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NCT03548584 · ClinicalTrials.gov registry record · Phase 3

A Trial to Evaluate the Safety, Efficacy, and Tolerability of Brexpiprazole in Treating Agitation Associated With Dementia of the Alzheimer's Type

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

Completed
Registry status
Phase 3
Development phase
345
Enrollment target

NCT03548584 is a Phase 3 study that has completed, run by Otsuka Pharmaceutical Development & Commercialization. The registered enrollment target is 345 participants.

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The verdict

NCT03548584, a Phase 3 study, has completed, sponsored by Otsuka Pharmaceutical Development & Commercialization.

COMPLETED
Registry status
Phase 3
Development phase
345 participants
Enrollment target

Study Summary

This study compares the efficacy of 2 doses of brexpiprazole with placebo in participants with agitation associated with dementia of the Alzheimer's type.

Interventions

  • OTHER Placebo
  • DRUG Brexpiprazole

Trial Details

FieldValue
Enrollment Target 345 participants
Start Date 2018-05-16
Est. Completion 2022-06-01
Phase Phase 3

What the Registry Record Tells You About NCT03548584

The ClinicalTrials.gov registry entry for NCT03548584 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 345 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 Placebo is the first listed.

NCT03548584 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT03548584 about?

NCT03548584 is a clinical study titled "A Trial to Evaluate the Safety, Efficacy, and Tolerability of Brexpiprazole in Treating Agitation Associated With Dementia of the Alzheimer's Type". This study compares the efficacy of 2 doses of brexpiprazole with placebo in participants with agitation associated with dementia of the Alzheimer's type.

What is the current status of trial NCT03548584?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 345 participants. The study started on 2018-05-16. Estimated completion is 2022-06-01.

What interventions are being tested in trial NCT03548584?

The interventions under investigation include: Placebo (OTHER), Brexpiprazole (DRUG).

Who is sponsoring clinical trial NCT03548584?

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.