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NCT02466425 · ClinicalTrials.gov registry record · Phase 3

Safety and Efficacy Study of SHP465 in Children and Adolescents Aged 6-17 Years With Attention-Deficit Hyperactivity Disorder (ADHD)

A Phase 3 study of Attention Deficit Hyperactivity Disorder (ADHD), sponsored by Shire.

Completed
Registry status
Phase 3
Development phase
264
Enrollment target
20
Study locations

NCT02466425 is a Phase 3 study of Attention Deficit Hyperactivity Disorder (ADHD) that has completed, run by Shire. The registered enrollment target is 264 participants, above the 130-participant average among 15 other Attention Deficit Hyperactivity Disorder (ADHD) trials with a reported enrollment target (103% higher). The trial reports 20 study locations across 10 states.

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The verdict

NCT02466425, a Phase 3 study of Attention Deficit Hyperactivity Disorder (ADHD), has completed, sponsored by Shire.

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

Study Summary

The study is designed to evaluate the efficacy and safety of SHP465 in the treatment of ADHD in children and adolescents (aged 6-17 years). The primary objective of this study is to evaluate the efficacy of SHP465 administered as a daily morning dose compared to placebo in the treatment of children and adolescents (6-17 years of age inclusive) diagnosed with ADHD.

Interventions

  • DRUG Placebo
  • DRUG SHP465

Study Locations (20)

Florida

  • Florida Clinical Research Center, Llc - Bradenton
  • Sarkis Clinical Trials - Gainesville
  • Clinical Neuroscience Solutions, Inc. - Jacksonville
  • Medical Research Group of Central Florida - Orange City
  • Clinical Neuroscience Solutions, Inc. - Orlando
  • Miami Research Associates, Llc - South Miami
  • Janus Center For Psychiatric Research - West Palm Beach

California

  • Nrc Research Institute - Orange
  • Pcsd Feighner Research - San Diego
  • Encompass Clinical Research - Spring Valley
  • Elite Clinical Trials, Inc - Wildomar

Illinois

  • Capstone Clinical Research - Libertyville
  • Baber Research Group Inc - Naperville

Alabama

  • Harmonex Neuroscience Research - Dothan

Colorado

  • McB Clinical Research Centers - Colorado Springs

Georgia

  • Northwest Behavioral Research Center - Marietta

Kansas

  • Psychiatric Associates - Overland Park

Louisiana

  • Louisiana Research Associates, Inc - New Orleans

Trial Details

FieldValue
Enrollment Target 264 participants
Start Date 2015-06-18
Est. Completion 2016-02-16
Phase Phase 3

Sponsor

Shire

245 total trials

What the Registry Record Tells You About NCT02466425

The ClinicalTrials.gov registry entry for NCT02466425 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 264 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 130-participant average among 15 other Attention Deficit Hyperactivity Disorder (ADHD) trials with a reported enrollment target (103% higher). The listed sponsor is Shire, which has 245 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Attention Deficit Hyperactivity Disorder (ADHD) appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT02466425 reports 20 study locations spanning 10 distinct geographic areas - top geographies include Florida, California, Illinois.

Frequently Asked Questions

What is clinical trial NCT02466425 about?

NCT02466425 is a clinical study titled "Safety and Efficacy Study of SHP465 in Children and Adolescents Aged 6-17 Years With Attention-Deficit Hyperactivity Disorder (ADHD)". The study is designed to evaluate the efficacy and safety of SHP465 in the treatment of ADHD in children and adolescents (aged 6-17 years). The primary objective of this study is to evaluate the efficacy of SHP465 administered as a daily morning dose compared to placebo in the treatment of children ...

What is the current status of trial NCT02466425?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 264 participants. The study started on 2015-06-18. Estimated completion is 2016-02-16.

What conditions does trial NCT02466425 study?

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

What interventions are being tested in trial NCT02466425?

The interventions under investigation include: Placebo (DRUG), SHP465 (DRUG).

Who is sponsoring clinical trial NCT02466425?

This trial is sponsored by Shire, which has 245 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02466425 being conducted?

This trial has 20 study locations across Alabama, California, Colorado, Florida, Georgia. 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.