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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 is a Phase 2 study that has completed, run by Otsuka Pharmaceutical Development & Commercialization. The registered enrollment target is 459 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00905307
The ClinicalTrials.gov registry entry for NCT00905307 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 459 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Otsuka Pharmaceutical Development & Commercialization, which has 221 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT00905307 reports 0 study locations.
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.
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