Double-blind, Placebo-controlled, Randomised Withdrawal, Extension, Safety and Efficacy Study of LDX in Children and Adolescents Aged 6-17

PHASE3CompletedINTERVENTIONAL
Enrollment

276

Participants

Timeline

Start Date

January 27, 2009

Primary Completion Date

October 26, 2011

Study Completion Date

October 26, 2011

Conditions
ADHD
Interventions
DRUG

Lisdexamfetamine dimesylate (LDX)

LDX 30, 50, or 70mg capsule once per day (open-label and double-blind periods)

DRUG

Placebo

Placebo capsule once per day (double-blind period)

Trial Locations (51)

1021

Vadaskert Kórház és Szakambulancia, Budapest

2660

ZNA Antwerpen, Commandant Weynsstraat 165, Hoboken

5700

Pándy Kálmán Kórház, Gyula

6750

Szegedi Tudományegyetem, Szeged

7632

Gyermek és Ifjúságpszichiátriai Szakrendelés és Gondozó, Pécs

9000

Universitair Ziekenhuis Gent, Kinder - en Jeugdpsychiatrie, Ghent

9124

Università degli Studi di Cagliari, Cagliari

13353

Universitätsmedizin Berlin, Berlin

22767

Praxis für Neuropädiatrie, Hamburg

23112

Vince and Associates Clinical Research, Overland Park

34295

Hôpital Gui de Chauliac, Montpellier

35039

Universitätsklinikum Gießen und Marburg GmbH, Universitätsklinikum Gießen und Marburg GmbH, Hans-Sachs-Straße 4,, Marburg

36037

Praxis Dr. Walter Robert Otto, Fulda

37075

Universitat Göttingen, Göttingen

38119

CNS Healthcare, Memphis

41119

Drottning Silvias Barnsjukhus, Otterhällegatan 12A, Gothenburg

47802

Miami Research Associates, South Miami

50931

Universität zu Köln, Klinik und Poliklinik für Psychiatrie und Psychotherapie des Kindes und Jugendalters, Cologne

55131

Klinikum der Johannes Gutenberg-Universität Mainz, Mainz

58093

Praxis Dr. Wolff, Hagen

61231

Institutsambulanz Bad Nauheim, Bad Nauheim

66212

Peninsula Research Associates, Inc., Rolling Hills Estates

68159

Zentralinstitut für Seelische Gesundheit Mannheim, Mannheim

70124

Azienda Ospedaliera Policlinico Consorziale, Bari

75019

Hôpital Robert Debré, Paris

79104

Albert-Ludwigs-Universitat Freiburg, Freiburg im Breisgau

80131

Azienda Ospedaliera della 2? Universita di Napoli, Napoli

96047

Schwerpunktpraxis für Entwicklung und Lernen, Bamberg

97070

Medizinisches Studienzentrum Würzburg, Würzburg

97080

Universität Würzburg, Würzburg

98125

Azienda Ospedaliera Universitaria Policlinico G. Martino, Messina

B-3000

Afdeling Psychiatrie, UZ Herestraat 49, Leuven

06202

Hospital Archet 2, Nice

D-22415

Praxis Dr med. Friedrich Kaiser und Dr. med. Ingrid Marinesse, Hamburg

60-792

Specjalistyczna Praktyka Lekarska, Poznan

85-094

Szpital Uniwersytecki im. dr. Antoniego Jurasza w Bydgoszczy, Bydgoszcz

87-100

Wojewódzki Osrodek Lecznictwa Psychiatrycznego, Torun

00-576

Samodzielny Publiczny Dzieciecy Szpital Kliniczny, Poradnia Psychiatryczna, ul. Marszalkowska 24,, Warsaw

80-282

Gdanski Uniwersytet Medyczna w Gdansku, Gdansk

542 24

Utvecklingsneurologiska Enheten (UNE), Mariestad

171 76

Astrid Lindgren Children's Hospital, Karolinska University Hospital, Stockholm

435 30

Barn och Ungdomsmedicin klinik Mölnlycke, Stockholm

B13 8QE

Parkview Clinic, Birmingham

CT11 9DH

East Kent NHS and Social Care Partnership Trust, Ramsgate

SS2 6XT

Lighthouse Child Development Centre, Southend-on-Sea

KY2 5AH

Victoria Hospital, Paediatric Unit, Kirkcaldy

DD1 9SY

Tayside Children's Hospital, Dundee

S10 5DD

Ryegate Children's Centre, Sheffield

SS16 5NL

Basildon Hospital - Child Development Centre,, Basildon

NN1 2BG

Northampton Child and Adolescent Mental Health Services, Northampton

WN2 2JA

Child and Family Mental Health Services, Wigan

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Shire

INDUSTRY