| lisdexamfetamine / Generic mfg. |
NCT01274221: Safety and Efficacy of SPD489 in Adolescent Subjects Aged 13-17 Years With Attention-Deficit/Hyperactivity Disorder (ADHD) |
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| Withdrawn | 3b | 0 | US | SPD489, Vyvanse, Lisdexamfetamine dimesylate, LDX, Placebo | Shire | ADHD | 05/11 | 05/11 | | |
NCT01106430 / 2009-011745-94: Comparison of Lisdexamfetamine Dimesylate With Atomoxetine HCl in Attention-Deficit/Hyperactivity Disorder (ADHD) Subjects With an Inadequate Response to Methylphenidate |
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| Completed | 3b | 267 | Europe, Canada, US | Lisdexamfetamine Dimesylate, Vyvanse, Atomoxetine Hydrochloride, Strattera | Shire | Attention-Deficit/Hyperactivity Disorder | 07/12 | 07/12 | | |
NCT00556296: Phase 3 Randomized Double-Blind Placebo-Controlled Study of NRP104 in Children Aged 6-12 With ADHD |
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| Completed | 3 | 297 | US | NRP104, NRp104, Placebo | New River Pharmaceuticals, Shire | Attention Deficit Hyperactivity Disorder | | 09/05 | | |
NCT00334880: Study to Assess the Safety and Efficacy of NRP104 in Adults With Attention-Deficit Hyperactivity Disorder (ADHD) |
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| Completed | 3 | 420 | US | NRP104 | New River Pharmaceuticals | Attention Deficit Hyperactivity Disorder, Attention Deficit Disorders With Hyperactivity, Attention Deficit Hyperactivity Disorders | | 11/06 | | |
NCT00337285: An Open-label Study of NRP104 in Adults With Attention Deficit Hyperactivity Disorder (ADHD) |
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| Completed | 3 | 349 | US | Vyvanse (lisdexamfetamine dimesylate), NRP104 | New River Pharmaceuticals, Shire | Attention Deficit Hyperactivity Disorder, Attention Deficit Disorders With Hyperactivity, Attention Deficit Hyperactivity Disorders | 11/07 | 06/08 | | |
NCT00500149: A Classroom Study to Assess the Time of Onset of Vyvanse (Lisdexamfetamine Dimesylate) in Pediatric Subjects Aged 6-12 With Attention Deficit/Hyperactivity Disorder (ADHD) |
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| Completed | 3 | 129 | US | Vyvanse (lisdexamfetamine dimesylate), Placebo | Shire | ADHD | 12/07 | 12/07 | | |
NCT00697515: Safety and Efficacy Workplace Environment Study of Lisdexamfetamine Dimesylate (LDX) in Adults With Attention-Deficit Hyperactivity Disorder (ADHD) |
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| Completed | 3 | 142 | US | LDX, Placebo | Shire | ADHD | 12/08 | 12/08 | | |
NCT00735371: Efficacy and Safety of Lisdexamfetamine Dimesylate (LDX) in Adolescents With Attention-Deficit/Hyperactivity Disorder (ADHD) |
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| Completed | 3 | 314 | US | LDX 30 mg, Vyvanse, LDX 50 mg, LDX 70 mg, Placebo | Shire | Attention Deficit Hyperactivity Disorder (ADHD) | 04/09 | 04/09 | | |
NCT00764868: Vyvanse Adolescent Open-Label Safety and Efficacy Extension Study |
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| Completed | 3 | 269 | US | Lisdexamfetamine Dimesylate (LDX), Vyvanse | Shire | ADHD | 04/10 | 04/10 | | |
NCT00763971 / 2008-000679-90: Randomized, Double-blind Safety and Efficacy Study of Lisdexamfetamine Dimesylate (LDX) in Children and Adolescents Aged 6-17 |
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| Completed | 3 | 336 | Europe | Lisdexamfetamine Dimesylate (LDX), Vyvanse™, Methylphenidate Hydrochloride, Concerta®, OROS MPH, Placebo | Shire | ADHD | 03/11 | 03/11 | | |
