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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-000821-29 | EudraCT Number | ||
| TAK-503-401 | Other Identifier | Takeda Development Center Americas, Inc. | |
| 2022-502630-71-00 | EU Trial (CTIS) Number | EU CTIS |
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| Name | Class |
|---|---|
| Takeda Development Center Americas, Inc. | INDUSTRY |
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The main aim of this study is learn more about long-term TAK-503 treatment in children and teenagers with ADHD for whom earlier stimulant treatment did not work.
The study has two parts (A and B). In Part A, participants will take tablets of TAK-503, atomoxetine or placebo and in Part B TAK-503 tablets.
This study will be conducted in two parts Part A and Part B. Part A is a double-blinded, double-dummy, placebo-controlled study with an atomoxetine arm as an active reference to TAK-503. Eligible participants with ADHD will be randomized in a 1:1:1 ratio among TAK-503, atomoxetine, and placebo treatment arms up to 49 weeks of double-blinded treatment. Upon completion of Part A, participants will roll over to Part B directly as per the study protocol directions for an additional 52 weeks of open-label TAK-503 treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A: Guanfacine hydrochloride (TAK-503) | Experimental | Participants randomized to TAK-503 will receive initial dose of 1 milligram (mg), and up titrated with weekly incremental dose of 1 mg until an optimal dose is reached. Participants aged 6 to 12 years will receive a dose of 1 to 4 mg and aged 13 to 17 years will receive a dose of 5 to 7 mg TAK-503 oral tablet once daily (QD) for 18 weeks. |
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| Part A: Atomoxetine hydrochloride | Active Comparator | Participants who weigh less than (<) 70 kilograms (kg) at baseline will receive Atomoxetine hydrochloride capsule orally at an initial dose of 0.5 milligram per kilogram (mg/kg) which may be increased to the target dose of 1.2 mg/kg oral capsule QD during the treatment of 18 weeks. Permitted doses of Atomoxetine hydrochloride capsule will be 10, 18, 25, 40, 60, and 80 mg QD. Participants who weigh >= 70 kg at baseline will receive Atomoxetine hydrochloride at an initial dose of 40 mg oral capsule QD which may be increased to 80 mg and then to 100 mg for 18 weeks. The total dose for participants who weigh >= 70 kg at baseline will not exceed 100 mg. |
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| Part A: Placebo | Placebo Comparator | Participants aged 6 to 12 years will receive a dose of 1 to 4 mg tablet of placebo matched to TAK-503 and aged 13 to 17 years will receive a dose of 5 to 7 mg tablets of placebo matched to TAK-503 orally QD for 18 weeks. Participants who weigh < 70 kg at baseline will receive placebo matched to Atomoxetine hydrochloride oral capsule at an initial dose of 0.5 mg/kg which may be increased to the target dose of 1.2 mg/kg QD oral capsule during the treatment of 18 weeks. Permitted doses of placebo matched to Atomoxetine hydrochloride will be 10, 18, 25, 40, 60, and 80 mg QD and participants who weigh >= 70 kg will receive placebo matched to Atomoxetine hydrochloride at an initial dose of 40 mg QD capsule orally which may be increased to 80 mg and then to 100 mg. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Guanfacine hydrochloride (TAK-503) | Drug | Participants aged 6 to 12 years will receive a dose of 1 to 4 mg and aged 13 to 17 years will receive a dose of 5 to 7 mg TAK-503 oral tablets once daily for 18 weeks in Part A or 52 weeks in Part B. |
| Measure | Description | Time Frame |
|---|---|---|
| Part A: Change From Baseline in the Cambridge Neuropsychological Test Automated Battery (CANTAB) Reaction Time (RTI) Task at Week 18 | The neurocognitive function effects of TAK-503 on adolescents and children were evaluated using CANTAB assessments. The RTI task of CANTAB measured motor, mental response speeds and assessed movement time, reaction time, response accuracy and impulsivity. In CANTAB RTI task, a yellow dot appeared in one of circles (five circles for five-choice variant) and participant must react as soon as possible, releasing the button at bottom of screen and selecting the circle in which the dot appeared. Time taken from yellow dot appearing, to the participants releasing press-pad was defined as reaction time. Movement time was defined as time taken from the participant releasing the press-pad to touching the screen. Times for this assessment were calculated for correct trials and measured in milliseconds (msec) ranging from 100 to 5100, with a higher time indicating worse performance of the task. Negative change from baseline indicates improvement in reaction speed. | At Baseline, Week 18 |
| Part A: Change From Baseline in the CANTAB RTI Task at Week 49 | The neurocognitive function effects of TAK-503 on adolescents and children were evaluated using CANTAB assessments. The RTI task of CANTAB measured motor, mental response speeds and assessed movement time, reaction time, response accuracy and impulsivity. In CANTAB RTI task, a yellow dot appeared in one of circles (five circle for five-choice variant) and participant must react as soon as possible, releasing the button at bottom of screen and selecting the circle in which the dot appeared. Time taken from yellow dot appearing, to the participants releasing press-pad was defined as reaction time. Movement time was defined as time taken from the participant releasing the press-pad to touching the screen. Times for this assessment were calculated for correct trials and measured in msec ranging from 100 to 5100, with a higher time indicating worse performance of the task. Negative change from baseline indicates improvement in reaction speed. | At Baseline, Week 49 |
| Part B: Change From Baseline in the CANTAB RTI Task at Week 49 | The neurocognitive function effects of TAK-503 on adolescents and children were evaluated using CANTAB assessments. The RTI task of CANTAB measured motor, mental response speeds and assessed movement time, reaction time, response accuracy and impulsivity. In CANTAB RTI task, a yellow dot appeared in one of circles (five circle for five-choice variant) and participant must react as soon as possible, releasing the button at bottom of screen and selecting the circle in which the dot appeared. Time taken from yellow dot appearing, to the participants releasing press-pad was defined as reaction time. Movement time was defined as time taken from the participant releasing the press-pad to touching the screen. Times for this assessment were calculated for correct trials and measured in msec ranging from 100 to 5100, with a higher time indicating worse performance of the task. Negative change from baseline indicates improvement in reaction speed. |
| Measure | Description | Time Frame |
|---|---|---|
| Part A: Change From Baseline in the Rapid Visual Information Processing (RVP) Task of the CANTAB: Mean Response Latency | The neurocognitive function effects of TAK-503 on adolescents and children diagnosed with ADHD was evaluated using the CANTAB cognitive assessments. RVP measured the ability to sustain attention over time and was a sensitive measure of frontal-parietal function. In this task, single digits appear in a pseudo-random order at a rate of 100 digits per minute in a box at the center of the screen. Participants were to detect a 3-digit target sequence (e.g. 2-4-6) and respond by pressing a button at the bottom of the screen when the final number of the sequence appears on the screen. Mean Response Latency was defined as the mean response time on trials where participants responded correctly. Higher time indicated worse performance. |
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Inclusion Criteria:
Study Part A:
Study Part B:
Exclusion Criteria:
Study Part A:
Participant has a current, controlled (requiring medication or therapy) or uncontrolled, comorbid psychiatric disorder (except oppositional defiant disorder), including but not limited to any of the following comorbid Axis I and Axis II disorders (the K-SADS-PL should be reviewed to confirm diagnosis, if necessary):
Participant is currently considered to be a suicide risk by the investigator; has made a previous suicide attempt; has a history of, or currently demonstrating, active suicidal ideation.
Participant has a substance abuse disorder as defined by DSM-5 criteria or has been suspected of a substance abuse or dependence disorder (except nicotine) within the past 6 months.
Participant has a clinically important abnormality on the urine drug and alcohol screen (except for the participants current ADHD stimulant, if applicable) at screening (Visit 1A).
Participant has been physically, sexually, and/or emotionally abused.
Participant has any other disorder that as judged by the investigator could contraindicate TAK-503 or confound the results of the safety and efficacy assessments.
Participant has any condition or illness including any clinically significant abnormal laboratory value at screening (Visit 1A) or, if the laboratory test was repeated, at baseline (Visit 2A) that, as judged by the investigator, would be an inappropriate risk to the participant and/or could confound the interpretation of study results.
Participant has current abnormal thyroid function, defined as abnormal thyroid-stimulating hormone and thyroxine at screening (Visit 1A). Treatment with a stable dose of thyroid medication for > = 3 months before screening will be permitted.
Participant has a known history or presence of: malignancy (except nonmelanoma skin cancer), pregnancy, and/or a developmental delay or abnormality associated with growth or sexual maturation delays that are not related to ADHD.
Children aged 6 to 12 years with a body weight less than (<) 25.0 kg or adolescents aged > = 13 years with a body weight < 34.0 kg at screening (Visit 1A) or baseline (Visit 2A).
Participant is significantly overweight based on the Centers for Disease Control (CDC) BMI-for-age sex-specific charts at screening (Visit 1A) or baseline (Visit 2A). For this study, significantly overweight will be defined as a BMI that is greater than the 95th percentile.
Participant has a known history or presence of: structural cardiac abnormalities, serious heart rhythm abnormalities, syncope, cardiac conduction problems (e.g. clinically significant heart block or QT interval prolongation), bradycardia, or exercise-related cardiac events including syncope and presyncope.
Participant has clinically significant electrocardiogram (ECG) findings, as judged by the investigator, at baseline (Visit 2A).
Participant has orthostatic hypotension* or a known history of hypertension. (*Orthostatic hypotension is defined as a sustained reduction of systolic blood pressure of at least 20 millimeter of mercury (mm Hg) or diastolic blood pressure of 10 mm Hg within 3 minutes of standing from supine.)
Participant has a known family history of sudden cardiac death or ventricular arrhythmia.
Participant is currently using any medication that violates protocol-specified washout criteria at baseline (Visit 2A), including any ADHD medication or other prohibited medications such as herbal supplements, medications that affect BP or heart rate (HR) or medications that have central nervous system (CNS) effects or affect cognitive performance, such as sedating antihistamines and decongestant sympathomimetics (inhaled bronchodilators are permitted) or a history of chronic use of sedating medications (i.e., antihistamines).
Participant has a medical condition except ADHD that requires treatment with any medication that affects the CNS.
Participant is female and pregnant or currently lactating.
Participant has taken another investigational product or participated in a clinical study within 30 days before screening (Visit 1A).
Participant does not tolerate or has a known or suspected allergy, hypersensitivity, or clinically significant intolerance to guanfacine hydrochloride, atomoxetine, or any TAK-503 or atomoxetine drug product component.
Participant has a history of a seizure disorder (except for a single childhood febrile seizure episode that occurred before the age of 3 years)
Participant is well-controlled on his/her current ADHD medication with acceptable tolerability, and the parent/treating physician does not object to the current medication.
Participant has alanine transaminase (ALT) greater than (>) 2*upper limit of normal (ULN) or aspartate aminotransferase (AST) >2*ULN or bilirubin >1.5*ULN at screening.
Study Part B:
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda Development Center Americas | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Harmonex Neuroscience Research | Dothan | Alabama | 36303 | United States | ||
| Advanced Research Center, Inc. |
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| Label | URL |
|---|---|
| Click here for more information about this trial in easy-to-understand language, including a Plain Language Summary of the results if the trial has been completed. | View source |
| Click here to ask Takeda's chatbot for comprehensive and easy-to-understand information about clinical trials - even across products and indications - in your local language. | View source |
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Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
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IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
The study was conducted in 2 parts: Part A (Double-blinded Period) and Part B (Open-label Period). In Part A, pediatric participants were randomized in a 1:1:1 ratio among TAK-503, atomoxetine, and placebo treatment arms up to 49 weeks of double-blinded treatment. Upon completion of Part A, participants directly rolled over to Trial Part B for an additional 52 weeks of open-label TAK-503 treatment.
Participants took part in the study at 29 investigative sites in Austria, Belgium, Germany, Netherlands, Portugal, Spain and the United States of America from 18 September 2019 to 02 September 2025. A total of 396 participants were screened, of which 288 were randomized and 108 were screen failures.
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| ID | Title | Description |
|---|---|---|
| FG000 | Double-Blinded Period (Part A): Placebo | Participants received TAK-503-matched placebo tablets, orally, once daily (QD) and atomoxetine-matched placebo capsule orally, QD for up to 18 weeks. |
| FG001 | Double-Blinded Period (Part A): TAK-503 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Part A:Double-blind Period-Upto 49 Weeks |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 12, 2024 | Feb 19, 2026 |
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This study contains two parts (Part A and Part B), where Part A will be double blind, double dummy parts of the study followed by Part B as an open label part of the study.
