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Completed Phase 4 Interventional Results available

A Study of TAK-503 in Children and Teenagers With Attention Deficit Hyperactivity Disorder (ADHD)

ClinicalTrials.gov ID: NCT04085172

Public ClinicalTrials.gov record NCT04085172. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced May 16, 2026, 12:41 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase 4, Multicenter, 2-part Study Composed of a Randomized, Double-blind, Parallel-group, Placebo-controlled, Active-comparator, Dose-optimization Evaluation Followed by a 1-Year Open-label Evaluation to Assess the Safety and Efficacy of Guanfacine Hydrochloride Prolonged-release (SPD503) in Children and Adolescents Aged 6 to 17 Years With Attention-deficit/Hyperactivity Disorder

Study identification

NCT ID
NCT04085172
Recruitment status
Completed
Study type
Interventional
Phase
Phase 4
Lead sponsor
Shire
Industry
Enrollment
396 participants

Conditions and interventions

Interventions

  • Atomoxetine hydrochloride Drug
  • Guanfacine hydrochloride (TAK-503) Drug
  • Placebo Other

Drug · Other

Eligibility (public fields only)

Age range
6 Years to 17 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Sep 17, 2019
Primary completion
Sep 1, 2025
Completion
Sep 1, 2025
Last update posted
Apr 12, 2026

2019 – 2025

United States locations

U.S. sites
20
U.S. states
13
U.S. cities
20
Facility City State ZIP Site status
Harmonex Neuroscience Research Dothan Alabama 36303
Advanced Research Center, Inc. Anaheim California 92805
Sun Valley Research Center, Inc. Imperial California 92251
Alliance Research Long Beach California 90807
PCSD Feighner Research San Diego California 92108
Homestead Medical Research Homestead Florida 33030
Clinical Neuroscience Solutions, Inc. Jacksonville Florida 32256
Care Research Center, Inc. Miami Florida 33130
Clinical Neuroscience Solutions, Inc. Orlando Florida 32801
AMR Conventions Research, Ltd Naperville Illinois 60563
Collective Medical Research LLC Prairie Village Kansas 66208
Qualmedica Research, LLC Bowling Green Kentucky 42101
Qualmedica Research, LLC Owensboro Kentucky 42301
Alivation Research, LLC Lincoln Nebraska 68526
Center for Psychiatry and Behavioral Medicine, Inc. Las Vegas Nevada 89128
University of Cincinnati Cincinnati Ohio 45219
Cutting Edge Research Group Oklahoma City Oklahoma 73116
Clinical Neuroscience Solutions, Inc. Memphis Tennessee 38119
Family Psychiatry of The Woodlands The Woodlands Texas 77381
Clinical Research Partners, LLC Petersburg Virginia 23805

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 30 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04085172, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Apr 12, 2026 · Synced May 16, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT04085172 live on ClinicalTrials.gov.

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