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

Information source: Shire
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Attention-deficit/Hyperactivity Disorder

Intervention: Lisdexamfetamine dimesylate (Drug); Methylphenidate Hydrochloride (Drug); Placebo (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Shire

Summary

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

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale, Fourth Edition (ADHD-RS-IV) Total Score at Week 6

Secondary outcome: Percentage of Participants With an Improvement on Clinical Global Impression - Global Improvement (CGI-I) at Week 6

Eligibility

Minimum age: 13 Years. Maximum age: 17 Years. Gender(s): Both.

Criteria:

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.

Locations and Contacts

Schwerpunktpraxis fur Entwicklung und Lernen, Bamberg 96047, Germany

Klinik Fur Kinder- und Jugendpsychiatrie, Psychosomatik und Psychotherapie, Frankfurt 15236, Germany

Universitatsklinikum Freiburg, Freiburg 79104, Germany

Kinderarztpraxis Dr. Kaiser und Dr. MarineBe, Hamburg 22415, Germany

Zentralinstitut fur Seelische Gesundheit, Mannheim 68159, Germany

Medizinisches Studienzentrum Wurzburg, Wurzburg 97070, Germany

Vadaskert Gyermekpszichiatriai Korhaz es Szakambulancia, Budapest H-1021, Hungary

Bekes Megyei Pandy Kalman Korhaz, Gyula H-5700, Hungary

Pecsi Megyei Jogu varos Egyesitett Egeszsegugyi Intezmenyek, Pecs H-7632, Hungary

Szegedi Tudomanyegyetem, Szeged H-6725, Hungary

Gillbergcentrum, Goteborg 411 19, Sweden

PRIMA Barn-och Vuxenpsykiatri Jarva, Spanga 163 74, Sweden

Harmonex Neuroscience Research, Inc., Dothan, Alabama 36303, United States

Center for Advanced Improvement, Tucson, Arizona 85719, United States

Clinical Study Centers, LLC, Little Rock, Arkansas 72211, United States

Shanti Clinical Trials, Colton, California 92324, United States

Sun Valley Research Center, Imperial, California 92251, United States

Synergy Clinical Research Center, National City, California 91950, United States

Pacific Sleep Medicine, A Medical Corporation, Oceanside, California 92054, United States

Neuropsychiatric Research Center for Orange County, Orange, California 92868, United States

Peninsula Research Associates, Rolling Hills Estates, California 90274, United States

PCSD - Feighner Research, San Diego, California 92108, United States

University of California, San Francisco, San Francisco, California 94143, United States

Encompass Clinical Research, Spring Valley, California 91978, United States

Elite Clinical Trials, Wildomar, California 92595, United States

IMMUNOe International Research Center, Centennial, Colorado 80112, United States

MCB Clinical Research Centers, LLC, Colorado Springs, Colorado 80910, United States

Coastal Connecticut Research, LLC, New London, Connecticut 06320, United States

Florida Clinical Research Center, LLC, Bradenton, Florida 34201, United States

Amedica Research Institute, Inc, Hialeah, Florida 33013, United States

Clinical Neuroscience Solutions, Inc, Jacksonville, Florida 32256, United States

Sarkis Clinical Trials, Lake City, Florida 32055, United States

Florida Clinical Research Center, LLC, Maitland, Florida 32751, United States

Prevention & Strengthening Solutions, Inc., Miami, Florida 33169, United States

Scientific Clinical Research, Inc., North Miami, Florida 33161, United States

Medical Research Group of Central Florida, Orange City, Florida 32763, United States

Clinical Neuroscience Solutions, Inc., Orlando, Florida 32806, United States

Compass Research, LLC, Orlando, Florida 32806, United States

Miami Research Associates, South Miami, Florida 33143, United States

Stedman Clinical Trials, Tampa, Florida 33613, United States

Atlanta Institute of Medicine & Research, Inc, Atlanta, Georgia 30328, United States

Clinical Research Center, University of Illinois at Chicago, Chicago, Illinois 60608, United States

