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

A Phase 3, Randomised, Double-blind, Multicentre, Parallel-group, Placebo- and Active-reference, Dose-optimisation Efficacy and Safety Study of Extended-release Guanfacine Hydrochloride in Children and Adolescents Aged 6-17 Years With Attention-Deficit/Hyperactivity Disorder

For children and adolescents, how does SPD503 compare to placebo for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD).

Study Overview

• Status: Completed
• Conditions: Attention Deficit Hyperactivity Disorder
• Intervention / Treatment: Drug: Placebo Comparator; Drug: Extended-release Guanfacine Hydrochloride; Drug: Atomoxetine Hydrochloride

• Study Type: Interventional
• Enrollment (Actual): 338
• Phase: Phase 3

Contacts and Locations

Study Locations

• Austria
  • Graz, Austria, 8036
    • Medizinische Universitat Graz-Universitaklinik fur Kinder-und Jugendheilkunde
  • Wien, Austria, 1010
    • Institut für Psychosomatik
• Canada
  • Ontario
    • Niagara Falls, Ontario, Canada, L2E 6A4
      • Dr Grazyna B. Jackiewicz, MD
    • Ottawa, Ontario, Canada, K2G 1W2
      • JPM Van Stralen Medicine Professional Corp.
• France
  • Bordeaux, France, 33076
    • Centre Hospitalier Charles Perens - Service de Psychiatrie de l'Enfant et de l'Adolescent
  • Chartres, France, 28018
    • Centre Hospitalier des Pyrenees
  • Picardie
    • Amiens Cedex, Picardie, France, 80054
      • Centre HospitalierUniversitaire d'Amiens, Hoptial Nord
• Germany
  • Achim, Germany, 28832
    • Praxis Dr. Andreas Mahler
  • Berlin, Germany, 10629
    • emovis GmbH
  • Dresden, Germany, 01307
    • Universitaetsklinikum Carl Gustav Carus an der Technischen Universitaet Dresden
  • Dusseldorf, Germany, 40215
    • Praxisgemeinschaft Drs. Willem Geraets/Gabriele Lucassen
  • Fulda, Germany, 36037
    • Praxis Dr. Walter Robert Otto
  • Hamburg, Germany, 22415
    • Praxis Dr. Friedrich Kaiser un Ingrid Marinesse
  • Huttenberg, Germany, 35625
    • Institut fur Ganzheitiche Medzin und Wissenschaft GmbH
  • Mainz, Germany, 55131
    • Klinikum der Johannes-Guttenberg-Universitat Mainz
  • Mannheim, Germany, 68159
    • Zentralinstitut fur Seelische Geseundheit Mannheim Klinik for Psuchiatrie und Psychotherapie des Kindes
  • Schwerin, Germany
    • Somni Bene GmbH - Institut für Medizinische Forschung und Schlafmedizin
  • Nordrhein-Westfalen
    • Hagen, Nordrhein-Westfalen, Germany, 58093
      • Praxis Dr. Wolff
• Ireland
  • Dublin, Ireland, 12
    • Department of Child and Adolescent Psychiatry
• Italy
  • Pisa, Italy, 56018
    • IRCCS Stella Maris - U.O. Psichiatria e Psicofarmacologia Eta' Evolutiva
  • Rome, Italy, 00168
    • Universita Cattolica del Sacro Cuore
  • Verona, Italy, 37134
    • Ospedale Policlinico G.B.Rossi - Azienda Ospedaliera Universitaria Integrata Verona
• Poland
  • Gdansk, Poland, 80-542
    • NZOZ Gdan Skie Centrum Zdrowia
  • Torun, Poland, 87-100
    • Gabinet Psychiatrii Doroslych, Dzieci i Mlodziezy, Miroslaw Dabkowski
  • Dolnoslaskie
    • Wroclaw, Dolnoslaskie, Poland, 54-235
      • Centrum Neuropsychiatrii Neuromed
  • Kujawsko-pomorskie
    • Torun, Kujawsko-pomorskie, Poland, 87-100
      • Indywidualna Specjalistyczna Praktyka Lekarska Borys Gniot
  • Mazowieckie
    • Warszawa, Mazowieckie, Poland, 00-576
      • Samodzielny Publiczny Dzieciecy Szpital Kliniczny
  • Pomorskie
    • Gdansk, Pomorskie, Poland, 80-546
      • Centrum Badan Klinicznych PI-House sp. z o.o.
• Romania
  • Bucuresti, Romania
    • Spitalul Clinic de Psihiatrie "Prof. Dr. Alexandru Obregia"
  • Iasi, Romania
    • Spitalul Clinic de Psihiatrie Socola
  • Cluj
    • Cluj Napoca, Cluj, Romania, 400660
      • Spitalul Clinic de Urgenta pentru Copii Cluj
  • Timis
    • Timisoara, Timis, Romania, 300239
      • Spitalul Clinic de Urgenta pentru Copii "Louis Turcanu"
• Spain
  • Barcelona, Spain, 08035
    • Hospital Universitari Vall d'Hebron
  • Donostia-San Sebastián, Spain, 20009
    • Policlínica Guipuzkoa
  • Malaga, Spain, 29620
    • Hospital Marítimo, (USMI-J)
  • Santa Cruz de Tenerife, Spain, 38003
    • Hospital de Dia Infantil y Juvenil Dr Diego Guigou y Costa
  • Santander, Spain, 39011
    • Hospital Universitario Marques de Valdecilla
  • Valencia, Spain, 46010
    • Instituto Valenciano de Neurología Pediatrica
  • Barcelona
    • Terrassa, Barcelona, Spain, 08221
      • Mutua de Terrassa
• Sweden
  • Goteborg, Sweden, 411 18
    • Drottning Silvias barnsjukhus
  • Mölnlycke, Sweden, 43530
