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NCT01397786 · ClinicalTrials.gov registry record · Phase 3
Safety and Tolerability Study of Oral OPC-34712 as Maintenance Treatment in Adults With Schizophrenia
A Phase 3 study, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,044
- Enrollment target
NCT01397786: Completed Phase 3 study, sponsored by Otsuka Pharmaceutical Development & Commercialization.
NCT01397786 is a Phase 3 study that has completed, run by Otsuka Pharmaceutical Development & Commercialization. The registered enrollment target is 1,044 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (35% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01397786, a Phase 3 study, has completed, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,044 participants
- Enrollment target
Study 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.
Primary Outcome
A treatment-emergent adverse event (TEAE) is defined as an AE that started after start of investigational medicinal product (IMP) treatment; or if the event was continuous from baseline and was serious, IMP-related, or resulted in death, discontinuation, interruption or reduction of IMP.
Interventions
- DRUG OPC-34712
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,044 participants |
| Start Date | 2011-09 |
| Est. Completion | 2016-01 |
| Phase | Phase 3 |
What the finished NCT01397786 record still lists
NCT01397786 is an interventional study that assigns participants to a tested intervention. Its 1,044 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (35% higher).
The record links to 0 conditions, and to 1 intervention - of which OPC-34712 is the first listed.
NCT01397786 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01397786 about?
NCT01397786 is a clinical study titled "Safety and Tolerability Study of Oral OPC-34712 as Maintenance Treatment in Adults With Schizophrenia". 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.
What is the current status of trial NCT01397786?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,044 participants. The study started on 2011-09. Estimated completion is 2016-01.
What interventions are being tested in trial NCT01397786?
The interventions under investigation include: OPC-34712 (DRUG).
Who is sponsoring clinical trial NCT01397786?
This trial is sponsored by Otsuka Pharmaceutical Development & Commercialization, which has 221 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01397786's enrollment target sits among peer trials
1,044 284th of 2000 higher than 1,717 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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