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Dose-Optimization Study Evaluating the Efficacy, Safety and Tolerability of Vyvanse (Lisdexamfetamine Dimesylate) in Children Aged 6-12 Diagnosed With ADHD | Clinical Trials | Clareo Health

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Dose-Optimization Study Evaluating the Efficacy, Safety and Tolerability of Vyvanse (Lisdexamfetamine Dimesylate) in Children Aged 6-12 Diagnosed With ADHD

A Prospective, Open-Label, Multi-Center, Dose-Optimization Study Evaluating the Efficacy, Safety and Tolerability of Vyvanse (Lisdexamfetamine Dimesylate) 20-70mg in Children Aged 6-12 Diagnosed With ADHD

NCT00500071•Shire

View on ClinicalTrials.gov

Summary

Assess the efficacy \& tolerability of Vyvanse when children aged 6-12 years diagnosed with ADHD are dosed to optimal effect.

Detailed Description

Dose-Optimization Study Evaluating the Efficacy, Safety and Tolerability of Vyvanse (lisdexamfetamine dimesylate) in Children aged 6-12 Diagnosed with ADHD

Eligibility

Age

6 - 12 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Subject is a male or female aged 6-12 years inclusive at the time of consent.
•2. Females of Child-bearing Potential (FOCP) must have a negative serum beta Human Chorionic Gonadotropin (HCG) pregnancy test at Screening and a negative urine pregnancy test at Baseline and agree to comply with any applicable contraceptive requirements of the protocol.
•3. primary diagnosis of ADHD based on a detailed psychiatric evaluation.
•4. Subjects must have a baseline ADHD-RS-IV total score ≥28.
•5. Subject is functioning at an age-appropriate level intellectually.
•6. comply with all the testing and requirements.
•7. Subject is able to swallow a capsule.
•8. Subject has blood pressure measurements within the 95th percentile for age, gender, and height.

Exclusion Criteria

•1. Subject has a current, controlled (requiring a restricted medication) or uncontrolled, comorbid psychiatric diagnosis with significant symptoms such as Post Traumatic Stress Disorder, psychosis, bipolar illness, pervasive developmental disorder, severe obsessive compulsive disorder, severe depressive or severe anxiety disorder or other symptomatic manifestations.
•2. Subject has Conduct Disorder.
•3. Subject has a documented allergy, hypersensitivity, or intolerance to amphetamines.
•4. Subject has failed to respond to one or more adequate courses (dose and duration) of amphetamine therapy.
•5. The subject has a recent history (within the past 6 months) of suspected substance abuse or dependence.
•6. Subject has a positive urine drug result.
•7. Subject weighs less than 50 pounds (22.7kg).
•8. Subject is significantly overweight.
•9. Subject has a history of seizures (exclusive of febrile seizures), a tic disorder, a current diagnosis and/or family history of Tourette's Disorder.
•10. Subject has any reported history of abnormal thyroid function.
+4 more criteria

Locations (46)

Melmed Center

Scottsdale, Arizona, United States

Valley Clinical Research

El Centro, California, United States

Peninsula Research Assoc, Inc

Rolling Hills Estates, California, United States

UCSF-Langely Porter Psych Institute

San Francisco, California, United States

Encompass Clinical Research

Spring Valley, California, United States

Shire Clinical Research Site

Wildomar, California, United States

Sarkis Clinical Trials

Gainesville, Florida, United States

Shire Clinical Research Site

Hialeah, Florida, United States

CNS Research Institute, Inc

Jacksonville, Florida, United States

CORE Research, Inc

Maitland, Florida, United States

Key Dates

Start Date

June 28, 2007

Primary Completion Date

January 2, 2008

Completion Date

January 2, 2008

Last Updated

March 10, 2022

Enrollment

318

ACTUAL participants

Conditions

Attention Deficit Hyperactivity Disorder (ADHD)

Interventions

Vyvanse (lisdexamfetamine dimesylate)

DRUG

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COMPLETED

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 10, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Dose-Optimization Study Evaluating the Efficacy, Safety and Tolerability of Vyvanse (Lisdexamfetamine Dimesylate) in Children Aged 6-12 Diagnosed With ADHD

Inclusion Criteria

Exclusion Criteria

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