CLINICAL TRIALS PROFILE FOR LISDEXAMFETAMINE DIMESYLATE
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505(b)(2) Clinical Trials for LISDEXAMFETAMINE DIMESYLATE
| Trial Type | Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|---|
| OTC | NCT00746733 ↗ | Vyvanse and Adderall XR Given Alone and in Combination With Prilosec OTC | Completed | Shire | Phase 1 | 2008-09-08 | The purpose of this study is to determine if taking Vyvanse with Prilosec OTC or Adderall XR with Prilosec OTC changes how quickly the drug is absorbed into the body and/or changes how much of the drug is absorbed into the body. |
| >Trial Type | >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
All Clinical Trials for LISDEXAMFETAMINE DIMESYLATE
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT00500071 ↗ | Dose-Optimization Study Evaluating the Efficacy, Safety and Tolerability of Vyvanse (Lisdexamfetamine Dimesylate) in Children Aged 6-12 Diagnosed With ADHD | Completed | Shire | Phase 4 | 2007-06-28 | Assess the efficacy & tolerability of Vyvanse when children aged 6-12 years diagnosed with ADHD are dosed to optimal effect. |
| 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) | Completed | Shire | Phase 3 | 2007-06-13 | The primary objective of this study is to assess the time of onset of Vyvanse compared to placebo, in the analog classroom as measured by the Swanson, Kotkin, Agler, M. Flynn and Pelham (SKAMP) deportment scale in children (aged 6-12) diagnosed with Attention-Deficit/Hyperactivity Disorder (ADHD). |
| NCT00557011 ↗ | NRP104, Adderall XR or Placebo in Children Aged 6-12 Years With ADHD | Completed | New River Pharmaceuticals | Phase 2 | 2004-09-01 | The purpose of this study is to assess, in a controlled environment, the efficacy and safety of NRP104 and Adderall XR compared to placebo in treatment of children, aged 6-12, with ADHD. |
| NCT00573534 ↗ | Pilot Study of Vyvanse™ In ADHD Adolescents at Risk for Substance Abuse | Completed | New York State Psychiatric Institute | Phase 4 | 2008-03-01 | This is an open label pilot study to obtain information on the best way to study young adolescents with Attention Deficit Hyperactivity Disorder (ADHD)who may also be at risk of developing substance abuse, in part because of their ADHD. The plan is to recruit older children/young adolescents (age 11-15) who have ADHD and also have an older sibling with substance abuse. The treatment for ADHD in the 11-15 year old will be Vyvanse, a novel preparation of dextroamphetamine in which the molecule is inactivated and only becomes activated when it is digested. This preparation is felt to be safer from diversion while at the same time providing treatment for the younger siblings in which a bad outcome has already occurred in the family, namely the older sibling's substance abuse. As mentioned, this is an open-label study, a feasibility study to see if we can use this approach to study and treat high risk youth before they develop substance abuse. |
| NCT00697515 ↗ | Safety and Efficacy Workplace Environment Study of Lisdexamfetamine Dimesylate (LDX) in Adults With Attention-Deficit Hyperactivity Disorder (ADHD) | Completed | Shire | Phase 3 | 2008-07-18 | To evaluate the efficacy of LDX compared to placebo in adults with ADHD in the adult workplace environment (AWE) setting |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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