| Primary | Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHDRS) Total Score - Parent Version at Week 16 Endpoint | Measures the 18 symptoms contained in the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR) diagnosis of Attention-Deficit/Hyperactivity Disorder (ADHD). Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total scores range from 0-54. Least Square mean of change from baseline in ADHDRS is from a restricted maximum likelihood-based, mixed model repeated measures analysis which includes the effects of treatment, investigative site, baseline, visit, treatment-by-visit interaction, and baseline-by-visit interaction. | All randomized participants with a baseline and at least one post-baseline result. | Posted | | Least Squares Mean | Standard Error | units on a scale | | Baseline, 16 weeks | | | | ID | Title | Description |
|---|
| OG000 | ADHD+ Dyslexia (D): Atomoxetine | Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Atomoxetine Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine | | OG001 | ADHD+ Dyslexia (D): Placebo | Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Placebo Placebo was packaged in the same way as Atomoxetine, and administered orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG000-20.01± 1.45
- OG001-12.27± 1.41
|
|
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| | Mixed Models Analysis | | <0.001 | | | | | | | 95 | | | | | | No | Superiority or Other | | |
|
| Secondary | Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHDRS) Total and Subscores - Parent Version at Week 16 Endpoint | The ADHDRS-IV-Parent is an 18-item scale with 1 item for each of the 18 symptoms contained in the DSM-IV diagnosis of ADHD. Each item is scored on a 0 to 3 scale: 0=none (never or rarely); 1=mild (sometimes); 2=moderate (often); 3=severe (very often). Hyperactivity-impulsivity scores range 0-27, and inattention scores range 0-27. Total scores range from 0-54. Higher scores indicate higher impairment. | All randomized participants with a baseline and at least one post-baseline result, and last observation carried forward (LOCF). | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, 16 weeks | | | | ID | Title | Description |
|---|
| OG000 | ADHD+ Dyslexia (D): Atomoxetine | Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Atomoxetine Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine | | OG001 | ADHD+ Dyslexia (D): Placebo | Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Placebo Placebo was packaged in the same way as Atomoxetine, and administered orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine |
|
| Secondary | Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHDRS) Total and Subscores - Teacher Version at Week 16 Endpoint | The ADHDRS-IV-Teacher is an 18-item scale with 1 item for each of the 18 symptoms contained in the DSM-IV diagnosis of ADHD. Each item is scored on a 0 to 3 scale: 0=none (never or rarely); 1=mild (sometimes); 2=moderate (often); 3=severe (very often). Hyperactivity-impulsivity scores range from 0-27, and inattention scores range from 0-27. Total scores range from 0-54. Higher scores indicate higher impairment. | All randomized participants with a baseline and at least one post-baseline result, and last observation carried forward (LOCF). | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, 16 weeks | | | | ID | Title | Description |
|---|
| OG000 | ADHD+ Dyslexia (D): Atomoxetine | Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Atomoxetine Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine | | OG001 | ADHD+ Dyslexia (D): Placebo | Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Placebo Placebo was packaged in the same way as Atomoxetine, and administered orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine |
|
| Secondary | Change From Baseline in Woodcock-Johnson III Scores at Week 16 Endpoint | The Woodcock Johnson Tests of Achievement has a Standard Battery (Tests 1-12) of a broad set of scores and an Extended Battery (Tests 13-22) on specific academic strengths and weaknesses. Tests associated with reading skills (1, 2, 7, 9, 13, 17, 20) were administered. Scores for each individual test can range from 0 to over 200 where anything 69 and below is very low and anything 131 and above is very superior. Higher scores indicate better reading skills. | All randomized participants with a baseline and at least one post-baseline result, and last observation carried forward (LOCF). | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, 16 weeks | | | | ID | Title | Description |
|---|
| OG000 | ADHD+ Dyslexia (D): Atomoxetine | Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Atomoxetine Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine | | OG001 | ADHD+ Dyslexia (D): Placebo | Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Placebo Placebo was packaged in the same way as Atomoxetine, and administered orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine |
|