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| Part B: Guanfacine hydrochloride (TAK-503) | Experimental | Participants from Part A will roll over into Part B directly after 18 weeks and will receive TAK-503 at an initial dose of 1 mg, and up titrated with weekly incremental dose of 1 mg until an optimal dose is reached. Participants aged 6 to 12 years will receive a dose of 1 to 4 mg and aged 13 to 17 years will receive a dose of 5 to 7 mg TAK-503 oral tablet QD for 52 weeks of Part B. |
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| Atomoxetine hydrochloride | Drug | Participants will receive Atomoxetine hydrochloride oral capsule once daily for 18 weeks in Part A. |
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| Placebo | Other | Participants aged 6 to 12 years will receive a dose of 1 to 4 mg and aged 13 to 17 years will receive a dose of 5 to 7 mg placebo matched to TAK 503 oral tablets once daily for 18 weeks and placebo matched to atomoxetine hydrochloride oral capsules at once daily for 18 weeks in Part A. |
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| At Baseline, Week 49 |
| Baseline, Weeks 18 and 49 |
| Part B: Change From Baseline in the RVP Task of the CANTAB: Mean Response Latency | The neurocognitive function effects of TAK-503 on adolescents and children diagnosed with ADHD was evaluated using the CANTAB cognitive assessments. RVP measured the ability to sustain attention over time and was a sensitive measure of frontal-parietal function. In this task, single digits appear in a pseudo-random order at a rate of 100 digits per minute in a box at the center of the screen. Participants were to detect a 3-digit target sequence (e.g. 2-4-6) and respond by pressing a button at the bottom of the screen when the final number of the sequence appears on the screen. Mean Response Latency was defined as the mean response time on trials where participants responded correctly. Higher time indicated worse performance. | Baseline, Week 49 |
| Part A: Change From Baseline in the RVP Task of the CANTAB: A' | The neurocognitive function effects of TAK-503 on adolescents and children diagnosed with ADHD was evaluated using the CANTAB cognitive assessments. RVP measured the ability to sustain attention over time and was a sensitive measure of frontal-parietal function. In this task, single digits appear in a pseudo-random order at a rate of 100 digits per minute in a box at the center of the screen. Participants were to detect a 3-digit target sequence (e.g. 2-4-6) and respond by pressing a button at the bottom of the screen when the final number of the sequence appears on the screen. A' was defined as the standardized score for target sequence detection, ranging from 0-1. Higher score indicated better performance. | Baseline, Weeks 18 and 49 |
| Part B: Change From Baseline in the RVP Task of the CANTAB: A' | The neurocognitive function effects of TAK-503 on adolescents and children diagnosed with ADHD was evaluated using the CANTAB cognitive assessments. RVP measured the ability to sustain attention over time and was a sensitive measure of frontal-parietal function. In this task, single digits appear in a pseudo-random order at a rate of 100 digits per minute in a box at the center of the screen. Participants were to detect a 3-digit target sequence (e.g. 2-4-6) and respond by pressing a button at the bottom of the screen when the final number of the sequence appears on the screen. A' was defined as the standardized score for target sequence detection, ranging from 0-1. Higher score indicated better performance. | Baseline, Week 49 |
| Part A: Change From Baseline in the RVP Task of the CANTAB: Probability of Hit | The neurocognitive function effects of TAK-503 on adolescents and children diagnosed with ADHD was evaluated using the CANTAB cognitive assessments. RVP measured the ability to sustain attention over time and was a sensitive measure of frontal-parietal function. In this task, single digits appear in a pseudo-random order at a rate of 100 digits per minute in a box at the center of the screen. Participants were to detect a 3-digit target sequence (e.g. 2-4-6) and respond by pressing a button at the bottom of the screen when the final number of the sequence appears on the screen. Probability of Hit was defined as proportion of correct sequence responses divided by total number of sequences. Higher rate indicates better performance. | Baseline, Weeks 18 and 49 |
| Part B: Change From Baseline in the RVP Task of the CANTAB: Probability of Hit | The neurocognitive function effects of TAK-503 on adolescents and children diagnosed with ADHD was evaluated using the CANTAB cognitive assessments. RVP measured the ability to sustain attention over time and was a sensitive measure of frontal-parietal function. In this task, single digits appear in a pseudo-random order at a rate of 100 digits per minute in a box at the center of the screen. Participants were to detect a 3-digit target sequence (e.g. 2-4-6) and respond by pressing a button at the bottom of the screen when the final number of the sequence appears on the screen. Probability of Hit was defined as proportion of correct sequence responses divided by total number of sequences. Higher rate indicates better performance. | Baseline, Week 49 |
| Part A: Change From Baseline in the Spatial Working Memory (SWM) Task of the CANTAB | The ability to retain spatial information and manipulate remembered items in working memory was measured with SWM task. Task was self-ordered and assessed the individual's ability to strategize heuristically. The test was a sensitive measure of frontal lobe and executive dysfunction. The test began with a number of colored squares (boxes) shown on the screen. By selecting the boxes and using a process of elimination, the participant should find one yellow 'token' in each of a number of boxes and use them to fill up an empty column on the right-hand side of the screen. The outcome measures to be presented for each assessment of the task as follows: Total errors- number of times a box was selected that was certain to not have any tokens, across all trials ranging 0 (very good) to 66 (poor/impaired). Strategy (6 to 8 boxes)- number of times a participant begins a new search pattern from same box they started with previously, ranging 0 to 13. Higher score indicated a very poor strategy. | Baseline, Weeks 18 and 49 |
| Part B: Change From Baseline in the SWM Task of the CANTAB | The ability to retain spatial information and manipulate remembered items in working memory was measured with SWM task. Task was self-ordered and assessed the individual's ability to strategize heuristically. The test was a sensitive measure of frontal lobe and executive dysfunction. The test began with a number of colored squares (boxes) shown on the screen. By selecting the boxes and using a process of elimination, the participant should find one yellow 'token' in each of a number of boxes and use them to fill up an empty column on the right-hand side of the screen. The outcome measures to be presented for each assessment of the task as follows: Total errors- number of times a box was selected that was certain to not have any tokens, across all trials ranging 0 (very good) to 66 (poor/impaired). Strategy (6 to 8 boxes) - number of times a participant begins a new search pattern from same box they started with previously, ranging 0 to 13. Higher score indicated a very poor strategy. | Baseline, Week 49 |
| Part A: Change From Baseline in the Stop Signal Task (SST) Task of the CANTAB: Stop Signal Reaction Time and Median Reaction Time | The neurocognitive function effects of TAK-503 on adolescents and children diagnosed with ADHD was evaluated using the CANTAB cognitive assessments. SST measured response inhibition or control. The participant must respond to an arrow stimulus by touching either of 2 choices depending on the direction the arrow points. If an audio tone was present, the participant should not respond. Stop signal reaction time was defined as the estimate of time where an individual can successfully inhibit responses 50 percent (%) of the time. Median reaction time (All Go Trials) was defined as the median reaction time taken across all Go trials within an assessment. Higher time indicated worse performance. | Baseline, Weeks 18 and 49 |
| Part B: Change From Baseline in the SST Task of the CANTAB: Stop Signal Reaction Time and Median Reaction Time | The neurocognitive function effects of TAK-503 on adolescents and children diagnosed with ADHD was evaluated using the CANTAB cognitive assessments. SST measured response inhibition or control. The participant must respond to an arrow stimulus by touching either of 2 choices depending on the direction the arrow points. If an audio tone was present, the participant should not respond. Stop signal reaction time was defined as the estimate of time where an individual can successfully inhibit responses 50% of the time. Median reaction time (All Go Trials) was defined as the median reaction time taken across all Go trials within an assessment. Higher time indicated worse performance. | Baseline, Week 49 |
| Part A: Change From Baseline in the SST Task of the CANTAB: Direction Error (Go Trials), Direction Error (Stop Trials) and Missed Trials | The neurocognitive function effects of TAK-503 on adolescents and children was evaluated using the CANTAB assessments. SST measured response inhibition or control. The participant must respond to an arrow stimulus by touching either of 2 choices depending on the direction the arrow points. If an audio tone was present, the participant should not respond. Direction Error (Go Trials) was defined as the total number of trials where the participant pressed the wrong button to the direction of the arrow stimulus on a "Go" trial. Direction Error (Stop Trials) was defined as the total number of trials where the participant pressed the wrong button to the direction of the arrow stimulus on a "Stop" trial. Missed Trials was defined as the total number of trials which the participant missed. Higher value indicated worse performance. | Baseline, Weeks 18 and 49 |
| Part B: Change From Baseline in the SST Task of the CANTAB: Direction Error (Go Trials), Direction Error (Stop Trials) and Missed Trials | The neurocognitive function effects of TAK-503 on adolescents and children was evaluated using the CANTAB assessments. SST measured response inhibition or control. The participant must respond to an arrow stimulus by touching either of 2 choices depending on the direction the arrow points. If an audio tone was present, the participant should not respond. Direction Error (Go Trials) was defined as the total number of trials where the participant pressed the wrong button to the direction of the arrow stimulus on a "Go" trial. Direction Error (Stop Trials) was defined as the total number of trials where the participant pressed the wrong button to the direction of the arrow stimulus on a "Stop" trial. Missed Trials was defined as the total number of trials which the participant missed. Higher value indicated worse performance. | Baseline, Week 49 |
| Part A: Change From Baseline in the Delayed Matching to Sample (DMS) Task of the CANTAB: Percentage of Correct Responses | The neurocognitive function effects of TAK-503 on adolescents and children diagnosed with ADHD was evaluated using the CANTAB cognitive assessments. DMS measured both simultaneous matching and short-term visual memory. The participant was shown a complex visual pattern (the sample) and after a brief delay, 4 similar patterns. The participant must identify the pattern that matches the sample. Percentage of Correct Responses was defined as the percentage of trials during which the participant chose the correct response on the first attempt. Higher rate indicated better performance. | Baseline, Weeks 18 and 49 |
| Part B: Change From Baseline in the DMS Task of the CANTAB: Percentage of Correct Responses | The neurocognitive function effects of TAK-503 on adolescents and children diagnosed with ADHD was evaluated using the CANTAB cognitive assessments. DMS measured both simultaneous matching and short-term visual memory. The participant was shown a complex visual pattern (the sample) and after a brief delay, 4 similar patterns. The participant must identify the pattern that matches the sample. Percentage of Correct Responses was defined as the percentage of trials during which the participant chose the correct response on the first attempt. Higher rate indicated better performance. | Baseline, Week 49 |
| Part A: Change From Baseline in the DMS Task of the CANTAB: Mean Correct Latency | The neurocognitive function effects of TAK-503 on adolescents and children diagnosed with ADHD was evaluated using the CANTAB cognitive assessments. DMS measured both simultaneous matching and short-term visual memory. The participant was shown a complex visual pattern (the sample) and after a brief delay, 4 similar patterns. The participant must identify the pattern that matches the sample. Mean Correct Latency was defined as the average time between the presentation of the response stimuli objects and the participants selecting the correct box on their first attempt. Higher time indicated worse performance. | Baseline, Week 18 and 49 |
| Part B: Change From Baseline in the DMS Task of the CANTAB: Mean Correct Latency | The neurocognitive function effects of TAK-503 on adolescents and children diagnosed with ADHD was evaluated using the CANTAB cognitive assessments. DMS measured both simultaneous matching and short-term visual memory. The participant was shown a complex visual pattern (the sample) and after a brief delay, 4 similar patterns. The participant must identify the pattern that matches the sample. Mean Correct Latency was defined as the average time between the presentation of the response stimuli objects and the participants selecting the correct box on their first attempt. Higher time indicated worse performance. | Baseline, Week 49 |
| Part A: Change From Baseline in the DMS Task of the CANTAB: Mean Choices to Correct | The neurocognitive function effects of TAK-503 on adolescents and children diagnosed with ADHD was evaluated using the CANTAB cognitive assessments. DMS measured both simultaneous matching and short-term visual memory. The participant was shown a complex visual pattern (the sample) and after a brief delay, 4 similar patterns. The participant must identify the pattern that matches the sample. Mean choices to correct was defined as the mean number of choices that the participant made on each trial, including the correct choice. Higher number of choices indicated worse performance. | Baseline, Weeks 18 and 49 |
| Part B: Change From Baseline in the DMS Task of the CANTAB: Mean Choices to Correct | The neurocognitive function effects of TAK-503 on adolescents and children diagnosed with ADHD was evaluated using the CANTAB cognitive assessments. DMS measured both simultaneous matching and short-term visual memory. The participant was shown a complex visual pattern (the sample) and after a brief delay, 4 similar patterns. The participant must identify the pattern that matches the sample. Mean choices to correct was defined as the mean number of choices that the participant made on each trial, including the correct choice. Higher number of choices indicated worse performance. | Baseline, Week 49 |
| Parts A and B: Sexual Maturation Assessed Using Tanner Stage | The stage of puberty or sexual maturation was evaluated for each participant according to Tanner staging. The Tanner stage for genitals (male, stages I-V), breasts (females, stages I-V), and pubic hair (both sexes, stages I-V) was documented. Tanner staging was self-assessed. Self-assessment in this study was defined as participants or parents indicating which drawing of the scale corresponds to participants sexual maturation stage at the time of the specific visit. | Part A: Baseline, Weeks 18 and 49; Part B: Baseline, Week 49 |
| Parts A and B: Change From Baseline in Weight | Weight was measured in kg using a calibrated scale. | Part A: Baseline, Weeks 18 and 49; Part B: Baseline, Week 49 |
| Parts A and B: Change From Baseline in Height | A calibrated stadiometer was used for all height measurements and was measured in centimeter (cm). | Part A: Baseline, Weeks 18 and 49; Part B: Baseline, Week 49 |
| Parts A and B: Change From Baseline in Body Mass Index (BMI) | BMI was a measure of body fat based on height and weight. BMI = (weight in kg x10,000)/(height in cm^2). | Part A: Baseline, Weeks 18 and 49; Part B: Baseline, Week 49 |
| Parts A and B: Number of Participants With Clinically Significant Changes in Vital Signs: Pulse Rate, Blood Pressure (BP), Temperature, and Respiratory Rate | Vital signs assessments included pulse rate (beats/minutes), supine and standing BP (millimeters of mercury [mmHg]), oral or tympanic temperature (degrees Celsius [C]), and respiratory rate (breaths per minute). The number of participants was calculated based on number of participants with non-missing results for a given parameter at Baseline and at least 1 post-Baseline assessment. | Part A: From start of study drug administration up to Week 52; Part B: From start of study drug administration up to follow-up (Week 53) |
| Parts A and B: Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) | The heart rate (HR), PR interval, QRS interval, and QT interval were measured from all ECGs and the QTcB and QTcF were assessed. | Part A: From start of study drug administration up to Week 52; Part B: From start of study drug administration up to follow-up (Week 53) |
| Parts A and B: Number of Participants With Treatment-emergent Adverse Events (TEAEs) | An Adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. A TEAE was defined as any event emerging or manifesting at or after the initiation of treatment with an investigational product or medicinal product or any existing event that worsened in either intensity or frequency following exposure to the investigational product or medicinal product. TEAEs were defined as AEs whose onset occurs, severity worsens, or intensity increases after receiving the blinded trial intervention and up to 3 days after the last dose of double-blind trial medication. | Part A: From start of study drug administration up to Week 52; Part B: From start of study drug administration up to follow-up (Week 53) |
| Part A: Psychiatric Symptoms Assessed Using Brief Psychiatric Rating Scale for Children (BPRS-C): Total Score | Psychiatric symptoms were measured by the BPRS-C. The 21 items were grouped across 7 scales: Behavior Problems [Questions 1 to 3], Depression [Questions 4 to 6], Thinking Disturbance [Questions 7 to 9], Psychomotor Excitation [Questions 10 to 12], Withdrawal [Questions 13 to 15], Anxiety [Questions 16 to 18] and Organicity [Questions 19 to 21]. Each of the 21 items was rated on a 7-point severity Likert scale from 0 to 6 (not present=0; very mild=1; mild=2; moderate=3; moderately severe=4; severe=5; extremely severe=6). A total score was calculated by summing the values across the 21 items, ranging from 0 to 126. Higher scores indicated higher severity. | Baseline, Weeks 18 and 49 |
| Part B: Psychiatric Symptoms Assessed Using BPRS-C: Total Score | Psychiatric symptoms were measured by the BPRS-C. The 21 items were grouped across 7 scales: Behavior Problems [Questions 1 to 3], Depression [Questions 4 to 6], Thinking Disturbance [Questions 7 to 9], Psychomotor Excitation [Questions 10 to 12], Withdrawal [Questions 13 to 15], Anxiety [Questions 16 to 18] and Organicity [Questions 19 to 21]. Each of the 21 items was rated on a 7-point severity Likert scale from 0 to 6 (not present=0; very mild=1; mild=2; moderate=3; moderately severe=4; severe=5; extremely severe=6). A total score was calculated by summing the values across the 21 items, ranging from 0 to 126. Higher scores indicated higher severity. | Baseline, Weeks 23, 36 and 49 |
