At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 276 enrolled
Drug / intervention
Lisdexamfetamine dimesylate (LDX) +1 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, Double-blind, Placebo-controlled, Randomised Withdrawal, Multicentre, Extension, 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) and Placebo for ADHD. Completed, enrolled 276 participants across 51 sites in 9 countries.
Detailed Summary
The main aim of this study is to evaluate the long-term maintenance of efficacy of LDX after administered to children and adolescents aged 6-17 with ADHD for at least 6 months
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsADHD
CountriesBelgium, France, Germany, Hungary, Italy, Poland, Sweden, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedNov 2008
Enrollment StartJan 2009
Primary CompletionOct 2011
TodayJul 2026
First PostedNov 4, 2008
Enrollment StartJan 27, 2009
Primary CompletionOct 26, 2011
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 17.7 years ago
Interventions
Lisdexamfetamine dimesylate (LDX)drug
LDX 30, 50, or 70mg capsule once per day (open-label and double-blind periods)
Placebodrug
Placebo capsule once per day (double-blind period)