At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 460 enrolled
Drug / intervention
SM-13496 (lurasidone HCl) +3 moredrug
Likely dose
SM-13496 (lurasidone HCl) 40 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.
Randomized, Placebo-controlled, Double-blind, Parallel-group, Confirmatory Study of SM-13496 (Lurasidone HCl) in Patients With Schizophrenia <Phase III Study>
In Brief
A Phase 3 clinical trial evaluating SM-13496 (lurasidone HCl), Placebo, and 1 other intervention for Schizophrenia. Completed, enrolled 460 participants across 3 sites in 3 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, South Korea, Taiwan
Collaborators--
Timeline
Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJun 2008
First PostedJul 2008
Primary CompletionApr 2010
TodayJul 2026
First PostedJul 8, 2008
Enrollment StartJun 27, 2008
Primary CompletionApr 27, 2010
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 18.0 years ago
Interventions
SM-13496 (lurasidone HCl)drug
Lurasidone HCl: 40 mg/day
SM-13496 (lurasidone HCl)drug
Lurasidone HCl: 80 mg/day
Placebodrug
Risperidonedrug