| Parts A and B: Number of Participants With Suicidal Ideation (SI) or Behavior Assessed Using Columbia- Suicide Severity Rating Scale (CSSRS) | The C-SSRS was a structured tool used to assess SI and behavior. A maximum of 19 items were completed as follows: 7 items were required, a potential 10 additional items were completed upon a positive response to a required item, and 2 items were completed if suicide or suicide-like behavior was observed during the interview. Suicidal ideation, including intensity of ideation, behavior, & attempts with actual/potential lethality. Categories have binary responses (yes/no) & include Wish to be Dead; Non-specific Active Suicidal Thoughts; Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act; Active Suicidal Ideation with Some Intent to Act, without Specific Plan; Active Suicidal Ideation with Specific Plan and Intent, Preparatory Acts and Behavior; Aborted Attempt; Interrupted Attempt; Actual Attempt (non-fatal); Completed Suicide. Score of 1 or higher= suicidal ideation/behavior. Only non-zero categories were reported. | Baseline up to Week 52 |
| Parts A and B: Number of Participants With Side Effects Assessed Using Udvalg for Kliniske Undersøgelser (UKU) Side Effect Rating Scale: Asthenia or Lassitude or Increased Fatigability | UKU rating scale was developed for clinicians to assess side effects of psychopharmacological medications based on interviews and other relevant source information. UKU items relevant to the established safety profile of TAK-503 such as Asthenia/Lassitude/lncreased Fatiguability, Sleepiness/Sedation, Increased Duration of Sleep, and Orthostatic Dizziness were queried. Each side effect was categorized for severity, ranging from 0 (Normal) to 3 (Severe). | Part A: Baseline, Weeks 18 and 49; Part B: Baseline, Weeks 23, 36, 49, 50, 51 and 52 |
| Parts A and B: Number of Participants With Side Effects Assessed Using UKU Side Effect Rating Scale: Sleepiness or Sedation | UKU rating scale was developed for clinicians to assess side effects of psychopharmacological medications based on interviews and other relevant source information. UKU items relevant to the established safety profile of TAK-503 such as Asthenia/Lassitude/lncreased Fatiguability, Sleepiness/Sedation, Increased Duration of Sleep, and Orthostatic Dizziness were queried. Each side effect was categorized for severity, ranging from 0 (Normal) to 3 (Severe). | Part A: Baseline, Weeks 18 and 49; Part B: Baseline, Weeks 23, 36, 49, 50, 51 and 52 |
| Parts A and B: Number of Participants With Side Effects Assessed Using UKU Side Effect Rating Scale: Increased Duration of Sleep | UKU rating scale was developed for clinicians to assess side effects of psychopharmacological medications based on interviews and other relevant source information. UKU items relevant to the established safety profile of TAK-503 such as Asthenia/Lassitude/lncreased Fatiguability, Sleepiness/Sedation, Increased Duration of Sleep, and Orthostatic Dizziness were queried. Each side effect was categorized for severity, ranging from 0 (Normal) to 3 (Severe). | Part A: Baseline, Weeks 18 and 49; Part B: Baseline, Weeks 23, 36, 49, 50, 51 and 52 |
| Parts A and B: Number of Participants With Side Effects Assessed Using UKU Side Effect Rating Scale: Orthostatic Dizziness | UKU rating scale was developed for clinicians to assess side effects of psychopharmacological medications based on interviews and other relevant source information. UKU items relevant to the established safety profile of TAK-503 such as Asthenia/Lassitude/lncreased Fatiguability, Sleepiness/Sedation, Increased Duration of Sleep, and Orthostatic Dizziness were queried. Each side effect was categorized for severity, ranging from 0 (Normal) to 3 (Severe). | Part A: Baseline, Weeks 18 and 49; Part B: Baseline, Weeks 23, 36, 49, 50, 51 and 52 |
| Part A: Sedative Effects Assessed Using Pediatric Daytime Sleepiness Scale (PDSS): Total Score | The PDSS was a self-reported assessment of daytime sleepiness in children aged 11 to 15 years. PDSS questionnaire was designed to be easy to administer, score, and interpret. Sleepiness-related questions were based on previous research of situations that can be sensitive to sleep loss in this age group. The 8 questions were scored on Likert-scale from 0 to 4 (never=0; seldom=1; sometimes=2; frequently=3; always=4). The total score on the PDSS was derived by summing the values from the 8 questions and ranged from 0 (never sleepy) to 32 (always sleepy), with higher scores representing greater severity of excessive sleepiness. | Baseline, Weeks 18 and 49 |
| Part B: Sedative Effects Assessed Using PDSS: Total Score | The PDSS was a self-reported assessment of daytime sleepiness in children aged 11 to 15 years. PDSS questionnaire was designed to be easy to administer, score, and interpret. Sleepiness-related questions were based on previous research of situations that can be sensitive to sleep loss in this age group. The 8 questions were scored on Likert-scale from 0 to 4 (never=0; seldom=1; sometimes=2; frequently=3; always=4). The total score on the PDSS was derived by summing the values from the 8 questions and ranged from 0 (never sleepy) to 32 (always sleepy), with higher scores representing greater severity of excessive sleepiness. | Baseline, Weeks 23, 36 and 49 |
| Parts A and B: Symptoms Assessed Using ADHD-Rating Scale-5 (ADHD-RS-5): Total Score | The ADHD-RS-5 was used widely by mental health, educational, and medical practitioners in screening, diagnosis, and treatment evaluation to determine the frequency and severity of ADHD symptoms and impairments in children and adolescents. The ADHD-RS-5 was based on the diagnostic criteria for ADHD as described in the DSM-5 and consisted of 2 symptom subscales, inattention and hyperactivity-impulsivity, each with 9 items and a total scale of 18 items. Each item in the subscale was scored with a value ranging from 0 (no symptoms) to 3 (severe symptoms). Total score was obtained from summing the scores of each item and ranged from 0 to 54. Higher score indicated a worse outcome. | Part A: Baseline, Weeks 18 and 49; Part B: Baseline, Week 49 |
| Parts A and B: Symptoms Assessed Using ADHD-RS-5: Inattention Subscale Score | The ADHD-RS-5 was used widely by mental health, educational, and medical practitioners in screening, diagnosis, and treatment evaluation to determine the frequency and severity of ADHD symptoms and impairments in children and adolescents. The ADHD-RS-5 was based on the diagnostic criteria for ADHD as described in the DSM-5 and consisted of 2 symptom subscales, inattention and hyperactivity-impulsivity, each with 9 items and a total scale of 18 items. Each item in the subscale was scored with a value ranging from 0 (no symptoms) to 3 (severe symptoms). The ADHD-RS-5 subscale scores ranged from 0 to 27. Higher score indicated a worse outcome. | Part A: Baseline, Weeks 18 and 49; Part B: Baseline, Week 49 |
| Parts A and B: Symptoms Assessed Using ADHD-RS-5: Hyperactivity-Impulsivity Subscale Score | The ADHD-RS-5 was used widely by mental health, educational, and medical practitioners in screening, diagnosis, and treatment evaluation to determine the frequency and severity of ADHD symptoms and impairments in children and adolescents. The ADHD-RS-5 was based on the diagnostic criteria for ADHD as described in the DSM-5 and consisted of 2 symptom subscales, inattention and hyperactivity-impulsivity, each with 9 items and a total scale of 18 items. Each item in the subscale was scored with a value ranging from 0 (no symptoms) to 3 (severe symptoms). The ADHD-RS-5 subscale scores ranged from 0 to 27. Higher score indicated a worse outcome. | Part A: Baseline, Weeks 18 and 49; Part B: Baseline, Week 49 |
| Parts A and B: Number of Participants Assessed for Severity of Mental Illness Using Clinical Global Impression-Improvement (CGI-I) | Global clinical measurement of ADHD improvement as measured by CGI-I using the Clinical Global Impression-Severity (CGI-S) to establish baseline. The CGI-S was administered to assess the severity of mental illness at baseline. The CGI-I was administered to assess any improvement in symptoms and to guide the clinician on dosing adjustments. The CGI-I was scored on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Higher score indicated worst improvement. | Part A: Baseline, Weeks 1, 18 and 49; Part B: Baseline, Weeks 23, 36 and 49 |
| Parts A and B: Participants Functioning and Well-being Assessed Using Child Health and Illness Profile - Child Edition: Parent Report Form (CHIP-CE:PRF): Global Score | Parent Report Form of CHIP-CE:PRF was administered to provide information on self-esteem & school functioning. The 5 domains, 12 subdomains covered 76 items: Satisfaction: with health (7items)& self (4items); Comfort: physical (9items)& emotional symptoms (9items) & activity restrictions (4items) due to illness; Resilience: behaviors& family involvement (8items) in activities likely to enhance health, Social problem-solving (5items),Physical activity (6items); Risk avoidance: behaviors that if not avoided are likely to pose risks to health: Individual risk avoidance (4items), Threats to achievement (10items); Achievement: developmentally appropriate role functioning in school & with peers: Academic performance (5items), Peer relations (5items). For each domain/subdomain, means were calculated by taking average of each non-missing item in domain/subdomain. Global score was an average of scores for 5 domains. Each item uses a 5-response format (scored 1-5). Higher score=greater health. | Part A: Baseline, Weeks 18 and 49; Part B: Baseline, Weeks 23, 36 and 49 |
| Parts A and B: Behavioral, Social, and Academic Issues Assessed Using Conners 3 Parent Short Form (C3PS): Total Score | The Conners 3 was a focused tool for the assessment of ADHD and associated learning, behavior, and emotional problems in children 6 to 18 years of age. The C3PS was completed by a child's parent/guardian and comprised of 45 items with subsets of items related to six content scales: inattention, hyperactivity/impulsivity, executive functioning, learning problems, defiance/aggression and peer relations. The parent rated his/her child on the first 43 items of the C3PS using a 4-point Likert scale (0-3; where 0=not at all true [never, seldom] and 3=very much true [very often, very frequently]) based on past month; the last 2 items were fill-in-the-blank and do not contribute to the raw score(s). Total scores were evaluated by summing the 43 numeric items, resulting in a range of 0 to 129, where higher score indicated a greater frequency of issues | Part A: Baseline, Weeks 18 and 49; Part B: Baseline, Weeks 23, 36 and 49 |
| Anaheim |
| California |
| 92805 |
| United States |
| Sun Valley Research Center, Inc. | Imperial | California | 92251 | United States |
| Alliance Research | Long Beach | California | 90807 | United States |
| PCSD Feighner Research | San Diego | California | 92108 | United States |
| Homestead Medical Research | Homestead | Florida | 33030 | United States |
| Clinical Neuroscience Solutions, Inc. | Jacksonville | Florida | 32256 | United States |
| Care Research Center, Inc. | Miami | Florida | 33130 | United States |
| Clinical Neuroscience Solutions, Inc. | Orlando | Florida | 32801 | United States |
| AMR Conventions Research, Ltd | Naperville | Illinois | 60563 | United States |
| Collective Medical Research LLC | Prairie Village | Kansas | 66208 | United States |
| Qualmedica Research, LLC | Bowling Green | Kentucky | 42101 | United States |
| Qualmedica Research, LLC | Owensboro | Kentucky | 42301 | United States |
| Alivation Research, LLC | Lincoln | Nebraska | 68526 | United States |
| Center for Psychiatry and Behavioral Medicine, Inc. | Las Vegas | Nevada | 89128 | United States |
| University of Cincinnati | Cincinnati | Ohio | 45219 | United States |
| Cutting Edge Research Group | Oklahoma City | Oklahoma | 73116 | United States |
| Clinical Neuroscience Solutions, Inc. | Memphis | Tennessee | 38119 | United States |
| Family Psychiatry of The Woodlands | The Woodlands | Texas | 77381 | United States |
| Clinical Research Partners, LLC | Petersburg | Virginia | 23805 | United States |
| LKH-Klinikum Graz | Graz | 8036 | Austria |
| Medizinische Universtität Wien | Vienna | 1090 | Austria |
| UZ Brussel | Brussels | 1090 | Belgium |
| UPC KU Leuven Afdeling Kinderpsychiatrie ADHD-raadpleging | Leuven | 3000 | Belgium |
| Foyer Saint Francois | Namur | 5000 | Belgium |
| Zentralinstitut fuer Seelische Gesundheit | Mannheim | Baden-Wurttemberg | 68159 | Germany |
| Universitaetsklinikum Koeln | Cologne | North Rhine-Westphalia | 50931 | Germany |
| Rheinhessen-Fachklinik Mainz | Mainz | Rhineland-Palatinate | 55122 | Germany |
| Universitaetsklinikum Freiburg | Freiburg im Breisgau | 79104 | Germany |
| EB FlevoResearch | Almere Stad | 1311RL | Netherlands |
| EB UtrechtResearch | Utrecht | 3562KX | Netherlands |
| Hospital de Cascais - Dr. José de Almeida | Alcabideche | 2755-009 | Portugal |
| Centro Clinico Academico 2CA Associacao Braga, Hospital de Braga Piso 1, Ala E | Braga | 4710-243 | Portugal |
| Centro Hospitalar Universitario Cova da Beira, E.P.E | Covilha | 6200-502 | Portugal |
| Hospital da Senhora da Oliveira Guimarães | Guimarães | 4835-044 | Portugal |
| Hospital CUF Descobertas | Lisbon | 1998-018 | Portugal |
| Centro Materno Infantil do Norte (CMIN) Centro Hospitalar Universitario do Porto | Porto | 4099-001 | Portugal |
| Clinica Universidad de Navarra | Pamplona | Navarre | 31080 | Spain |
| Hospital Universitari Vall d'Hebron | Barcelona | 08035 | Spain |
| Clinica Dr. Quintero | Madrid | 28002 | Spain |
| Hospital Infanta Leonor | Madrid | 28031 | Spain |
| Hospital Universitario Fundacion Alcorcon | Madrid | 28922 | Spain |
| Complejo Hospitalario de Palencia | Palencia | 34005 | Spain |
| Corporacio Sanitaria Parc Tauli | Sabadell | 8208 | Spain |
| Instituto Valenciano de Neurología Pediátrica (INVANEP) | Valencia | 46010 | Spain |
| Barnneuropsykiatriska enheten, Sahlgrenska University hospital | Gothenburg | 41118 | Sweden |
| Regionhälsan | Mölnlycke | 43530 | Sweden |
| PRIMA Barn- och Vuxenpsykiatri AB | Norsborg | 145 67 | Sweden |
| Tayside Children Hospital | Dundee | DD1 9SY | United Kingdom |
| Lister Hospital | Stevenage | SG1 4AB | United Kingdom |
Participants aged 6 to 12 years received TAK-503 at doses ranging from 1 to 4 milligram (mg), and participants aged 13 to 17 years received doses ranging from 1 to 7 mg. TAK-503 was administered orally, QD for up to 49 weeks along with atomoxetine matched placebo capsule. All participants initiated treatment at 1 mg, with dose titration in weekly increments of 1 mg until an optimal dose was achieved. |
| FG002 | Double-Blinded Period (Part A): Atomoxetine | Participants received atomoxetine administered orally, QD for up to 49 weeks along with TAK-503 matched placebo. Participants weighing less than (<) 70 kilograms (kg) at baseline initiated treatment at 0.5 milligrams per kilogram (mg/kg), with titration to a target dose of 1.2 mg/kg. Participants weighing greater than or equal to (>=) 70 kg at baseline initiated treatment at 40 mg, QD, with weekly dose increases to 80 mg and then to 100 mg if tolerated. The maximum daily dose for participants weighing >=70 kg did not exceed 100 mg. |
| FG003 | Open-Label Period (Part B): Part A (Placebo) - Part B (TAK-503) | Participants who completed Part A in the placebo arm rolled over directly into Part B and received TAK-503 for up to 52 weeks. TAK-503 was administered orally, QD. Participants aged 6 to 12 years received doses ranging from 1 to 4 mg, and participants aged 13 to 17 years received doses ranging from 1 to 7 mg. All participants initiated treatment at 1 mg, with dose titration in weekly increments of 1 mg until an optimal dose was achieved. |
| FG004 | Open-Label Period (Part B): Part A (TAK-503) - Part B (TAK-503) | Participants who completed Part A in the TAK-503 arm rolled over directly into Part B after washout period of >= 30 days and then received TAK-503 for up to 52 weeks. TAK-503 was administered orally, QD. Participants aged 6 to 12 years received doses ranging from 1 to 4 mg, and participants aged 13 to 17 years received doses ranging from 1 to 7 mg. All participants initiated treatment at 1 mg, with dose titration in weekly increments of 1 mg until an optimal dose was achieved. |
| FG005 | Open-Label Period (Part B): Part A (Atomoxetine) - Part B (TAK-503) | Participants who completed Part A in the atomoxetine arm rolled over directly into Part B after washout period of >= 30 days and then received TAK-503 for up to 52 weeks. TAK-503 was administered orally, QD. Participants aged 6 to 12 years received doses ranging from 1 to 4 mg, and participants aged 13 to 17 years received doses ranging from 1 to 7 mg. All participants initiated treatment at 1 mg, with dose titration in weekly increments of 1 mg until an optimal dose was achieved. |
| Treated Participants in Double-Blinded Period |
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| COMPLETED |
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| NOT COMPLETED |
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| Part B:Open-label Period-Upto 52 Weeks |
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The double-blind safety set included all randomized participants in Study Part A who received >=1 intervention dose.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Double-Blinded Period (Part A): Placebo | Participants received TAK-503-matched placebo tablets, orally, QD and atomoxetine-matched placebo capsule orally, QD for up to 18 weeks. |
| BG001 | Double-Blinded Period (Part A): TAK-503 | Participants aged 6 to 12 years received TAK-503 at doses ranging from 1 to 4 mg, and participants aged 13 to 17 years received doses ranging from 1 to 7 mg. TAK-503 was administered orally, QD for up to 49 weeks along with atomoxetine matched placebo capsule. All participants initiated treatment at 1 mg, with dose titration in weekly increments of 1 mg until an optimal dose was achieved. |
| BG002 | Double-Blinded Period (Part A): Atomoxetine | Participants received atomoxetine administered orally, QD for up to 49 weeks along with TAK-503 matched placebo. Participants weighing <70 kg at baseline initiated treatment at 0.5 mg/kg, with titration to a target dose of 1.2 mg/kg. Participants weighing >= 70 kg at baseline initiated treatment at 40 mg, QD, with weekly dose increases to 80 mg and then to 100 mg if tolerated. The maximum daily dose for participants weighing >=70 kg did not exceed 100 mg. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Part A: Change From Baseline in the Cambridge Neuropsychological Test Automated Battery (CANTAB) Reaction Time (RTI) Task at Week 18 | The neurocognitive function effects of TAK-503 on adolescents and children were evaluated using CANTAB assessments. The RTI task of CANTAB measured motor, mental response speeds and assessed movement time, reaction time, response accuracy and impulsivity. In CANTAB RTI task, a yellow dot appeared in one of circles (five circles for five-choice variant) and participant must react as soon as possible, releasing the button at bottom of screen and selecting the circle in which the dot appeared. Time taken from yellow dot appearing, to the participants releasing press-pad was defined as reaction time. Movement time was defined as time taken from the participant releasing the press-pad to touching the screen. Times for this assessment were calculated for correct trials and measured in milliseconds (msec) ranging from 100 to 5100, with a higher time indicating worse performance of the task. Negative change from baseline indicates improvement in reaction speed. | The FAS included all participants in the double-blind safety set with >=1 postbaseline CANTAB assessments in Study Part A. Here, "Overall Number of Participants Analyzed" signifies the participants who were evaluable for this outcome measure. | Posted | Least Squares Mean | Standard Error | msec | At Baseline, Week 18 |