    • Barn och Ungdomsmedicin klinik Mölnlycke
  • Varberg, Sweden, 432 43
    • BUP mottagningen Varberg
• Ukraine
  • Donetsk, Ukraine, 83037
    • Regional Clinical Psychiatric Hospital
  • Kharkiv, Ukraine, 61153
    • Municipal Institution "Institute of healthcare for children and adolescences NAMNU
  • Kherson, Ukraine, 73488
    • Kherson Regional Psychiatric Hospital
  • Lviv, Ukraine, 79021
    • Lviv Regional Clinical Psychiatric Hospital
  • Odesa, Ukraine, 65084
    • Odesa Regional Psychoneurological Dispensary, Outpatient Dept
  • Poltava, Ukraine, 36000
    • O.F. Maltsev Poltava Regional Psychiatric Hospital
  • Vinnytsia, Ukraine, 21005
    • Vinnytsia National Medical University - Vinnytsia Regional Psycho-Neurological Hospital
  • Kharkiv
    • Kharkov, Kharkiv, Ukraine, 61068
      • Institute of Neurology, Psychiatry and Narcology of the AMS of Ukraine
• United Kingdom
  • Horsham, United Kingdom
    • Horsham Child and Adolescent Mental Health Services
  • Wigan, United Kingdom, WN2 2JA
    • 5 Boroughs Partnership NHS Trust
  • Fife
    • Kirkcaldy, Fife, United Kingdom, KY2 5AH
      • Victoria Hospital
  • Norfolk
    • Great Yarmouth, Norfolk, United Kingdom, NR31 6SQ
      • James Paget University Hospital NHS Trust
  • Southampton
    • Ashurst, Southampton, United Kingdom, SO40 7AR
      • Ashurt Child and Family Centre
• United States
  • California
    • San Diego, California, United States, 92108
      • Psychiatric Centers at San Diego, Feighner Research
  • Florida
    • Maitland, Florida, United States, 32751
      • Florida Clinical Research Center, LLC
  • Georgia
    • Atlanta, Georgia, United States, 30308
      • Atlanta Center for Medical Research
  • Kansas
    • Overland Park, Kansas, United States, 66211
      • Psychiatric Associates
  • Michigan
    • Rochester Hills, Michigan, United States, 48307
      • Rochester Center for Behavioral Medicine
  • Nebraska
    • Omaha, Nebraska, United States, 68198-5581
      • University of Nebraska Medical Center, Dept. of Psychiatry
  • North Dakota
    • Fargo, North Dakota, United States, 58103
      • Innovis Health
  • Tennessee
    • Memphis, Tennessee, United States, 38119
      • Clinical Neuroscience Solutions, INC.
  • Texas
    • Houston, Texas, United States, 77008
      • Claghorn-Lesem Research Clinic
    • Lake Jackson, Texas, United States, 77566
      • R/D Clincial Research, Inc.
  • Virginia
    • Herndon, Virginia, United States, 20170
      • NeuroScience Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 17 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Male or female, aged 6 17 years at the time of consent/assent at Screening (Visit 1).
2. Subject's parent or legally authorised representative (LAR) must provide signature of informed consent, and there must be documentation of assent (if applicable) by the subject indicating that the subject is aware of the investigational nature of the study and the required procedures and restrictions in accordance with the International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) Guidance E6, and applicable regulations before completing any study related procedures at Screening (Visit 1).
3. Subject meets Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) criteria for a primary diagnosis of ADHD, combined sub-type, hyperactive/impulsive sub-type, or inattentive sub-type based on a detailed psychiatric evaluation using the Kiddie Schedule for Affective Disorders and Schizophrenia - Present and Lifetime version (K-SADS-PL).
4. Subject has a minimum ADHD-RS-IV total score of 32 at Baseline (Visit 2).
5. Subject has a minimum CGI-S score of 4 at Baseline (Visit 2).
6. Subject is functioning at an age-appropriate level intellectually, as judged by the Investigator.
7. Subject and parent/LAR understand, are willing, able, and likely to fully comply with the study procedures and restrictions defined in this protocol.
8. Subject is able to swallow intact tablets and capsules.
9. Subject who is a female of child-bearing potential (FOCP), defined as greater than or equal to 9 years of age or <9 years of age and is menarchal, must have a negative serum beta Human Chorionic Gonadotropin (hCG) pregnancy test at Screening (Visit 1) and a negative urine pregnancy test at Baseline (Visit 2) and agree to comply with any applicable contraceptive requirements of the protocol.
10. Subject has supine and standing blood pressure (BP) measurement within the 95th percentile for age, sex, and height