NCT00784654 / 2008-000720-10: Double-blind, Placebo-controlled, Randomised Withdrawal, Extension, Safety and Efficacy Study of LDX in Children and Adolescents Aged 6-17 |
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| Completed | 3 | 276 | Europe, US | Lisdexamfetamine dimesylate (LDX), Vyvanse, SPD489, Placebo | Shire | ADHD | 10/11 | 10/11 | | |
NCT01090713: Efficacy Study of Lisdexamfetamine to Treat Binge Eating Disorder |
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| Completed | 3 | 50 | US | lisdexamfetamine, Placebo control | Lindner Center of HOPE, Shire, University of Cincinnati | Binge Eating Disorder | 10/12 | 10/12 | | |
NCT01738698: Adjunctive SPD489 to Antipsychotic Medication in Clinically Stable Adults With Persistent Predominant Negative Symptoms of Schizophrenia |
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| Terminated | 3 | 4 | US | SPD489 40mg, lisdexamfetamine dimesylate, LDX, Vyvanse, SPD489 100mg, SPD489 160mg, Placebo | Shire | Schizophrenia | 04/13 | 04/13 | | |
NCT01760889: SPD489 Low Dose and High Dose Ranges When Added to Stable Doses of Antipsychotic Medications in Clinically Stable Adults With Negative Symptoms of Schizophrenia |
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| Terminated | 3 | 1 | US | SPD489 low dose range (40mg, 80mg, and 100mg), lisdexamfetamine dimesylate, LDX, Vyvanse, SPD489 high dose range (120mg, 140mg and 160mg), Placebo | Shire | Schizophrenia | 04/13 | 04/13 | | |
NCT01760993: Long-term Safety of SPD489 When Added to Stable Doses of Antipsychotic Medications in Clinically Stable Adults With Negative Symptoms of Schizophrenia |
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| Terminated | 3 | 2 | US | SPD489, lisdexamfetamine dimesylate, LDX, Vyvanse | Shire | Schizophrenia | 04/13 | 04/13 | | |
| Completed | 3 | 390 | Europe, US | SPD489 (Lisdexamfetamine dimesylate), Vyvanse, Venvanse, LDX, Placebo | Shire | Binge Eating Disorder | 09/13 | 09/13 | | |
| Completed | 3 | 383 | Europe, US | SPD489 (Lisdexamfetamine dimesylate), Vyvanse, Venvanse, LDX, Placebo | Shire | Binge Eating Disorder | 09/13 | 09/13 | | |
NCT01000064: Treatment of Traumatic Brain Injury (TBI)-Related Attention Deficits |
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| Terminated | 3 | 22 | US | Vyvanse, fMRI, functional magnetic resonance imaging, Placebo | Vanderbilt University, Shire | Traumatic Brain Injury, Attention Deficit Disorder | 12/13 | 05/15 | | |
NCT01436162 / 2011-003006-25: Efficacy and Safety Study of SPD489 in Combination With an Antidepressant in the Treatment of Adults With Major Depressive Disorder |
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| Completed | 3 | 1105 | Europe, US, RoW | Antidepressant + SPD489 (Lisdexamfetamine dimesylate ), Vyvanse, Antidepressant + Placebo | Shire | Major Depressive Disorder | 12/13 | 12/13 | | |
NCT01436149 / 2011-003018-17: Efficacy and Safety Study of SPD489 in Combination With an Antidepressant in the Treatment of Adults With Major Depressive Disorder |
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| Completed | 3 | 1262 | Europe, Canada, US, RoW | SPD489 (Lisdexamfetamine dimesylate ), Vyvanse, Placebo | Shire | Major Depressive Disorder | 12/13 | 12/13 | | |
NCT01093963: Efficacy Study of Lisdexamfetamine to Treat Bipolar Depression |