| Secondary | Change From Baseline in Comprehensive Test of Phonological Processing (CTOPP) at Week 16 Endpoint | The CTOPP assesses phonological awareness, phonological memory, and rapid naming and is appropriate for ages 7 to 24. The test contains six core subtests. The composite scores are 1) Phonological Awareness, comprised of the standard scores of the Elision and Blending Words; 2) Phonological Memory, comprised of standard scores for Memory for Digits and Non-word Repetition; and 3) Rapid Naming, comprised of standard scores for Rapid Digit Naming and Rapid Letter Naming. Standard scores range from 1-20, and composite scores range from 35-165. Higher scores are better. | All randomized participants with a baseline and at least one post-baseline result, and last observation carried forward (LOCF). | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, 16 weeks | | | | ID | Title | Description |
|---|
| OG000 | ADHD+ Dyslexia (D): Atomoxetine | Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Atomoxetine Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine | | OG001 | ADHD+ Dyslexia (D): Placebo | Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Placebo Placebo was packaged in the same way as Atomoxetine, and administered orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine |
|
| Secondary | Change From Baseline in Gray Oral Reading Test-4 (GORT-4) at Week 16 Endpoint | The GORT-4 is a norm-referenced test of oral reading rate, accuracy, fluency, and comprehension valid for individuals aged 6 to 18 years old. The test has two parallel forms, Form A and Form B, that are administered in an alternating fashion (e.g. Week 0-Form A, Week 16-Form B, Week 32-Form A.) with each containing 14 separate stories and 5 multiple-choice comprehension questions for each story. GORT-4 yields the following scores: rate, accuracy, fluency, comprehension, and overall reading ability. Standard scores range from 1-20. Higher scores indicate better reading skills. | All randomized participants with a baseline and at least one post-baseline result, and last observation carried forward (LOCF). | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, 16 weeks | | | | ID | Title | Description |
|---|
| OG000 | ADHD+ Dyslexia (D): Atomoxetine | Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Atomoxetine Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine | | OG001 | ADHD+ Dyslexia (D): Placebo | Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Placebo Placebo was packaged in the same way as Atomoxetine, and administered orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine |
|
| Secondary | Change From Baseline in Test of Word Reading Efficiency (TOWRE) at Week 16 Endpoint | The TOWRE is a measure of an individual's ability to pronounce printed words accurately and fluently and is appropriate for individuals aged 6 to 24 years old. The TOWRE contains two subtests: Sight Word Efficiency (SWE) which assesses the number of real printed words that can be accurately identified within 45 seconds and Phonemic Decoding Efficiency (PDE) which measures the number of pronounceable printed non-words that can be accurately decoded within 45 seconds. Scores range from 45-146. Higher scores indicate higher reading proficiency. | All randomized participants with a baseline and at least one post-baseline result, and last observation carried forward (LOCF). | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, 16 weeks | | | | ID | Title | Description |
|---|
| OG000 | ADHD+ Dyslexia (D): Atomoxetine | Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Atomoxetine Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine | | OG001 | ADHD+ Dyslexia (D): Placebo | Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Placebo Placebo was packaged in the same way as Atomoxetine, and administered orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine |
|
| Secondary | Change From Baseline in Working Memory Test Battery for Children (WMTB-C) at Week 16 Endpoint | WMTB-C is assessment of working memory capacities, consisting of 9 subtests (Trials Correct Scores [Range from 55-145], Higher scores are better) reflecting 3 main components of working memory: central executive (CE) control/regulation of working memory (Backward Digit Recall, Listening Recall, Counting Recall); phonological loop (PL) responsible for holding verbal information for short periods (Digit Recall, Word List Matching, Word List Recall, Non-word List Recall); and visuo-spatial sketchpad (VSSP) which holds information in visual and spatial form (Block Recall, Mazes Memory). | All randomized participants with a baseline and at least one post-baseline result, and last observation carried forward (LOCF). | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, 16 weeks | | | | ID | Title | Description |
|---|
| OG000 | ADHD+ Dyslexia (D): Atomoxetine | Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Atomoxetine Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine | | OG001 | ADHD+ Dyslexia (D): Placebo | Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Placebo Placebo was packaged in the same way as Atomoxetine, and administered orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine |
|