Exclusion Criteria:

1. Subject has a current, controlled (requiring a prohibited medication or behavioural modification program) or uncontrolled, co-morbid psychiatric diagnosis [except oppositional defiant disorder (ODD)], including any severe co-morbid Axis II disorders or severe Axis I disorders such as post traumatic stress disorder (PTSD), bipolar illness, psychosis, pervasive developmental disorder, obsessive-compulsive disorder (OCD), substance abuse disorder, or other symptomatic manifestations or lifetime history of bipolar illness, psychosis or conduct disorder that, in the opinion of the Investigator, contraindicate treatment with SPD503 or STRATTERA or confound efficacy or safety assessments.
2. Subject is well-controlled on their current medication, with acceptable tolerability, and the parent/caregiver does not object to the current medication.
3. Subject has any condition or illness including a clinically significant abnormal Screening (Visit 1) laboratory values which, in the opinion of the Investigator, represents an inappropriate risk to the subject and/or could confound the interpretation of the study. Mild stable asthma treated without the use of beta-2 agonist is not exclusionary.
4. Subject has a known history or presence of structural cardiac abnormalities, cardiovascular or cerebrovascular disease, serious heart rhythm abnormalities, syncope, tachycardia, cardiac conduction problems (eg, clinically significant heart block or QT interval prolongation), exercise-related cardiac events including syncope and pre syncope, or clinically significant bradycardia.
5. Subject has a known family history of sudden cardiac death, ventricular arrhythmia, or QT prolongation.
6. Subjects with orthostatic hypotension or a known history of hypertension.
7. Subject has glaucoma.
8. Subject has clinically significant ECG findings as judged by the Investigator with consideration of the central ECG laboratory's interpretation.
9. Subject has a history of a seizure disorder (other than a single childhood febrile seizure occurring before the age of 3 years) or the presence of a serious tic disorder including Tourette's Syndrome.
10. Current use of any prohibited medication or other medications, including monoamine oxidase inhibitors, herbal supplements, that affect BP or heart rate potent CYP2D6 inhibitors, medications known to prolong the QT/QTc interval, medications that lower seizure threshold, pressor agents, beta-2 agonists, medications that affect noradrenaline, medications that have central nervous system (CNS) effects or affect cognitive performance, such as sedating antihistamines and decongestant sympathomimetics (inhaled bronchodilators are permitted) or a history of chronic use of sedating medications [ie, antihistamines]) in violation of the protocol specified washout criteria at Baseline (Visit 2).
11. Subject has a history of alcohol or other substance abuse or dependence, as defined by DSM-IV (with the exception of nicotine) within the last 6 months.
12. Subject has taken another investigational product within 30 days prior to Baseline (Visit 2).
13. Subject is significantly overweight based on Center for Disease Control and Prevention Body Mass Index (BMI)-for-age gender specific charts at the Screening (Visit 1). Significantly overweight is defined as a BMI >95th percentile.
14. Children aged 6 12 years with a body weight of less than 25kg or adolescents aged 13 17 years with a body weight of less than 34kg or greater than 91kg at Screening (Visit 1).
15. Subject has a known or suspected allergy, hypersensitivity, or clinically significant intolerance to guanfacine hydrochloride or atomoxetine hydrochloride, or any components found in SPD503 or STRATTERA.
16. Clinically important abnormality on drug and alcohol screen (excluding the subject's current ADHD stimulant if applicable) at Screening (Visit 1)
17. Subject is female and is pregnant or currently lactating.
18. Subject failed screening or was previously enrolled in this study.
19. Subject is currently considered a suicide risk in the opinion of the Investigator, has previously made a suicide attempt, or has a prior history of, or is currently demonstrating active suicide ideation. Subjects with intermittent passive suicidal ideation are not necessarily excluded based on the assessment of the Investigator.
20. History of failure to respond to an adequate trial of an α2-agonist or atomoxetine hydrochloride for the treatment of ADHD (consisting of an appropriate dose and adequate duration of therapy in the opinion of the investigator).
21. Subjects with renal or hepatic insufficiency.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo	Drug: Placebo Comparator; Placebo
EXPERIMENTAL: Extended-release Guanfacine Hydrochloride	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.; Other Names: Intuniv
OTHER: Atomoxetine Hydrochloride; Active Reference	Drug: Atomoxetine Hydrochloride; Capsule, once daily, optimised dose (10mg to 100mg based on weight), 8-9-weeks maintenance duration on optimised dose; Other Names: Strattera

