At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 244 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 Phase 2, Multicenter, Open-label Study to Assess the Safety and Tolerability of Oral OPC-34712 as Monotherapy in Adult Patients With Schizophrenia
Otsuka Pharmaceutical Development & Commercialization, Inc.·interventional·Posted Jul 25, 2012·Updated Oct 29, 2015
In Brief
A Phase 2 clinical trial evaluating OPC-34712 for Schizophrenia. Completed, enrolled 244 participants across 68 sites in 12 countries.
Detailed Summary
This will be a multicenter, 52 week, open label study to assess the safety and tolerability of oral OPC-34712 (1 to 6 mg) as monotherapy in adult patients with schizophrenia. The study will be conducted on an outpatient basis. Enrollment into the study will be drawn from eligible subjects who have completed participation in Study 331-07- 203 and who, in the investigator's judgment, would benefit from continued treatment with oral OPC-34712.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSchizophrenia
CountriesBulgaria, Croatia, India, Philippines, Romania, Russia, Serbia, Slovakia, South Korea, Taiwan, Ukraine, United States
Collaborators--
Timeline
Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartAug 2009
Primary CompletionAug 2011
Study CompletionSep 2011
First PostedJul 2012
TodayJul 2026
First PostedJul 25, 2012
Enrollment StartAug 1, 2009
Primary CompletionAug 1, 2011
Study CompletionSep 1, 2011
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 13.9 years ago
Interventions
OPC-34712drug
oral administered once daily