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NCT01649557 · ClinicalTrials.gov registry record · Phase 2
Multicenter, Open-label, Safety and Tolerability Study
A Phase 2 study of Schizophrenia, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- Completed
- Registry status
- Phase 2
- Development phase
- 244
- Enrollment target
- 20
- Study locations
NCT01649557: Completed Phase 2 study of Schizophrenia, sponsored by Otsuka Pharmaceutical Development & Commercialization.
NCT01649557 is a Phase 2 study of Schizophrenia that has completed, run by Otsuka Pharmaceutical Development & Commercialization. The registered enrollment target is 244 participants, above the 218-participant average among 315 other Schizophrenia trials with a reported enrollment target (12% higher). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01649557, a Phase 2 study of Schizophrenia, has completed, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 244 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
AE was defined as any new medical problem, or exacerbation of an existing problem, experienced by a participant while enrolled in the trial, whether or not it was considered drug related by the investigator. A serious adverse event (SAE) was any untoward medical occurrence that resulted in death or was life-threatening or required inpatient hospitalization or prolonged hospitalization. A treatment-emergent AE (TEAE) was defined as an AE that started after start of study medication or an AE that
Conditions Studied
Interventions
- DRUG OPC-34712
Study Locations (20)
California
- Otsuka Investigational Site - Escondido
- Otsuka Investigational Site - Garden Grove
- Otsuka Investigational Site - Long Beach
- Otsuka Investigational Site - Oceanside
- Otsuka Investigational Site - Pasadena
- Otsuka Investigational Site - San Diego
- Otsuka Investigational Site - San Diego
- Otsuka Investigational Site - Santa Ana
Other
- Otsuka Investigational Site - Burgas
- Otsuka Investigational Site - Kazanlak
- Otsuka Investigational Site - Pazardzhik
- Otsuka Investigational Site - Plovdiv
Florida
- Otsuka Investigational Site - Bradenton
- Otsuka Investigational Site - Maitland
Arkansas
- Otsuka Investigational Site - Little Rock
District of Columbia
- Otsuka Investigational Site - Washington D.C.
Missouri
- Otsuka Investigational Site - St Louis
New York
- Otsuka Investigational Site - Cedarhurst
Pennsylvania
- Otsuka Investigational Site - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 244 participants |
| Start Date | 2009-08 |
| Est. Completion | 2011-09 |
| Phase | Phase 2 |
What the finished NCT01649557 record still lists
NCT01649557 is an interventional study that assigns participants to a tested intervention. The registered 244 participants enrollment target is mid-sized for trials with a published cap, above the 218-participant average among 315 other Schizophrenia trials with a reported enrollment target (12% higher).
The record links to 1 condition, with Schizophrenia appearing as the primary indexed condition, and to 1 intervention - of which OPC-34712 is the first listed.
NCT01649557 names 20 study sites across 9 states, led by California, Other, Florida.
Frequently Asked Questions
What is clinical trial NCT01649557 about?
NCT01649557 is a clinical study titled "Multicenter, Open-label, Safety and Tolerability Study". 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 c...
What is the current status of trial NCT01649557?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 244 participants. The study started on 2009-08. Estimated completion is 2011-09.
What conditions does trial NCT01649557 study?
This clinical trial studies the following conditions: Schizophrenia.
What interventions are being tested in trial NCT01649557?
The interventions under investigation include: OPC-34712 (DRUG).
Who is sponsoring clinical trial NCT01649557?
This trial is sponsored by Otsuka Pharmaceutical Development & Commercialization, which has 221 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01649557 being conducted?
This trial has 20 study locations across Arkansas, California, District of Columbia, Florida, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Schizophrenia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01649557's enrollment target sits among peer trials
244 78th of 315 higher than 237 of 315 other Schizophrenia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Schizophrenia 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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