Status:
COMPLETED
Efficacy and Safety of SPD503 in Combination With Psychostimulants
Lead Sponsor:
Shire
Conditions:
ADHD
Eligibility:
All Genders
6-17 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to assess the efficacy and safety of SPD503 in subjects with ADHD when co-administered with psychostimulants in children and adolescents aged 6-17 years with a diagnosis o...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Healthy subjects with ADHD currently taking a stable dose of psychostimulant for at least 4 weeks
- Aged 6-17 years with a sub-optimal
- Partial response to stimulants
- Subjects must be \< 95th percentile for BMI with weight \>= 55lbs and \<= 176lbs
Exclusion
Key Trial Info
Start Date :
September 2 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 10 2009
Estimated Enrollment :
461 Patients enrolled
Trial Details
Trial ID
NCT00734578
Start Date
September 2 2008
End Date
December 10 2009
Last Update
June 14 2021
Active Locations (61)
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1
Harmonex Neuroscience Research
Dothan, Alabama, United States, 36303
2
Melmed Center
Scottsdale, Arizona, United States, 85254
3
Clinical Study Centers, LLC
Little Rock, Arkansas, United States, 72205
4
Valley Clinical Research, Inc.
El Centro, California, United States, 92243