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NCT04092686 · ClinicalTrials.gov registry record · Phase 3

A Clinical Trial That Will Study the Efficacy and Safety of an Investigational Drug in Acutely Psychotic People With Schizophrenia

A Phase 3 study, sponsored by Otsuka Pharmaceutical Development & Commercialization.

Completed
Registry status
Phase 3
Development phase
464
Enrollment target

NCT04092686 is a Phase 3 study that has completed, run by Otsuka Pharmaceutical Development & Commercialization. The registered enrollment target is 464 participants.

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The verdict

NCT04092686, a Phase 3 study, has completed, sponsored by Otsuka Pharmaceutical Development & Commercialization.

COMPLETED
Registry status
Phase 3
Development phase
464 participants
Enrollment target

Study Summary

A clinical trial to study the efficacy and safety of an investigational drug in acutely psychotic people with schizophrenia. Participants in the study will either receive the drug being studied or a placebo. This study is accepting male and female participants between 18 -65 years old who have been diagnosed with schizophrenia. This study will be conducted in 60 locations world wide. The study will last up to nine (9) weeks.

Interventions

  • DRUG Placebo
  • DRUG SEP-363856 75mg
  • DRUG SEP-363856 100mg

Trial Details

FieldValue
Enrollment Target 464 participants
Start Date 2019-10-14
Est. Completion 2023-06-14
Phase Phase 3

What the Registry Record Tells You About NCT04092686

The ClinicalTrials.gov registry entry for NCT04092686 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 464 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 3 interventions - of which Placebo is the first listed.

NCT04092686 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT04092686 about?

NCT04092686 is a clinical study titled "A Clinical Trial That Will Study the Efficacy and Safety of an Investigational Drug in Acutely Psychotic People With Schizophrenia". A clinical trial to study the efficacy and safety of an investigational drug in acutely psychotic people with schizophrenia. Participants in the study will either receive the drug being studied or a placebo. This study is accepting male and female participants between 18 -65 years old who have been ...

What is the current status of trial NCT04092686?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 464 participants. The study started on 2019-10-14. Estimated completion is 2023-06-14.

What interventions are being tested in trial NCT04092686?

The interventions under investigation include: Placebo (DRUG), SEP-363856 75mg (DRUG), SEP-363856 100mg (DRUG).

Who is sponsoring clinical trial NCT04092686?

This trial is sponsored by Otsuka Pharmaceutical Development & Commercialization, which has 221 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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.