Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 is a Phase 3 study that has completed, run by Otsuka Pharmaceutical Development & Commercialization. The registered enrollment target is 305 participants.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04115319
The ClinicalTrials.gov registry entry for NCT04115319 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 305 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 2 interventions - of which SEP363856 is the first listed.
NCT04115319 reports 0 study locations.
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
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.