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NCT01074294 · ClinicalTrials.gov registry record · Phase 2

Study of the Safety and Efficacy of OPC-34712 as a Complementary Therapy in the Treatment of Adult Attention Deficit/Hyperactivity Disorder

A Phase 2 study of Attention Deficit Hyperactivity Disorder, sponsored by Otsuka Pharmaceutical Development & Commercialization.

Completed
Registry status
Phase 2
Development phase
740
Enrollment target
20
Study locations

NCT01074294 is a Phase 2 study of Attention Deficit Hyperactivity Disorder that has completed, run by Otsuka Pharmaceutical Development & Commercialization. The registered enrollment target is 740 participants, above the 198-participant average among 88 other Attention Deficit Hyperactivity Disorder trials with a reported enrollment target (274% higher). The trial reports 20 study locations across 10 states.

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The verdict

NCT01074294, a Phase 2 study of Attention Deficit Hyperactivity Disorder, has completed, sponsored by Otsuka Pharmaceutical Development & Commercialization.

COMPLETED
Registry status
Phase 2
Development phase
740 participants
Enrollment target
20
Study locations

Study Summary

This study tests the effects of an investigational antipsychotic drug (called OPC-34712) in adults with attention deficit hyperactivity disorder (ADHD) when taken with an approved stimulant medication to explore a possible impact on sleep, quality of life and cognitive function.

Interventions

  • DRUG Placebo
  • DRUG OPDC-34712
  • DRUG Stimulant Therapy

Study Locations (20)

Florida

  • - Bradenton
  • - Jacksonville
  • - Maitland
  • - North Miami
  • - Orlando
  • - South Miami

California

  • - Beverly Hills
  • - Irvine
  • - Pasadena
  • - San Francisco

Georgia

  • - Atlanta
  • - Smyrna

New Jersey

  • - Cherry Hill
  • - Willingboro

Arkansas

  • - Little Rock

Indiana

  • - Indianapolis

Kansas

  • - Overland Park

Michigan

  • - Rochester Hills

Trial Details

FieldValue
Enrollment Target 740 participants
Start Date 2010-03-16
Est. Completion 2011-06-20
Phase Phase 2

What the Registry Record Tells You About NCT01074294

The ClinicalTrials.gov registry entry for NCT01074294 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 740 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 198-participant average among 88 other Attention Deficit Hyperactivity Disorder trials with a reported enrollment target (274% higher). 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 Attention Deficit Hyperactivity Disorder appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.

NCT01074294 reports 20 study locations spanning 10 distinct geographic areas - top geographies include Florida, California, Georgia.

Frequently Asked Questions

What is clinical trial NCT01074294 about?

NCT01074294 is a clinical study titled "Study of the Safety and Efficacy of OPC-34712 as a Complementary Therapy in the Treatment of Adult Attention Deficit/Hyperactivity Disorder". This study tests the effects of an investigational antipsychotic drug (called OPC-34712) in adults with attention deficit hyperactivity disorder (ADHD) when taken with an approved stimulant medication to explore a possible impact on sleep, quality of life and cognitive function.

What is the current status of trial NCT01074294?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 740 participants. The study started on 2010-03-16. Estimated completion is 2011-06-20.

What conditions does trial NCT01074294 study?

This clinical trial studies the following conditions: Attention Deficit Hyperactivity Disorder.

What interventions are being tested in trial NCT01074294?

The interventions under investigation include: Placebo (DRUG), OPDC-34712 (DRUG), Stimulant Therapy (DRUG).

Who is sponsoring clinical trial NCT01074294?

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

Where is trial NCT01074294 being conducted?

This trial has 20 study locations across Arkansas, California, Florida, Georgia, Indiana. 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.