At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 457 enrolled
Drug / intervention
SM-13496 40mg +2 moredrug
Likely dose
SM-13496 40mgfrom 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.
Randomized, Double-blind, Parallel- Group, Placebo-controlled, Confirmatory Study of SM-13496 (Lurasidone HCl) in Patients With Schizophrenia <Phase 3>
In Brief
A Phase 3 clinical trial evaluating SM-13496 40mg, SM-13496 80mg, and 1 other intervention for Schizophrenia. Completed, enrolled 457 participants across 4 sites in 4 countries.
Detailed Summary
The study evaluates the efficacy and safety of SM-13496 compared with placebo in patients with schizophrenia.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSchizophrenia
CountriesJapan, Malaysia, South Korea, Taiwan
Collaborators--
Timeline
Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJun 2012
Enrollment StartJul 2012
Primary CompletionNov 2014
TodayJul 2026
First PostedJun 8, 2012
Enrollment StartJul 2, 2012
Primary CompletionNov 17, 2014
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 14.1 years ago
Interventions
SM-13496 40mgdrug
once daily orally
SM-13496 80mgdrug
once daily orally
Placebodrug
once daily orally