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| Primary | Part A: Change From Baseline in the CANTAB RTI Task at Week 49 | The neurocognitive function effects of TAK-503 on adolescents and children were evaluated using CANTAB assessments. The RTI task of CANTAB measured motor, mental response speeds and assessed movement time, reaction time, response accuracy and impulsivity. In CANTAB RTI task, a yellow dot appeared in one of circles (five circle for five-choice variant) and participant must react as soon as possible, releasing the button at bottom of screen and selecting the circle in which the dot appeared. Time taken from yellow dot appearing, to the participants releasing press-pad was defined as reaction time. Movement time was defined as time taken from the participant releasing the press-pad to touching the screen. Times for this assessment were calculated for correct trials and measured in msec ranging from 100 to 5100, with a higher time indicating worse performance of the task. Negative change from baseline indicates improvement in reaction speed. | FAS. "Overall Number of Participants Analyzed" signifies the participants who were evaluable for this outcome measure. As per the planned analysis in protocol, the data was analyzed only for TAK-503 and Atomoxetine arms for Part A at Week 49. | Posted | Least Squares Mean | Standard Error | msec | At Baseline, Week 49 |
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| Primary | Part B: Change From Baseline in the CANTAB RTI Task at Week 49 | The neurocognitive function effects of TAK-503 on adolescents and children were evaluated using CANTAB assessments. The RTI task of CANTAB measured motor, mental response speeds and assessed movement time, reaction time, response accuracy and impulsivity. In CANTAB RTI task, a yellow dot appeared in one of circles (five circle for five-choice variant) and participant must react as soon as possible, releasing the button at bottom of screen and selecting the circle in which the dot appeared. Time taken from yellow dot appearing, to the participants releasing press-pad was defined as reaction time. Movement time was defined as time taken from the participant releasing the press-pad to touching the screen. Times for this assessment were calculated for correct trials and measured in msec ranging from 100 to 5100, with a higher time indicating worse performance of the task. Negative change from baseline indicates improvement in reaction speed. | The open-label safety set included all participants who received >=1 dose of TAK-503 in Study Part B. Here, "Overall Number of Participants Analyzed" signifies the participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | msec | At Baseline, Week 49 |
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| Secondary | Part A: Change From Baseline in the Rapid Visual Information Processing (RVP) Task of the CANTAB: Mean Response Latency | The neurocognitive function effects of TAK-503 on adolescents and children diagnosed with ADHD was evaluated using the CANTAB cognitive assessments. RVP measured the ability to sustain attention over time and was a sensitive measure of frontal-parietal function. In this task, single digits appear in a pseudo-random order at a rate of 100 digits per minute in a box at the center of the screen. Participants were to detect a 3-digit target sequence (e.g. 2-4-6) and respond by pressing a button at the bottom of the screen when the final number of the sequence appears on the screen. Mean Response Latency was defined as the mean response time on trials where participants responded correctly. Higher time indicated worse performance. | The FAS included all participants in the double-blind safety set with >=1 postbaseline CANTAB assessments in Study Part A. Here, "Overall Number of Participants Analyzed" signifies the participants who were evaluable for this outcome measure and "number analysed" signifies participants at the specific timepoints. | Posted | Least Squares Mean | Standard Error | msec | Baseline, Weeks 18 and 49 |
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| Secondary | Part B: Change From Baseline in the RVP Task of the CANTAB: Mean Response Latency | The neurocognitive function effects of TAK-503 on adolescents and children diagnosed with ADHD was evaluated using the CANTAB cognitive assessments. RVP measured the ability to sustain attention over time and was a sensitive measure of frontal-parietal function. In this task, single digits appear in a pseudo-random order at a rate of 100 digits per minute in a box at the center of the screen. Participants were to detect a 3-digit target sequence (e.g. 2-4-6) and respond by pressing a button at the bottom of the screen when the final number of the sequence appears on the screen. Mean Response Latency was defined as the mean response time on trials where participants responded correctly. Higher time indicated worse performance. | The open-label safety set included all participants who received >=1 dose of TAK-503 in Study Part B. Here, "Overall Number of Participants Analyzed" signifies the participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | msec | Baseline, Week 49 |
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| Secondary | Part A: Change From Baseline in the RVP Task of the CANTAB: A' | The neurocognitive function effects of TAK-503 on adolescents and children diagnosed with ADHD was evaluated using the CANTAB cognitive assessments. RVP measured the ability to sustain attention over time and was a sensitive measure of frontal-parietal function. In this task, single digits appear in a pseudo-random order at a rate of 100 digits per minute in a box at the center of the screen. Participants were to detect a 3-digit target sequence (e.g. 2-4-6) and respond by pressing a button at the bottom of the screen when the final number of the sequence appears on the screen. A' was defined as the standardized score for target sequence detection, ranging from 0-1. Higher score indicated better performance. | The FAS included all participants in the double-blind safety set with >=1 postbaseline CANTAB assessments in Study Part A. Here, "Overall Number of Participants Analyzed" signifies the participants who were evaluable for this outcome measure and "number analysed" signifies participants at the specific timepoints. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Weeks 18 and 49 |
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| Secondary | Part B: Change From Baseline in the RVP Task of the CANTAB: A' | The neurocognitive function effects of TAK-503 on adolescents and children diagnosed with ADHD was evaluated using the CANTAB cognitive assessments. RVP measured the ability to sustain attention over time and was a sensitive measure of frontal-parietal function. In this task, single digits appear in a pseudo-random order at a rate of 100 digits per minute in a box at the center of the screen. Participants were to detect a 3-digit target sequence (e.g. 2-4-6) and respond by pressing a button at the bottom of the screen when the final number of the sequence appears on the screen. A' was defined as the standardized score for target sequence detection, ranging from 0-1. Higher score indicated better performance. | The open-label safety set included all participants who received >=1 dose of TAK-503 in Study Part B. Here, "Overall Number of Participants Analyzed" signifies the participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Week 49 |
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| Secondary | Part A: Change From Baseline in the RVP Task of the CANTAB: Probability of Hit | The neurocognitive function effects of TAK-503 on adolescents and children diagnosed with ADHD was evaluated using the CANTAB cognitive assessments. RVP measured the ability to sustain attention over time and was a sensitive measure of frontal-parietal function. In this task, single digits appear in a pseudo-random order at a rate of 100 digits per minute in a box at the center of the screen. Participants were to detect a 3-digit target sequence (e.g. 2-4-6) and respond by pressing a button at the bottom of the screen when the final number of the sequence appears on the screen. Probability of Hit was defined as proportion of correct sequence responses divided by total number of sequences. Higher rate indicates better performance. | The FAS included all participants in the double-blind safety set with >=1 postbaseline CANTAB assessments in Study Part A. Here, "Overall Number of Participants Analyzed" signifies the participants who were evaluable for this outcome measure and "number analysed" signifies participants at the specific timepoints. | Posted | Least Squares Mean | Standard Error | proportion | Baseline, Weeks 18 and 49 |
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| Secondary | Part B: Change From Baseline in the RVP Task of the CANTAB: Probability of Hit | The neurocognitive function effects of TAK-503 on adolescents and children diagnosed with ADHD was evaluated using the CANTAB cognitive assessments. RVP measured the ability to sustain attention over time and was a sensitive measure of frontal-parietal function. In this task, single digits appear in a pseudo-random order at a rate of 100 digits per minute in a box at the center of the screen. Participants were to detect a 3-digit target sequence (e.g. 2-4-6) and respond by pressing a button at the bottom of the screen when the final number of the sequence appears on the screen. Probability of Hit was defined as proportion of correct sequence responses divided by total number of sequences. Higher rate indicates better performance. | The open-label safety set included all participants who received >=1 dose of TAK-503 in Study Part B. Here, "Overall Number of Participants Analyzed" signifies the participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | proportion | Baseline, Week 49 |
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| Secondary | Part A: Change From Baseline in the Spatial Working Memory (SWM) Task of the CANTAB | The ability to retain spatial information and manipulate remembered items in working memory was measured with SWM task. Task was self-ordered and assessed the individual's ability to strategize heuristically. The test was a sensitive measure of frontal lobe and executive dysfunction. The test began with a number of colored squares (boxes) shown on the screen. By selecting the boxes and using a process of elimination, the participant should find one yellow 'token' in each of a number of boxes and use them to fill up an empty column on the right-hand side of the screen. The outcome measures to be presented for each assessment of the task as follows: Total errors- number of times a box was selected that was certain to not have any tokens, across all trials ranging 0 (very good) to 66 (poor/impaired). Strategy (6 to 8 boxes)- number of times a participant begins a new search pattern from same box they started with previously, ranging 0 to 13. Higher score indicated a very poor strategy. | The FAS included all participants in the double-blind safety set with >=1 postbaseline CANTAB assessments in Study Part A. Here, "Overall Number of Participants Analyzed" signifies the participants who were evaluable for this outcome measure and "number analysed" signifies participants at the specific timepoints. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Weeks 18 and 49 |
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| Secondary | Part B: Change From Baseline in the SWM Task of the CANTAB | The ability to retain spatial information and manipulate remembered items in working memory was measured with SWM task. Task was self-ordered and assessed the individual's ability to strategize heuristically. The test was a sensitive measure of frontal lobe and executive dysfunction. The test began with a number of colored squares (boxes) shown on the screen. By selecting the boxes and using a process of elimination, the participant should find one yellow 'token' in each of a number of boxes and use them to fill up an empty column on the right-hand side of the screen. The outcome measures to be presented for each assessment of the task as follows: Total errors- number of times a box was selected that was certain to not have any tokens, across all trials ranging 0 (very good) to 66 (poor/impaired). Strategy (6 to 8 boxes) - number of times a participant begins a new search pattern from same box they started with previously, ranging 0 to 13. Higher score indicated a very poor strategy. | The open-label safety set included all participants who received >=1 dose of TAK-503 in Study Part B. Here, "Overall Number of Participants Analyzed" signifies the participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Week 49 |
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| Secondary | Part A: Change From Baseline in the Stop Signal Task (SST) Task of the CANTAB: Stop Signal Reaction Time and Median Reaction Time | The neurocognitive function effects of TAK-503 on adolescents and children diagnosed with ADHD was evaluated using the CANTAB cognitive assessments. SST measured response inhibition or control. The participant must respond to an arrow stimulus by touching either of 2 choices depending on the direction the arrow points. If an audio tone was present, the participant should not respond. Stop signal reaction time was defined as the estimate of time where an individual can successfully inhibit responses 50 percent (%) of the time. Median reaction time (All Go Trials) was defined as the median reaction time taken across all Go trials within an assessment. Higher time indicated worse performance. | The FAS included all participants in the double-blind safety set with >=1 postbaseline CANTAB assessments in Study Part A. Here, "Overall Number of Participants Analyzed" signifies the participants who were evaluable for this outcome measure and "number analysed" signifies participants at the specific timepoints. | Posted | Least Squares Mean | Standard Error | msec | Baseline, Weeks 18 and 49 |
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| Secondary | Part B: Change From Baseline in the SST Task of the CANTAB: Stop Signal Reaction Time and Median Reaction Time | The neurocognitive function effects of TAK-503 on adolescents and children diagnosed with ADHD was evaluated using the CANTAB cognitive assessments. SST measured response inhibition or control. The participant must respond to an arrow stimulus by touching either of 2 choices depending on the direction the arrow points. If an audio tone was present, the participant should not respond. Stop signal reaction time was defined as the estimate of time where an individual can successfully inhibit responses 50% of the time. Median reaction time (All Go Trials) was defined as the median reaction time taken across all Go trials within an assessment. Higher time indicated worse performance. | The open-label safety set included all participants who received >=1 dose of TAK-503 in Study Part B. Here, "Overall Number of Participants Analyzed" signifies the participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | msec | Baseline, Week 49 |
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| Secondary | Part A: Change From Baseline in the SST Task of the CANTAB: Direction Error (Go Trials), Direction Error (Stop Trials) and Missed Trials | The neurocognitive function effects of TAK-503 on adolescents and children was evaluated using the CANTAB assessments. SST measured response inhibition or control. The participant must respond to an arrow stimulus by touching either of 2 choices depending on the direction the arrow points. If an audio tone was present, the participant should not respond. Direction Error (Go Trials) was defined as the total number of trials where the participant pressed the wrong button to the direction of the arrow stimulus on a "Go" trial. Direction Error (Stop Trials) was defined as the total number of trials where the participant pressed the wrong button to the direction of the arrow stimulus on a "Stop" trial. Missed Trials was defined as the total number of trials which the participant missed. Higher value indicated worse performance. | The FAS included all participants in the double-blind safety set with >=1 postbaseline CANTAB assessments in Study Part A. Here, "Overall Number of Participants Analyzed" signifies the participants who were evaluable for this outcome measure and "number analysed" signifies participants at the specific timepoints. | Posted | Least Squares Mean | Standard Error | number of trials | Baseline, Weeks 18 and 49 |
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| Secondary | Part B: Change From Baseline in the SST Task of the CANTAB: Direction Error (Go Trials), Direction Error (Stop Trials) and Missed Trials | The neurocognitive function effects of TAK-503 on adolescents and children was evaluated using the CANTAB assessments. SST measured response inhibition or control. The participant must respond to an arrow stimulus by touching either of 2 choices depending on the direction the arrow points. If an audio tone was present, the participant should not respond. Direction Error (Go Trials) was defined as the total number of trials where the participant pressed the wrong button to the direction of the arrow stimulus on a "Go" trial. Direction Error (Stop Trials) was defined as the total number of trials where the participant pressed the wrong button to the direction of the arrow stimulus on a "Stop" trial. Missed Trials was defined as the total number of trials which the participant missed. Higher value indicated worse performance. | The open-label safety set included all participants who received >=1 dose of TAK-503 in Study Part B. Here, "Overall Number of Participants Analyzed" signifies the participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | number of trials | Baseline, Week 49 |
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| Secondary | Part A: Change From Baseline in the Delayed Matching to Sample (DMS) Task of the CANTAB: Percentage of Correct Responses | The neurocognitive function effects of TAK-503 on adolescents and children diagnosed with ADHD was evaluated using the CANTAB cognitive assessments. DMS measured both simultaneous matching and short-term visual memory. The participant was shown a complex visual pattern (the sample) and after a brief delay, 4 similar patterns. The participant must identify the pattern that matches the sample. Percentage of Correct Responses was defined as the percentage of trials during which the participant chose the correct response on the first attempt. Higher rate indicated better performance. | The FAS included all participants in the double-blind safety set with >=1 postbaseline CANTAB assessments in Study Part A. Here, "Overall Number of Participants Analyzed" signifies the participants who were evaluable for this outcome measure and "number analysed" signifies participants at the specific timepoints. | Posted | Least Squares Mean | Standard Error | percentage | Baseline, Weeks 18 and 49 |
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| Secondary | Part B: Change From Baseline in the DMS Task of the CANTAB: Percentage of Correct Responses | The neurocognitive function effects of TAK-503 on adolescents and children diagnosed with ADHD was evaluated using the CANTAB cognitive assessments. DMS measured both simultaneous matching and short-term visual memory. The participant was shown a complex visual pattern (the sample) and after a brief delay, 4 similar patterns. The participant must identify the pattern that matches the sample. Percentage of Correct Responses was defined as the percentage of trials during which the participant chose the correct response on the first attempt. Higher rate indicated better performance. | The open-label safety set included all participants who received >=1 dose of TAK-503 in Study Part B. Here, "Overall Number of Participants Analyzed" signifies the participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | percentage | Baseline, Week 49 |