Capstone Clinical Research, Libertyville, Illinois 60048, United States

Baber Research Group, Naperville, Illinois 60563, United States

Pedia Research, LLC, Newburgh, Indiana 47630, United States

Psychiatric Associates, Overland Park, Kansas 66211, United States

Pedia Research, LLC, Owensboro, Kentucky 42301, United States

Louisiana Resarch Associates, Inc., New Orleans, Louisiana 70114, United States

Marc Hertzman, MD, PC, Rockville, Maryland 20852, United States

Rochester Center for Behavioral Medicine, Rochester Hills, Michigan 48307, United States

Clinical Neurophysiology Services, PC, Sterling Heights, Michigan 48314, United States

Behavioral Medical Center - Troy, Troy, Michigan 48083, United States

Comprehensive Psychiatric Associates, Gladstone, Missouri 64118, United States

Psychiatric Care & Research Center, O'Fallon, Missouri 63368, United States

St. Charles Psychiatric Associates - Midwest Research Group, St. Charles, Missouri 63301, United States

Premier Psychiatric Research Institute, LLC, Lincoln, Nebraska 68526, United States

University of Nebraska Medical Center Dept Of Psychiatry, Omaha, Nebraska 68198, United States

Center for Psychiatry & Behavioral Medicine, Inc., Las Vegas, Nevada 89128, United States

Center for Emotional Fitness, Cherry Hill, New Jersey 08002, United States

The NeuroCognitive Institute, Mt. Arlington, New Jersey 07856, United States

Albuquerque Neuroscience, Inc., Albuquerque, New Mexico 87109, United States

Brain Resource Center, New York, New York 10023, United States

Mount Sinai School of Medicine/Dept of Psychiaatry, New York, New York 10029, United States

Duke University medical Center/ Duke ADHD Program, Durham, North Carolina 27705, United States

PMG Research of Wilmington, Wilmington, North Carolina 28401, United States

True North Clinical Research, Kentville, Nova Scotia B4N 4K9, Canada

University of Cincinnati College of Medicine/UCPC, Cincinnati, Ohio 45219, United States

The Ohio State University Nisonger Center, Columbus, Ohio 43210, United States

Tulsa Clinical Research, LLC, Tulsa, Oklahoma 74104, United States

The Kids Clinic, Whitby, Ontario L1N 2L1, Canada

Cyn3rgy Research, Gresham, Oregon 97030, United States

Oregon Center for Clinical Investigations Inc, Portland, Oregon 97210, United States

Summit Research Network, Portland, Oregon 97210, United States

Oregon Center for Clinical Investigations, Inc, Salem, Oregon 97301, United States

University Services, West Chester, Pennsylvania 19380, United States

Omega Medical Research, Warwick, Rhode Island 02886, United States

Rainbow Research, Inc., Barnwell, South Carolina 29812, United States

Clinical Neuroscience Solutions, Inc., Memphis, Tennessee 38119, United States

FutureSearch Trials of Dallas, LP, Dallas, Texas 75231, United States

Research Across America/Psychiatric Medical Associates, Dallas, Texas 75234, United States

Bayou City Research, Houston, Texas 77007, United States

Claghorn-Lesem Research Clinic, Ltd., Houston, Texas 77008, United States

Clinical Trial Network, Houston, Texas 77074, United States

Houston Clinical Trials, LLC, Houston, Texas 77098, United States

Red Oak Psychiatry Associates, PA, Houston, Texas 77090, United States

Texas Center for Drug Development, Inc., Houston, Texas 77081, United States

Westex Clinical Investigations, Lubbock, Texas 79423, United States

Clinical Trials of Texas, Inc., San Antonio, Texas 78229, United States

Univ of Texas Health Science Center at San Antonio, San Antonio, Texas 78229, United States

Ericksen Research and Development - Westside Medical, Clinton, Utah 84015, United States

University of Virginia Child and Family Psychiatry Clinic, Charlottesville, Virginia 22903, United States

Northwest Clinical Research Center, Bellevue, Washington 98007, United States

Eastside Thereapeutic Resource, Kirkland, Washington 98033, United States

Summit Research Network (Seattle), LLC, Seattle, Washington 98104, United States

Rockwood Clinic, P.S., Spokane, Washington 99202, United States

Additional Information

Starting date: April 2012
Last updated: March 4, 2015

Page last updated: August 23, 2015

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