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Completed Phase 3 Interventional Results available

Dose-optimization in Adolescents Aged 13-17 Diagnosed With Attention-deficit/Hyperactivity Disorder (ADHD) Using Extended-release Guanfacine HCl

ClinicalTrials.gov ID: NCT01081132

Public ClinicalTrials.gov record NCT01081132. 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 28, 2026, 3:49 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 3, Double-blind, Randomized, Multi-center, Placebo Controlled, Dose-optimization Study Evaluating the Safety, Efficacy, and Tolerability of Once Daily Dosing With Extended-release Guanfacine Hydrochloride in Adolescents Aged 13-17 Years Diagnosed With Attention-deficit/Hyperactivity Disorder (ADHD)

Brief summary

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

To assess the efficacy of optimized Extended-release Guanfacine Hydrochloride compared with placebo in the treatment of adolescents aged 13-17 years with a diagnosis of ADHD as measured by the ADHD-RS-IV

Study identification

NCT ID
NCT01081132
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Shire
Industry
Enrollment
314 participants

Conditions and interventions

Eligibility (public fields only)

Age range
13 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 19, 2011 (Actual)
Primary completion
May 16, 2013 (Actual)
Completion
May 16, 2013 (Actual)
Last update posted
Jun 28, 2021

2011 – 2013

United States locations

U.S. sites
54
U.S. states
26
U.S. cities
52
Facility City State ZIP Site status
Harmonex Neuroscience Research Dothan Alabama 36303 —
Clinical Study Centers, LLC Little Rock Arkansas 72211 —
Peninsula Research Associates Rolling Hills Estates California 90274 —
Psychiatric Centers at San Diego (PCSD-Feighner Research Institute) San Diego California 92108 —
Encompass Clinical Research Spring Valley California 91978 —
Elite Clinical Trials, Inc. Wildomar California 92595 —
IMMUNO International Research Centers Centennial Colorado 80112 —
Coastal Connecticut Research LLC New London Connecticut 06320 —
Florida Clinical Research Center, LLC Bradenton Florida 34201 —
Sarkis Clinical Trials Gainesville Florida 32607 —
Amedica Research Institute, Inc. Hialeah Florida 33013 —
Clinical Neuroscience Solutions, Inc. Jacksonville Florida 32216 —
George M. Joseph, MD, PA Jacksonville Beach Florida 32250 —
Morteza Nadjafi, MD, FAPA Orlando Florida 32803 —
Clinical Neuroscience Solutions, Inc. Orlando Florida 32806 —
Miami Research Associates South Miami Florida 33143 —
Janus Center for Psychiatric Research West Palm Beach Florida 33407 —
Northwest Behavioral Research Center Roswell Georgia 30076 —
Institute for Behavioral Medicine Smyrna Georgia 30080 —
Capstone Clinical Research Libertyville Illinois 60048 —
AMR-Baber Research Inc. Naperville Illinois 60563 —
Goldpoint Clinical Research, LLC Indianapolis Indiana 46260 —
Clinco, Inc. Terre Haute Indiana 47802 —
Psychiatric Associates Overland Park Kansas 66211 —
Four Rivers Clinical Research, Inc. Paducah Kentucky 42003 —
Rochester Center for Behavioral Medicine Rochester Hills Michigan 48307 —
Clinical Neurophysiology Services, PC Sterling Heights Michigan 48314 —
Comprehensive Psychiatric Associates Gladstone Missouri 64118 —
St Charles Psychiatric Associates - Midwest Research Group Saint Charles Missouri 63301 —
Center for Psychiatry and Behavioral Medicine, Inc. Las Vegas Nevada 89128 —
Albuquerque Neuroscience Inc. Albuquerque New Mexico 87109 —
Finger Lakes Clinical Research Rochester New York 14618 —
Richmond Behavioral Associates Staten Island New York 10312 —
Triangle Neuropsychiatry Durham North Carolina 27707 —
NorthCoast Clinical Trials Beachwood Ohio 44122 —
The Ohio State University Columbus Ohio 43210 —
IPS Research Company Oklahoma City Oklahoma 73103 —
Tulsa Clinical Research, LLC Tulsa Oklahoma 74104 —
OCCI, Inc. Portland Oregon 97210 —
Oregon Center for Clinical Investigations, Inc. Salem Oregon 97301 —
CRI Worldwide Philadelphia Pennsylvania 19139 —
University Services Sleep Diagnostic and Treatment Centers West Chester Pennsylvania 19380 —
Rainbow Research Barnwell South Carolina 29812 —
The Jackson Clinic Jackson Tennessee 38305 —
Clinical Neuroscience Solutions, Inc. Memphis Tennessee 38119 —
Research Strategies of Memphis, LLC Memphis Tennessee 38119 —
FutureSearch Trials Austin Texas 78731 —
InSite Clinical Research DeSoto Texas 75115 —
R/D Clinical Research, Inc. Lake Jackson Texas 77566 —
Westex Clinical Investigations Lubbock Texas 79423 —
Neuroscience, Inc. Herndon Virginia 20170 —
Alliance Research Group Richmond Virginia 23230 —
Northwest Clinical Research Center Bellevue Washington 98007 —
East Side 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.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01081132, 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 28, 2021 · Synced Oct 28, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01081132 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →