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NCT01396421 · ClinicalTrials.gov registry record · Phase 3

Study of the Effectiveness of Three Different Doses of OPC-34712 in the Treatment of Adults With Acute Schizophrenia

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

Completed
Registry status
Phase 3
Development phase
636
Enrollment target
20
Study locations

NCT01396421 is a Phase 3 study of Acute Schizophrenia that has completed, run by Otsuka Pharmaceutical Development & Commercialization. The registered enrollment target is 636 participants. The trial reports 20 study locations across 9 states.

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The verdict

NCT01396421, a Phase 3 study of Acute Schizophrenia, has completed, sponsored by Otsuka Pharmaceutical Development & Commercialization.

COMPLETED
Registry status
Phase 3
Development phase
636 participants
Enrollment target
20
Study locations

Study Summary

The purpose of this study is to compare the effectiveness, safety and tolerability of three different doses of OPC-34712 with placebo in the treatment of acute schizophrenia in adults.

Conditions Studied

Interventions

  • DRUG Placebo
  • DRUG OPC-34712 [Brexpiprazole] High Dose
  • DRUG Experimental: OPC-34712 [Brexpiprazole] Middle Dose
  • DRUG Experimental: OPC-34712 [Brexpiprazole] Low Dose

Study Locations (20)

California

  • - Garden Grove
  • - Glendale
  • - Oakland
  • - Oceanside
  • - San Diego
  • - San Diego

Florida

  • - Bradenton
  • - Miami Springs
  • - Orlando

Ontario

  • - Burlington
  • - Chatham
  • - Chatham

New York

  • - Fresh Meadows
  • - Jamaica

South Carolina

  • - Charleston
  • - Charleston

Arkansas

  • - Little Rock

Ohio

  • - Dayton

Texas

  • - Austin

Trial Details

FieldValue
Enrollment Target 636 participants
Start Date 2011-07
Est. Completion 2014-01
Phase Phase 3

What the Registry Record Tells You About NCT01396421

The ClinicalTrials.gov registry entry for NCT01396421 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 636 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 1 condition, with Acute Schizophrenia appearing as the primary indexed condition, and to 4 interventions - of which Placebo is the first listed.

NCT01396421 reports 20 study locations spanning 9 distinct geographic areas - top geographies include California, Florida, Ontario.

Frequently Asked Questions

What is clinical trial NCT01396421 about?

NCT01396421 is a clinical study titled "Study of the Effectiveness of Three Different Doses of OPC-34712 in the Treatment of Adults With Acute Schizophrenia". The purpose of this study is to compare the effectiveness, safety and tolerability of three different doses of OPC-34712 with placebo in the treatment of acute schizophrenia in adults.

What is the current status of trial NCT01396421?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 636 participants. The study started on 2011-07. Estimated completion is 2014-01.

What conditions does trial NCT01396421 study?

This clinical trial studies the following conditions: Acute Schizophrenia.

What interventions are being tested in trial NCT01396421?

The interventions under investigation include: Placebo (DRUG), OPC-34712 [Brexpiprazole] High Dose (DRUG), Experimental: OPC-34712 [Brexpiprazole] Middle Dose (DRUG), Experimental: OPC-34712 [Brexpiprazole] Low Dose (DRUG).

Who is sponsoring clinical trial NCT01396421?

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

Where is trial NCT01396421 being conducted?

This trial has 20 study locations across Arkansas, California, Florida, New York, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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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.