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NCT01393613 · ClinicalTrials.gov registry record · Phase 3

Efficacy Study of OPC-34712 in Adults With Acute Schizophrenia

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

Completed
Registry status
Phase 3
Development phase
674
Enrollment target
20
Study locations

NCT01393613 is a Phase 3 study of Acute Schizophrenia that has completed, run by Otsuka Pharmaceutical Development & Commercialization. The registered enrollment target is 674 participants. The trial reports 20 study locations across 11 states.

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The verdict

NCT01393613, a Phase 3 study of Acute Schizophrenia, has completed, sponsored by Otsuka Pharmaceutical Development & Commercialization.

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

Study Summary

The purpose of this study is to assess the efficacy, safety, and tolerability of fixed doses of OPC-34712 versus placebo for the treatment of adult subjects with an acute relapse of schizophrenia.

Conditions Studied

Interventions

  • DRUG Placebo
  • DRUG OPC-34712

Study Locations (20)

California

  • - Escondido
  • - Long Beach
  • - Orange
  • - Pico Rivera
  • - San Diego

Texas

  • - Austin
  • - Dallas
  • - Houston

Arkansas

  • - Little Rock
  • - Springdale

Florida

  • - North Miami
  • - North Miami

Louisiana

  • - Lake Charles
  • - Shreveport

Kansas

  • - Overland Park

Mississippi

  • - Flowood

Missouri

  • - St Louis

Trial Details

FieldValue
Enrollment Target 674 participants
Start Date 2011-07
Est. Completion 2014-02
Phase Phase 3

What the Registry Record Tells You About NCT01393613

The ClinicalTrials.gov registry entry for NCT01393613 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 674 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 2 interventions - of which Placebo is the first listed.

NCT01393613 reports 20 study locations spanning 11 distinct geographic areas - top geographies include California, Texas, Arkansas.

Frequently Asked Questions

What is clinical trial NCT01393613 about?

NCT01393613 is a clinical study titled "Efficacy Study of OPC-34712 in Adults With Acute Schizophrenia". The purpose of this study is to assess the efficacy, safety, and tolerability of fixed doses of OPC-34712 versus placebo for the treatment of adult subjects with an acute relapse of schizophrenia.

What is the current status of trial NCT01393613?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 674 participants. The study started on 2011-07. Estimated completion is 2014-02.

What conditions does trial NCT01393613 study?

This clinical trial studies the following conditions: Acute Schizophrenia.

What interventions are being tested in trial NCT01393613?

The interventions under investigation include: Placebo (DRUG), OPC-34712 (DRUG).

Who is sponsoring clinical trial NCT01393613?

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

Where is trial NCT01393613 being conducted?

This trial has 20 study locations across Arkansas, California, Florida, Kansas, Louisiana. 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.