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| Secondary | Part A: Change From Baseline in the DMS Task of the CANTAB: Mean Correct Latency | The neurocognitive function effects of TAK-503 on adolescents and children diagnosed with ADHD was evaluated using the CANTAB cognitive assessments. DMS measured both simultaneous matching and short-term visual memory. The participant was shown a complex visual pattern (the sample) and after a brief delay, 4 similar patterns. The participant must identify the pattern that matches the sample. Mean Correct Latency was defined as the average time between the presentation of the response stimuli objects and the participants selecting the correct box on their first attempt. Higher time indicated worse performance. | The FAS included all participants in the double-blind safety set with >=1 postbaseline CANTAB assessments in Study Part A. Here, "Overall Number of Participants Analyzed" signifies the participants who were evaluable for this outcome measure and "number analysed" signifies participants at the specific timepoints. | Posted | Least Squares Mean | Standard Error | msec | Baseline, Week 18 and 49 |
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| Secondary | Part B: Change From Baseline in the DMS Task of the CANTAB: Mean Correct Latency | The neurocognitive function effects of TAK-503 on adolescents and children diagnosed with ADHD was evaluated using the CANTAB cognitive assessments. DMS measured both simultaneous matching and short-term visual memory. The participant was shown a complex visual pattern (the sample) and after a brief delay, 4 similar patterns. The participant must identify the pattern that matches the sample. Mean Correct Latency was defined as the average time between the presentation of the response stimuli objects and the participants selecting the correct box on their first attempt. Higher time indicated worse performance. | The open-label safety set included all participants who received >=1 dose of TAK-503 in Study Part B. Here, "Overall Number of Participants Analyzed" signifies the participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | msec | Baseline, Week 49 |
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| Secondary | Part A: Change From Baseline in the DMS Task of the CANTAB: Mean Choices to Correct | The neurocognitive function effects of TAK-503 on adolescents and children diagnosed with ADHD was evaluated using the CANTAB cognitive assessments. DMS measured both simultaneous matching and short-term visual memory. The participant was shown a complex visual pattern (the sample) and after a brief delay, 4 similar patterns. The participant must identify the pattern that matches the sample. Mean choices to correct was defined as the mean number of choices that the participant made on each trial, including the correct choice. Higher number of choices indicated worse performance. | The FAS included all participants in the double-blind safety set with >=1 postbaseline CANTAB assessments in Study Part A. Here, "Overall Number of Participants Analyzed" signifies the participants who were evaluable for this outcome measure and "number analysed" signifies participants at the specific timepoints. | Posted | Least Squares Mean | Standard Error | number of choices | Baseline, Weeks 18 and 49 |
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| Secondary | Part B: Change From Baseline in the DMS Task of the CANTAB: Mean Choices to Correct | The neurocognitive function effects of TAK-503 on adolescents and children diagnosed with ADHD was evaluated using the CANTAB cognitive assessments. DMS measured both simultaneous matching and short-term visual memory. The participant was shown a complex visual pattern (the sample) and after a brief delay, 4 similar patterns. The participant must identify the pattern that matches the sample. Mean choices to correct was defined as the mean number of choices that the participant made on each trial, including the correct choice. Higher number of choices indicated worse performance. | The open-label safety set included all participants who received >=1 dose of TAK-503 in Study Part B. Here, "Overall Number of Participants Analyzed" signifies the participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | number of choices | Baseline, Week 49 |
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| Secondary | Parts A and B: Sexual Maturation Assessed Using Tanner Stage | The stage of puberty or sexual maturation was evaluated for each participant according to Tanner staging. The Tanner stage for genitals (male, stages I-V), breasts (females, stages I-V), and pubic hair (both sexes, stages I-V) was documented. Tanner staging was self-assessed. Self-assessment in this study was defined as participants or parents indicating which drawing of the scale corresponds to participants sexual maturation stage at the time of the specific visit. | The double-blind safety set included all randomized participants in Study Part A who received >=1 intervention dose. The open-label safety set included all participants who received >=1 dose of TAK-503 in Study Part B. Here, "number analysed" signifies participants at the specific timepoints. | Posted | Count of Participants | Participants | Part A: Baseline, Weeks 18 and 49; Part B: Baseline, Week 49 |
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| Secondary | Parts A and B: Change From Baseline in Weight | Weight was measured in kg using a calibrated scale. | The double-blind safety set included all randomized participants in Study Part A who received >=1 intervention dose. The open-label safety set included all participants who received >=1 dose of TAK-503 in Study Part B. Here, "number analysed" signifies participants at the specific timepoints. | Posted | Mean | Standard Deviation | kg | Part A: Baseline, Weeks 18 and 49; Part B: Baseline, Week 49 |
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| Secondary | Parts A and B: Change From Baseline in Height | A calibrated stadiometer was used for all height measurements and was measured in centimeter (cm). | The double-blind safety set included all randomized participants in Study Part A who received >=1 intervention dose. The open-label safety set included all participants who received >=1 dose of TAK-503 in Study Part B. Here, "number analysed" signifies participants at the specific timepoint. | Posted | Mean | Standard Deviation | cm | Part A: Baseline, Weeks 18 and 49; Part B: Baseline, Week 49 |
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| Secondary | Parts A and B: Change From Baseline in Body Mass Index (BMI) | BMI was a measure of body fat based on height and weight. BMI = (weight in kg x10,000)/(height in cm^2). | The double-blind safety set included all randomized participants in Study Part A who received >=1 intervention dose. The open-label safety set included all participants who received >=1 dose of TAK-503 in Study Part B. Here, "number analysed" signifies participants at the specific category. | Posted | Mean | Standard Deviation | kilograms per meter square (kg/m^2) | Part A: Baseline, Weeks 18 and 49; Part B: Baseline, Week 49 |
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| Secondary | Parts A and B: Number of Participants With Clinically Significant Changes in Vital Signs: Pulse Rate, Blood Pressure (BP), Temperature, and Respiratory Rate | Vital signs assessments included pulse rate (beats/minutes), supine and standing BP (millimeters of mercury [mmHg]), oral or tympanic temperature (degrees Celsius [C]), and respiratory rate (breaths per minute). The number of participants was calculated based on number of participants with non-missing results for a given parameter at Baseline and at least 1 post-Baseline assessment. | The double-blind safety set included all randomized participants in Study Part A who received >=1 intervention dose. The open-label safety set included all participants who received >=1 dose of TAK-503 in Study Part B. Here, "Overall Number of Participants Analyzed" signifies the participants who were evaluable for this outcome measure and "number analysed" signifies participants at the specific category. | Posted | Count of Participants | Participants | Part A: From start of study drug administration up to Week 52; Part B: From start of study drug administration up to follow-up (Week 53) |
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| Secondary | Parts A and B: Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) | The heart rate (HR), PR interval, QRS interval, and QT interval were measured from all ECGs and the QTcB and QTcF were assessed. | The double-blind safety set included all randomized participants in Study Part A who received >=1 intervention dose. The open-label safety set included all participants who received >=1 dose of TAK-503 in Study Part B. | Posted | Count of Participants | Participants | Part A: From start of study drug administration up to Week 52; Part B: From start of study drug administration up to follow-up (Week 53) |
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| Secondary | Parts A and B: Number of Participants With Treatment-emergent Adverse Events (TEAEs) | An Adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. A TEAE was defined as any event emerging or manifesting at or after the initiation of treatment with an investigational product or medicinal product or any existing event that worsened in either intensity or frequency following exposure to the investigational product or medicinal product. TEAEs were defined as AEs whose onset occurs, severity worsens, or intensity increases after receiving the blinded trial intervention and up to 3 days after the last dose of double-blind trial medication. | The double-blind safety set included all randomized participants in Study Part A who received >=1 intervention dose. The open-label safety set included all participants who received >=1 dose of TAK-503 in Study Part B. | Posted | Count of Participants | Participants | Part A: From start of study drug administration up to Week 52; Part B: From start of study drug administration up to follow-up (Week 53) |
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| Secondary | Part A: Psychiatric Symptoms Assessed Using Brief Psychiatric Rating Scale for Children (BPRS-C): Total Score | Psychiatric symptoms were measured by the BPRS-C. The 21 items were grouped across 7 scales: Behavior Problems [Questions 1 to 3], Depression [Questions 4 to 6], Thinking Disturbance [Questions 7 to 9], Psychomotor Excitation [Questions 10 to 12], Withdrawal [Questions 13 to 15], Anxiety [Questions 16 to 18] and Organicity [Questions 19 to 21]. Each of the 21 items was rated on a 7-point severity Likert scale from 0 to 6 (not present=0; very mild=1; mild=2; moderate=3; moderately severe=4; severe=5; extremely severe=6). A total score was calculated by summing the values across the 21 items, ranging from 0 to 126. Higher scores indicated higher severity. | The double-blind safety set included all randomized participants in Study Part A who received >=1 intervention dose. Here, "Overall Number of Participants Analyzed" signifies the participants who were evaluable for this outcome measure and "number analysed" signifies participants at the specific timepoints. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Weeks 18 and 49 |
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| Secondary | Part B: Psychiatric Symptoms Assessed Using BPRS-C: Total Score | Psychiatric symptoms were measured by the BPRS-C. The 21 items were grouped across 7 scales: Behavior Problems [Questions 1 to 3], Depression [Questions 4 to 6], Thinking Disturbance [Questions 7 to 9], Psychomotor Excitation [Questions 10 to 12], Withdrawal [Questions 13 to 15], Anxiety [Questions 16 to 18] and Organicity [Questions 19 to 21]. Each of the 21 items was rated on a 7-point severity Likert scale from 0 to 6 (not present=0; very mild=1; mild=2; moderate=3; moderately severe=4; severe=5; extremely severe=6). A total score was calculated by summing the values across the 21 items, ranging from 0 to 126. Higher scores indicated higher severity. | The open-label safety set included all participants who received >=1 dose of TAK-503 in Study Part B. Here, "Overall Number of Participants Analyzed" signifies the participants who were evaluable for this outcome measure and "number analysed" signifies participants at the specific timepoints. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Weeks 23, 36 and 49 |
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| Secondary | Parts A and B: Number of Participants With Suicidal Ideation (SI) or Behavior Assessed Using Columbia- Suicide Severity Rating Scale (CSSRS) | The C-SSRS was a structured tool used to assess SI and behavior. A maximum of 19 items were completed as follows: 7 items were required, a potential 10 additional items were completed upon a positive response to a required item, and 2 items were completed if suicide or suicide-like behavior was observed during the interview. Suicidal ideation, including intensity of ideation, behavior, & attempts with actual/potential lethality. Categories have binary responses (yes/no) & include Wish to be Dead; Non-specific Active Suicidal Thoughts; Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act; Active Suicidal Ideation with Some Intent to Act, without Specific Plan; Active Suicidal Ideation with Specific Plan and Intent, Preparatory Acts and Behavior; Aborted Attempt; Interrupted Attempt; Actual Attempt (non-fatal); Completed Suicide. Score of 1 or higher= suicidal ideation/behavior. Only non-zero categories were reported. | The double-blind safety set included all randomized participants in Study Part A who received >=1 intervention dose. The open-label safety set included all participants who received >=1 dose of TAK-503 in Study Part B. | Posted | Count of Participants | Participants | Baseline up to Week 52 |
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| Secondary | Parts A and B: Number of Participants With Side Effects Assessed Using Udvalg for Kliniske Undersøgelser (UKU) Side Effect Rating Scale: Asthenia or Lassitude or Increased Fatigability | UKU rating scale was developed for clinicians to assess side effects of psychopharmacological medications based on interviews and other relevant source information. UKU items relevant to the established safety profile of TAK-503 such as Asthenia/Lassitude/lncreased Fatiguability, Sleepiness/Sedation, Increased Duration of Sleep, and Orthostatic Dizziness were queried. Each side effect was categorized for severity, ranging from 0 (Normal) to 3 (Severe). | The double-blind safety set included all randomized participants in Study Part A who received >=1 intervention dose. The open-label safety set included all participants who received >=1 dose of TAK-503 in Study Part B. Here, "Overall Number of Participants Analyzed" signifies the participants who were evaluable for this outcome measure and "number analysed" signifies participants at the specific timepoints. | Posted | Count of Participants | Participants | Part A: Baseline, Weeks 18 and 49; Part B: Baseline, Weeks 23, 36, 49, 50, 51 and 52 |
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| Secondary | Parts A and B: Number of Participants With Side Effects Assessed Using UKU Side Effect Rating Scale: Sleepiness or Sedation | UKU rating scale was developed for clinicians to assess side effects of psychopharmacological medications based on interviews and other relevant source information. UKU items relevant to the established safety profile of TAK-503 such as Asthenia/Lassitude/lncreased Fatiguability, Sleepiness/Sedation, Increased Duration of Sleep, and Orthostatic Dizziness were queried. Each side effect was categorized for severity, ranging from 0 (Normal) to 3 (Severe). | The double-blind safety set included all randomized participants in Study Part A who received >=1 intervention dose. The open-label safety set included all participants who received >=1 dose of TAK-503 in Study Part B. Here, "Overall Number of Participants Analyzed" signifies the participants who were evaluable for this outcome measure and "number analysed" signifies participants at the specific timepoints. | Posted | Count of Participants | Participants | Part A: Baseline, Weeks 18 and 49; Part B: Baseline, Weeks 23, 36, 49, 50, 51 and 52 |
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| Secondary | Parts A and B: Number of Participants With Side Effects Assessed Using UKU Side Effect Rating Scale: Increased Duration of Sleep | UKU rating scale was developed for clinicians to assess side effects of psychopharmacological medications based on interviews and other relevant source information. UKU items relevant to the established safety profile of TAK-503 such as Asthenia/Lassitude/lncreased Fatiguability, Sleepiness/Sedation, Increased Duration of Sleep, and Orthostatic Dizziness were queried. Each side effect was categorized for severity, ranging from 0 (Normal) to 3 (Severe). | The double-blind safety set included all randomized participants in Study Part A who received >=1 intervention dose. The open-label safety set included all participants who received >=1 dose of TAK-503 in Study Part B. Here, "Overall Number of Participants Analyzed" signifies the participants who were evaluable for this outcome measure and "number analysed" signifies participants at the specific timepoints. | Posted | Count of Participants | Participants | Part A: Baseline, Weeks 18 and 49; Part B: Baseline, Weeks 23, 36, 49, 50, 51 and 52 |
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| Secondary | Parts A and B: Number of Participants With Side Effects Assessed Using UKU Side Effect Rating Scale: Orthostatic Dizziness | UKU rating scale was developed for clinicians to assess side effects of psychopharmacological medications based on interviews and other relevant source information. UKU items relevant to the established safety profile of TAK-503 such as Asthenia/Lassitude/lncreased Fatiguability, Sleepiness/Sedation, Increased Duration of Sleep, and Orthostatic Dizziness were queried. Each side effect was categorized for severity, ranging from 0 (Normal) to 3 (Severe). | The double-blind safety set included all randomized participants in Study Part A who received >=1 intervention dose. The open-label safety set included all participants who received >=1 dose of TAK-503 in Study Part B. Here, "Overall Number of Participants Analyzed" signifies the participants who were evaluable for this outcome measure and "number analysed" signifies participants at the specific timepoints. | Posted | Count of Participants | Participants | Part A: Baseline, Weeks 18 and 49; Part B: Baseline, Weeks 23, 36, 49, 50, 51 and 52 |
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| Secondary | Part A: Sedative Effects Assessed Using Pediatric Daytime Sleepiness Scale (PDSS): Total Score | The PDSS was a self-reported assessment of daytime sleepiness in children aged 11 to 15 years. PDSS questionnaire was designed to be easy to administer, score, and interpret. Sleepiness-related questions were based on previous research of situations that can be sensitive to sleep loss in this age group. The 8 questions were scored on Likert-scale from 0 to 4 (never=0; seldom=1; sometimes=2; frequently=3; always=4). The total score on the PDSS was derived by summing the values from the 8 questions and ranged from 0 (never sleepy) to 32 (always sleepy), with higher scores representing greater severity of excessive sleepiness. | The double-blind safety set included all randomized participants in Study Part A who received >=1 intervention dose. Here, "Overall Number of Participants Analyzed" signifies the participants who were evaluable for this outcome measure and "number analysed" signifies participants at the specific timepoints. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Weeks 18 and 49 |
