Status:
COMPLETED
Safety, Tolerability and Efficacy of SPD503 in Treating ADHD in Children Aged 6-17
Lead Sponsor:
Shire
Conditions:
Attention Deficit Disorder With Hyperactivity
Eligibility:
All Genders
6-17 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine the effects of SPD503 compared to placebo on tasks of sustained attention in children and adolescents aged 6-17 diagnosed with ADHD.
Eligibility Criteria
Inclusion
- Subjects with a primary diagnosis of ADHD
- Minimum baseline visit ADHD-RS-IV score of 24 and a baseline CGI-S score =\>4
- Male or non-pregnant female subject who agrees to comply with any applicable contraceptive requirements
- Subject weighs \> 55 lbs and is not morbidly overweight
Exclusion
- Subject has a comorbid psychiatric diagnosis (except ODD) with significant symptoms such as any severe comorbid Axis II disorders or severe Axis I disorders
- Subject has a history of seizure disorder
- Subject has any specific cardiac condition or family history of significant cardiac condition
- Subject is pregnant, lactating or within six month post-partum
Key Trial Info
Start Date :
May 12 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 5 2005
Estimated Enrollment :
182 Patients enrolled
Trial Details
Trial ID
NCT00150592
Start Date
May 12 2005
End Date
October 5 2005
Last Update
June 10 2021
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