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Completed Phase 3 Interventional Results available

Maintenance of Efficacy of Extended-Release Guanfacine HCl in Children and Adolescents With Attention-deficit/Hyperactivity Disorder (ADHD)

ClinicalTrials.gov ID: NCT01081145

Public ClinicalTrials.gov record NCT01081145. 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 Oct 24, 2026, 4:24 AM 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 3, Double-blind, Placebo-controlled, Multicentre, Randomised Withdrawal, Long-term Maintenance of Efficacy and Safety Study of Extended-release Guanfacine Hydrochloride in Children and Adolescents Aged 6-17 With Attention Deficit/Hyperactivity Disorder

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The primary objective of this study is to evaluate the long-term maintenance of efficacy of Extended-Release Guanfacine HCl in children and adolescents (6-17 years) with attention-deficit/hyperactivity disorder (ADHD) who respond to an initial open-label, short term treatment with SPD503.

Study identification

NCT ID
NCT01081145
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Shire
Industry
Enrollment
528 participants

Conditions and interventions

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
May 11, 2010 (Actual)
Primary completion
Jun 3, 2013 (Actual)
Completion
Jun 3, 2013 (Actual)
Last update posted
Jun 14, 2021

2010 – 2013

United States locations

U.S. sites
27
U.S. states
19
U.S. cities
27
Facility City State ZIP Site status
Harmonex Neuroscience Research Dothan Alabama 36303 —
Clinical Study Centers, LLC Little Rock Arkansas 72205 —
Psychiatric Centers at San Diego, Feighner Research San Diego California 92108 —
Encompass Clinical Research - North Coast Spring Valley California 91978 —
Elite Clinical Trials, Inc. Wildomar California 92595 —
Florida Clinical Research Center, LLC Bradenton Florida 34208 —
Sarkis Clinical Trials Gainesville Florida 32607 —
Amedica Research Institute, Inc. Hialeah Florida 33013 —
Clinical Neuroscience Solutions, Inc. Jacksonville Florida 32216 —
Florida Clinical Research Center, LLC Maitland Florida 32751 —
Clinical Neuroscience Solutions, Inc. Orlando Florida 32806 —
AMR-Baber Research Inc. Naperville Illinois 60563 —
Goldpoint Clinical Research, LLC Indianapolis Indiana 46260 —
Louisiana Research Associates, Inc. New Orleans Louisiana 70114 —
Delmarva Family Resources Salisbury Maryland 21801 —
University of Nebraska Medical Center Omaha Nebraska 68198 —
Center for Psychiatry and Behavioral Medicine, Inc. Las Vegas Nevada 89128 —
Mount Sinai School of Medicine New York New York 10029 —
Triangle Neuropsychiatry, PLLC Durham North Carolina 27707 —
Ohio State University, Nisonger Center Columbus Ohio 43210 —
IPS Research Company Oklahoma City Oklahoma 73103 —
Oregon Center for Clinical Investigations, Inc. (OCCI, Inc.) Salem Oregon 97301 —
CRI Worldwide, LLC Philadelphia Pennsylvania 19139 —
FutureSearch Clinical Trials Austin Texas 78756 —
ADHD Clinic of San Antonio San Antonio Texas 78247 —
Alliance Research Group, LLC Richmond Virginia 23230 —
Eastside Therapeutic Resource Kirkland Washington 98033 —

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 54 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01081145, 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 Jun 14, 2021 · Synced Oct 24, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01081145 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →