At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 340 enrolled
Drug / intervention
extended-release guanfacine hydrochloride (SPD503) +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 3, Double-blind, Randomized, Multicenter, Placebo-controlled, Dose Optimization Study Evaluating the Tolerability and Efficacy of AM and PM Once Daily Dosing With Extended-release Guanfacine Hydrochloride in Children Aged 6-12 With a Diagnosis of Attention-Deficit/Hyperactivity Disorder
In Brief
A Phase 3 clinical trial evaluating extended-release guanfacine hydrochloride (SPD503), placebo, and 1 other intervention for Attention-Deficit/Hyperactivity Disorder. Completed, enrolled 340 participants across 46 sites in 2 countries.
Detailed Summary
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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAttention-Deficit/Hyperactivity Disorder
CountriesCanada, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedOct 2009
Enrollment StartNov 2009
Primary CompletionOct 2010
TodayJul 2026
First PostedOct 20, 2009
Enrollment StartNov 17, 2009
Primary CompletionOct 9, 2010
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 16.7 years ago
Interventions
extended-release guanfacine hydrochloride (SPD503)drug
dosed in AM
placebodrug
dosed in the AM or PM
extended-release guanfacine hydrochloridedrug
Dosed in the PM