| Secondary | Change From Baseline in Life Participation Scale-child (LPS-C) Score at Week 16 Endpoint | LPS-C is a short (24 item, 0-3 points per item) parent-rated scale that is designed to assess changes in adaptive functioning related to treatment for ADHD. This scale measures improvements in social, emotional, cognitive, educational, and affiliative (family, friends) functioning, which indirectly reflect improvements in executive functioning. Happy/social subscores range from 0-18, and self-control subscores range from 0-54. Total scores range from 0-72. Higher scores are better for LPS. | All randomized participants with a baseline and at least one post-baseline result, and last observation carried forward (LOCF). | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, 16 weeks | | | | ID | Title | Description |
|---|
| OG000 | ADHD+ Dyslexia (D): Atomoxetine | Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Atomoxetine Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine | | OG001 | ADHD+ Dyslexia (D): Placebo | Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Placebo Placebo was packaged in the same way as Atomoxetine, and administered orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine |
|
| Secondary | Change From Baseline in Kiddie Sluggish Cognitive Tempo (K-SCT) at Week 16 Endpoint | The K-SCT rating scale contains 3 components: Youth, Parent, and Teacher ratings. It queries 17 candidate SCT symptoms, such as daydreams, lost in a fog, sluggish/drowsy. Scores range from 0-51. Lower scores indicate less sluggish. | All randomized participants with a baseline and at least one post-baseline result, and last observation carried forward (LOCF). | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, 16 weeks | | | | ID | Title | Description |
|---|
| OG000 | ADHD+ Dyslexia (D): Atomoxetine | Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Atomoxetine Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine | | OG001 | ADHD+ Dyslexia (D): Placebo | Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Placebo Placebo was packaged in the same way as Atomoxetine, and administered orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine |
|
| Secondary | Change From Baseline in Multidimensional Self Concept Scale (MSCS) at Week 16 Endpoint | The MSCS is an overall assessment of self concept or an individual measure of any of the six scaled dimensions of self concept: Social, Competence, Affect, Academic, Family, and Physical. Standard scores range from 45-145. Higher scores are better (indicate higher self concept). | All randomized participants with a baseline and at least one post-baseline result, and last observation carried forward (LOCF). | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, 16 weeks | | | | ID | Title | Description |
|---|
| OG000 | ADHD+ Dyslexia (D): Atomoxetine | Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Atomoxetine Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine | | OG001 | ADHD+ Dyslexia (D): Placebo | Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Placebo Placebo was packaged in the same way as Atomoxetine, and administered orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine |
|
| Secondary | Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHDRS) Total and Subscores - Parent Version at Week 32 Endpoint | The ADHDRS-IV-parent is an 18-item scale with 1 item for each of the 18 symptoms contained in the DSM-IV diagnosis of ADHD. Each item is scored on a 0 to 3 scale: 0=none (never or rarely); 1=mild (sometimes); 2=moderate (often); 3 =severe (very often). Hyperactivity-impulsivity scores range from 0-27, and inattention scores range from 0-27. Total scores range from 0-54. Higher scores indicate higher impairment. | All randomized participants who entered open-label phase with a baseline and at least one post-baseline result, and last observation carried forward (LOCF). | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, 32 weeks | | | | ID | Title | Description |
|---|
| OG000 | ADHD+ Dyslexia (D): Atomoxetine | Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Atomoxetine Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine | | OG001 | ADHD Alone: Atomoxetine | Participants with attention-deficit/hyperactivity disorder (ADHD) alone treated with Atomoxetine. Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine |
|
| Secondary | Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHDRS) Total and Subscores - Teacher Version at Week 32 Endpoint | The ADHDRS-IV-Teacher is an 18-item scale with 1 item for each of the 18 symptoms contained in the DSM-IV diagnosis of ADHD. Each item is scored on a 0 to 3 scale: 0=none (never or rarely); 1=mild (sometimes); 2=moderate (often); 3 =severe (very often). Hyperactivity-impulsivity scores range from 0-27, and inattention scores range from 0-27. Total scores range from 0-54. Higher scores indicate higher impairment. | All randomized participants who entered open-label phase with a baseline and at least one post-baseline result, and last observation carried forward (LOCF). | Posted | | Mean | Standard Deviation | units | | Baseline, 32 weeks | | | | ID | Title | Description |