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| Secondary | Part B: Sedative Effects Assessed Using PDSS: Total Score | The PDSS was a self-reported assessment of daytime sleepiness in children aged 11 to 15 years. PDSS questionnaire was designed to be easy to administer, score, and interpret. Sleepiness-related questions were based on previous research of situations that can be sensitive to sleep loss in this age group. The 8 questions were scored on Likert-scale from 0 to 4 (never=0; seldom=1; sometimes=2; frequently=3; always=4). The total score on the PDSS was derived by summing the values from the 8 questions and ranged from 0 (never sleepy) to 32 (always sleepy), with higher scores representing greater severity of excessive sleepiness. | The open-label safety set included all participants who received >=1 dose of TAK-503 in Study Part B. Here, "Overall Number of Participants Analyzed" signifies the participants who were evaluable for this outcome measure and "number analysed" signifies participants at the specific timepoints. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Weeks 23, 36 and 49 |
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| Secondary | Parts A and B: Symptoms Assessed Using ADHD-Rating Scale-5 (ADHD-RS-5): Total Score | The ADHD-RS-5 was used widely by mental health, educational, and medical practitioners in screening, diagnosis, and treatment evaluation to determine the frequency and severity of ADHD symptoms and impairments in children and adolescents. The ADHD-RS-5 was based on the diagnostic criteria for ADHD as described in the DSM-5 and consisted of 2 symptom subscales, inattention and hyperactivity-impulsivity, each with 9 items and a total scale of 18 items. Each item in the subscale was scored with a value ranging from 0 (no symptoms) to 3 (severe symptoms). Total score was obtained from summing the scores of each item and ranged from 0 to 54. Higher score indicated a worse outcome. | The FAS in Study Part A. The open-label safety set in Study Part B. Here, "Overall Number of Participants Analyzed" signifies the participants who were evaluable for this outcome measure and "number analysed" signifies participants at the specific timepoints. As per the planned analysis in SAP, comparative statistical analysis was not carried out for Part B due to a single drug being administered. | Posted | Mean | Standard Deviation | score on a scale | Part A: Baseline, Weeks 18 and 49; Part B: Baseline, Week 49 |
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| Secondary | Parts A and B: Symptoms Assessed Using ADHD-RS-5: Inattention Subscale Score | The ADHD-RS-5 was used widely by mental health, educational, and medical practitioners in screening, diagnosis, and treatment evaluation to determine the frequency and severity of ADHD symptoms and impairments in children and adolescents. The ADHD-RS-5 was based on the diagnostic criteria for ADHD as described in the DSM-5 and consisted of 2 symptom subscales, inattention and hyperactivity-impulsivity, each with 9 items and a total scale of 18 items. Each item in the subscale was scored with a value ranging from 0 (no symptoms) to 3 (severe symptoms). The ADHD-RS-5 subscale scores ranged from 0 to 27. Higher score indicated a worse outcome. | The FAS in Study Part A. The open-label safety set in Study Part B. Here, "Overall Number of Participants Analyzed" signifies the participants who were evaluable for this outcome measure and "number analysed" signifies participants at the specific timepoints. As per the planned analysis in SAP, comparative statistical analysis was not carried out for Part B due to a single drug being administered. | Posted | Mean | Standard Deviation | score on a scale | Part A: Baseline, Weeks 18 and 49; Part B: Baseline, Week 49 |
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| Secondary | Parts A and B: Symptoms Assessed Using ADHD-RS-5: Hyperactivity-Impulsivity Subscale Score | The ADHD-RS-5 was used widely by mental health, educational, and medical practitioners in screening, diagnosis, and treatment evaluation to determine the frequency and severity of ADHD symptoms and impairments in children and adolescents. The ADHD-RS-5 was based on the diagnostic criteria for ADHD as described in the DSM-5 and consisted of 2 symptom subscales, inattention and hyperactivity-impulsivity, each with 9 items and a total scale of 18 items. Each item in the subscale was scored with a value ranging from 0 (no symptoms) to 3 (severe symptoms). The ADHD-RS-5 subscale scores ranged from 0 to 27. Higher score indicated a worse outcome. | The FAS in Study Part A. The open-label safety set in Study Part B. Here, "Overall Number of Participants Analyzed" signifies the participants who were evaluable for this outcome measure and "number analysed" signifies participants at the specific timepoints. As per the planned analysis in SAP, comparative statistical analysis was not carried out for Part B due to a single drug being administered. | Posted | Mean | Standard Deviation | score on a scale | Part A: Baseline, Weeks 18 and 49; Part B: Baseline, Week 49 |
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| Secondary | Parts A and B: Number of Participants Assessed for Severity of Mental Illness Using Clinical Global Impression-Improvement (CGI-I) | Global clinical measurement of ADHD improvement as measured by CGI-I using the Clinical Global Impression-Severity (CGI-S) to establish baseline. The CGI-S was administered to assess the severity of mental illness at baseline. The CGI-I was administered to assess any improvement in symptoms and to guide the clinician on dosing adjustments. The CGI-I was scored on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Higher score indicated worst improvement. | The FAS included all participants in the double-blind safety set with >=1 postbaseline CANTAB assessments in Study Part A. The open-label safety set included all participants who received >=1 dose of TAK-503 in Study Part B. Here, "Overall Number of Participants Analyzed" signifies the participants who were evaluable for this outcome measure and "number analysed" signifies participants at the specific timepoints. | Posted | Count of Participants | Participants | Part A: Baseline, Weeks 1, 18 and 49; Part B: Baseline, Weeks 23, 36 and 49 |
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| Secondary | Parts A and B: Participants Functioning and Well-being Assessed Using Child Health and Illness Profile - Child Edition: Parent Report Form (CHIP-CE:PRF): Global Score | Parent Report Form of CHIP-CE:PRF was administered to provide information on self-esteem & school functioning. The 5 domains, 12 subdomains covered 76 items: Satisfaction: with health (7items)& self (4items); Comfort: physical (9items)& emotional symptoms (9items) & activity restrictions (4items) due to illness; Resilience: behaviors& family involvement (8items) in activities likely to enhance health, Social problem-solving (5items),Physical activity (6items); Risk avoidance: behaviors that if not avoided are likely to pose risks to health: Individual risk avoidance (4items), Threats to achievement (10items); Achievement: developmentally appropriate role functioning in school & with peers: Academic performance (5items), Peer relations (5items). For each domain/subdomain, means were calculated by taking average of each non-missing item in domain/subdomain. Global score was an average of scores for 5 domains. Each item uses a 5-response format (scored 1-5). Higher score=greater health. | The FAS included all participants in the double-blind safety set with >=1 postbaseline CANTAB assessments in Study Part A. The open-label safety set included all participants who received >=1 dose of TAK-503 in Study Part B. Here, "Overall Number of Participants Analyzed" signifies the participants who were evaluable for this outcome measure and "number analysed" signifies participants at the specific timepoints. | Posted | Mean | Standard Deviation | score on scale | Part A: Baseline, Weeks 18 and 49; Part B: Baseline, Weeks 23, 36 and 49 |
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| Secondary | Parts A and B: Behavioral, Social, and Academic Issues Assessed Using Conners 3 Parent Short Form (C3PS): Total Score | The Conners 3 was a focused tool for the assessment of ADHD and associated learning, behavior, and emotional problems in children 6 to 18 years of age. The C3PS was completed by a child's parent/guardian and comprised of 45 items with subsets of items related to six content scales: inattention, hyperactivity/impulsivity, executive functioning, learning problems, defiance/aggression and peer relations. The parent rated his/her child on the first 43 items of the C3PS using a 4-point Likert scale (0-3; where 0=not at all true [never, seldom] and 3=very much true [very often, very frequently]) based on past month; the last 2 items were fill-in-the-blank and do not contribute to the raw score(s). Total scores were evaluated by summing the 43 numeric items, resulting in a range of 0 to 129, where higher score indicated a greater frequency of issues | The FAS included all participants in the double-blind safety set with >=1 postbaseline CANTAB assessments in Study Part A. The open-label safety set included all participants who received >=1 dose of TAK-503 in Study Part B. Here, "Overall Number of Participants Analyzed" signifies the participants who were evaluable for this outcome measure and "number analysed" signifies participants at the specific timepoints. | Posted | Mean | Standard Deviation | score on a scale | Part A: Baseline, Weeks 18 and 49; Part B: Baseline, Weeks 23, 36 and 49 |
|
Part A: From start of study drug administration up to Week 52; Part B: From start of study drug administration up to follow up (Week 53)
The double-blind safety set included all randomized participants in Study Part A who received >=1 intervention dose. The open-label safety set included all participants who received >=1 dose of TAK-503 in Study Part B.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Double-Blinded Period (Part A): Placebo | Participants received TAK-503-matched placebo tablets, orally, QD and atomoxetine-matched placebo capsule orally, QD up to 18 weeks. | 0 | 96 | 0 | 96 | 27 | 96 |
| EG001 | Double-Blinded Period (Part A): TAK-503 | Participants aged 6 to 12 years received TAK-503 at doses ranging from 1 to 4 mg, and participants aged 13 to 17 years received doses ranging from 1 to 7 mg. TAK-503 was administered orally, QD up to 49 weeks along with atomoxetine matched placebo capsule. All participants initiated treatment at 1 mg, with dose titration in weekly increments of 1 mg until an optimal dose was achieved. | 0 | 96 | 0 | 96 | 50 | 96 |
| EG002 | Double-Blinded Period (Part A): Atomoxetine | Participants received atomoxetine administered orally, QD up to 49 weeks along with TAK-503 matched placebo. Participants weighing <70 kg at baseline initiated treatment at 0.5 mg/kg, with titration to a target dose of 1.2 mg/kg. Participants weighing >= 70 kg at baseline initiated treatment at 40 mg, QD, with weekly dose increases to 80 mg and then to 100 mg if tolerated. The maximum daily dose for participants weighing >=70 kg did not exceed 100 mg. | 0 | 95 | 0 | 95 | 49 | 95 |
| EG003 | Open-Label Period (Part B): Part A (Placebo) - Part B (TAK-503) | Participants who completed Part A in the placebo arm rolled over directly into Part B and received TAK-503 for up to 52 weeks. TAK-503 was administered orally, QD. Participants aged 6 to 12 years received doses ranging from 1 to 4 mg, and participants aged 13 to 17 years received doses ranging from 1 to 7 mg. All participants initiated treatment at 1 mg, with dose titration in weekly increments of 1 mg until an optimal dose was achieved. | 0 | 63 | 1 | 63 | 25 | 63 |
| EG004 | Open-Label Period (Part B): Part A (TAK-503) - Part B (TAK-503) | Participants who completed Part A in the TAK-503 arm rolled over directly into Part B after washout period of >= 30 days and then received TAK-503 for up to 52 weeks. TAK-503 was administered orally, QD. Participants aged 6 to 12 years received doses ranging from 1 to 4 mg, and participants aged 13 to 17 years received doses ranging from 1 to 7 mg. All participants initiated treatment at 1 mg, with dose titration in weekly increments of 1 mg until an optimal dose was achieved. | 0 | 28 | 0 | 28 | 8 | 28 |
| EG005 | Open-Label Period (Part B): Part A (Atomoxetine) - Part B (TAK-503) | Participants who completed Part A in the atomoxetine arm rolled over directly into Part B after washout period of >= 30 days and then received TAK-503 for up to 52 weeks. TAK-503 was administered orally, QD. Participants aged 6 to 12 years received doses ranging from 1 to 4 mg, and participants aged 13 to 17 years received doses ranging from 1 to 7 mg. All participants initiated treatment at 1 mg, with dose titration in weekly increments of 1 mg until an optimal dose was achieved. | 0 | 30 | 0 | 30 | 12 | 30 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Appendicitis | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Irritability | Psychiatric disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Pharyngitis streptococcal | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Takeda | +1-877-825-3327 | trialdisclosures@takeda.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 21, 2025 | Feb 19, 2026 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D016316 | Guanfacine |
| D000069445 | Atomoxetine Hydrochloride |
| ID | Term |
|---|---|
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D010648 | Phenylacetates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D011437 | Propylamines |
| D000588 | Amines |
Not provided
Not provided
| Adverse Event |
|
| Lost to Follow-up |
|
| Lack of Efficacy |
|
| Other |
|
| Not Treated in Open-Label Period |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
| Mean Five-Choice Reaction Time: Placebo vs Atomoxetine | Difference in LS mean | 2 | 2-Sided | 95 | -44.9 | 48.8 | Superiority |
| Mean Five-Choice Movement Time: Placebo vs TAK-503 | Difference in LS mean | -15.8 | 2-Sided | 95 | -42.4 | 10.8 | Other |
| Mean Five-Choice Movement Time: Placebo vs Atomoxetine | Difference in LS mean | -7.8 | 2-Sided | 95 | -34.2 | 18.7 | Superiority |
| OG001 | Double-Blinded Period (Part A): Atomoxetine | Participants received atomoxetine administered orally, QD for up to 49 weeks along with TAK-503 matched placebo. Participants weighing <70 kg at baseline initiated treatment at 0.5 mg/kg, with titration to a target dose of 1.2 mg/kg. Participants weighing >= 70 kg at baseline initiated treatment at 40 mg, QD, with weekly dose increases to 80 mg and then to 100 mg if tolerated. The maximum daily dose for participants weighing >=70 kg did not exceed 100 mg. |
|
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| OG001 | Open-Label Period (Part B): Part A (TAK-503) - Part B (TAK-503) | Participants who completed Part A in the TAK-503 arm rolled over directly into Part B after washout period of >= 30 days and then received TAK-503 for up to 52 weeks. TAK-503 was administered orally, QD. Participants aged 6 to 12 years received doses ranging from 1 to 4 mg, and participants aged 13 to 17 years received doses ranging from 1 to 7 mg. All participants initiated treatment at 1 mg, with dose titration in weekly increments of 1 mg until an optimal dose was achieved. |
| OG002 | Open-Label Period (Part B): Part A (Atomoxetine) - Part B (TAK-503) | Participants who completed Part A in the atomoxetine arm rolled over directly into Part B after washout period of >= 30 days and then received TAK-503 for up to 52 weeks. TAK-503 was administered orally, QD. Participants aged 6 to 12 years received doses ranging from 1 to 4 mg, and participants aged 13 to 17 years received doses ranging from 1 to 7 mg. All participants initiated treatment at 1 mg, with dose titration in weekly increments of 1 mg until an optimal dose was achieved. |
|
|
Participants aged 6 to 12 years received TAK-503 at doses ranging from 1 to 4 mg, and participants aged 13 to 17 years received doses ranging from 1 to 7 mg. TAK-503 was administered orally, QD for up to 49 weeks along with atomoxetine matched placebo capsule. All participants initiated treatment at 1 mg, with dose titration in weekly increments of 1 mg until an optimal dose was achieved.
| OG002 | Double-Blinded Period (Part A): Atomoxetine | Participants received atomoxetine administered orally, QD for up to 49 weeks along with TAK-503 matched placebo. Participants weighing <70 kg at baseline initiated treatment at 0.5 mg/kg, with titration to a target dose of 1.2 mg/kg. Participants weighing >= 70 kg at baseline initiated treatment at 40 mg, QD, with weekly dose increases to 80 mg and then to 100 mg if tolerated. The maximum daily dose for participants weighing >=70 kg did not exceed 100 mg. |
|
|
| OG001 |
| Open-Label Period (Part B): Part A (TAK-503) - Part B (TAK-503) |
Participants who completed Part A in the TAK-503 arm rolled over directly into Part B after washout period of >= 30 days and then received TAK-503 for up to 52 weeks. TAK-503 was administered orally, QD. Participants aged 6 to 12 years received doses ranging from 1 to 4 mg, and participants aged 13 to 17 years received doses ranging from 1 to 7 mg. All participants initiated treatment at 1 mg, with dose titration in weekly increments of 1 mg until an optimal dose was achieved. |
| OG002 | Open-Label Period (Part B): Part A (Atomoxetine) - Part B (TAK-503) | Participants who completed Part A in the atomoxetine arm rolled over directly into Part B after washout period of >= 30 days and then received TAK-503 for up to 52 weeks. TAK-503 was administered orally, QD. Participants aged 6 to 12 years received doses ranging from 1 to 4 mg, and participants aged 13 to 17 years received doses ranging from 1 to 7 mg. All participants initiated treatment at 1 mg, with dose titration in weekly increments of 1 mg until an optimal dose was achieved. |
|
|
| OG002 | Double-Blinded Period (Part A): Atomoxetine | Participants received atomoxetine administered orally, QD for up to 49 weeks along with TAK-503 matched placebo. Participants weighing <70 kg at baseline initiated treatment at 0.5 mg/kg, with titration to a target dose of 1.2 mg/kg. Participants weighing >= 70 kg at baseline initiated treatment at 40 mg, QD, with weekly dose increases to 80 mg and then to 100 mg if tolerated. The maximum daily dose for participants weighing >=70 kg did not exceed 100 mg. |
|
|
| Open-Label Period (Part B): Part A (TAK-503) - Part B (TAK-503) |
Participants who completed Part A in the TAK-503 arm rolled over directly into Part B after washout period of >= 30 days and then received TAK-503 for up to 52 weeks. TAK-503 was administered orally, QD. Participants aged 6 to 12 years received doses ranging from 1 to 4 mg, and participants aged 13 to 17 years received doses ranging from 1 to 7 mg. All participants initiated treatment at 1 mg, with dose titration in weekly increments of 1 mg until an optimal dose was achieved. |
| OG002 | Open-Label Period (Part B): Part A (Atomoxetine) - Part B (TAK-503) | Participants who completed Part A in the atomoxetine arm rolled over directly into Part B after washout period of >= 30 days and then received TAK-503 for up to 52 weeks. TAK-503 was administered orally, QD. Participants aged 6 to 12 years received doses ranging from 1 to 4 mg, and participants aged 13 to 17 years received doses ranging from 1 to 7 mg. All participants initiated treatment at 1 mg, with dose titration in weekly increments of 1 mg until an optimal dose was achieved. |
|
|
Participants aged 6 to 12 years received TAK-503 at doses ranging from 1 to 4 mg, and participants aged 13 to 17 years received doses ranging from 1 to 7 mg. TAK-503 was administered orally, QD for up to 49 weeks along with atomoxetine matched placebo capsule. All participants initiated treatment at 1 mg, with dose titration in weekly increments of 1 mg until an optimal dose was achieved.
