Safety and Efficacy of ADDERALL XR in the Treatment of Adolescents Aged 13-17 With Attention Deficit Hyperactivity Disorder (ADHD)
This study has been completed.
Sponsor:
Shire Development LLC
Information provided by:
Shire Development LLC
ClinicalTrials.gov Identifier:
NCT00507065
First received: July 19, 2007
Last updated: March 30, 2009
Last verified: November 2007
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Purpose
Assess the safety and efficacy of ADDERALL XR compared to placebo in the treatment of adolescents (aged 13-17) with ADHD. Subjects were assigned to one of two cohorts based on weight (<= 75 kg or > 75 kg).
| Condition | Intervention | Phase |
|---|---|---|
|
ADHD |
Drug: Mixed salts of a single-entity amphetamine (ADDERALL XR) |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | A Phase III, Randomized, Multicenter, Double-Blind, Parallel-Group, Placebo-Controlled Safety and Efficacy Study of ADDERALL XR With an Open Label Extension, in the Treatment of Adolescents Aged 13-17 With ADHD |
Resource links provided by NLM:
MedlinePlus related topics:
Attention Deficit Hyperactivity Disorder
Drug Information available for:
Methamphetamine hydrochloride
Amphetamine sulfate
Amphetamine
Methamphetamine
Adderall
U.S. FDA Resources
Further study details as provided by Shire Development LLC:
Primary Outcome Measures:
- Change from baseline to final visit of the double-blind phase of the study in the ADHD-RS-IV score in the cohort weighing less than or equal to 75 kg. [ Time Frame: approximately 4 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Change from baseline to final visit of double-blind phase of the study in ADHD-RS-IV score in the cohort weighing >75 kg and the CGI for ADHD in both cohorts. [ Time Frame: Approximately 4 weeks ] [ Designated as safety issue: No ]
- Adverse events, labs, physical exam, ECG [ Time Frame: approximately 4 weeks ] [ Designated as safety issue: Yes ]
| Enrollment: | 329 |
| Study Start Date: | May 2003 |
| Study Completion Date: | April 2004 |
Eligibility| Ages Eligible for Study: | 13 Years to 17 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Males/females 13-17 years of age meeting DSM-IV criteria for a primary diagnosis of ADHD
Exclusion Criteria:
- Controlled or uncontrolled comorbid psychiatric diagnosis (except ODD) with significant symptoms such as PTSD, psychosis, bipolar disease, severe OCD
- Known non-responder to stimulant medication
- Documented allergy or intolerance to ADDERALL, ADDERALL XR or amphetamines
- Conduct Disorder, hypertension, history of seizure
- Tic disorder or Tourette's disorder
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00507065
Locations
| United States, New York | |
| New York University - Child Study Center | |
| New York, New York, United States | |
Sponsors and Collaborators
Shire Development LLC
Investigators
| Study Director: | Raymond Pratt, MD | Shire Development LLC |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00507065 History of Changes |
| Other Study ID Numbers: | SLI381-314A |
| Study First Received: | July 19, 2007 |
| Last Updated: | March 30, 2009 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Mental Disorders Diagnosed in Childhood Mental Disorders Amphetamine Adderall Central Nervous System Stimulants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses |
Sympathomimetics Autonomic Agents Peripheral Nervous System Agents Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Adrenergic Agents Adrenergic Uptake Inhibitors Neurotransmitter Uptake Inhibitors Dopamine Uptake Inhibitors |
ClinicalTrials.gov processed this record on May 23, 2013