Safety and Efficacy of SPD503 in Treating ADHD in Children and Adolescents Aged 6-17

This study has been completed.

Sponsored by:	Shire Pharmaceutical Development
Information provided by:	Shire Pharmaceutical Development
ClinicalTrials.gov Identifier:	NCT00150618

Purpose

The purpose of this study is to determine the efficacy of SPD503 compared to placebo in the treatment of children and adolescents aged 6-17 with ADHD.

Condition	Intervention	Phase
Attention Deficit Disorder With Hyperactivity	Drug: Guanfacine hydrochloride	Phase III

MedlinePlus related topics: Attention Deficit Hyperactivity Disorder

Drug Information available for: Guanfacine Guanfacine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Phase III, Randomized, Double-Blind, Multi-Center, Parallel-Group, Placebo-Controlled Safety and Efficacy Study of SPD503 in Children and Adolescents Aged 6-17 With Attention Deficit Hyperactivity Disorder (ADHD)

Further study details as provided by Shire Pharmaceutical Development:

Primary Outcome Measures:

Score on ADHD Rating Scale at 6 weeks

Secondary Outcome Measures:

Conners' Parent Rating Scale-Revise Short Version
Clinical Global Impressions Scale
Parent's Global Assessment
Child Health Questionnaire

Estimated Enrollment:	300
Study Start Date:	April 2004
Study Completion Date:	May 2006

Eligibility

Ages Eligible for Study:	6 Years to 17 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subjects with a primary diagnosis of ADHD
Females of childbearing potential must have a negative serum beta human chorionic gonadotropin (HCG) pregnancy test
Male or non-pregnant female subject who agrees to comply with any applicable contraceptive requirements

Exclusion Criteria:

Subject has a current, uncontrolled, comorbid psychiatric diagnosis with significant symptoms such as severe comorbid Axis II disorders or severe Axis I disorders
Subject weighs less than 55 lbs or is morbidly overweight with a BMI => 35
Subject has a history of seizure during the last 2 years or a serious tic disorder, including Tourette's Disorder
Subject is pregnant or lactating

Contacts and Locations

No Contacts or Locations Provided

More Information

Study ID Numbers:	SPD503-304
Study First Received:	September 6, 2005
Last Updated:	November 2, 2007
ClinicalTrials.gov Identifier:	NCT00150618
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Signs and Symptoms
Attention Deficit Disorder with Hyperactivity
Guanfacine
Mental Disorders
Mental Disorders Diagnosed in Childhood

Neurologic Manifestations
Attention Deficit and Disruptive Behavior Disorders
Hyperkinesis
Dyskinesias

Additional relevant MeSH terms:

Neurotransmitter Agents
Disease
Adrenergic alpha-Agonists
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Nervous System Diseases
Physiological Effects of Drugs

Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions
Adrenergic Agonists
Pathologic Processes
Therapeutic Uses

ClinicalTrials.gov processed this record on January 16, 2009