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Sponsored by: |
Shire Pharmaceutical Development |
Information provided by: | Shire Pharmaceutical Development |
ClinicalTrials.gov Identifier: | NCT00152035 |
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 saccharate, d, l-amphetamine aspartate monohydrate. |
Phase III |
MedlinePlus related topics: | Attention Deficit Hyperactivity Disorder |
ChemIDplus related topics: | Sodium chloride Dextroamphetamine Dextroamphetamine sulfate Amphetamine Amphetamine sulfate Amphetamine aspartate Dextroamphetamine saccharate Aspartic acid |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase III, Multi-Center, 12-Month, Open-Label Safety Study of SPD465 in Adults With Attention-Deficit Hyperactivity Disorder (ADHD). |
Estimated Enrollment: | 1040 |
Study Start Date: | March 2005 |
Study Completion Date: | May 2007 |
Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | SPD465-304 |
First Received: | September 7, 2005 |
Last Updated: | November 2, 2007 |
ClinicalTrials.gov Identifier: | NCT00152035 |
Health Authority: | United States: Food and Drug Administration |
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