|---|
| OG000 | ADHD+ Dyslexia (D): Atomoxetine | Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Atomoxetine Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine | | OG001 | ADHD Alone: Atomoxetine | Participants with attention-deficit/hyperactivity disorder (ADHD) alone treated with Atomoxetine. Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine |
|
| Secondary | Change From Baseline in Woodcock-Johnson III Scores at Week 32 Endpoint | The Woodcock Johnson Tests of Achievement has a Standard Battery (Tests 1-12) of a broad set of scores and an Extended Battery (Tests 13-22) on specific academic strengths and weaknesses. Tests associated with reading skills (1, 2, 7, 9, 13, 17, 20) were administered. Scores for each individual test can range from 0 to over 200 where anything 69 and below is very low and anything 131 and above is very superior. Higher scores indicate better reading skills. | All randomized participants who entered open-label phase with a baseline and at least one post-baseline result, and last observation carried forward (LOCF). | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, 32 weeks | | | | ID | Title | Description |
|---|
| OG000 | ADHD+ Dyslexia (D): Atomoxetine | Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Atomoxetine Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine | | OG001 | ADHD Alone: Atomoxetine | Participants with attention-deficit/hyperactivity disorder (ADHD) alone treated with Atomoxetine. Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine |
|
| Secondary | Change From Baseline in Comprehensive Test of Phonological Processing (CTOPP) at Week 32 Endpoint | The CTOPP assesses phonological awareness, phonological memory, and rapid naming and is appropriate for ages 7 to 24. The test contains six core subtests. The composite scores are 1) Phonological Awareness, comprised of the standard scores of the Elision and Blending Words; 2) Phonological Memory, comprised of standard scores for Memory for Digits and Non-word Repetition; and 3) Rapid Naming, comprised of standard scores for Rapid Digit Naming and Rapid Letter Naming. Standard scores range from 1-20, and composite scores range from 35-165. Higher scores are better. | All randomized participants who entered open-label phase with a baseline and at least one post-baseline result, and last observation carried forward (LOCF). | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, 32 weeks | | | | ID | Title | Description |
|---|
| OG000 | ADHD+ Dyslexia (D): Atomoxetine | Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Atomoxetine Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine | | OG001 | ADHD Alone: Atomoxetine | Participants with attention-deficit/hyperactivity disorder (ADHD) alone treated with Atomoxetine. Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine |
|
| Secondary | Change From Baseline in Gray Oral Reading Test-4 (GORT-4) at Week 32 Endpoint | The GORT-4 is a norm-referenced test of oral reading rate, accuracy, fluency, and comprehension valid for individuals aged 6 to 18 years old. The test has two parallel forms, Form A and Form B, that are administered in an alternating fashion (e.g. Week 0-Form A, Week 16-Form B, Week 32-Form A.) with each containing 14 separate stories and 5 multiple-choice comprehension questions for each story. GORT-4 yields the following scores: rate, accuracy, fluency, comprehension, and overall reading ability. Standard scores range from 1-20. Higher scores indicate better reading skills. | All randomized participants who entered open-label phase with a baseline and at least one post-baseline result, and last observation carried forward (LOCF). | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, 32 weeks | | | | ID | Title | Description |
|---|
| OG000 | ADHD+ Dyslexia (D): Atomoxetine | Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Atomoxetine Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine | | OG001 | ADHD Alone: Atomoxetine | Participants with attention-deficit/hyperactivity disorder (ADHD) alone treated with Atomoxetine. Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine |
|
| Secondary | Change From Baseline in Test of Word Reading Efficiency (TOWRE) at Week 32 Endpoint | The TOWRE is a measure of an individual's ability to pronounce printed words accurately and fluently and is appropriate for individuals aged 6 to 24 years old. The TOWRE contains two subtests: Sight Word Efficiency (SWE) which assesses the number of real printed words that can be accurately identified within 45 seconds and Phonemic Decoding Efficiency (PDE) which measures the number of pronounceable printed non-words that can be accurately decoded within 45 seconds. Scores range from 45-146. Higher scores indicate higher reading proficiency. | All randomized participants who entered open-label phase with a baseline and at least one post-baseline result, and last observation carried forward (LOCF). | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, 32 weeks | | | | ID | Title | Description |
|---|
