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Last Updated: January 26, 2023

CLINICAL TRIALS PROFILE FOR VYVANSE


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505(b)(2) Clinical Trials for Vyvanse

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 Vyvanse

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).
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.
NCT00733356 ↗ The Effects of Vyvanse(TM) on Brain Hemodynamics and Reading Completed Shire Phase 4 2008-07-01 This is a single-blind, Investigator Initiated study to evaluate the safety and efficacy of Vyvanse™ and provide pilot data in two areas: (1) on the use of Near-Infrared Spectroscopy to detect medication effects in children with ADHD; and (2) on the influence of Vyvanse ™ on reading fluency and comprehension, over a period of approximately 6-8 weeks. Subjects will be between the ages of 6 and 12 at the beginning of the study.
NCT00733356 ↗ The Effects of Vyvanse(TM) on Brain Hemodynamics and Reading Completed Kimberley Lakes Phase 4 2008-07-01 This is a single-blind, Investigator Initiated study to evaluate the safety and efficacy of Vyvanse™ and provide pilot data in two areas: (1) on the use of Near-Infrared Spectroscopy to detect medication effects in children with ADHD; and (2) on the influence of Vyvanse ™ on reading fluency and comprehension, over a period of approximately 6-8 weeks. Subjects will be between the ages of 6 and 12 at the beginning of the study.
NCT00733356 ↗ The Effects of Vyvanse(TM) on Brain Hemodynamics and Reading Completed University of California, Irvine Phase 4 2008-07-01 This is a single-blind, Investigator Initiated study to evaluate the safety and efficacy of Vyvanse™ and provide pilot data in two areas: (1) on the use of Near-Infrared Spectroscopy to detect medication effects in children with ADHD; and (2) on the influence of Vyvanse ™ on reading fluency and comprehension, over a period of approximately 6-8 weeks. Subjects will be between the ages of 6 and 12 at the beginning of the study.
NCT00735371 ↗ Efficacy and Safety of Lisdexamfetamine Dimesylate (LDX) in Adolescents With Attention-Deficit/Hyperactivity Disorder (ADHD) Completed Shire Phase 3 2008-10-08 The study will evaluate the efficacy of LDX treatment group compared to placebo on the change from Baseline ADHD-RS-IV score at endpoint.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Vyvanse

Condition Name

Condition Name for Vyvanse
Intervention Trials
Attention Deficit Hyperactivity Disorder 15
ADHD 6
Major Depressive Disorder 5
Attention-deficit/Hyperactivity Disorder 5
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Condition MeSH

Condition MeSH for Vyvanse
Intervention Trials
Attention Deficit Disorder with Hyperactivity 38
Hyperkinesis 25
Disease 21
Depressive Disorder 8
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Clinical Trial Locations for Vyvanse

Trials by Country

Trials by Country for Vyvanse
Location Trials
United States 368
Canada 21
Germany 7
Spain 7
United Kingdom 5
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Trials by US State

Trials by US State for Vyvanse
Location Trials
New York 21
California 18
Pennsylvania 18
North Carolina 16
Florida 16
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Clinical Trial Progress for Vyvanse

Clinical Trial Phase

Clinical Trial Phase for Vyvanse
Clinical Trial Phase Trials
Phase 4 30
Phase 3 9
Phase 2/Phase 3 1
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Clinical Trial Status

Clinical Trial Status for Vyvanse
Clinical Trial Phase Trials
Completed 44
Terminated 8
Unknown status 5
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Clinical Trial Sponsors for Vyvanse

Sponsor Name

Sponsor Name for Vyvanse
Sponsor Trials
Shire 42
University of Pennsylvania 5
Massachusetts General Hospital 4
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Sponsor Type

Sponsor Type for Vyvanse
Sponsor Trials
Other 61
Industry 43
NIH 3
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