Status:
COMPLETED
Safety and Tolerability of SPD503 and Psychostimulants in Children and Adolescents Aged 6-17 With Attention-Deficit/Hyperactivity Disorder (ADHD)
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 assess the safety and tolerability of administering SPD503 (Guanfacine hydrochloride) with psychostimulants (amphetamine or methylphenidate) for treatment of ADHD in ch...
Eligibility Criteria
Inclusion
- Subjects with a primary diagnosis of ADHD
- Subject on a stable dose of a psychostimulant approved for the treatment of ADHD for at least 1 month, with sub-optimal control in the Investigator's opinion
- 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 and mild anxiety) 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 :
August 16 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 27 2004
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT00151996
Start Date
August 16 2004
End Date
December 27 2004
Last Update
June 10 2021
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