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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 is a Phase 3 study that has completed, run by Otsuka Pharmaceutical Development & Commercialization. The registered enrollment target is 381 participants.
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.
Interventions
- DRUG Brexpiprazole
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 381 participants |
| Start Date | 2017-10-24 |
| Est. Completion | 2019-07-31 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03287869
The ClinicalTrials.gov registry entry for NCT03287869 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 381 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 1 intervention - of which Brexpiprazole is the first listed.
NCT03287869 reports 0 study locations.
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.
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