Status:
COMPLETED
Safety and Efficacy of SPD503 in Treating Attention-Deficit/Hyperactivity Disorder (ADHD) in Children 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 assess the safety and efficacy of SPD503 (Guanfacine hydrochloride) compared to placebo in the treatment of ADHD in children and adolescents aged 6-17
Eligibility Criteria
Inclusion
- Subjects with a primary diagnosis of ADHD
- Male or non-pregnant female subject who agrees to comply with any applicable contraceptive requirements
Exclusion
- Subject has current uncontrolled comorbid psychiatric diagnosis (except ODD) with significant symptoms
- History of seizure during the last 2 years
- Subject has any specific cardiac condition or family history of significant cardiac condition
- Subject is pregnant or lactating
Key Trial Info
Start Date :
January 29 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 23 2003
Estimated Enrollment :
345 Patients enrolled
Trial Details
Trial ID
NCT00152009
Start Date
January 29 2003
End Date
August 23 2003
Last Update
June 10 2021
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