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NCT00110461 · ClinicalTrials.gov registry record · Phase 3
Aripiprazole in Children and Adolescents With Bipolar I Disorder
A Phase 3 study, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- Completed
- Registry status
- Phase 3
- Development phase
- 296
- Enrollment target
NCT00110461 is a Phase 3 study that has completed, run by Otsuka Pharmaceutical Development & Commercialization. The registered enrollment target is 296 participants.
The verdict
NCT00110461, a Phase 3 study, has completed, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 296 participants
- Enrollment target
Study Summary
The purpose of this trial is to test the safety and efficacy of two doses of aripiprazole in child and adolescent patients with bipolar I disorder, manic or mixed episode with or without psychotic features.
Interventions
- DRUG placebo
- DRUG Aripiprazole
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 296 participants |
| Start Date | 2005-03 |
| Est. Completion | 2007-02 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00110461
The ClinicalTrials.gov registry entry for NCT00110461 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 296 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 2 interventions - of which placebo is the first listed.
NCT00110461 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00110461 about?
NCT00110461 is a clinical study titled "Aripiprazole in Children and Adolescents With Bipolar I Disorder". The purpose of this trial is to test the safety and efficacy of two doses of aripiprazole in child and adolescent patients with bipolar I disorder, manic or mixed episode with or without psychotic features.
What is the current status of trial NCT00110461?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 296 participants. The study started on 2005-03. Estimated completion is 2007-02.
What interventions are being tested in trial NCT00110461?
The interventions under investigation include: placebo (DRUG), Aripiprazole (DRUG).
Who is sponsoring clinical trial NCT00110461?
This trial is sponsored by Otsuka Pharmaceutical Development & Commercialization, which has 221 total clinical trials registered on ClinicalTrials.gov.
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