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

PHASE3CompletedINTERVENTIONAL
Enrollment

528

Participants

Timeline

Start Date

May 11, 2010

Primary Completion Date

June 3, 2013

Study Completion Date

June 3, 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 age and 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 age and weight.

Trial Locations (81)

1090

Universitair Ziekenhuis Brussel, Jette

1180

Psypluriel, Uccle

1200

Cliniques Universitaires Saint Luc, Brussels

1602

Ziekenhuis Inkendaal Koninklijke Instelling v.z.w., Vlezenbeek

2660

Ziekenhuis Netwerk Antwerpen, Hoboken

3945

Huisartspraktijk Jaak Mortelmans, Ham

5000

Centre de référence Neuropédiatrique Multidisciplinaire, Namur

6229

Mondriaan Zorggroep Heerlen, Kinder en Jeugdp sychiatrie, Maastricht

9000

Universitair Ziekenhuis Gent, Ghent

10029

Mount Sinai School of Medicine, New York

10629

Emovis GmbH, Berlin

19139

CRI Worldwide, LLC, Philadelphia

20009

Policlínica Guipuzkoa, Donostia / San Sebastian

20017

"Azienda Ospedaliera Guido Salvini", Rho

20129

Azienda Osp. Fatebenefratelli - Polo Territoriale UONPIA, Milan

21033

Centre Hospitalier Universitaire Bocage-Hôpital d'enfants, Dijon

21801

Delmarva Family Resources, Salisbury

23230

Alliance Research Group, LLC, Richmond

27707

Triangle Neuropsychiatry, PLLC, Durham

28031

Hospital Infanta Leonor, Madrid

31008

Clínica Universitaria de Navarra, Pamplona

32216

Clinical Neuroscience Solutions, Inc., Jacksonville

32607

Sarkis Clinical Trials, Gainesville

32751

Florida Clinical Research Center, LLC, Maitland

32806

Clinical Neuroscience Solutions, Inc., Orlando

33013

Amedica Research Institute, Inc., Hialeah

34208

Florida Clinical Research Center, LLC, Bradenton

34295

Hôpital Gui de Chauliac, Montpellier

35143

Azienda ULSS 16 Padova, Padua

36303

Harmonex Neuroscience Research, Dothan

43210

Ohio State University, Nisonger Center, Columbus

46010

Instituto Valenciano de Neurología Pediatrica, Valencia

46260

Goldpoint Clinical Research, LLC, Indianapolis

46282

Sozialpsychiatrisches Centrum Dr. med. Ralph Meyers, Dorsten

55131

Klinikum der Johannes-Gutenberg-Universität Mainz, Mainz

56018

IRCCS Fondazione Stella Maris, Calambrone

60563

AMR-Baber Research Inc., Naperville

68198

University of Nebraska Medical Center, Omaha

68250

Centre Hospitalier de Rouffach, Rouffach

70114

Louisiana Research Associates, Inc., New Orleans

72076

Center for Pediatric Clinical Studies, Tübingen

72205

Clinical Study Centers, LLC, Little Rock

73103

IPS Research Company, Oklahoma City

75935

Hopital Robert-Debre', Paris

78247

ADHD Clinic of San Antonio, San Antonio

78756

FutureSearch Clinical Trials, Austin

79104

Universitatsklinikum Freiburg, Freiburg im Breisgau

80054

Centre Hospitalier Universitaire d'Amiens, Hôpital Nord, Amiens

81241

Praxis Dr. med. Dipl. Psych. Anton Lindermüller, München

89075

Universitätsklinik Ulm, Ulm

89128

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

91978

Encompass Clinical Research - North Coast, Spring Valley

92108

Psychiatric Centers at San Diego, Feighner Research, San Diego

92595

Elite Clinical Trials, Inc., Wildomar

95123

Azienda Ospedaliero-Universitaria Policlinico-Vittorio, Catania

97070

Medizinisches Studienzentrum Wurzburg, Würzburg

97301

Oregon Center for Clinical Investigations, Inc. (OCCI, Inc.), Salem

98033

Eastside Therapeutic Resource, Kirkland

289221

Hospital Fundacion Alcorcon, Alcorcón

V6H3N1

Children's and Women's Health Centre of British Columbia, Vancouver

K2G1W2

JPM van Stralen Medicine Professional Corporation, Ottawa

L1N8M7

ADHD Clinic/The Kid's Clinic, Whitby

S7N-OW8

Royal University Hospital, Saskatoon

06200

Hopitaux Pediatriques de Nice - CHI Lenval, Nice

75 015

Hopital Robert Debre Centre pediatrique des pathologies du sommeil, Paris

37 000

Hopital Gatien de Clocheville CHU de Tours, Tours

07743

Friedrich-Schiller-Universitat Jena, Jena

00168

Drottning Silvias Barnsjukhus, Roma

Università Cattolica del Sacro Cuore, Roma

1311 RL

FlevoResearch, Almere Stad

6229 HX

Academisch Ziekenhuis Maastricht, Maastricht

07198

Hospital Son Llàtzer, Laboratorio de Neurociencias IUNICS, Palma

08035

Hospital Universitari Vall d'Hebron, Barcelona

435 30

Barn och Ungdomsmedicin klinik Mölnlycke, Mölnlycke

NR4 7PA

Norfolk Community Health and Care NHS Trust, Norwich

S10 5DD

Ryegate Children's Centre, Sheffield

S6 3BR

Centenary House Child and Adolescent Mental Health Services, Sheffield

AL7 4HQ

Queen Elizabeth II Hospital, Welwyn Garden City

RM16 2PX

Thurrock Community Hospital, Grays

L12 2AP

Royal Liverpool University Hospital, Liverpool

SG1 4AB

Lister Hospital, Stevenage

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Shire

INDUSTRY