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NCT00905307 · ClinicalTrials.gov registry record · Phase 2
Study to Evaluate the Efficacy, Safety, and Tolerability of Oral OPC-34712 and Aripiprazole for Treatment of Acute Schizophrenia
A Phase 2 study, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- Completed
- Registry status
- Phase 2
- Development phase
- 459
- Enrollment target
NCT00905307: Completed Phase 2 study, sponsored by Otsuka Pharmaceutical Development & Commercialization.
NCT00905307 is a Phase 2 study that has completed, run by Otsuka Pharmaceutical Development & Commercialization. The registered enrollment target is 459 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (245% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00905307, a Phase 2 study, has completed, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 459 participants
- Enrollment target
Study Summary
This will be a multicenter, randomized, double-blind, placebo-controlled study designed to assess the tolerability, safety, and efficacy of OPC-34712 (0.25 to 6.0 mg) for the treatment of adult subjects hospitalized with an acute relapse of schizophrenia. Aripiprazole (10 to 20 mg) is included as a positive control to confirm the assay sensitivity of the study. A total of approximately 563 subjects will be screened at an estimated 75 sites worldwide in order to obtain approximately 450 randomized subjects.
Primary Outcome
The PANSS consists of three subscales containing a total of 30 symptom constructs. For each symptom construct, severity is rated on a 7-point scale, with a score of 1 indicating absence of symptoms and a score of 7 indicating extremely severe symptoms. PANSS total score is the sum of the rating scores for 7 positive scale items, 7 negative scale items and 16 general psychopathology scale items from the PANSS panel. The PANSS total score ranges from 30-210, with higher scores indicating more seve
Interventions
- DRUG Placebo
- DRUG Aripiprazole
- DRUG OPC-34712
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 459 participants |
| Start Date | 2009-07 |
| Est. Completion | 2010-11 |
| Phase | Phase 2 |
What the finished NCT00905307 record still lists
NCT00905307 is an interventional study that assigns participants to a tested intervention. The registered 459 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (245% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT00905307 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00905307 about?
NCT00905307 is a clinical study titled "Study to Evaluate the Efficacy, Safety, and Tolerability of Oral OPC-34712 and Aripiprazole for Treatment of Acute Schizophrenia". This will be a multicenter, randomized, double-blind, placebo-controlled study designed to assess the tolerability, safety, and efficacy of OPC-34712 (0.25 to 6.0 mg) for the treatment of adult subjects hospitalized with an acute relapse of schizophrenia. Aripiprazole (10 to 20 mg) is included as a ...
What is the current status of trial NCT00905307?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 459 participants. The study started on 2009-07. Estimated completion is 2010-11.
What interventions are being tested in trial NCT00905307?
The interventions under investigation include: Placebo (DRUG), Aripiprazole (DRUG), OPC-34712 (DRUG).
Who is sponsoring clinical trial NCT00905307?
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 NCT00905307's enrollment target sits among peer trials
459 84th of 2000 higher than 1,917 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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