Status:
COMPLETED
Safety and Efficacy of SPD503 in Treating ADHD in Children and Adolescents Aged 6-17
Lead Sponsor:
Shire
Conditions:
Attention Deficit Disorder With Hyperactivity
Eligibility:
All Genders
6-17 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to determine the efficacy of SPD503 compared to placebo in the treatment of children and adolescents aged 6-17 with ADHD.
Eligibility Criteria
Inclusion
- Subjects with a primary diagnosis of ADHD
- Females of childbearing potential must have a negative serum beta human chorionic gonadotropin (HCG) pregnancy test
- Male or non-pregnant female subject who agrees to comply with any applicable contraceptive requirements
Exclusion
- Subject has a current, uncontrolled, comorbid psychiatric diagnosis with significant symptoms such as severe comorbid Axis II disorders or severe Axis I disorders
- Subject weighs less than 55 lbs or is morbidly overweight with a BMI =\> 35
- Subject has a history of seizure during the last 2 years or a serious tic disorder, including Tourette's Disorder
- Subject is pregnant or lactating
Key Trial Info
Start Date :
March 30 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 7 2004
Estimated Enrollment :
324 Patients enrolled
Trial Details
Trial ID
NCT00150618
Start Date
March 30 2004
End Date
October 7 2004
Last Update
June 10 2021
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