At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 1,044 enrolled
Drug / intervention
OPC-34712drug
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 Long-term, Phase 3, Multicenter, Open-label Trial to Evaluate the Safety and Tolerability of Oral OPC-34712 as Maintenance Treatment in Adults With Schizophrenia
Otsuka Pharmaceutical Development & Commercialization, Inc.·interventional·Posted Jul 20, 2011·Updated May 10, 2017
In Brief
A Phase 3 clinical trial evaluating OPC-34712 for Schizophrenia. Completed, enrolled 1,044 participants across 148 sites in 19 countries.
Detailed Summary
The purpose of this study is to assess the long-term safety, tolerability and efficacy of oral OPC-34712 as monotherapy in adults with schizophrenia.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSchizophrenia
CountriesCanada, Colombia, Croatia, Japan, Latvia, Malaysia, Mexico, Philippines, Poland, Puerto Rico, Romania, Russia, Serbia, Slovakia, South Korea, Taiwan, Turkey (Türkiye), Ukraine, United States
Collaborators--
Timeline
Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJul 2011
Enrollment StartSep 2011
Primary CompletionJan 2016
TodayJul 2026
First PostedJul 20, 2011
Enrollment StartSep 1, 2011
Primary CompletionJan 1, 2016
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 15.0 years ago
Interventions
OPC-34712drug
Phase A: 1-2 mgs/day by mouth, max of 4 wks. Phase B: 1-4 mgs/day by mouth, up to 52 weeks