Efficacy and Safety of SPD503 in Combination With Psychostimulants
Completed
Shire
Phase 3
2008-09-02
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.
A Drug Interaction Study of SPD503 and Concerta Administered Alone and In Combination in Normal Healthy Volunteers
Completed
Shire
Phase 1
2009-05-18
This is a drug-drug interaction study; the purpose of this study is to examine the
pharmacokinetics (levels of drug in the blood) of SPD503 (guanfacine hydrochloride) and
Concerta (methylphenidate HCl) when given alone, and in combination.
Tolerability and Efficacy of AM and PM Once Daily Dosing With Extended-release Guanfacine Hydrochloride in Children 6-12 With Attention-Deficit/Hyperactivity Disorder (ADHD) (The ADHD Tempo Study)
Completed
Shire
Phase 3
2009-11-17
The primary purpose is to assess the efficacy of once daily dosing with optimized SPD503 (1,
2, 3 and 4mg/day), dosed either in the morning or evening, compared to placebo, in children
with ADHD as measured by change from baseline score at endpoint on the ADHD-RS-IV.
Electrophysiological Effects of Guanfacine Extended Release in Attention Deficit Hyperactivity Disorder (ADHD)
Completed
Shire
Phase 4
2010-03-01
All subjects with the study will be children (age 6-12) with Attention Deficit Hyperactivity
Disorder (ADHD). After baseline assessment confirms the presence of ADHD, children will have
an Event related potential (ERP) (a type of electroencephalogram [EEG]) study. After the
baseline EEG, children will be randomized to either placebo or GXR for a 4-week, parallel
groups trial. During this trial, dosing will be flexibly adjusted according to patient
response or presence of side effects. The dosage will range from 1-4 mg. At the end of the
four week trial, a follow up ERP study will be obtained.
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