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Last Updated: December 7, 2021

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CLINICAL TRIALS PROFILE FOR LISDEXAMFETAMINE DIMESYLATE

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505(b)(2) Clinical Trials for lisdexamfetamine dimesylate

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
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 >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 >Phase >Start Date >Summary

Clinical Trial Conditions for lisdexamfetamine dimesylate

Condition Name

Condition Name for lisdexamfetamine dimesylate
Intervention Trials
ADHD 8
Attention Deficit Hyperactivity Disorder 7
Attention-deficit/Hyperactivity Disorder 4
Attention Deficit Disorder With Hyperactivity 3
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Condition MeSH

Condition MeSH for lisdexamfetamine dimesylate
Intervention Trials
Attention Deficit Disorder with Hyperactivity 29
Hyperkinesis 18
Disease 16
Bulimia 6
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Clinical Trial Locations for lisdexamfetamine dimesylate

Trials by Country

Trials by Country for lisdexamfetamine dimesylate
Location Trials
United States 262
Germany 24
Spain 18
United Kingdom 17
Canada 15
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Trials by US State

Trials by US State for lisdexamfetamine dimesylate
Location Trials
California 13
Florida 12
Texas 12
New York 12
North Carolina 11
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Clinical Trial Progress for lisdexamfetamine dimesylate

Clinical Trial Phase

Clinical Trial Phase for lisdexamfetamine dimesylate
Clinical Trial Phase Trials
Phase 4 17
Phase 3 13
Phase 2 3
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Clinical Trial Status

Clinical Trial Status for lisdexamfetamine dimesylate
Clinical Trial Phase Trials
Completed 36
Recruiting 4
Terminated 3
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Clinical Trial Sponsors for lisdexamfetamine dimesylate

Sponsor Name

Sponsor Name for lisdexamfetamine dimesylate
Sponsor Trials
Shire 31
New York University School of Medicine 2
NYU Langone Health 2
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Sponsor Type

Sponsor Type for lisdexamfetamine dimesylate
Sponsor Trials
Industry 35
Other 25
NIH 2
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