At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 217 enrolled
Drug / intervention
SPD503 (Guanfacine hydrochloride) +1 moredrug
Likely dose
SPD503 (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 Double-Blind, Randomized, Multi-Center, Flexible Dose Study Evaluating the Efficacy and Safety of SPD503 (Guanfacine Hydrochloride) in Children Aged 6-12 With Symptoms of Oppositionality and a Diagnosis of Attention Deficit/Hyperactivity Disorder
In Brief
A Phase 3 clinical trial evaluating SPD503 (Guanfacine hydrochloride) and Placebo for ADHD. Completed, enrolled 217 participants across 34 sites.
Detailed Summary
To assess efficacy and safety of SPD503(guanfacine hydrochloride) in subjects with ADHD and oppositional symptoms.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsADHD
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 2006
Enrollment StartDec 2006
Primary CompletionJan 2008
TodayJul 2026
First PostedAug 23, 2006
Enrollment StartDec 4, 2006
Primary CompletionJan 4, 2008
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 19.9 years ago
Interventions
SPD503 (Guanfacine hydrochloride)drug
Subjects will start at 1mg tablet each morning and will subsequently be titrated (in 1 mg weekly increments) to optimal dose based upon tolerance and response to investigational product (not to exceed 4 mg/day).
Placebodrug
Placebo