396
Participants
Start Date
September 18, 2019
Primary Completion Date
September 2, 2025
Study Completion Date
September 2, 2025
Guanfacine hydrochloride (TAK-503)
Participants aged 6 to 12 years will receive a dose of 1 to 4 mg and aged 13 to 17 years will receive a dose of 5 to 7 mg TAK-503 oral tablets once daily for 18 weeks in Part A or 52 weeks in Part B.
Atomoxetine hydrochloride
Participants will receive Atomoxetine hydrochloride oral capsule once daily for 18 weeks in Part A.
Placebo
Participants aged 6 to 12 years will receive a dose of 1 to 4 mg and aged 13 to 17 years will receive a dose of 5 to 7 mg placebo matched to TAK 503 oral tablets once daily for 18 weeks and placebo matched to atomoxetine hydrochloride oral capsules at once daily for 18 weeks in Part A.
Medizinische Universtität Wien, Vienna
UZ Brussel, Brussels
UPC KU Leuven Afdeling Kinderpsychiatrie ADHD-raadpleging, Leuven
Foyer Saint Francois, Namur
LKH-Klinikum Graz, Graz
Corporacio Sanitaria Parc Tauli, Sabadell
Clinical Research Partners, LLC, Petersburg
Clinica Dr. Quintero, Madrid
Hospital Infanta Leonor, Madrid
Hospital Universitario Fundacion Alcorcon, Madrid
Clinica Universidad de Navarra, Pamplona
Clinical Neuroscience Solutions, Inc., Jacksonville
Clinical Neuroscience Solutions, Inc., Orlando
Homestead Medical Research, Homestead
Care Research Center, Inc., Miami
Complejo Hospitalario de Palencia, Palencia
Harmonex Neuroscience Research, Dothan
Clinical Neuroscience Solutions, Inc., Memphis
Barnneuropsykiatriska enheten, Sahlgrenska University hospital, Gothenburg
Qualmedica Research, LLC, Bowling Green
Qualmedica Research, LLC, Owensboro
Regionhälsan, Mölnlycke
University of Cincinnati, Cincinnati
Instituto Valenciano de Neurología Pediátrica (INVANEP), Valencia
Universitaetsklinikum Koeln, Cologne
Rheinhessen-Fachklinik Mainz, Mainz
AMR Conventions Research, Ltd, Naperville
Collective Medical Research LLC, Prairie Village
Zentralinstitut fuer Seelische Gesundheit, Mannheim
Alivation Research, LLC, Lincoln
Cutting Edge Research Group, Oklahoma City
Family Psychiatry of The Woodlands, The Woodlands
Universitaetsklinikum Freiburg, Freiburg im Breisgau
Center for Psychiatry and Behavioral Medicine, Inc., Las Vegas
Alliance Research, Long Beach
PCSD Feighner Research, San Diego
Sun Valley Research Center, Inc., Imperial
Advanced Research Center, Inc., Anaheim
EB FlevoResearch, Almere Stad
EB UtrechtResearch, Utrecht
Hospital de Cascais - Dr. José de Almeida, Alcabideche
Centro Clinico Academico 2CA Associacao Braga, Hospital de Braga Piso 1, Ala E, Braga
Centro Hospitalar Universitario Cova da Beira, E.P.E, Covilha
Hospital da Senhora da Oliveira Guimarães, Guimarães
Hospital CUF Descobertas, Lisbon
Centro Materno Infantil do Norte (CMIN) Centro Hospitalar Universitario do Porto, Porto
Hospital Universitari Vall d'Hebron, Barcelona
PRIMA Barn- och Vuxenpsykiatri AB, Norsborg
Tayside Children Hospital, Dundee
Lister Hospital, Stevenage
Lead Sponsor
Takeda Development Center Americas, Inc.
INDUSTRY
Shire
INDUSTRY