A Study of TAK-503 in Children and Teenagers With Attention Deficit Hyperactivity Disorder (ADHD)
Sponsored by Shire
About this trial
Last updated a year ago
Study ID
SPD503-401
Status
Active, not recruiting
Type
Interventional
Phase
Phase 4
Placebo
Yes
Accepting
6 to 17 Years
All
Not accepting
Healthy Volunteers
Trial Timing
Started 6 years ago
What is this trial about?
The main aim of this study is learn more about long-term TAK-503 treatment in children
and teenagers with ADHD for whom earlier stimulant treatment did not work.
The study has two parts (A and B). In Part A, participants will take tablets of TAK-503,
atomoxetine or placebo and in Part B TAK-503 tablets.
What are the participation requirements?
Inclusion Criteria
Boys and girls between 6 and 17 years can take part.
Must have been diagnosed with ADHD and earlier stimulant therapy must not have worked.
Exclusion Criteria
Cannot weigh less than 25 kg (children up to 12 years) or less than 34 kg (teenagers of 13 years or older).
Additional entry criteria will be discussed with the study doctor.