The purpose of this study is to assess the safety and effectiveness of SPD465 in the treatment of ADHD. The study will also look at how SPD465 affects sleep.

Condition	Intervention	Phase
Attention Deficit Disorder with Hyperactivity.	Drug: Neutral salts of dextroamphetamine sulfate, USP, amphetamine sulfate, USP, d-amphetamine saccarate, d, l-amphetamine aspartate monohydrate.	Phase III

Further Study Details: 

Primary Outcomes: The evaluation of safety will be based on the occurrence of treatment emergent AEs and specific evaluation of vitals signs, ECG, laboratory and physical examination.
Secondary Outcomes: ADHD-rating scale (ADHD-RS-IV) taken at the Visit 1 and all visits thereafter.; Clinical Global Impression of Improvement scale assessed at Visits 1 through 15/Early Termination (ET).; Pittsburgh Sleep Quality Index (PSQI) - assessed at Visits 1 through 15/ET.
Expected Total Enrollment:  1040

Ages Eligible for Study:  18 Years   -   55 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Subject satisfied all entry criteria for the antecedent protocol (SPD465-301 or SPD465-303) and completed a minimum of 4 of the 7 weeks of double-blind treatment without experiencing any clinically significant adverse events.
• Subject must be male or non-pregnant female who agrees to comply with using acceptable contraceptive methods.

Exclusion Criteria:

• Subject was terminated from antecedent protocol (SPD465-301 or SPD465-303) for non-compliance and/or experienced a serious advers event or adverse event resulting in termination from the protocol.
• Comorbid psychiatric diagnosis with significant symptoms such as Axis II disorders or severe Asix I disorders.
• History of seizure, tic disorder, or a current diagnosis and/or family history of Tourette''''s Disorder.
• Females who are pregnant of lactating.

Study ID Numbers:  SPD465-304
Last Updated:  September 8, 2005
Record first received:  September 7, 2005
ClinicalTrials.gov Identifier:  NCT00152035
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-09-13