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Total Score at Week 10/13 - Last Observation Carried Forward (LOCF)	The ADHD-RS-IV consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54. Outcome measure is at 10 weeks for ages 6-12 years and at 13 weeks for ages 13-17 years.	Baseline and Up to 10 weeks for children aged 6-12 years and up to 13 weeks for adolescents aged 13-17 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores	Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale. Outcome measure is at 10 weeks for ages 6-12 years and at 13 weeks for ages 13-17 years.	Up to 10 weeks for children aged 6-12 years and up to 13 weeks for adolescents aged 13-17 years
Change From Baseline in the Weiss Functional Impairment Rating Scale - Parent Report (WFIRS-P) Learning and School Domain Scores at Week 10/13 - LOCF	The WFIRS-P Learning in School Domain is the mean of 10 items, ranging from 0 (never/not at all) to 3 (very often/very much). Higher scores indicate greater functional impairment. Outcome measure is at 10 weeks for ages 6-12 years and at 13 weeks for ages 13-17 years.	Baseline and Up to 10 weeks for children aged 6-12 years and up to 13 weeks for adolescents aged 13-17 years
Change From Baseline in the WFIRS-P Family Domain Score at Week 10/13 - LOCF	The WFIRS-P Family Domain is the mean of 10 items, ranging from 0 (never/not at all) to 3 (very often/very much). Higher scores indicate greater functional impairment. Outcome measure is at 10 weeks for ages 6-12 years and at 13 weeks for ages 13-17 years.	Baseline and Up to 10 weeks for children aged 6-12 years and up to 13 weeks for adolescents aged 13-17 years
Clinical Global Impression-Severity of Illness (CGI-S) - LOCF	CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill). Outcome measure is at 10 weeks for ages 6-12 years and at 13 weeks for ages 13-17 years.	Up to 10 weeks for children aged 6-12 years and up to 13 weeks for adolescents aged 13-17 years
Health Utilities Index-2/3 (HUI 2/3) Scores - LOCF	HUI is used to describe health status and to obtain utility scores by collecting data using one or more questionnaires in formats selected to match the specific study design criteria. Scoring ranges from 0.00 (dead) to 1.00 (perfect health). Higher scores represent better health status. Outcome measure is at 10 weeks for ages 6-12 years and at 13 weeks for ages 13-17 years.	Up to 10 weeks for children aged 6-12 years and up to 13 weeks for adolescents aged 13-17 years
Change From Baseline in the WFIRS-P Global Score at Week 10/13 - LOCF	The WFIRS-P Global Score is the mean of 50 items, ranging from 0 (never/not at all) to 3 (very often/very much). Higher scores indicate greater functional impairment. Outcome measure is at 10 weeks for ages 6-12 years and at 13 weeks for ages 13-17 years.	Baseline and Up to 10 weeks for children aged 6-12 years and up to 13 weeks for adolescents aged 13-17 years
Change From Baseline in the WFIRS-P Academic Performance Domain Score at Week 10/13 - LOCF	The WFIRS-P Academic Performance Domain is the mean of 4 items, ranging from 0 (never/not at all) to 3 (very often/very much). Higher scores indicate greater functional impairment. Outcome measure is at 10 weeks for ages 6-12 years and at 13 weeks for ages 13-17 years.	Up to 10 weeks for children aged 6-12 years and up to 13 weeks for adolescents aged 13-17 years
