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NCT03238326 · ClinicalTrials.gov registry record · Phase 3
Safety and Tolerability of Open-Label Flexible-dose Brexpiprazole as Maintenance Treatment in Adolescents With Schizophrenia
A Phase 3 study, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- Completed
- Registry status
- Phase 3
- Development phase
- 295
- Enrollment target
NCT03238326: Completed Phase 3 study, sponsored by Otsuka Pharmaceutical Development & Commercialization.
NCT03238326 is a Phase 3 study that has completed, run by Otsuka Pharmaceutical Development & Commercialization. The registered enrollment target is 295 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (62% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03238326, a Phase 3 study, has completed, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 295 participants
- Enrollment target
Study Summary
To further characterize the long-term safety and tolerability of brexpiprazole in adolescents with schizophrenia
Primary Outcome
An AE is defined as any untoward medical occurrence in a clinical trial participant administered a medicinal product and which does not necessarily have a causal relationship with the study treatment.
Interventions
- DRUG Brexpiprazole
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 295 participants |
| Start Date | 2017-08-23 |
| Est. Completion | 2025-04-22 |
| Phase | Phase 3 |
What the finished NCT03238326 record still lists
NCT03238326 is an interventional study that assigns participants to a tested intervention. The registered 295 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 (62% lower).
The record links to 0 conditions, and to 1 intervention - of which Brexpiprazole is the first listed.
NCT03238326 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03238326 about?
NCT03238326 is a clinical study titled "Safety and Tolerability of Open-Label Flexible-dose Brexpiprazole as Maintenance Treatment in Adolescents With Schizophrenia". To further characterize the long-term safety and tolerability of brexpiprazole in adolescents with schizophrenia
What is the current status of trial NCT03238326?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 295 participants. The study started on 2017-08-23. Estimated completion is 2025-04-22.
What interventions are being tested in trial NCT03238326?
The interventions under investigation include: Brexpiprazole (DRUG).
Who is sponsoring clinical trial NCT03238326?
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 NCT03238326's enrollment target sits among peer trials
295 1166th of 2000 higher than 835 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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