| OG002 | Double-Blinded Period (Part A): Atomoxetine | Participants received atomoxetine administered orally, QD for up to 49 weeks along with TAK-503 matched placebo. Participants weighing <70 kg at baseline initiated treatment at 0.5 mg/kg, with titration to a target dose of 1.2 mg/kg. Participants weighing >= 70 kg at baseline initiated treatment at 40 mg, QD, with weekly dose increases to 80 mg and then to 100 mg if tolerated. The maximum daily dose for participants weighing >=70 kg did not exceed 100 mg. |
|
|
| OG001 |
| Open-Label Period (Part B): Part A (TAK-503) - Part B (TAK-503) |
Participants who completed Part A in the TAK-503 arm rolled over directly into Part B after washout period of >= 30 days and then received TAK-503 for up to 52 weeks. TAK-503 was administered orally, QD. Participants aged 6 to 12 years received doses ranging from 1 to 4 mg, and participants aged 13 to 17 years received doses ranging from 1 to 7 mg. All participants initiated treatment at 1 mg, with dose titration in weekly increments of 1 mg until an optimal dose was achieved. |
| OG002 | Open-Label Period (Part B): Part A (Atomoxetine) - Part B (TAK-503) | Participants who completed Part A in the atomoxetine arm rolled over directly into Part B after washout period of >= 30 days and then received TAK-503 for up to 52 weeks. TAK-503 was administered orally, QD. Participants aged 6 to 12 years received doses ranging from 1 to 4 mg, and participants aged 13 to 17 years received doses ranging from 1 to 7 mg. All participants initiated treatment at 1 mg, with dose titration in weekly increments of 1 mg until an optimal dose was achieved. |
|
|
| OG001 | Double-Blinded Period (Part A): TAK-503 | Participants aged 6 to 12 years received TAK-503 at doses ranging from 1 to 4 mg, and participants aged 13 to 17 years received doses ranging from 1 to 7 mg. TAK-503 was administered orally, QD for up to 49 weeks along with atomoxetine matched placebo capsule. All participants initiated treatment at 1 mg, with dose titration in weekly increments of 1 mg until an optimal dose was achieved. |
| OG002 | Double-Blinded Period (Part A): Atomoxetine | Participants received atomoxetine administered orally, QD for up to 49 weeks along with TAK-503 matched placebo. Participants weighing <70 kg at baseline initiated treatment at 0.5 mg/kg, with titration to a target dose of 1.2 mg/kg. Participants weighing >= 70 kg at baseline initiated treatment at 40 mg, QD, with weekly dose increases to 80 mg and then to 100 mg if tolerated. The maximum daily dose for participants weighing >=70 kg did not exceed 100 mg. |
|
|
| OG001 | Open-Label Period (Part B): Part A (TAK-503) - Part B (TAK-503) | Participants who completed Part A in the TAK-503 arm rolled over directly into Part B after washout period of >= 30 days and then received TAK-503 for up to 52 weeks. TAK-503 was administered orally, QD. Participants aged 6 to 12 years received doses ranging from 1 to 4 mg, and participants aged 13 to 17 years received doses ranging from 1 to 7 mg. All participants initiated treatment at 1 mg, with dose titration in weekly increments of 1 mg until an optimal dose was achieved. |
| OG002 | Open-Label Period (Part B): Part A (Atomoxetine) - Part B (TAK-503) | Participants who completed Part A in the atomoxetine arm rolled over directly into Part B after washout period of >= 30 days and then received TAK-503 for up to 52 weeks. TAK-503 was administered orally, QD. Participants aged 6 to 12 years received doses ranging from 1 to 4 mg, and participants aged 13 to 17 years received doses ranging from 1 to 7 mg. All participants initiated treatment at 1 mg, with dose titration in weekly increments of 1 mg until an optimal dose was achieved. |
|
|
Participants aged 6 to 12 years received TAK-503 at doses ranging from 1 to 4 mg, and participants aged 13 to 17 years received doses ranging from 1 to 7 mg. TAK-503 was administered orally, QD for up to 49 weeks along with atomoxetine matched placebo capsule. All participants initiated treatment at 1 mg, with dose titration in weekly increments of 1 mg until an optimal dose was achieved.
| OG002 | Double-Blinded Period (Part A): Atomoxetine | Participants received atomoxetine administered orally, QD for up to 49 weeks along with TAK-503 matched placebo. Participants weighing <70 kg at baseline initiated treatment at 0.5 mg/kg, with titration to a target dose of 1.2 mg/kg. Participants weighing >= 70 kg at baseline initiated treatment at 40 mg, QD, with weekly dose increases to 80 mg and then to 100 mg if tolerated. The maximum daily dose for participants weighing >=70 kg did not exceed 100 mg. |
|
|
| OG001 |
| Open-Label Period (Part B): Part A (TAK-503) - Part B (TAK-503) |
Participants who completed Part A in the TAK-503 arm rolled over directly into Part B after washout period of >= 30 days and then received TAK-503 for up to 52 weeks. TAK-503 was administered orally, QD. Participants aged 6 to 12 years received doses ranging from 1 to 4 mg, and participants aged 13 to 17 years received doses ranging from 1 to 7 mg. All participants initiated treatment at 1 mg, with dose titration in weekly increments of 1 mg until an optimal dose was achieved. |
| OG002 | Open-Label Period (Part B): Part A (Atomoxetine) - Part B (TAK-503) | Participants who completed Part A in the atomoxetine arm rolled over directly into Part B after washout period of >= 30 days and then received TAK-503 for up to 52 weeks. TAK-503 was administered orally, QD. Participants aged 6 to 12 years received doses ranging from 1 to 4 mg, and participants aged 13 to 17 years received doses ranging from 1 to 7 mg. All participants initiated treatment at 1 mg, with dose titration in weekly increments of 1 mg until an optimal dose was achieved. |
|
|
| Double-Blinded Period (Part A): TAK-503 |
Participants aged 6 to 12 years received TAK-503 at doses ranging from 1 to 4 mg, and participants aged 13 to 17 years received doses ranging from 1 to 7 mg. TAK-503 was administered orally, QD for up to 49 weeks along with atomoxetine matched placebo capsule. All participants initiated treatment at 1 mg, with dose titration in weekly increments of 1 mg until an optimal dose was achieved. |
| OG002 | Double-Blinded Period (Part A): Atomoxetine | Participants received atomoxetine administered orally, QD for up to 49 weeks along with TAK-503 matched placebo. Participants weighing <70 kg at baseline initiated treatment at 0.5 mg/kg, with titration to a target dose of 1.2 mg/kg. Participants weighing >= 70 kg at baseline initiated treatment at 40 mg, QD, with weekly dose increases to 80 mg and then to 100 mg if tolerated. The maximum daily dose for participants weighing >=70 kg did not exceed 100 mg. |
|
|
| OG001 | Open-Label Period (Part B): Part A (TAK-503) - Part B (TAK-503) | Participants who completed Part A in the TAK-503 arm rolled over directly into Part B after washout period of >= 30 days and then received TAK-503 for up to 52 weeks. TAK-503 was administered orally, QD. Participants aged 6 to 12 years received doses ranging from 1 to 4 mg, and participants aged 13 to 17 years received doses ranging from 1 to 7 mg. All participants initiated treatment at 1 mg, with dose titration in weekly increments of 1 mg until an optimal dose was achieved. |
| OG002 | Open-Label Period (Part B): Part A (Atomoxetine) - Part B (TAK-503) | Participants who completed Part A in the atomoxetine arm rolled over directly into Part B after washout period of >= 30 days and then received TAK-503 for up to 52 weeks. TAK-503 was administered orally, QD. Participants aged 6 to 12 years received doses ranging from 1 to 4 mg, and participants aged 13 to 17 years received doses ranging from 1 to 7 mg. All participants initiated treatment at 1 mg, with dose titration in weekly increments of 1 mg until an optimal dose was achieved. |
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| OG002 | Double-Blinded Period (Part A): Atomoxetine | Participants received atomoxetine administered orally, QD for up to 49 weeks along with TAK-503 matched placebo. Participants weighing <70 kg at baseline initiated treatment at 0.5 mg/kg, with titration to a target dose of 1.2 mg/kg. Participants weighing >= 70 kg at baseline initiated treatment at 40 mg, QD, with weekly dose increases to 80 mg and then to 100 mg if tolerated. The maximum daily dose for participants weighing >=70 kg did not exceed 100 mg. |
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Participants who completed Part A in the TAK-503 arm rolled over directly into Part B after washout period of >= 30 days and then received TAK-503 for up to 52 weeks. TAK-503 was administered orally, QD. Participants aged 6 to 12 years received doses ranging from 1 to 4 mg, and participants aged 13 to 17 years received doses ranging from 1 to 7 mg. All participants initiated treatment at 1 mg, with dose titration in weekly increments of 1 mg until an optimal dose was achieved. |
| OG002 | Open-Label Period (Part B): Part A (Atomoxetine) - Part B (TAK-503) | Participants who completed Part A in the atomoxetine arm rolled over directly into Part B after washout period of >= 30 days and then received TAK-503 for up to 52 weeks. TAK-503 was administered orally, QD. Participants aged 6 to 12 years received doses ranging from 1 to 4 mg, and participants aged 13 to 17 years received doses ranging from 1 to 7 mg. All participants initiated treatment at 1 mg, with dose titration in weekly increments of 1 mg until an optimal dose was achieved. |
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| OG002 | Double-Blinded Period (Part A): Atomoxetine | Participants received atomoxetine administered orally, QD for up to 49 weeks along with TAK-503 matched placebo. Participants weighing <70 kg at baseline initiated treatment at 0.5 mg/kg, with titration to a target dose of 1.2 mg/kg. Participants weighing >= 70 kg at baseline initiated treatment at 40 mg, QD, with weekly dose increases to 80 mg and then to 100 mg if tolerated. The maximum daily dose for participants weighing >=70 kg did not exceed 100 mg. |
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Participants who completed Part A in the TAK-503 arm rolled over directly into Part B after washout period of >= 30 days and then received TAK-503 for up to 52 weeks. TAK-503 was administered orally, QD. Participants aged 6 to 12 years received doses ranging from 1 to 4 mg, and participants aged 13 to 17 years received doses ranging from 1 to 7 mg. All participants initiated treatment at 1 mg, with dose titration in weekly increments of 1 mg until an optimal dose was achieved. |
| OG002 | Open-Label Period (Part B): Part A (Atomoxetine) - Part B (TAK-503) | Participants who completed Part A in the atomoxetine arm rolled over directly into Part B after washout period of >= 30 days and then received TAK-503 for up to 52 weeks. TAK-503 was administered orally, QD. Participants aged 6 to 12 years received doses ranging from 1 to 4 mg, and participants aged 13 to 17 years received doses ranging from 1 to 7 mg. All participants initiated treatment at 1 mg, with dose titration in weekly increments of 1 mg until an optimal dose was achieved. |
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| OG002 | Open-Label Period (Part B): Part A (Placebo) - Part B (TAK-503) | Participants who completed Part A in the placebo arm rolled over directly into Part B and received TAK-503 for up to 52 weeks. TAK-503 was administered orally, QD. Participants aged 6 to 12 years received doses ranging from 1 to 4 mg, and participants aged 13 to 17 years received doses ranging from 1 to 7 mg. All participants initiated treatment at 1 mg, with dose titration in weekly increments of 1 mg until an optimal dose was achieved. |
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Participants who completed Part A in the TAK-503 arm rolled over directly into Part B after washout period of >= 30 days and then received TAK-503 for up to 52 weeks. TAK-503 was administered orally, QD. Participants aged 6 to 12 years received doses ranging from 1 to 4 mg, and participants aged 13 to 17 years received doses ranging from 1 to 7 mg. All participants initiated treatment at 1 mg, with dose titration in weekly increments of 1 mg until an optimal dose was achieved. |
| OG002 | Open-Label Period (Part B): Part A (Atomoxetine) - Part B (TAK-503) | Participants who completed Part A in the atomoxetine arm rolled over directly into Part B after washout period of >= 30 days and then received TAK-503 for up to 52 weeks. TAK-503 was administered orally, QD. Participants aged 6 to 12 years received doses ranging from 1 to 4 mg, and participants aged 13 to 17 years received doses ranging from 1 to 7 mg. All participants initiated treatment at 1 mg, with dose titration in weekly increments of 1 mg until an optimal dose was achieved. |
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| OG002 | Double-Blinded Period (Part A): Atomoxetine | Participants received atomoxetine administered orally, QD for up to 49 weeks along with TAK-503 matched placebo. Participants weighing <70 kg at baseline initiated treatment at 0.5 mg/kg, with titration to a target dose of 1.2 mg/kg. Participants weighing >= 70 kg at baseline initiated treatment at 40 mg, QD, with weekly dose increases to 80 mg and then to 100 mg if tolerated. The maximum daily dose for participants weighing >=70 kg did not exceed 100 mg. |
| OG003 | Open-Label Period (Part B): Part A (Placebo) - Part B (TAK-503) | Participants who completed Part A in the placebo arm rolled over directly into Part B and received TAK-503 for up to 52 weeks. TAK-503 was administered orally, QD. Participants aged 6 to 12 years received doses ranging from 1 to 4 mg, and participants aged 13 to 17 years received doses ranging from 1 to 7 mg. All participants initiated treatment at 1 mg, with dose titration in weekly increments of 1 mg until an optimal dose was achieved. |
| OG004 | Open-Label Period (Part B): Part A (TAK-503) - Part B (TAK-503) | Participants who completed Part A in the TAK-503 arm rolled over directly into Part B after washout period of >= 30 days and then received TAK-503 for up to 52 weeks. TAK-503 was administered orally, QD. Participants aged 6 to 12 years received doses ranging from 1 to 4 mg, and participants aged 13 to 17 years received doses ranging from 1 to 7 mg. All participants initiated treatment at 1 mg, with dose titration in weekly increments of 1 mg until an optimal dose was achieved. |
| OG005 | Open-Label Period (Part B): Part A (Atomoxetine) - Part B (TAK-503) | Participants who completed Part A in the atomoxetine arm rolled over directly into Part B after washout period of >= 30 days and then received TAK-503 for up to 52 weeks. TAK-503 was administered orally, QD. Participants aged 6 to 12 years received doses ranging from 1 to 4 mg, and participants aged 13 to 17 years received doses ranging from 1 to 7 mg. All participants initiated treatment at 1 mg, with dose titration in weekly increments of 1 mg until an optimal dose was achieved. |
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| OG003 | Open-Label Period (Part B): Part A (Placebo) - Part B (TAK-503) | Participants who completed Part A in the placebo arm rolled over directly into Part B and received TAK-503 for up to 52 weeks. TAK-503 was administered orally, QD. Participants aged 6 to 12 years received doses ranging from 1 to 4 mg, and participants aged 13 to 17 years received doses ranging from 1 to 7 mg. All participants initiated treatment at 1 mg, with dose titration in weekly increments of 1 mg until an optimal dose was achieved. |
| OG004 | Open-Label Period (Part B): Part A (TAK-503) - Part B (TAK-503) | Participants who completed Part A in the TAK-503 arm rolled over directly into Part B after washout period of >= 30 days and then received TAK-503 for up to 52 weeks. TAK-503 was administered orally, QD. Participants aged 6 to 12 years received doses ranging from 1 to 4 mg, and participants aged 13 to 17 years received doses ranging from 1 to 7 mg. All participants initiated treatment at 1 mg, with dose titration in weekly increments of 1 mg until an optimal dose was achieved. |
| OG005 | Open-Label Period (Part B): Part A (Atomoxetine) - Part B (TAK-503) | Participants who completed Part A in the atomoxetine arm rolled over directly into Part B after washout period of >= 30 days and then received TAK-503 for up to 52 weeks. TAK-503 was administered orally, QD. Participants aged 6 to 12 years received doses ranging from 1 to 4 mg, and participants aged 13 to 17 years received doses ranging from 1 to 7 mg. All participants initiated treatment at 1 mg, with dose titration in weekly increments of 1 mg until an optimal dose was achieved. |
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Participants received atomoxetine administered orally, QD for up to 49 weeks along with TAK-503 matched placebo. Participants weighing <70 kg at baseline initiated treatment at 0.5 mg/kg, with titration to a target dose of 1.2 mg/kg. Participants weighing >= 70 kg at baseline initiated treatment at 40 mg, QD, with weekly dose increases to 80 mg and then to 100 mg if tolerated. The maximum daily dose for participants weighing >=70 kg did not exceed 100 mg.
