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Effectiveness of Vyvanse Compared to Concerta in Adolescents With Attention-deficit/Hyperactivity Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01552902
Recruitment Status : Completed
First Posted : March 13, 2012
Results First Posted : March 18, 2015
Last Update Posted : March 18, 2015
Information provided by (Responsible Party):

Brief Summary:
The purpose of this study is to determine effectiveness of Vyvanse compared to Concerta in adolescents with Attention-deficit/Hyperactivity Disorder (ADHD).

Condition or disease Intervention/treatment Phase
Attention-deficit/Hyperactivity Disorder Drug: Lisdexamfetamine dimesylate Drug: Methylphenidate Hydrochloride Drug: Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 549 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 4, Randomized, Double-blind, Multicenter, Parallel-group, Active-controlled, Forced-dose Titration, Safety and Efficacy Study of SPD489 (VYVANSE®) Compared With OROS-MPH (CONCERTA®) With a Placebo Reference Arm, in Adolescents Aged 13-17 Years With Attention-deficit/Hyperactivity Disorder (ADHD)
Study Start Date : April 2012
Actual Primary Completion Date : May 2014
Actual Study Completion Date : May 2014

Arm Intervention/treatment
Experimental: Lisdexamfetamine dimesylate Drug: Lisdexamfetamine dimesylate
Daily oral dosing in the AM ranging from 30- 70 mg. 4 week forced dose titration, 2 week dose maintenance
Other Name: SPD489, Vyvanse, LDX

Active Comparator: Methylphenidate Hydrochloride Drug: Methylphenidate Hydrochloride
Daily oral dosing in the AM ranging from 18-72 mg. 4 week force dose titration, 2 week dose maintenance
Other Name: Concerta, OROS-MPH

Placebo Comparator: Placebo Drug: Placebo
Daily oral dosing in the AM for 6 weeks

Primary Outcome Measures :
  1. Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale, Fourth Edition (ADHD-RS-IV) Total Score at Week 6 [ Time Frame: Baseline, Week 6 ]
    The ADHD-RS-IV was developed to measure the behaviors of children with ADHD and is commonly used in clinical studies of ADHD. The ADHD-RS-IV consisted of 18 items designed to reflect current symptomatology of ADHD based on Diagnostic and Statistical Manual of Mental Disorders, 4th Edition-Text Revision (DSM-IV-TR) criteria. Each item was scored on a 4-point scale ranging from 0 (reflecting no symptoms) to 3 (reflecting severe symptoms) with total scores ranging from 0-54, Higher score = more severe symptoms.

Secondary Outcome Measures :
  1. Percentage of Participants With an Improvement on Clinical Global Impression - Global Improvement (CGI-I) at Week 6 [ Time Frame: Week 6 ]
    The Clinical Global Impressions Scale permits a global evaluation of the participant's severity of illness and improvement over time. The scale included a severity of illness item and a global improvement item. The investigator performed the CGI-I to rate the improvement of a participant's ADHD symptoms based on a 7-point scale (1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; or 7=very much worse.). Percentage of participants with an improved measurement (response of very much improved and much improved) is reported.

Other Outcome Measures:
  1. Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs [ Time Frame: Baseline up to 3 days after last dose (last dose at Week 6) ]
    An adverse event (AE) was defined as any untoward medical occurrence in a clinical investigation participant administered as a pharmaceutical product that did not necessarily have a causal relationship with this treatment. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs were events between first dose of double-blind investigational product and up to 3 days after last dose that were absent before treatment or that worsened relative to pretreatment state.

  2. Change From Baseline in Blood Pressure at Week 6 [ Time Frame: Baseline, Week 6 ]
  3. Change From Baseline in Pulse Rate at Week 6 [ Time Frame: Baseline, Week 6 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Subject must be 13-17 years of age, inclusive, at the time of consent.
  • Subject must weigh more than 79.5lb.
  • The parent/LAR must be available at approximately 7:00AM (±2 hours) to dispense the dose of investigational product for the study duration.
  • Subject, who is a female, must have a negative serum beta human chorionic gonadotropin (β-HCG) pregnancy test and a negative urine pregnancy test and agree to comply with any applicable contraceptive requirements of the protocol.
  • Subject has an ADHD-RS-IV total score ≥28.
  • Subject is able to swallow a capsule.
  • Subject does not have hypertension and has a resting sitting blood pressure less than or equal to 135/85mmHg.

Exclusion Criteria

  • Subject has a current, controlled (with medications prohibited in this study) or uncontrolled, comorbid psychiatric diagnosis with significant symptoms such as any significant comorbid Axis II disorder or significant Axis I disorder (such as post traumatic stress disorder, psychosis, bipolar illness, pervasive developmental disorder, severe obsessive compulsive disorder, depressive or anxiety disorder.
  • Diagnosis of conduct disorder. Oppositional defiant disorder is not exclusionary.
  • Subject is considered a suicide risk, has previously made a suicide attempt, or is currently demonstrating active suicidal ideation. Subjects with intermittent passive suicidal ideation are not necessarily excluded.
  • Subject is underweight or overweight.
  • Subject has a concurrent chronic or acute illness (such as severe allergic rhinitis or an infectious process requiring antibiotics), disability, or other condition. Mild, stable asthma is not exclusionary.
  • Subject has a history of seizures (other than infantile febrile seizures), a chronic or current tic disorder, or a current diagnosis and/or a known family history of Tourette's Disorder.
  • Subject has a known history of symptomatic cardiovascular disease, advanced arteriosclerosis, structural cardiac abnormality, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, or other serious cardiac problems that may place him/her at increased vulnerability to the sympathomimetic effects of a stimulant medication.
  • Subject has a known family history of sudden cardiac death or ventricular arrhythmia.
  • Subject has any clinically significant ECG or clinically significant laboratory abnormality.
  • Subject has current abnormal thyroid function, defined as abnormal thyroid stimulating hormone (TSH) and thyroxine (T4). Treatment with a stable dose of thyroid medication for at least 3 months is permitted.
  • Subject has a documented allergy, hypersensitivity, or intolerance to amphetamine or to any excipients in the investigational product.
  • Subject has a documented allergy, hypersensitivity, or intolerance to MPH or to any excipients in the reference product.
  • Subject has failed to fully respond to an adequate course(s) (dose and duration) of MPH or amphetamine therapy.
  • Subject has a history of suspected substance abuse or dependence disorder (excluding nicotine). Subjects with a lifetime history of amphetamine, cocaine, or other stimulant abuse and/or dependence will be excluded.
  • Subject has a positive urine drug result.
  • Subject has previously participated in this study or another clinical study involving SPD489/NRP104.
  • Subject has glaucoma.
  • Subject is required to take or anticipates the need to take medications that have CNS effects or affect performance, such as sedating antihistamines and decongestant sympathomimetics, or are monoamine oxidase inhibitors. Stable use of bronchodilator inhalers is not exclusionary.
  • Subject is female and is pregnant or lactating.
  • Subject is well controlled on his/her current ADHD medication.
  • Subject has a pre-existing severe gastrointestinal tract narrowing.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01552902

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Responsible Party: Shire Identifier: NCT01552902     History of Changes
Other Study ID Numbers: SPD489-406
2011-005452-34 ( EudraCT Number )
First Posted: March 13, 2012    Key Record Dates
Results First Posted: March 18, 2015
Last Update Posted: March 18, 2015
Last Verified: June 2014
Keywords provided by Shire:
Additional relevant MeSH terms:
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Lisdexamfetamine Dimesylate
Attention Deficit Disorder with Hyperactivity
Pathologic Processes
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Central Nervous System Stimulants
Physiological Effects of Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents