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 sites333 target enrollmentMay 16, 2011

ConditionsAttention-Deficit/Hyperactivity Disorder (ADHD)MedDRA version: 15.0Level: LLTClassification code 10068451Term: ADHD, combined typeSystem Organ Class: 10037175 - Psychiatric disorders MedDRA version: 15.0Level: LLTClassification code 10068453Term: ADHD, predominantly inattentive typeSystem Organ Class: 10037175 - Psychiatric disorders MedDRA version: 15.0Level: LLTClassification code 10068452Term: ADHD, predominantly hyperactive-impulsive typeSystem Organ Class: 10037175 - Psychiatric disorders MedDRA version: 15.0Level: LLTClassification code 10064104Term: ADHDSystem Organ Class: 10037175 - Psychiatric disorders Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

DrugsINTUNIV™Strattera

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Attention-Deficit/Hyperactivity Disorder (ADHD)
Sponsor: Shire Pharmaceutical Development Ltd
Enrollment: 333
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

May 16, 2011

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.
•8\.Subject is able to swallow intact tablets and capsules.
•9\.Subject who is a female of child\-bearing potential (FOCP), defined as \>/\=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 a supine and standing 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 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.