At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 674 enrolled
Drug / intervention
OPC-34712 +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 Fixed-dose OPC-34712 in the Treatment of Adults With Acute Schizophrenia
Otsuka Pharmaceutical Development & Commercialization, Inc.·interventional·Posted Jul 13, 2011·Updated Nov 26, 2015
In Brief
A Phase 3 clinical trial evaluating OPC-34712 and Placebo for Acute Schizophrenia. Completed, enrolled 674 participants across 60 sites in 8 countries.
Detailed Summary
The purpose of this study is to assess the efficacy, safety, and tolerability of fixed doses of OPC-34712 versus placebo for the treatment of adult subjects with an acute relapse of schizophrenia.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Schizophrenia
CountriesColombia, Croatia, Mexico, Philippines, Russia, Slovakia, Taiwan, United States
Collaborators--
Timeline
Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
Enrollment StartJul 2011
First PostedJul 2011
Primary CompletionFeb 2014
TodayJul 2026
First PostedJul 13, 2011
Enrollment StartJul 1, 2011
Primary CompletionFeb 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 15.0 years ago
Interventions
OPC-34712drug
Higher dose tablet, once daily, for six weeks,
OPC-34712drug
Middle dose tablet, once daily, for six weeks
OPC-34712drug
Lower dose tablet, once daily, for six weeks
Placebodrug
Placebo, once daily, for six weeks