A Double-Blind Placebo Controlled Study of Atomoxetine Hydrochloride for the Treatment of ADHD in Children and Adolescents With ADHD and Comorbid Dyslexia

INTERVENTION: Trade Name: Strattera Product Name: Atomoxetine Hydrochloride Product Code: LY139603 Pharmaceutical Form: Capsule, hard INN or Proposed INN: Atomoxetine hydrochloride CAS Number: 82248‐59‐7 Other descriptive name: ATOMOXETINE HYDROCHLORIDE Concentration unit: mg/kg milligram(s)/kilogram Concentration type: range Concentration number: 1‐1.4 Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use CONDITION: Attention‐Deficit/Hyperactivity Disorder ; MedDRA version: 23.0 Level: LLT Classification code 10003735 Term: Attention deficit‐hyperactivity disorder System Organ Class: 100000004873 Therapeutic area: Diseases [C] ‐ Nervous System Diseases [C10] PRIMARY OUTCOME: Main Objective: The primary objective of this study is to test the hypothesis that atomoxetine given orally once daily for approximately 16 weeks will provide superior efficacy compared to placebo for the treatment of ADHD in children and adolescents with ADHD and comorbid Dyslexia (ADHD+D) as measured by the Attention‐Deficit/Hyperactivity Disorder Rating Scale‐IV‐Parent Version: Investigator‐Administered and Scored (ADHDRS‐IV‐Parent:Inv). Primary end point(s): Change From Baseline in Attention‐Deficit/Hyperactivity Disorder Rating Scale (ADHDRS) Total Score ‐ Parent Version at Week 16 Endpoint Secondary Objective: 1) To assess the effect of atomoxetine versus placebo for approximately 16 weeks on the secondary measures (see section E.5.2); 2) To assess the safety and tolerability of atomoxetine over approximately 16 and 32 weeks in the ADHD alone group, ADHD+D group, and dyslexia alone group as assessed by laboratory, vitals, and ECG measures and adverse events elicited during open‐ended questioning. Timepoint(s) of evaluation of this end point: Baseline, 16 weeks INCLUSION CRITERIA: •patients must meet Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM‐IV) criteria for Attention‐Deficit/Hyperactivity Disorder (ADHD) •patients must achieve a score of 80 or more on the Full Scale Intelligence Quotient •child or adolescent patients must be 10 to 16 years old •must be able to communicate in English •must be able to swallow capsules •be reliable to keep appointments for clinic visits and all related tests Are the trial subjects under 18? yes Number of subjects for this age range: 209 F.1.2 Adults (18‐64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range SECONDARY OUTCOME: Secondary end point(s): a) Change From Baseline in Attention‐Deficit/Hyperactivity Disorder Rating Scale (ADHDRS) Total and Subscores ‐ Parent Version at Week 16 Endpoint ; b) Change From Baseline in Attention‐Deficit/Hyperactivity Disorder Rating Scale (ADHDRS) Total and Subscores ‐ Teacher Version at Week 16 Endpoint ; c) Change From Baseline in Woodcock‐Johnson III Scores at Week 16 Endpoint; d) Change From Baseline in Comprehensive Test of Phonological Processing (CTOPP) at Week 16 Endpoint ; e) Change From Baseline in Gray Oral Reading Test‐4 (GORT‐4) at Week 16 Endpoint ; f) Change From Baseline in Test of Word Reading Efficiency (TOWRE) at Week 16 Endpoint ; g) Change From Baseline in Working Memory Test Battery for Children (WMTB‐C) at Week 16 Endpoint; h) Change From Baseline in Life Participation Scale‐child (LPS‐C) Score at Week 16 Endpoint ; i) Change From Baseline in Kiddie Sluggish Cognitive Tempo (K‐SCT) at Week 16 Endpoint; j) Change From Baseline in Multidimensional Self Concept Scale (MSCS) at Week 16 Endpoint ; k) Change From Baseline in Attention‐Deficit/Hyperactivity Disorder Rating Scale (ADHDRS) Total and Subscores ‐ Parent Version at Week 32 Endpoint ; l) Change From Baseline in Attention‐Deficit/Hyperactivity Disorder Rating Scale (ADHDRS) Total and Subscores ‐ Teacher Version at Week 32 Endpoint ; m) Change From Baseline in Woodcock‐Johnson III Scores at Week 32 Endpoint; n) Change From Baseline in Comprehensive Test of Phonological Processing (CTOPP) at Week 32 Endpoint ; o) Change From Baseline in Gray Oral Reading Test‐4 (GORT‐4) at Week 32 Endpoint ; p) Change From Baseline in Test of Word Reading Efficiency (TOWRE) at Week 32 Endpoint ; q) Change From Baseline in Working Memory Test Battery for Children (WMTB‐C) at Week 32 Endpoint ; r) Change From Baseline in Life Participation Scale‐child (LPS‐C) Score at Week 32 Endpoint ; s) Change From Baseline in Kiddie Sluggish Cognitive Tempo (K‐SCT) at Week 32 Endpoint ; t) Change From Baseline in Multidimensional Self Concept Scale (MSCS) at Week 32 Endpoint Timepoint(s) of evaluation of this end point: a‐j) Baseline, 16 weeks ; k‐t) Baseline, 32 weeks