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

Shire32 sites in 1 country217 target enrollmentDecember 4, 2006

ConditionsADHD

InterventionsSPD503 (Guanfacine hydrochloride)Placebo

DrugsSPD503 (Guanfacine hydrochloride)Placebo

Overview

Phase: Phase 3
Intervention: SPD503 (Guanfacine hydrochloride)
Conditions: ADHD
Sponsor: Shire
Enrollment: 217
Locations: 32
Primary Endpoint: Change From Baseline in the Oppositional Subscale of the Conners' Parent Rating Scale-Revised Long Form (CPRS-R:L) Score at Up to 8 Weeks
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

December 4, 2006

End Date

January 4, 2008

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Shire

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Healthy subjects with ADHD and oppositional symptoms
•ADHD-RS\>=24
•T-score of Opp subscale CPRS-R:L \>=65
•Normal ECG and BP
•\>= 55 lbs

Exclusion Criteria

Not provided

Arms & Interventions

SPD503 (Guanfacine hydrochloride)

Intervention: SPD503 (Guanfacine hydrochloride)

Placebo

Intervention: Placebo

Outcomes

Primary Outcomes

Change From Baseline in the Oppositional Subscale of the Conners' Parent Rating Scale-Revised Long Form (CPRS-R:L) Score at Up to 8 Weeks

Time Frame: Baseline and up to 8 weeks

The oppositional subscale of the CPRS-R:L contains 10 items designed to reflect criteria for oppositional defiance disorder (ODD). Each item is scored on a range from 0 (not true at all) to 3 (very much true) with total scores ranging from 0 to 30. Higher scores are reflective of more severe symptoms.

Secondary Outcomes

Assessment of Clinical Global Impression-Severity of Illness (CGI-S)(up to 8 weeks)
Change From Baseline in Electrocardiogram Results (QTcF Interval) at Up to 8 Weeks(Baseline and up to 8 weeks)
Number of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I)(up to 8 weeks)
Change From Baseline in the Parent Stress Index-Short Form (PSI/SF) Score at Up to 8 Weeks(Baseline and up to 8 weeks)
Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS-IV) Total Score at Up to 8 Weeks(Baseline and up to 8 weeks)
Change From Baseline in the 40-Item Conduct Problem Scale of the New York Parent's Rating Scale-School-aged (NYPRS-S) Score at Up to 8 Weeks(Baseline and up to 8 weeks)
Number of Participants With Overall Satisfaction on the Medication Satisfaction Survey (MSS)(up to 8 weeks)
Change From Baseline in Pulse Rate at Up to 8 Weeks(Baseline and up to 8 weeks)
Change From Baseline in Systolic Blood Pressure at Up to 8 Weeks(Baseline and up to 8 weeks)
Change From Baseline in Diastolic Blood Pressure at Up to 8 Weeks(Baseline and up to 8 weeks)