A Phase III, Randomized, Multi-Center, Double-Blind, Parallel-Group, Placebo-Controlled Safety and Efficacy Study of SPD503 in Children and Adolescents Aged 6-17 With Attention-Deficit/Hyperactivity Disorder (ADHD)

Shire0 sites345 target enrollmentJanuary 29, 2003

ConditionsAttention Deficit Disorder With Hyperactivity

InterventionsSPD503 (Guanfacine hydrochloride) (2 mg)SPD503 (3 mg)SPD503 (4 mg)Placebo

DrugsSPD503 (4 mg)SPD503 (Guanfacine hydrochloride) (2 mg)SPD503 (3 mg)Placebo

Overview

Phase: Phase 3
Intervention: SPD503 (Guanfacine hydrochloride) (2 mg)
Conditions: Attention Deficit Disorder With Hyperactivity
Sponsor: Shire
Enrollment: 345
Primary Endpoint: Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS-IV) Score at Up to 5 Weeks
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

The purpose of this study is to assess the safety and efficacy of SPD503 (Guanfacine hydrochloride) compared to placebo in the treatment of ADHD in children and adolescents aged 6-17

Registry

clinicaltrials.gov

Start Date

January 29, 2003

End Date

August 23, 2003

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Shire

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subjects with a primary diagnosis of ADHD
•Male or non-pregnant female subject who agrees to comply with any applicable contraceptive requirements

Exclusion Criteria

•Subject has current uncontrolled comorbid psychiatric diagnosis (except ODD) with significant symptoms
•History of seizure during the last 2 years
•Subject has any specific cardiac condition or family history of significant cardiac condition
•Subject is pregnant or lactating

Arms & Interventions

SPD503 (Guanfacine HCl) (2 mg)

Intervention: SPD503 (Guanfacine hydrochloride) (2 mg)

SPD503 (3 mg)

Intervention: SPD503 (3 mg)

SPD503 (4 mg)

Intervention: SPD503 (4 mg)

Placebo

Intervention: Placebo

Outcomes

Primary Outcomes

Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS-IV) Score at Up to 5 Weeks

Time Frame: Baseline and up to 5 weeks

Change in the Attention Deficit Hyperactivity Disorder Rating Scale-fourth edition (ADHD-RS-IV) total score from baseline. The ADHD-RS-IV consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54.

Secondary Outcomes

Change From Baseline in Conner's Parent Rating Scale-revised Short Version (CPRS-R) Score at Up to 5 Weeks(Baseline and up to 5 weeks)
Change From Baseline in Conner's Teacher Rating Scale-revised Short Version (CTRS-R) Score at Up to 5 Weeks(Baseline and up to 5 weeks)
Number of Participants With Improvement in Clinical Global Impression-Improvement (CGI-I)(up to 5 weeks)
Change From Baseline in Child Health Questionnaire-Parent Form (CHQ-PF50) Score at 5 Weeks(Baseline and 5 weeks)
Number of Participants With Improvement in Parent Global Assessment (PGA)(up to 5 weeks)