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Sponsored by: |
Shire Pharmaceutical Development |
---|---|
Information provided by: | Shire Pharmaceutical Development |
ClinicalTrials.gov Identifier: | NCT00763971 |
The main aim of this study is to see if giving LDX to children and adolescents aged 6-17 years with ADHD decreases symptoms of ADHD.
Condition | Intervention | Phase |
---|---|---|
ADHD |
Drug: LDX Drug: Methylphenidate Hydrochloride Drug: Placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study |
Official Title: | A Phase III, Randomised, Double-Blind, Multicentre, Parallel-Group, Placebo- and Active-Controlled, Dose-Optimisation Safety and Efficacy Study of Lisdexamfetamine Dimesylate (LDX) in Children and Adolescents Aged 6-17 With Attention-Deficit/Hyperactivity Disorder (ADHD) |
Estimated Enrollment: | 333 |
Study Start Date: | October 2008 |
Estimated Study Completion Date: | September 2009 |
Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
LDX: Experimental
Overencapsulated LDX 30, 50, or 70mg
|
Drug: LDX
30, 50 or 70mg capsule once per day (Overencapsulated)
|
Concerta: Active Comparator
Overencapsulated Concerta 18, 36, or 54mg
|
Drug: Methylphenidate Hydrochloride
18, 36, or 54mg tablet one per day (Overencapsulated)
|
Placebo: Placebo Comparator
Overencapsulated Placebo
|
Drug: Placebo
Placebo capsule once per day (Overencapsulated)
|
Ages Eligible for Study: | 6 Years to 17 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Subject has failed to respond to more than one adequate course (dose and duration) of stimulant therapy.
One course must have been a long-acting formulation.
Contact: Shire Call Center | +1 866 842 5335 |
Responsible Party: | Shire Pharmaceutical ( Timothy Whitaker, MD ) |
Study ID Numbers: | SPD489-325 |
Study First Received: | September 30, 2008 |
Last Updated: | September 10, 2009 |
ClinicalTrials.gov Identifier: | NCT00763971 History of Changes |
Health Authority: | United States: Food and Drug Administration; United Kingdom: Medicines and Healthcare Products Regulatory Agency; Belgium: Federal Agency for Medicinal Products and Health Products; France: Afssaps - French Health Products Safety Agency; Germany: Federal Institute for Drugs and Medical Devices; Netherlands: The Central Committee on Research Involving Human Subjects (CCMO); Spain: Spanish Agency of Medicines; Sweden: Medical Products Agency |
Dopamine Uptake Inhibitors Neurotransmitter Agents Dopamine Attention Deficit Disorder with Hyperactivity Mental Disorders Dextroamphetamine |
Mental Disorders Diagnosed in Childhood Methylphenidate Attention Deficit and Disruptive Behavior Disorders Hyperkinesis Central Nervous System Stimulants Dopamine Agents |
Dopamine Uptake Inhibitors Neurotransmitter Agents Neurotransmitter Uptake Inhibitors Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Attention Deficit and Disruptive Behavior Disorders Methylphenidate Central Nervous System Stimulants |
Pharmacologic Actions Attention Deficit Disorder with Hyperactivity Mental Disorders Therapeutic Uses Dextroamphetamine Mental Disorders Diagnosed in Childhood Dopamine Agents Central Nervous System Agents |