At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 461 enrolled
Drug / intervention
SPD503-AM +2 moredrug
Likely dose
SPD503-AM 4mgfrom 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 III, Double-Blind, Randomized, Placebo-Controlled, Multi-Center, Dose Optimization Study Evaluating the Efficacy and Safety of SPD503 in Combination With Psychostimulants in Children and Adolescents Aged 6-17 Years With a Diagnosis of Attention-Deficit/Hyperactivity Disorder (ADHD)
In Brief
A Phase 3 clinical trial evaluating SPD503-AM, SPD503-PM, and 1 other intervention for ADHD. Completed, enrolled 461 participants across 61 sites.
Detailed Summary
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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsADHD
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedAug 2008
Enrollment StartSep 2008
Primary CompletionDec 2009
TodayJul 2026
First PostedAug 14, 2008
Enrollment StartSep 2, 2008
Primary CompletionDec 10, 2009
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 17.9 years ago
Interventions
SPD503-AMdrug
SPD503 (Guanfacine Extended Release)-AM Optimized 1-4mg
SPD503-PMdrug
SPD503 (Guanfacine Extended Release)-PM Optimized 1-4mg
Placebodrug
Placebo matched to Guanfacine Hydrochloride Extended Release