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Sponsored by: |
Shire Pharmaceutical Development |
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Information provided by: | Shire Pharmaceutical Development |
ClinicalTrials.gov Identifier: | NCT00202605 |
The purpose of the study is to evaluate how safe and how well SPD465 works compared to placebo in adults with ADHD. It is hypothesized that SPD465 will achieve an extended duration of clinical benefit.
Condition | Intervention | Phase |
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Attention Deficit Disorder With Hyperactivity |
Drug: Neutral salts of dextroamphetamine sulfate, USP, amphetamine sulfate, USP, d-amphetamine saccharate,
d,I-amphetamine aspartate monohydrate |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety/Efficacy Study |
Official Title: | A Phase II, Randomized, Double-Blind, Multi-Center, Placebo-Controlled, Crossover Study of SPD465 in Adults With Attention-Deficit Hyperactivity Disorder (ADHD) |
Estimated Enrollment: | 72 |
Study Start Date: | September 2005 |
Study Completion Date: | April 2006 |
Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Arkansas | |
Clinical Study Center | |
Little Rock, Arkansas, United States | |
United States, California | |
UCI Child Development Center | |
Irvine, California, United States | |
United States, Nevada | |
Center for Psychiatry and Behavioral Medicine, Inc. | |
Las Vegas, Nevada, United States | |
United States, Texas | |
Bayou City Research, Ltd. | |
Houston, Texas, United States |
Study ID Numbers: | SPD465-203 |
Study First Received: | September 12, 2005 |
Last Updated: | November 2, 2007 |
ClinicalTrials.gov Identifier: | NCT00202605 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Dopamine Uptake Inhibitors Neurotransmitter Agents Adrenergic Agents Attention Deficit and Disruptive Behavior Disorders Aspartic Acid Central Nervous System Stimulants Dyskinesias N-Methylaspartate Signs and Symptoms Methamphetamine |
Dopamine Attention Deficit Disorder with Hyperactivity Mental Disorders Dextroamphetamine Mental Disorders Diagnosed in Childhood Hyperkinesis Neurologic Manifestations Dopamine Agents Amphetamine Peripheral Nervous System Agents |
Dopamine Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Adrenergic Agents Molecular Mechanisms of Pharmacological Action Adrenergic Uptake Inhibitors Physiological Effects of Drugs Signs and Symptoms Pathologic Processes Attention Deficit Disorder with Hyperactivity Mental Disorders Therapeutic Uses Mental Disorders Diagnosed in Childhood Hyperkinesis Disease |
Sympathomimetics Nervous System Diseases Attention Deficit and Disruptive Behavior Disorders Central Nervous System Stimulants Dyskinesias Pharmacologic Actions Methamphetamine Autonomic Agents Dextroamphetamine Neurologic Manifestations Amphetamine Dopamine Agents Peripheral Nervous System Agents Central Nervous System Agents |