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NCT02442778 · ClinicalTrials.gov registry record · Phase 3

Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Agitation in Participants With Dementia of the Alzheimer's Type

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

Completed
Registry status
Phase 3
Development phase
522
Enrollment target

NCT02442778 is a Phase 3 study that has completed, run by Otsuka Pharmaceutical Development & Commercialization. The registered enrollment target is 522 participants.

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The verdict

NCT02442778, a Phase 3 study, has completed, sponsored by Otsuka Pharmaceutical Development & Commercialization.

COMPLETED
Registry status
Phase 3
Development phase
522 participants
Enrollment target

Study Summary

Participants with agitation secondary to dementia of the Alzheimer's type. The diagnosis of probable Alzheimer's disease (AD) will be based on the "2011 Diagnostic Guidelines for Alzheimer's Disease" issued by the National Institute on Aging (NIA)-Alzheimer's Association (AA) workgroups.

Interventions

  • DRUG Placebo
  • DRUG AVP-786-28
  • DRUG AVP-786-42.63
  • DRUG AVP-786-18

Trial Details

FieldValue
Enrollment Target 522 participants
Start Date 2015-11-11
Est. Completion 2019-09-09
Phase Phase 3

What the Registry Record Tells You About NCT02442778

The ClinicalTrials.gov registry entry for NCT02442778 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 522 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 4 interventions - of which Placebo is the first listed.

NCT02442778 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT02442778 about?

NCT02442778 is a clinical study titled "Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Agitation in Participants With Dementia of the Alzheimer's Type". Participants with agitation secondary to dementia of the Alzheimer's type. The diagnosis of probable Alzheimer's disease (AD) will be based on the "2011 Diagnostic Guidelines for Alzheimer's Disease" issued by the National Institute on Aging (NIA)-Alzheimer's Association (AA) workgroups.

What is the current status of trial NCT02442778?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 522 participants. The study started on 2015-11-11. Estimated completion is 2019-09-09.

What interventions are being tested in trial NCT02442778?

The interventions under investigation include: Placebo (DRUG), AVP-786-28 (DRUG), AVP-786-42.63 (DRUG), AVP-786-18 (DRUG).

Who is sponsoring clinical trial NCT02442778?

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.