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NCT04072354 · ClinicalTrials.gov registry record · Phase 3

A Clinical Trial to 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
463
Enrollment target

NCT04072354 is a Phase 3 study that has completed, run by Otsuka Pharmaceutical Development & Commercialization. The registered enrollment target is 463 participants.

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The verdict

NCT04072354, a Phase 3 study, has completed, sponsored by Otsuka Pharmaceutical Development & Commercialization.

COMPLETED
Registry status
Phase 3
Development phase
463 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 13 years old -65 years old who have been diagnosed with schizophrenia.

Interventions

  • DRUG Placebo
  • DRUG SEP-363856 75mg
  • DRUG SEP-363856 50mg

Trial Details

FieldValue
Enrollment Target 463 participants
Start Date 2019-09-17
Est. Completion 2023-09-12
Phase Phase 3

What the Registry Record Tells You About NCT04072354

The ClinicalTrials.gov registry entry for NCT04072354 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 463 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.

NCT04072354 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT04072354 about?

NCT04072354 is a clinical study titled "A Clinical Trial to 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 13 years old -65 years old who ...

What is the current status of trial NCT04072354?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 463 participants. The study started on 2019-09-17. Estimated completion is 2023-09-12.

What interventions are being tested in trial NCT04072354?

The interventions under investigation include: Placebo (DRUG), SEP-363856 75mg (DRUG), SEP-363856 50mg (DRUG).

Who is sponsoring clinical trial NCT04072354?

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.