Change From Baseline in the WFIRS-P Behavior in School Domain Score at Week 10/13 - LOCF	The WFIRS-P Behavior in School Domain is the mean of 6 items, ranging from 0 (never/not at all) to 3 (very often/very much). Higher scores indicate greater functional impairment. Outcome measure is at 10 weeks for ages 6-12 years and at 13 weeks for ages 13-17 years.	Up to 10 weeks for children aged 6-12 years and up to 13 weeks for adolescents aged 13-17 years
Change From Baseline in the WFIRS-P Life Skills Domain Score at Week 10/13 - LOCF	The WFIRS-P Life Skills Domain is the mean of 10 items, ranging from 0 (never/not at all) to 3 (very often/very much). Higher scores indicate greater functional impairment. Outcome measure is at 10 weeks for ages 6-12 years and at 13 weeks for ages 13-17 years.	Up to 10 weeks for children aged 6-12 years and up to 13 weeks for adolescents aged 13-17 years
Change From Baseline in the WFIRS-P Child Self-Concept Domain Score at Week 10/13 - LOCF	The WFIRS-P Child Self-Concept Domain is the mean of 3 items, ranging from 0 (never/not at all) to 3 (very often/very much). Higher scores indicate greater functional impairment. Outcome measure is at 10 weeks for ages 6-12 years and at 13 weeks for ages 13-17 years.	Up to 10 weeks for children aged 6-12 years and up to 13 weeks for adolescents aged 13-17 years
Change From Baseline in the WFIRS-P Social Domain Score at Week 10/13 - LOCF	The WFIRS-P Social Domain is the mean of 7 items, ranging from 0 (never/not at all) to 3 (very often/very much). Higher scores indicate greater functional impairment. Outcome measure is at 10 weeks for ages 6-12 years and at 13 weeks for ages 13-17 years.	Up to 10 weeks for children aged 6-12 years and up to 13 weeks for adolescents aged 13-17 years
Change From Baseline in the WFIRS-P Risk Domain Score at Week 10/13 - LOCF	The WFIRS-P Risk Domain is the mean of 10 items, ranging from 0 (never/not at all) to 3 (very often/very much). Higher scores indicate greater functional impairment. Outcome measure is at 10 weeks for ages 6-12 years and at 13 weeks for ages 13-17 years.	Up to 10 weeks for children aged 6-12 years and up to 13 weeks for adolescents aged 13-17 years
Change From Baseline in Brief Psychiatric Rating Scale for Children (BPRS-C) Total Score at Weeks 10/13 - LOCF	The BPRS-C characterizes childhood behavioral and emotional symptomatology. A total of 21 items are rated on a scale from 0 (not present) to 6 (extremely severe) with a total score ranging from 0 to 126. A decrease in score indicates a reduction in psychopathology. Outcome measure is at 10 weeks for ages 6-12 years and at 13 weeks for ages 13-17 years.	Baseline and up to 10 weeks for children aged 6-12 years and up to 13 weeks for adolescents aged 13-17 years
Structure Side-Effect Questionnaire	The Structured Side-effect Questionnaire is a simple checklist of 17 side effects. The subject indicates whether a side effect has occurred since the last visit by marking 'yes' on the checklist for each of the events listed. Outcome measure is at 12 weeks for ages 6-12 years and at 15 weeks for ages 13-17 years.	Up to 12 weeks for children aged 6-12 years and up to 15 weeks for adolescents aged 13-17 years
Columbia-Suicide Severity Rating Scale (C-SSRS)	C-SSRS is a semi-structured interview that captures the occurence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. The interview includes definitions and suggested questions to solicit the type of information needed to determine if a suicide-related thought or behaviour occurred. The assessment is done by the nature of the responses, not by a numbered scale. Outcome measure is at 12 weeks for ages 6-12 years and at 15 weeks for ages 13-17 years.	Up to 12 weeks for children aged 6-12 years and up to 15 weeks for adolescents aged 13-17 years

