At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 157 enrolled
Drug / intervention
Asenapinedrug
Likely dose
Asenapine 5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Long-term Study of Asenapine in Subjects With Residual Subtype, Receiving Multiple or/and High Dose Drugs, or Treatment Refractory Schizophrenia (Protocol P06238)
In Brief
A Phase 3 clinical trial evaluating Asenapine for Schizophrenia. Completed, enrolled 157 participants.
Detailed Summary
This is a multi-site, open-label fixed-flexible dose long-term study of asenapine in participants with schizophrenia. Participants in this study consist of schizophrenia with residual subtype or receiving high dose/multiple antipsychotic drugs, treatment refractory, or elderly participants with schizophrenia. The treatment period is up to 52 weeks.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSchizophrenia
Countries--
Collaborators--
Timeline
Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedNov 2010
Enrollment StartApr 2011
Primary CompletionAug 2014
TodayJul 2026
First PostedNov 19, 2010
Enrollment StartApr 5, 2011
Primary CompletionAug 21, 2014
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 15.6 years ago
Interventions
Asenapinedrug
5 mg or 10 mg fast-dissolving sublingual tablets BID for up to 52 weeks