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NCT03287869 · ClinicalTrials.gov registry record · Phase 3
A Trial to Evaluate the Safety and Tolerability of Brexpiprazole in the Treatment of Participants With Bipolar I Disorder.
A Phase 3 study, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- Completed
- Registry status
- Phase 3
- Development phase
- 381
- Enrollment target
NCT03287869: Completed Phase 3 study, sponsored by Otsuka Pharmaceutical Development & Commercialization.
NCT03287869 is a Phase 3 study that has completed, run by Otsuka Pharmaceutical Development & Commercialization. The registered enrollment target is 381 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (51% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03287869, a Phase 3 study, has completed, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 381 participants
- Enrollment target
Study Summary
This study evaluated the safety and evaluate the safety and tolerability of open-label brexpiprazole (2 - 4 mg/day, with a starting dose of 2 mg/day) for the treatment of adult subjects with bipolar I disorder. All participants received a starting dose of brexpiprazole.
Primary Outcome
An adverse event (AE) was defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A TEAE is defined as an adverse event with an onset
Interventions
- DRUG Brexpiprazole
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 381 participants |
| Start Date | 2017-10-24 |
| Est. Completion | 2019-07-31 |
| Phase | Phase 3 |
What the finished NCT03287869 record still lists
NCT03287869 is an interventional study that assigns participants to a tested intervention. The registered 381 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 (51% lower).
The record links to 0 conditions, and to 1 intervention - of which Brexpiprazole is the first listed.
NCT03287869 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03287869 about?
NCT03287869 is a clinical study titled "A Trial to Evaluate the Safety and Tolerability of Brexpiprazole in the Treatment of Participants With Bipolar I Disorder.". This study evaluated the safety and evaluate the safety and tolerability of open-label brexpiprazole (2 - 4 mg/day, with a starting dose of 2 mg/day) for the treatment of adult subjects with bipolar I disorder. All participants received a starting dose of brexpiprazole.
What is the current status of trial NCT03287869?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 381 participants. The study started on 2017-10-24. Estimated completion is 2019-07-31.
What interventions are being tested in trial NCT03287869?
The interventions under investigation include: Brexpiprazole (DRUG).
Who is sponsoring clinical trial NCT03287869?
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 NCT03287869's enrollment target sits among peer trials
381 982nd of 2000 higher than 1,018 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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