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

Shire Pharmaceutical Development Ltd0 sites252 target enrollmentDecember 28, 2010

DrugsINTUNIV™Strattera

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Not specified
Sponsor: Shire Pharmaceutical Development Ltd
Enrollment: 252
Status: Active, not recruiting
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

December 28, 2010

End Date

TBD

Last Updated

12 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Shire Pharmaceutical Development Ltd

Eligibility Criteria

Inclusion Criteria

•1\.Male or female, aged 6 to 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 Good Clinical Practice 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.

Exclusion Criteria

•1\.Subject has any current, controlled (requiring a prohibited medication or behavioural modification program) or uncontrolled, co\-morbid psychiatric diagnosis \[except oppositional defiant disorder (ODD)], including any severe comorbid 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 mediation.
•3\.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.
•4\.Subject has a known family history of sudden cardiac death, ventricular arrhythmia, or QT prolongation.
•5\.Subjects with orthostatic hypotension or a known history of hypertension.
•6\.Subject has glaucoma.
•7\.Subject has clinically significant ECG findings as judged by the Investigator with consideration of the central ECG laboratory’s interpretation.
•8\.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.
•9\.Current use of any prohibited medication or other medications, including monoamine oxidase inhibitors, herbal supplements, that affect BP or heart rate, potent CYP2D6 inhibitors, medicines known to prolong the QT/QTc interval, medications that lower seizure threshold, pressor agents, beta\-2 agonists, medications that affect noradrenaline, medications that have 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\).