Efficacy and Safety of SPD503 in Combination With Psychostimulants - Full Text View

Sponsored by:	Shire Pharmaceutical Development
Information provided by:	Shire Pharmaceutical Development
ClinicalTrials.gov Identifier:	NCT00734578

Purpose

The purpose of this study is to assess the efficacy and safety of SPD503 in subjects with ADHD when co-administered with psychostimulants in children and adolescents aged 6-17 years with a diagnosis of ADHD with a sub-optimal, partial response to stimulants.

Condition	Intervention	Phase
ADHD	Drug: Guanfacine Hydrochloride Extended Release Drug: Placebo	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Phase III, Double-Blind, Randomized, Placebo-Controlled, Multi-Center, Dose Optimization Study Evaluating the Efficacy and Safety of SPD503 in Combination With Psychostimulants in Children and Adolescents Aged 6-17 Years With a Diagnosis of Attention-Deficit/Hyperactivity Disorder (ADHD)

Resource links provided by NLM:

Drug Information available for: Guanfacine Guanfacine hydrochloride

U.S. FDA Resources

Further study details as provided by Shire Pharmaceutical Development:

Primary Outcome Measures:

Clinician-administered ADHD rating scale (ADHD-RS-IV) [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

CGI of Severity and Improvement (CGI-S and CGI-I),CGI-P, PGA, Wil-Hammer Before School Functioning Scale, Oppositional Subscale of CPRS-R:L, PSQ [ Time Frame: 10 Weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	441
Study Start Date:	September 2008
Estimated Study Completion Date:	September 2009
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental Guanfacine Extended Release-AM	Drug: Guanfacine Hydrochloride Extended Release Guanfacine Extended Release-AM Optimized 1-4mg
B: Experimental Guanfacine Extended Release-PM	Drug: Guanfacine Hydrochloride Extended Release Guanfacine Extended Release-PM Optimized 1-4mg
C: Placebo Comparator Placebo	Drug: Placebo Placebo matched to Guanfacine Hydrochloride Extended Release

Detailed Description:

Not required

Eligibility

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

Criteria

Inclusion Criteria:

Healthy subjects with ADHD currently taking a stable dose of psychostimulant for at least 4 weeks
Aged 6-17 years with a sub-optimal
Partial response to stimulants
Subjects must be < 95th percentile for BMI with weight >= 55lbs and <= 176lbs

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00734578

Contacts

Contact: Shire Call Center

1-866-842-5335

Show 62 Study Locations

Sponsors and Collaborators

Shire Pharmaceutical Development

Investigators

Principal Investigator:

Timothy Wilens

Massachusetts General Hospital

More Information

No publications provided

Responsible Party:	Shire Pharmaceutical Development, Inc. ( Timothy Whitaker, MD )
Study ID Numbers:	SPD503-313
Study First Received:	August 12, 2008
Last Updated:	August 20, 2009
ClinicalTrials.gov Identifier:	NCT00734578 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Shire Pharmaceutical Development:

Not required

Study placed in the following topic categories:

Neurotransmitter Agents
Adrenergic alpha-Agonists
Adrenergic Agents
Attention Deficit Disorder with Hyperactivity
Guanfacine
Mental Disorders

Mental Disorders Diagnosed in Childhood
Attention Deficit and Disruptive Behavior Disorders
Hyperkinesis
Cardiovascular Agents
Antihypertensive Agents
Adrenergic Agonists

Additional relevant MeSH terms:

Neurotransmitter Agents
Adrenergic alpha-Agonists
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Physiological Effects of Drugs
Attention Deficit and Disruptive Behavior Disorders
Cardiovascular Agents
Antihypertensive Agents

Pharmacologic Actions
Adrenergic Agonists
Attention Deficit Disorder with Hyperactivity
Mental Disorders
Guanfacine
Therapeutic Uses
Mental Disorders Diagnosed in Childhood

ClinicalTrials.gov processed this record on September 04, 2009