Attention-Deficit/Hyperactivity Disorder (ADHD) is a psychiatric disorder characterized by 3 main symptoms: inattention, hyperactivity and impulsivity. This study will evaluate the long-term safety of SPD485 in the symptomatic treatment of children aged 6-12 diagnosed with ADHD

Condition	Intervention	Phase
Attention Deficit Disorder with Hyyperactivity.	Drug: ''''d, I (threo)-methylphenidate, Methylphenidate Transdermal System	Phase III

Further Study Details: 

Primary Outcomes: Treatment emergent adverse events over 12 months.
Secondary Outcomes: ADHD-RS-IV scores; Parent Global Assessment; Clinical Global Impressions Scale; Child''''s Sleep Habits Questionnaire
Expected Total Enrollment:  450

Ages Eligible for Study:  6 Years   -   12 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Subject must have participated in and completed SPD485-201 or participated in and completed a minimum of five of the seven weeks of double-blind treatment in study SPD485-302. Subjects who are participating in N17-021 may enroll in this study following completion of the End of Study/Termination visit procedures.
• Females of childbearing potential must have a negative urine pregnancy test at Baseline and must abstain from sexual activity that could result in pregnancy, or use acceptable contraceptives.

Exclusion Criteria:

• Subject was terminated from SPD485-102, SPD495-201, SPD485-302 OR N17-021 for non-compliance or experienced a serious adverse event resulting in termination from the antecedent protocols
• Female subject is pregnant or lactating

Study ID Numbers:  SPD485-303
Last Updated:  September 8, 2005
Record first received:  September 7, 2005
ClinicalTrials.gov Identifier:  NCT00151957
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-09-13