW, Panagides J, Zhao J, Phiri P, den Hollander W, Ha X, Kouassi A, Alphs L, Schooler N, Szegedi A, Cazorla P. Asenapine versus olanzapine in people with persistent negative symptoms of schizophrenia. J Clin Psychopharmacol. 2012 Feb;32(1):36-45. doi: 10.1097/JCP.0b013e31823f880a.
Other Identifiers
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Aphrodite
Identifier Type: -
Identifier Source: secondary_id
A7501014
Identifier Type: -
Identifier Source: secondary_id
P05772
Identifier Type: -
Identifier Source: org_study_id
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