SPD503 (Guanfacine Hydrochloride) in ADHD Plus Oppositional Symptoms - Full Text View

Sponsored by:	Shire Pharmaceutical Development
Information provided by:	Shire Pharmaceutical Development
ClinicalTrials.gov Identifier:	NCT00367835

Purpose

To assess efficacy and safety of SPD503(guanfacine hydrochloride) in subjects with ADHD and oppositional symptoms.

Condition	Intervention	Phase
ADHD	Drug: guanfacine hydrochloride Drug: Placebo	Phase III

Drug Information available for: Guanfacine Guanfacine hydrochloride

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Double-Blind, Randomized, Multi-Center, Flexible Dose Study Evaluating the Efficacy and Safety of SPD503 (Guanfacine Hydrochloride) in Children Aged 6-12 With Symptoms of Oppositionality and a Diagnosis of Attention Deficit/Hyperactivity Disorder

Further study details as provided by Shire Pharmaceutical Development:

Primary Outcome Measures:

Score on the oppositional subscale of the CPRS-R:L at 8 weeks [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

ADHD-RS [ Time Frame: As Change from Baseline (approximately 13 weeks) ] [ Designated as safety issue: No ]
CGI-S [ Time Frame: As Change from Baseline (approximately 8 weeks) ] [ Designated as safety issue: No ]
CGI-I [ Time Frame: As Change from Baseline (approximately 8 weeks) ] [ Designated as safety issue: No ]
Conduct subscale of NYPRS-S [ Time Frame: As Change from Baseline (approximately 8 weeks) ] [ Designated as safety issue: No ]
PSI/SF [ Time Frame: As Change from Baseline (approximately 8 weeks) ] [ Designated as safety issue: No ]
MSS at 8 weeks [ Time Frame: One administration at week 8 ] [ Designated as safety issue: No ]
Safety and tolerability based on treatment-emergent adverse events, clinical laboratory tests, physical examinations, vital signs, and electrocardiograms [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	130
Study Start Date:	September 2006
Study Completion Date:	January 2008
Primary Completion Date:	December 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: guanfacine hydrochloride Subjects will start at 1mg tablet each morning and will subsequently be titrated (in 1mg weekly increments) to optimal dose based upon tolerance and response to investigational product (not to exceed 4mg/day).
2: Placebo Comparator	Drug: Placebo Placebo

Eligibility

Criteria

Inclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00367835

Sponsors and Collaborators

Shire Pharmaceutical Development

Investigators

Principal Investigator:

Thomas Spencer, M.D.

Massachusetts General Hospital

More Information

Responsible Party:	Shire ( Timothy Whitaker, M.D. )
Study ID Numbers:	SPD503-307
Study First Received:	August 22, 2006
Last Updated:	March 19, 2008
ClinicalTrials.gov Identifier:	NCT00367835
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Attention Deficit Disorder with Hyperactivity
Guanfacine
Mental Disorders

Mental Disorders Diagnosed in Childhood
Attention Deficit and Disruptive Behavior Disorders
Hyperkinesis

Additional relevant MeSH terms:

Neurotransmitter Agents
Adrenergic alpha-Agonists
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Therapeutic Uses

Physiological Effects of Drugs
Cardiovascular Agents
Antihypertensive Agents
Adrenergic Agonists
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009