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NCT04115319 · ClinicalTrials.gov registry record · Phase 3
A Study of the Long-term Safety and Tolerability of an Investigational Drug in People With Schizophrenia.
A Phase 3 study, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- Completed
- Registry status
- Phase 3
- Development phase
- 305
- Enrollment target
NCT04115319: Completed Phase 3 study, sponsored by Otsuka Pharmaceutical Development & Commercialization.
NCT04115319 is a Phase 3 study that has completed, run by Otsuka Pharmaceutical Development & Commercialization. The registered enrollment target is 305 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04115319, a Phase 3 study, has completed, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 305 participants
- Enrollment target
Study Summary
A clinical study to evaluate the long-term safety and tolerability of an investigational drug in people with schizophrenia. This study is accepting male and female participants between 18 years old -65 years old who have been diagnosed with schizophrenia. This study will be conducted in approximately 50 study centers worldwide. The study will last approximately 57 weeks.
Primary Outcome
An AE was any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Untoward medical occurrences that occured after first administration of study drug were considered AEs. A SAE is an AE that meets one or more criteria: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, or is a congenital anomaly or birth defect.
Interventions
- DRUG SEP363856
- DRUG quetiapine XR
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 305 participants |
| Start Date | 2019-11-21 |
| Est. Completion | 2022-12-30 |
| Phase | Phase 3 |
What the finished NCT04115319 record still lists
NCT04115319 is an interventional study that assigns participants to a tested intervention. The registered 305 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 (60% lower).
The record links to 0 conditions, and to 2 interventions - of which SEP363856 is the first listed.
NCT04115319 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04115319 about?
NCT04115319 is a clinical study titled "A Study of the Long-term Safety and Tolerability of an Investigational Drug in People With Schizophrenia.". A clinical study to evaluate the long-term safety and tolerability of an investigational drug in people with schizophrenia. This study is accepting male and female participants between 18 years old -65 years old who have been diagnosed with schizophrenia. This study will be conducted in approximate...
What is the current status of trial NCT04115319?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 305 participants. The study started on 2019-11-21. Estimated completion is 2022-12-30.
What interventions are being tested in trial NCT04115319?
The interventions under investigation include: SEP363856 (DRUG), quetiapine XR (DRUG).
Who is sponsoring clinical trial NCT04115319?
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 NCT04115319's enrollment target sits among peer trials
305 1117th of 2000 higher than 884 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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