At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 338 enrolled
Drug / intervention
Extended-release Guanfacine Hydrochloride +2 moredrug
Likely dose
Extended-release Guanfacine Hydrochloride 1mgfrom 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, Randomised, Double-blind, Multicentre, Parallel-group, Placebo- and Active-reference, Dose-optimisation Efficacy and Safety Study of Extended-release Guanfacine Hydrochloride in Children and Adolescents Aged 6-17 Years With Attention-Deficit/Hyperactivity Disorder
In Brief
A Phase 3 clinical trial evaluating Extended-release Guanfacine Hydrochloride, Atomoxetine Hydrochloride, and 1 other intervention for Attention Deficit Hyperactivity Disorder. Completed, enrolled 338 participants across 66 sites in 13 countries.
Detailed Summary
For children and adolescents, how does SPD503 compare to placebo for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAttention Deficit Hyperactivity Disorder
CountriesAustria, Canada, France, Germany, Ireland, Italy, Poland, Romania, Spain, Sweden, Ukraine, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedNov 2010
Enrollment StartJan 2011
Primary CompletionMay 2013
TodayJul 2026
First PostedNov 19, 2010
Enrollment StartJan 17, 2011
Primary CompletionMay 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 15.6 years ago
Interventions
Extended-release Guanfacine Hydrochloridedrug
Tablet, once daily, optimised dose (1mg to 7mg based on age and weight), 6-week maintenance duration on optimised dose.
Atomoxetine Hydrochloridedrug
Capsule, once daily, optimised dose (10mg to 100mg based on weight), 8-9-weeks maintenance duration on optimised dose
Placebo Comparatordrug
Placebo