At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 267 enrolled
Drug / intervention
Lisdexamfetamine Dimesylate +1 moredrug
Likely dose
Lisdexamfetamine Dimesylate 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 3b, Double-blind, Randomised, Active-controlled, Parallel Group Study to Assess the Time to Response of Lisdexamfetamine Dimesylate to Atomoxetine Hydrochloride in Children and Adolescents Aged 6-17 Years With Attention-Deficit/Hyperactivity Disorder (ADHD) Who Have Had an Inadequate Response to Methylphenidate Therapy
In Brief
A Phase 3 clinical trial evaluating Lisdexamfetamine Dimesylate and Atomoxetine Hydrochloride for Attention-Deficit/Hyperactivity Disorder. Completed, enrolled 267 participants across 64 sites in 10 countries.
Detailed Summary
This study will evaluate how long it takes for ADHD symptoms to improve in subjects who are judged by the Investigator to have had an inadequate response to methylphenidate therapy. The study will also test the safety of Lisdexamfetamine Dimesylate and how well it works.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAttention-Deficit/Hyperactivity Disorder
CountriesBelgium, Canada, Germany, Hungary, Italy, Poland, Spain, Sweden, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedApr 2010
Enrollment StartJun 2010
Primary CompletionJul 2012
TodayJul 2026
First PostedApr 19, 2010
Enrollment StartJun 28, 2010
Primary CompletionJul 19, 2012
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 16.2 years ago
Interventions
Lisdexamfetamine Dimesylatedrug
Oral 30, 50, or 70mg once-daily for 9 weeks
Atomoxetine Hydrochloridedrug
Oral 10mg to 100mg once-daily for 9 weeks