Efficacy and Safety of Extended-release Guanfacine Hydrochloride in Children and Adolescents Aged 6-17 Years With Attention-Deficit/Hyperactivity Disorder (ADHD)

PHASE3CompletedINTERVENTIONAL
Enrollment

338

Participants

Timeline

Start Date

January 17, 2011

Primary Completion Date

May 1, 2013

Study Completion Date

May 1, 2013

Conditions
Attention Deficit Hyperactivity Disorder
Interventions
DRUG

Extended-release Guanfacine Hydrochloride

Tablet, once daily, optimised dose (1mg to 7mg based on age and weight), 6-week maintenance duration on optimised dose.

DRUG

Atomoxetine Hydrochloride

Capsule, once daily, optimised dose (10mg to 100mg based on weight), 8-9-weeks maintenance duration on optimised dose

DRUG

Placebo Comparator

Placebo

Trial Locations (66)

12

Department of Child and Adolescent Psychiatry, Dublin

1010

Institut für Psychosomatik, Vienna

8036

Medizinische Universitat Graz-Universitaklinik fur Kinder-und Jugendheilkunde, Graz

10629

Emovis GmbH, Berlin

20009

Policlínica Guipuzkoa, Donostia / San Sebastian

20170

NeuroScience Inc., Herndon

21005

Vinnytsia National Medical University - Vinnytsia Regional Psycho-Neurological Hospital, Vinnytsia

22415

Praxis Dr. Friedrich Kaiser un Ingrid Marinesse, Hamburg

28018

Centre Hospitalier des Pyrenees, Chartres

28832

Praxis Dr. Andreas Mahler, Achim

29620

Hospital Marítimo, (USMI-J), Málaga

30308

Atlanta Center for Medical Research, Atlanta

32751

Florida Clinical Research Center, LLC, Maitland

33076

Centre Hospitalier Charles Perens - Service de Psychiatrie de l'Enfant et de l'Adolescent, Bordeaux

35625

Institut fur Ganzheitiche Medzin und Wissenschaft GmbH, Hüttenberg

36000

O.F. Maltsev Poltava Regional Psychiatric Hospital, Poltava

36037

Praxis Dr. Walter Robert Otto, Fulda

37134

Ospedale Policlinico G.B.Rossi - Azienda Ospedaliera Universitaria Integrata Verona, Verona

38003

Hospital de Dia Infantil y Juvenil Dr Diego Guigou y Costa, Santa Cruz de Tenerife

38119

Clinical Neuroscience Solutions, Inc., Memphis

39011

Hospital Universitario Marques de Valdecilla, Santander

40215

Praxisgemeinschaft Drs. Willem Geraets/Gabriele Lucassen, Düsseldorf

43530

Barn och Ungdomsmedicin klinik Mölnlycke, Mölnlycke

46010

Instituto Valenciano de Neurología Pediatrica, Valencia

48307

Rochester Center for Behavioral Medicine, Rochester Hills

55131

Klinikum der Johannes-Guttenberg-Universitat Mainz, Mainz

56018

IRCCS Stella Maris - U.O. Psichiatria e Psicofarmacologia Eta' Evolutiva, Pisa

58093

Praxis Dr. Wolff, Hagen

58103

Innovis Health, Fargo

61068

Institute of Neurology, Psychiatry and Narcology of the AMS of Ukraine, Kharkiv

61153

"Municipal Institution Institute of healthcare for children and adolescences NAMNU", Kharkiv

65084

Odesa Regional Psychoneurological Dispensary, Outpatient Dept, Odesa

66211

Psychiatric Associates, Overland Park

68159

Zentralinstitut fur Seelische Geseundheit Mannheim Klinik for Psuchiatrie und Psychotherapie des Kindes, Mannheim

73488

Kherson Regional Psychiatric Hospital, Kherson

77008

Claghorn-Lesem Research Clinic, Houston

77566

R/D Clincial Research, Inc., Lake Jackson

79021

Lviv Regional Clinical Psychiatric Hospital, Lviv

80054

Centre HospitalierUniversitaire d'Amiens, Hoptial Nord, Amiens

83037

Regional Clinical Psychiatric Hospital, Donetsk

92108

Psychiatric Centers at San Diego, Feighner Research, San Diego

300239

"Spitalul Clinic de Urgenta pentru Copii Louis Turcanu", Timișoara

400660

Spitalul Clinic de Urgenta Pentru Copii Cluj, Cluj-Napoca

68198-5581

University of Nebraska Medical Center, Dept. of Psychiatry, Omaha

L2E 6A4

Dr Grazyna B. Jackiewicz, MD, Niagara Falls

K2G 1W2

JPM Van Stralen Medicine Professional Corp., Ottawa

01307

Universitaetsklinikum Carl Gustav Carus an der Technischen Universitaet Dresden, Dresden

Unknown

Somni Bene GmbH - Institut für Medizinische Forschung und Schlafmedizin, Schwerin

"Spitalul Clinic de Psihiatrie Prof. Dr. Alexandru Obregia", Bucharest

Spitalul Clinic de Psihiatrie Socola, Iași

Horsham Child and Adolescent Mental Health Services, Horsham

00168

Università Cattolica del Sacro Cuore, Rome

87-100

Indywidualna Specjalistyczna Praktyka Lekarska Borys Gniot, Torun

Gabinet Psychiatrii Doroslych, Dzieci i Mlodziezy, Miroslaw Dabkowski, Torun

54-235

Centrum Neuropsychiatrii Neuromed, Wroclaw

00-576

Samodzielny Publiczny Dzieciecy Szpital Kliniczny, Warsaw

80-546

Centrum Badan Klinicznych PI-House Sp. z o.o., Gdansk

80-542

NZOZ Gdan Skie Centrum Zdrowia, Gdansk

08221

Mutua de Terrassa, Terrassa

08035

Hospital Universitari Vall d'Hebron, Barcelona

411 18

Drottning Silvias Barnsjukhus, Gothenburg

432 43

BUP mottagningen Varberg, Varberg

KY2 5AH

Victoria Hospital, Kirkcaldy

NR31 6SQ

James Paget University Hospital NHS Trust, Great Yarmouth

SO40 7AR

Ashurt Child and Family Centre, Ashurst

WN2 2JA

5 Boroughs Partnership NHS Trust, Wigan

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Shire

INDUSTRY