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NCT00706654 · ClinicalTrials.gov registry record · Phase 3
Intramuscular Depot Formulation of Aripiprazole as Maintenance Treatment in Patients With Schizophrenia
A Phase 3 study, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- Completed
- Registry status
- Phase 3
- Development phase
- 937
- Enrollment target
NCT00706654 is a Phase 3 study that has completed, run by Otsuka Pharmaceutical Development & Commercialization. The registered enrollment target is 937 participants.
The verdict
NCT00706654, a Phase 3 study, has completed, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 937 participants
- Enrollment target
Study Summary
The purpose of the this trial is to evaluate the efficacy, safety, and tolerability of an intramuscular (IM) depot formulation of aripiprazole as maintenance treatment in patients with schizophrenia The trial is designed into three treatment phases. Phase 1 is designed to allow for a subject to be converted from the current anti-psychotic treatment to oral non-generic aripiprazole monotherapy (oral conversion phase from 4 to 6 weeks). During Phase 2 the subject will be stabilized on oral non-generic aripiprazole monotherapy. Once the subject is stabilized in Phase 2 (oral stabilization phase from minimum 8 weeks to maximum 28 weeks), they are eligible to be randomized into the double-blind IM depot maintenance phase, Phase 3. During Phase 3, the subject will be assessed for exacerbation of psychotic symptoms and impending relapse for up to 38 weeks.
Interventions
- DRUG Placebo depot
- DRUG Placebo tablets
- DRUG Aripiprazole depot 300 or 400 mg
- DRUG Aripiprazole 10-30 mg orally
- DRUG Aripiprazole depot 25 or 50 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 937 participants |
| Start Date | 2008-09-01 |
| Est. Completion | 2012-08-01 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00706654
The ClinicalTrials.gov registry entry for NCT00706654 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 937 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 5 interventions - of which Placebo depot is the first listed.
NCT00706654 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00706654 about?
NCT00706654 is a clinical study titled "Intramuscular Depot Formulation of Aripiprazole as Maintenance Treatment in Patients With Schizophrenia". The purpose of the this trial is to evaluate the efficacy, safety, and tolerability of an intramuscular (IM) depot formulation of aripiprazole as maintenance treatment in patients with schizophrenia The trial is designed into three treatment phases. Phase 1 is designed to allow for a subject to be ...
What is the current status of trial NCT00706654?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 937 participants. The study started on 2008-09-01. Estimated completion is 2012-08-01.
What interventions are being tested in trial NCT00706654?
The interventions under investigation include: Placebo depot (DRUG), Placebo tablets (DRUG), Aripiprazole depot 300 or 400 mg (DRUG), Aripiprazole 10-30 mg orally (DRUG), Aripiprazole depot 25 or 50 mg (DRUG).
Who is sponsoring clinical trial NCT00706654?
This trial is sponsored by Otsuka Pharmaceutical Development & Commercialization, which has 221 total clinical trials registered on ClinicalTrials.gov.
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