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Comparison of Lisdexamfetamine Dimesylate With Atomoxetine HCl in Attention-Deficit/Hyperactivity Disorder (ADHD) Subjects With an Inadequate Response to Methylphenidate - NCT01106430-73103(Clinical Trial 685983)



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City:  Oklahoma City
State:  
OK
Zip Code: 73103
Conditions: Attention-Deficit/Hyperactivity Disorder
Purpose: This study will evaluate how long it takes for ADHD symptoms to improve in subjects who are judged by the Investigator to have had an inadequate response to methylphenidate therapy. The study will also test the safety of Lisdexamfetamine Dimesylate and how well it works.
Study summary:
Criteria: Inclusion Criteria: - Subject has had a historical or current inadequate response to an appropriate course (dose and duration) of MPH therapy defined as the presence of residual symptoms with associated impairment that suggests an alternative drug treatment is appropriate - Subject is a male or female aged 6-17 years inclusive at the time of consent - Subject must meet Diagnostic and Statistical Manual of Mental Disorders, fourth edition. - Text Revision (DSM IV TR) criteria for a primary diagnosis of ADHD based on a detailed psychiatric evaluation - Subject must have a baseline ADHD-RS-IV total score 28. Exclusion Criteria: - Subject has failed to respond to more than one adequate previous course (dose and duration) of MPH therapy - Subject has previously been exposed to STRATTERA or to amphetamine therapy - Subject has previously demonstrated intolerable side effects to stimulants - Subject has a current, controlled (requiring a restricted medication) or uncontrolled, comorbid psychiatric diagnosis with significant symptoms such as any severe comorbid Axis II disorder or severe Axis I disorder or other symptomatic manifestations, such as agitated states, marked anxiety, or tension that, in the opinion of the examining physician, will contraindicate treatment with SPD489 or STRATTERA or confound efficacy or safety assessments. - Subject has a conduct disorder. Oppositional Defiant Disorder is not exclusionary.
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Data Source: ClinicalTrials.gov
Date Processed: September 22, 2010
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