At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 636 enrolled
Drug / intervention
OPC-34712 [Brexpiprazole] High Dose +3 moredrug
Likely dose
Not stated in 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.
A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Three Fixed Doses of OPC-34712 in the Treatment of Adults With Acute Schizophrenia
Otsuka Pharmaceutical Development & Commercialization, Inc.·interventional·Posted Jul 18, 2011·Updated Oct 29, 2015
In Brief
A Phase 3 clinical trial evaluating OPC-34712 [Brexpiprazole] High Dose, Experimental: OPC-34712 [Brexpiprazole] Middle Dose, and 2 other interventions for Acute Schizophrenia. Completed, enrolled 636 participants across 60 sites in 9 countries.
Detailed Summary
The purpose of this study is to compare the effectiveness, safety and tolerability of three different doses of OPC-34712 with placebo in the treatment of acute schizophrenia in adults.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Schizophrenia
CountriesCanada, Japan, Latvia, Poland, Romania, Serbia, South Korea, Ukraine, United States
Collaborators--
Timeline
Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
Enrollment StartJul 2011
First PostedJul 2011
Primary CompletionJan 2014
TodayJul 2026
First PostedJul 18, 2011
Enrollment StartJul 1, 2011
Primary CompletionJan 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 15.0 years ago
Interventions
OPC-34712 [Brexpiprazole] High Dosedrug
Higher dose, tablet, once daily, for six weeks
Experimental: OPC-34712 [Brexpiprazole] Middle Dosedrug
Middle dose, tablet, once daily, for six weeks
Experimental: OPC-34712 [Brexpiprazole] Low Dosedrug
Lower dose, tablet, once daily, for six weeks
Placebodrug
Placebo, once daily, for six weeks