| OG000 | ADHD+ Dyslexia (D): Atomoxetine | Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Atomoxetine Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine | | OG001 | ADHD Alone: Atomoxetine | Participants with attention-deficit/hyperactivity disorder (ADHD) alone treated with Atomoxetine. Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine |
|
| Secondary | Change From Baseline in Working Memory Test Battery for Children (WMTB-C) at Week 32 Endpoint | WMTB-C is assessment of working memory capacities, consisting of 9 subtests (Trials Correct Scores [Range from 55-145], Higher scores are better) reflecting 3 main components of working memory: central executive (CE) control/regulation of working memory (Backward Digit Recall, Listening Recall, Counting Recall); phonological loop (PL) responsible for holding verbal information for short periods (Digit Recall, Word List Matching, Word List Recall, Non-word List Recall); and visuo-spatial sketchpad (VSSP) which holds information in visual and spatial form (Block Recall, Mazes Memory). | All randomized participants who entered open-label phase with a baseline and at least one post-baseline result, and last observation carried forward (LOCF). | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, 32 weeks | | | | ID | Title | Description |
|---|
| OG000 | ADHD+ Dyslexia (D): Atomoxetine | Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Atomoxetine Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine | | OG001 | ADHD Alone: Atomoxetine | Participants with attention-deficit/hyperactivity disorder (ADHD) alone treated with Atomoxetine. Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine |
|
| Secondary | Change From Baseline in Life Participation Scale-child (LPS-C) Score at Week 32 Endpoint | LPS-C is a short (24 item, 0-3 points per item) parent-rated scale that is designed to assess changes in adaptive functioning related to treatment for ADHD. This scale measures improvements in social, emotional, cognitive, educational, and affiliative (family, friends) functioning, which indirectly reflect improvements in executive functioning. Happy/social subscores range from 0-18, and self-control subscores range from 0-54. Total scores range from 0-72. Higher scores are better for LPS. | All randomized participants who entered open-label phase with a baseline and at least one post-baseline result, and last observation carried forward (LOCF). | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, 32 weeks | | | | ID | Title | Description |
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| OG000 | ADHD+ Dyslexia (D): Atomoxetine | Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Atomoxetine Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine | | OG001 | ADHD Alone: Atomoxetine | Participants with attention-deficit/hyperactivity disorder (ADHD) alone treated with Atomoxetine. Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine |
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| Secondary | Change From Baseline in Kiddie Sluggish Cognitive Tempo (K-SCT) at Week 32 Endpoint | The K-SCT rating scale contains 3 components: Youth, Parent, and Teacher ratings. It queries 17 candidate SCT symptoms, such as daydreams, lost in a fog, sluggish/drowsy. Scores range from 0-51. Lower scores indicate less sluggish. | All randomized participants who entered open-label phase with a baseline and at least one post-baseline result, and last observation carried forward (LOCF). | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, 32 weeks | | | | ID | Title | Description |
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| OG000 | ADHD+ Dyslexia (D): Atomoxetine | Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Atomoxetine Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine | | OG001 | ADHD Alone: Atomoxetine | Participants with attention-deficit/hyperactivity disorder (ADHD) alone treated with Atomoxetine. Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine |
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| Secondary | Change From Baseline in Multidimensional Self Concept Scale (MSCS) at Week 32 Endpoint | The MSCS is an overall assessment of self concept or an individual measure of any of the six scaled dimensions of self concept: Social, Competence, Affect, Academic, Family, and Physical. Standard scores range from 45-145. Higher scores are better (indicate higher self concept). | All randomized participants who entered open-label phase with a baseline and at least one post-baseline result, and last observation carried forward (LOCF). | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, 32 weeks | | | | ID | Title | Description |
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| OG000 | ADHD+ Dyslexia (D): Atomoxetine | Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Atomoxetine Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine | | OG001 | ADHD Alone: Atomoxetine | Participants with attention-deficit/hyperactivity disorder (ADHD) alone treated with Atomoxetine. Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine |
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