Collaborators and Investigators

• Sponsor: Shire

Publications and helpful links

General Publications

• Hervas A, Huss M, Johnson M, McNicholas F, van Stralen J, Sreckovic S, Lyne A, Bloomfield R, Sikirica V, Robertson B. Efficacy and safety of extended-release guanfacine hydrochloride in children and adolescents with attention-deficit/hyperactivity disorder: a randomized, controlled, phase III trial. Eur Neuropsychopharmacol. 2014 Dec;24(12):1861-72. doi: 10.1016/j.euroneuro.2014.09.014. Epub 2014 Oct 23.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 17, 2011
• Primary Completion (ACTUAL): May 1, 2013
• Study Completion (ACTUAL): May 1, 2013

Study Registration Dates

• First Submitted: November 16, 2010
• First Submitted That Met QC Criteria: November 18, 2010
• First Posted (ESTIMATE): November 19, 2010

Study Record Updates

• Last Update Posted (ACTUAL): July 2, 2021
• Last Update Submitted That Met QC Criteria: June 10, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: ADHD
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Dyskinesias; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Attention Deficit Disorder with Hyperactivity; Hyperkinesis; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Adrenergic Uptake Inhibitors; Atomoxetine Hydrochloride; Guanfacine
• Other Study ID Numbers: SPD503-316; 2010-018579-12 (EUDRACT_NUMBER)