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

PHASE3CompletedINTERVENTIONAL
Enrollment

314

Participants

Timeline

Start Date

September 19, 2011

Primary Completion Date

May 16, 2013

Study Completion Date

May 16, 2013

Conditions
Attention-Deficit/Hyperactivity Disorder
Interventions
DRUG

Extended-release Guanfacine Hydrochloride

The test product will be provided as 1, 2, 3, and 4mg tablets. Subjects will be administered a once-daily dose between 1-7mg/day depending on weight.

OTHER

Placebo

Matching placebo will be provided as 1,2,3, and 4mg tablets. Subjects will be administered a once-daily dose of placebo between 1-7mg/day depending on weight.

Trial Locations (54)

10312

Richmond Behavioral Associates, Staten Island

14618

Finger Lakes Clinical Research, Rochester

19139

CRI Worldwide, Philadelphia

19380

University Services Sleep Diagnostic and Treatment Centers, West Chester

20170

Neuroscience, Inc., Herndon

23230

Alliance Research Group, Richmond

27707

Triangle Neuropsychiatry, Durham

29812

Rainbow Research, Barnwell

30076

Northwest Behavioral Research Center, Roswell

30080

Institute for Behavioral Medicine, Smyrna

32216

Clinical Neuroscience Solutions, Inc., Jacksonville

32250

George M. Joseph, MD, PA, Jacksonville Beach

32607

Sarkis Clinical Trials, Gainesville

32803

Morteza Nadjafi, MD, FAPA, Orlando

32806

Clinical Neuroscience Solutions, Inc., Orlando

33013

Amedica Research Institute, Inc., Hialeah

33143

Miami Research Associates, South Miami

33407

Janus Center for Psychiatric Research, West Palm Beach

34201

Florida Clinical Research Center, LLC, Bradenton

36303

Harmonex Neuroscience Research, Dothan

38119

Clinical Neuroscience Solutions, Inc., Memphis

Research Strategies of Memphis, LLC, Memphis

38305

The Jackson Clinic, Jackson

42003

Four Rivers Clinical Research, Inc., Paducah

43210

The Ohio State University, Columbus

44122

NorthCoast Clinical Trials, Beachwood

46260

Goldpoint Clinical Research, LLC, Indianapolis

47802

Clinco, Inc., Terre Haute

48307

Rochester Center for Behavioral Medicine, Rochester Hills

48314

Clinical Neurophysiology Services, PC, Sterling Heights

60048

Capstone Clinical Research, Libertyville

60563

AMR-Baber Research Inc., Naperville

63301

St Charles Psychiatric Associates - Midwest Research Group, Saint Charles

64118

Comprehensive Psychiatric Associates, Gladstone

66211

Psychiatric Associates, Overland Park

72211

Clinical Study Centers, LLC, Little Rock

73103

IPS Research Company, Oklahoma City

74104

Tulsa Clinical Research, LLC, Tulsa

75115

InSite Clinical Research, DeSoto

77566

R/D Clinical Research, Inc., Lake Jackson

78731

FutureSearch Trials, Austin

79423

Westex Clinical Investigations, Lubbock

80112

IMMUNO International Research Centers, Centennial

87109

Albuquerque Neuroscience Inc., Albuquerque

89128

Center for Psychiatry and Behavioral Medicine, Inc., Las Vegas

90274

Peninsula Research Associates, Rolling Hills Estates

91978

Encompass Clinical Research, Spring Valley

92108

Psychiatric Centers at San Diego (PCSD-Feighner Research Institute), San Diego

92595

Elite Clinical Trials, Inc., Wildomar

97210

OCCI, Inc., Portland

97301

Oregon Center for Clinical Investigations, Inc., Salem

98007

Northwest Clinical Research Center, Bellevue

98033

East Side Therapeutic Resource, Kirkland

06320

Coastal Connecticut Research LLC, New London

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Shire

INDUSTRY