At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 336 enrolled
Drug / intervention
Lisdexamfetamine Dimesylate (LDX) +2 moredrug
Likely dose
Lisdexamfetamine Dimesylate (LDX) 70mgfrom 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, Randomised, Double-Blind, Multicentre, Parallel-Group, Placebo- and Active-Controlled, Dose-Optimisation Safety and Efficacy Study of Lisdexamfetamine Dimesylate (LDX) in Children and Adolescents Aged 6-17 With Attention-Deficit/Hyperactivity Disorder (ADHD)
In Brief
A Phase 3 clinical trial evaluating Lisdexamfetamine Dimesylate (LDX), Methylphenidate Hydrochloride, and 1 other intervention for ADHD. Completed, enrolled 336 participants across 49 sites in 10 countries.
Detailed Summary
The main aim of this study is to see if giving LDX to children and adolescents aged 6-17 years with ADHD decreases symptoms of ADHD.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsADHD
CountriesBelgium, France, Germany, Hungary, Italy, Netherlands, Poland, Spain, Sweden, United Kingdom
Collaborators--
Timeline
Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedOct 2008
Enrollment StartNov 2008
Primary CompletionMar 2011
TodayJul 2026
First PostedOct 1, 2008
Enrollment StartNov 17, 2008
Primary CompletionMar 16, 2011
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 17.8 years ago
Interventions
Lisdexamfetamine Dimesylate (LDX)drug
30, 50 or 70mg capsule once per day (Overencapsulated)
Methylphenidate Hydrochloridedrug
18, 36, or 54mg tablet one per day (Overencapsulated)
Placebodrug
Placebo capsule once per day (Overencapsulated)