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| Terminated | 3 | 25 | US | Lisdexamfetamine, Placebo | Lindner Center of HOPE, Shire, University of Cincinnati | Bipolar Depression | 02/14 | 02/14 | | |
NCT01131559: Adjunctive Lisdexamfetamine (LDX) in Bipolar Depression |
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| Terminated | 3 | 50 | US | Lisdexamfetamine, Vyvanse, Placebo control, Sugar pill, fake pill with no active medication | Lindner Center of HOPE, Shire, University of Cincinnati | Bipolar, Depression | 02/14 | 02/14 | | |
NSS, NCT01234298: SPD489 as Adjunctive Treatment in Adults With Negative Symptoms of Schizophrenia |
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| Withdrawn | 3 | 0 | NA | SPD489 Low-Dose, Vyvanse, Lisdexamfetamine dimesylate, LDX, SPD489 High-Dose, Placebo | Shire | Negative Symptoms of Schizophrenia | 02/14 | 02/14 | | |
| Terminated | 3 | 1570 | Europe, Canada, US, RoW | SPD489 (Lisdexamfetamine dimesylate) + Antidepressant, Vyvanse, LDX | Shire | Major Depressive Disorder | 03/14 | 03/14 | | |
| Completed | 3 | 604 | Europe, US | Lisdexamfetamine dimesylate, Vyvanse, SPD489, LDX | Shire | Binge Eating Disorder | 10/14 | 10/14 | | |
NCT02009163 / 2012-004457-88: Evaluate the Maintenance of Efficacy of SPD489 in Adults Aged 18-55 Years With Moderate to Severe Binge Eating Disorder |
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| Completed | 3 | 418 | Europe, Canada, US | Lisdexamfetamine dimesylate, SPD489, LDX, Placebo | Shire | Binge Eating Disorder | 04/15 | 04/15 | | |
NCT02555150: A Comparison of PRC-063 and Lisdexamfetamine in the Driving Performance of Adults With ADHD |
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| Completed | 3 | 40 | US | PRC-063, lisdexamfetamine dimesylate, Placebo | Rhodes Pharmaceuticals, L.P., Purdue Pharma LP | Attention Deficit Hyperactivity Disorder | 01/17 | 01/17 | | |
NCT03260205: Safety and Efficacy Study in Preschool Children Aged 4-5 Years With Attention-deficit/Hyperactivity Disorder (ADHD) |
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| Completed | 3 | 199 | US | Placebo, SPD489 (Lisdexamfetamine dimesylate), SPD489 | Shire | Attention Deficit Hyperactivity Disorder (ADHD) | 10/18 | 10/18 | | |
NCT02466386: Safety and Tolerability Study of SPD489 in Preschool Children Aged 4-5 Years, Diagnosed With Attention-deficit/Hyperactivity Disorder |
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| Completed | 3 | 113 | US | SPD489, Lisdexamfetamine dimesylate | Shire | Attention Deficit Hyperactivity Disorder (ADHD) | 01/20 | 01/20 | | |
| Completed | 3 | 180 | | | University of New South Wales , National Health and Medical Research Council, Curran Foundation | Addiction, Methamphetamine dependence | | | | |
NCT03924193: Cognitive-Behavioral and Pharmacologic (LDX) Treatment of Binge-Eating Disorder and Obesity: Acute Treatment |
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| Completed | 3 | 141 | US | Lisdexamfetamine Dimesylate, Cognitive-Behavioral Therapy, Combination LDX and Cognitive-Behavioral Therapy | Yale University, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Binge-Eating Disorder, Obesity | 09/23 | 09/23 | | |
NCT03926052: Cognitive-Behavioral and Pharmacologic (LDX) Treatment of Binge-Eating Disorder and Obesity: Maintenance Treatment |
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| Active, not recruiting | 3 | 80 | US | Lisdexamfetamine Dimesylate, Placebo | Yale University, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Binge-Eating Disorder, Obesity | 07/24 | 07/24 | | |
