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NCT00102518 · ClinicalTrials.gov registry record · Phase 3
Aripiprazole Open-Label, Safety and Tolerability Study
A Phase 3 study, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- Completed
- Registry status
- Phase 3
- Development phase
- 325
- Enrollment target
NCT00102518: Completed Phase 3 study, sponsored by Otsuka Pharmaceutical Development & Commercialization.
NCT00102518 is a Phase 3 study that has completed, run by Otsuka Pharmaceutical Development & Commercialization. The registered enrollment target is 325 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (58% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00102518, a Phase 3 study, has completed, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 325 participants
- Enrollment target
Study Summary
The purpose of this study is to test the long-term safety and tolerability of aripiprazole in adolescent patients with schizophrenia, and child and adolescent patients with bipolar I disorder, manic or mixed episode.
Primary Outcome
Percentage of Subjects Experiencing SAEs. The incidences of SAEs are summarized by system organ class in CT-8.5.1; by system organ class and MedDRA preferred term and by system organ class, MedDRA preferred term, and severity.
Interventions
- DRUG Aripiprazole
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 325 participants |
| Start Date | 2004-09 |
| Est. Completion | 2007-02 |
| Phase | Phase 3 |
What the finished NCT00102518 record still lists
NCT00102518 is an interventional study that assigns participants to a tested intervention. The registered 325 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (58% lower).
The record links to 0 conditions, and to 1 intervention - of which Aripiprazole is the first listed.
NCT00102518 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00102518 about?
NCT00102518 is a clinical study titled "Aripiprazole Open-Label, Safety and Tolerability Study". The purpose of this study is to test the long-term safety and tolerability of aripiprazole in adolescent patients with schizophrenia, and child and adolescent patients with bipolar I disorder, manic or mixed episode.
What is the current status of trial NCT00102518?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 325 participants. The study started on 2004-09. Estimated completion is 2007-02.
What interventions are being tested in trial NCT00102518?
The interventions under investigation include: Aripiprazole (DRUG).
Who is sponsoring clinical trial NCT00102518?
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 NCT00102518's enrollment target sits among peer trials
325 1076th of 2000 higher than 922 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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