At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 324 enrolled
Drug / intervention
SPD503 (1 mg) +4 moredrug
Likely dose
SPD503 1-4 mg daily (titrated doses)AI-extracted
Key inclusion· 2
- ✓Primary diagnosis of Attention Deficit Hyperactivity Disorder (ADHD)
- ✓Age 6-17 years (from trial title and standard inclusion)
Key exclusion· 4
- ✕Current, uncontrolled comorbid psychiatric diagnosis with significant symptoms, including severe Axis I or II disorders
- ✕Body weight less than 55 lbs or morbidly overweight with BMI ≥35
- ✕History of seizure in the last 2 years or serious tic disorder, including Tourette's Disorder
- ✕Pregnancy or lactation
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase III, Randomized, Double-Blind, Multi-Center, Parallel-Group, Placebo-Controlled Safety and Efficacy Study of SPD503 in Children and Adolescents Aged 6-17 With Attention Deficit Hyperactivity Disorder (ADHD)
In Brief
A Phase 3 clinical trial evaluating SPD503 (1 mg), SPD503 (2 mg), and 3 other interventions for Attention Deficit Disorder With Hyperactivity. Completed, enrolled 324 participants.
Detailed Summary
The purpose of this study is to determine the efficacy of SPD503 compared to placebo in the treatment of children and adolescents aged 6-17 with ADHD.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
Countries--
Collaborators--
Timeline
Phase 3CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartMar 2004
Primary CompletionOct 2004
First PostedSep 2005
TodayJul 2026
First PostedSep 8, 2005
Enrollment StartMar 30, 2004
Primary CompletionOct 7, 2004
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 20.8 years ago
Interventions
SPD503 (1 mg)drug
SPD503 (2 mg)drug
SPD503 (3 mg)drug
SPD503 (4 mg)drug
Placebodrug