| OG003 | Open-Label Period (Part B): Part A (Placebo) - Part B (TAK-503) | Participants who completed Part A in the placebo arm rolled over directly into Part B and received TAK-503 for up to 52 weeks. TAK-503 was administered orally, QD. Participants aged 6 to 12 years received doses ranging from 1 to 4 mg, and participants aged 13 to 17 years received doses ranging from 1 to 7 mg. All participants initiated treatment at 1 mg, with dose titration in weekly increments of 1 mg until an optimal dose was achieved. |
| OG004 | Open-Label Period (Part B): Part A (TAK-503) - Part B (TAK-503) | Participants who completed Part A in the TAK-503 arm rolled over directly into Part B after washout period of >= 30 days and then received TAK-503 for up to 52 weeks. TAK-503 was administered orally, QD. Participants aged 6 to 12 years received doses ranging from 1 to 4 mg, and participants aged 13 to 17 years received doses ranging from 1 to 7 mg. All participants initiated treatment at 1 mg, with dose titration in weekly increments of 1 mg until an optimal dose was achieved. |
| OG005 | Open-Label Period (Part B): Part A (Atomoxetine) - Part B (TAK-503) | Participants who completed Part A in the atomoxetine arm rolled over directly into Part B after washout period of >= 30 days and then received TAK-503 for up to 52 weeks. TAK-503 was administered orally, QD. Participants aged 6 to 12 years received doses ranging from 1 to 4 mg, and participants aged 13 to 17 years received doses ranging from 1 to 7 mg. All participants initiated treatment at 1 mg, with dose titration in weekly increments of 1 mg until an optimal dose was achieved. |
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Participants received atomoxetine administered orally, QD for up to 49 weeks along with TAK-503 matched placebo. Participants weighing <70 kg at baseline initiated treatment at 0.5 mg/kg, with titration to a target dose of 1.2 mg/kg. Participants weighing >= 70 kg at baseline initiated treatment at 40 mg, QD, with weekly dose increases to 80 mg and then to 100 mg if tolerated. The maximum daily dose for participants weighing >=70 kg did not exceed 100 mg. |
| OG003 | Open-Label Period (Part B): Part A (Placebo) - Part B (TAK-503) | Participants who completed Part A in the placebo arm rolled over directly into Part B and received TAK-503 for up to 52 weeks. TAK-503 was administered orally, QD. Participants aged 6 to 12 years received doses ranging from 1 to 4 mg, and participants aged 13 to 17 years received doses ranging from 1 to 7 mg. All participants initiated treatment at 1 mg, with dose titration in weekly increments of 1 mg until an optimal dose was achieved. |
| OG004 | Open-Label Period (Part B): Part A (TAK-503) - Part B (TAK-503) | Participants who completed Part A in the TAK-503 arm rolled over directly into Part B after washout period of >= 30 days and then received TAK-503 for up to 52 weeks. TAK-503 was administered orally, QD. Participants aged 6 to 12 years received doses ranging from 1 to 4 mg, and participants aged 13 to 17 years received doses ranging from 1 to 7 mg. All participants initiated treatment at 1 mg, with dose titration in weekly increments of 1 mg until an optimal dose was achieved. |
| OG005 | Open-Label Period (Part B): Part A (Atomoxetine) - Part B (TAK-503) | Participants who completed Part A in the atomoxetine arm rolled over directly into Part B after washout period of >= 30 days and then received TAK-503 for up to 52 weeks. TAK-503 was administered orally, QD. Participants aged 6 to 12 years received doses ranging from 1 to 4 mg, and participants aged 13 to 17 years received doses ranging from 1 to 7 mg. All participants initiated treatment at 1 mg, with dose titration in weekly increments of 1 mg until an optimal dose was achieved. |
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| OG002 | Double-Blinded Period (Part A): Atomoxetine | Participants received atomoxetine administered orally, QD for up to 49 weeks along with TAK-503 matched placebo. Participants weighing <70 kg at baseline initiated treatment at 0.5 mg/kg, with titration to a target dose of 1.2 mg/kg. Participants weighing >= 70 kg at baseline initiated treatment at 40 mg, QD, with weekly dose increases to 80 mg and then to 100 mg if tolerated. The maximum daily dose for participants weighing >=70 kg did not exceed 100 mg. |
| OG003 | Open-Label Period (Part B): Part A (Placebo) - Part B (TAK-503) | Participants who completed Part A in the placebo arm rolled over directly into Part B and received TAK-503 for up to 52 weeks. TAK-503 was administered orally, QD. Participants aged 6 to 12 years received doses ranging from 1 to 4 mg, and participants aged 13 to 17 years received doses ranging from 1 to 7 mg. All participants initiated treatment at 1 mg, with dose titration in weekly increments of 1 mg until an optimal dose was achieved. |
| OG004 | Open-Label Period (Part B): Part A (TAK-503) - Part B (TAK-503) | Participants who completed Part A in the TAK-503 arm rolled over directly into Part B after washout period of >= 30 days and then received TAK-503 for up to 52 weeks. TAK-503 was administered orally, QD. Participants aged 6 to 12 years received doses ranging from 1 to 4 mg, and participants aged 13 to 17 years received doses ranging from 1 to 7 mg. All participants initiated treatment at 1 mg, with dose titration in weekly increments of 1 mg until an optimal dose was achieved. |
| OG005 | Open-Label Period (Part B): Part A (Atomoxetine) - Part B (TAK-503) | Participants who completed Part A in the atomoxetine arm rolled over directly into Part B after washout period of >= 30 days and then received TAK-503 for up to 52 weeks. TAK-503 was administered orally, QD. Participants aged 6 to 12 years received doses ranging from 1 to 4 mg, and participants aged 13 to 17 years received doses ranging from 1 to 7 mg. All participants initiated treatment at 1 mg, with dose titration in weekly increments of 1 mg until an optimal dose was achieved. |
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Participants received atomoxetine administered orally, QD for up to 49 weeks along with TAK-503 matched placebo. Participants weighing <70 kg at baseline initiated treatment at 0.5 mg/kg, with titration to a target dose of 1.2 mg/kg. Participants weighing >= 70 kg at baseline initiated treatment at 40 mg, QD, with weekly dose increases to 80 mg and then to 100 mg if tolerated. The maximum daily dose for participants weighing >=70 kg did not exceed 100 mg. |
| OG003 | Open-Label Period (Part B): Part A (Placebo) - Part B (TAK-503) | Participants who completed Part A in the placebo arm rolled over directly into Part B and received TAK-503 for up to 52 weeks. TAK-503 was administered orally, QD. Participants aged 6 to 12 years received doses ranging from 1 to 4 mg, and participants aged 13 to 17 years received doses ranging from 1 to 7 mg. All participants initiated treatment at 1 mg, with dose titration in weekly increments of 1 mg until an optimal dose was achieved. |
| OG004 | Open-Label Period (Part B): Part A (TAK-503) - Part B (TAK-503) | Participants who completed Part A in the TAK-503 arm rolled over directly into Part B after washout period of >= 30 days and then received TAK-503 for up to 52 weeks. TAK-503 was administered orally, QD. Participants aged 6 to 12 years received doses ranging from 1 to 4 mg, and participants aged 13 to 17 years received doses ranging from 1 to 7 mg. All participants initiated treatment at 1 mg, with dose titration in weekly increments of 1 mg until an optimal dose was achieved. |
| OG005 | Open-Label Period (Part B): Part A (Atomoxetine) - Part B (TAK-503) | Participants who completed Part A in the atomoxetine arm rolled over directly into Part B after washout period of >= 30 days and then received TAK-503 for up to 52 weeks. TAK-503 was administered orally, QD. Participants aged 6 to 12 years received doses ranging from 1 to 4 mg, and participants aged 13 to 17 years received doses ranging from 1 to 7 mg. All participants initiated treatment at 1 mg, with dose titration in weekly increments of 1 mg until an optimal dose was achieved. |
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| OG002 | Double-Blinded Period (Part A): Atomoxetine | Participants received atomoxetine administered orally, QD for up to 49 weeks along with TAK-503 matched placebo. Participants weighing <70 kg at baseline initiated treatment at 0.5 mg/kg, with titration to a target dose of 1.2 mg/kg. Participants weighing >= 70 kg at baseline initiated treatment at 40 mg, QD, with weekly dose increases to 80 mg and then to 100 mg if tolerated. The maximum daily dose for participants weighing >=70 kg did not exceed 100 mg. |
| OG003 | Open-Label Period (Part B): Part A (Placebo) - Part B (TAK-503) | Participants who completed Part A in the placebo arm rolled over directly into Part B and received TAK-503 for up to 52 weeks. TAK-503 was administered orally, QD. Participants aged 6 to 12 years received doses ranging from 1 to 4 mg, and participants aged 13 to 17 years received doses ranging from 1 to 7 mg. All participants initiated treatment at 1 mg, with dose titration in weekly increments of 1 mg until an optimal dose was achieved. |
| OG004 | Open-Label Period (Part B): Part A (TAK-503) - Part B (TAK-503) | Participants who completed Part A in the TAK-503 arm rolled over directly into Part B after washout period of >= 30 days and then received TAK-503 for up to 52 weeks. TAK-503 was administered orally, QD. Participants aged 6 to 12 years received doses ranging from 1 to 4 mg, and participants aged 13 to 17 years received doses ranging from 1 to 7 mg. All participants initiated treatment at 1 mg, with dose titration in weekly increments of 1 mg until an optimal dose was achieved. |
| OG005 | Open-Label Period (Part B): Part A (Atomoxetine) - Part B (TAK-503) | Participants who completed Part A in the atomoxetine arm rolled over directly into Part B after washout period of >= 30 days and then received TAK-503 for up to 52 weeks. TAK-503 was administered orally, QD. Participants aged 6 to 12 years received doses ranging from 1 to 4 mg, and participants aged 13 to 17 years received doses ranging from 1 to 7 mg. All participants initiated treatment at 1 mg, with dose titration in weekly increments of 1 mg until an optimal dose was achieved. |
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| OG002 | Double-Blinded Period (Part A): Atomoxetine | Participants received atomoxetine administered orally, QD for up to 49 weeks along with TAK-503 matched placebo. Participants weighing <70 kg at baseline initiated treatment at 0.5 mg/kg, with titration to a target dose of 1.2 mg/kg. Participants weighing >= 70 kg at baseline initiated treatment at 40 mg, QD, with weekly dose increases to 80 mg and then to 100 mg if tolerated. The maximum daily dose for participants weighing >=70 kg did not exceed 100 mg. |
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| OG001 | Open-Label Period (Part B): Part A (TAK-503) - Part B (TAK-503) | Participants who completed Part A in the TAK-503 arm rolled over directly into Part B after washout period of >= 30 days and then received TAK-503 for up to 52 weeks. TAK-503 was administered orally, QD. Participants aged 6 to 12 years received doses ranging from 1 to 4 mg, and participants aged 13 to 17 years received doses ranging from 1 to 7 mg. All participants initiated treatment at 1 mg, with dose titration in weekly increments of 1 mg until an optimal dose was achieved. |
| OG002 | Open-Label Period (Part B): Part A (Atomoxetine) - Part B (TAK-503) | Participants who completed Part A in the atomoxetine arm rolled over directly into Part B after washout period of >= 30 days and then received TAK-503 for up to 52 weeks. TAK-503 was administered orally, QD. Participants aged 6 to 12 years received doses ranging from 1 to 4 mg, and participants aged 13 to 17 years received doses ranging from 1 to 7 mg. All participants initiated treatment at 1 mg, with dose titration in weekly increments of 1 mg until an optimal dose was achieved. |
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| Double-Blinded Period (Part A): TAK-503 |
Participants aged 6 to 12 years received TAK-503 at doses ranging from 1 to 4 mg, and participants aged 13 to 17 years received doses ranging from 1 to 7 mg. TAK-503 was administered orally, QD for up to 49 weeks along with atomoxetine matched placebo capsule. All participants initiated treatment at 1 mg, with dose titration in weekly increments of 1 mg until an optimal dose was achieved. |
| OG002 | Double-Blinded Period (Part A): Atomoxetine | Participants received atomoxetine administered orally, QD for up to 49 weeks along with TAK-503 matched placebo. Participants weighing <70 kg at baseline initiated treatment at 0.5 mg/kg, with titration to a target dose of 1.2 mg/kg. Participants weighing >= 70 kg at baseline initiated treatment at 40 mg, QD, with weekly dose increases to 80 mg and then to 100 mg if tolerated. The maximum daily dose for participants weighing >=70 kg did not exceed 100 mg. |
| OG003 | Open-Label Period (Part B): Part A (Placebo) - Part B (TAK-503) | Participants who completed Part A in the placebo arm rolled over directly into Part B and received TAK-503 for up to 52 weeks. TAK-503 was administered orally, QD. Participants aged 6 to 12 years received doses ranging from 1 to 4 mg, and participants aged 13 to 17 years received doses ranging from 1 to 7 mg. All participants initiated treatment at 1 mg, with dose titration in weekly increments of 1 mg until an optimal dose was achieved. |
| OG004 | Open-Label Period (Part B): Part A (TAK-503) - Part B (TAK-503) | Participants who completed Part A in the TAK-503 arm rolled over directly into Part B after washout period of >= 30 days and then received TAK-503 for up to 52 weeks. TAK-503 was administered orally, QD. Participants aged 6 to 12 years received doses ranging from 1 to 4 mg, and participants aged 13 to 17 years received doses ranging from 1 to 7 mg. All participants initiated treatment at 1 mg, with dose titration in weekly increments of 1 mg until an optimal dose was achieved. |
| OG005 | Open-Label Period (Part B): Part A (Atomoxetine) - Part B (TAK-503) | Participants who completed Part A in the atomoxetine arm rolled over directly into Part B after washout period of >= 30 days and then received TAK-503 for up to 52 weeks. TAK-503 was administered orally, QD. Participants aged 6 to 12 years received doses ranging from 1 to 4 mg, and participants aged 13 to 17 years received doses ranging from 1 to 7 mg. All participants initiated treatment at 1 mg, with dose titration in weekly increments of 1 mg until an optimal dose was achieved. |
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| OG002 | Double-Blinded Period (Part A): Atomoxetine | Participants received atomoxetine administered orally, QD for up to 49 weeks along with TAK-503 matched placebo. Participants weighing <70 kg at baseline initiated treatment at 0.5 mg/kg, with titration to a target dose of 1.2 mg/kg. Participants weighing >= 70 kg at baseline initiated treatment at 40 mg, QD, with weekly dose increases to 80 mg and then to 100 mg if tolerated. The maximum daily dose for participants weighing >=70 kg did not exceed 100 mg. |
| OG003 | Open-Label Period (Part B): Part A (Placebo) - Part B (TAK-503) | Participants who completed Part A in the placebo arm rolled over directly into Part B and received TAK-503 for up to 52 weeks. TAK-503 was administered orally, QD. Participants aged 6 to 12 years received doses ranging from 1 to 4 mg, and participants aged 13 to 17 years received doses ranging from 1 to 7 mg. All participants initiated treatment at 1 mg, with dose titration in weekly increments of 1 mg until an optimal dose was achieved. |
| OG004 | Open-Label Period (Part B): Part A (TAK-503) - Part B (TAK-503) | Participants who completed Part A in the TAK-503 arm rolled over directly into Part B after washout period of >= 30 days and then received TAK-503 for up to 52 weeks. TAK-503 was administered orally, QD. Participants aged 6 to 12 years received doses ranging from 1 to 4 mg, and participants aged 13 to 17 years received doses ranging from 1 to 7 mg. All participants initiated treatment at 1 mg, with dose titration in weekly increments of 1 mg until an optimal dose was achieved. |
| OG005 | Open-Label Period (Part B): Part A (Atomoxetine) - Part B (TAK-503) | Participants who completed Part A in the atomoxetine arm rolled over directly into Part B after washout period of >= 30 days and then received TAK-503 for up to 52 weeks. TAK-503 was administered orally, QD. Participants aged 6 to 12 years received doses ranging from 1 to 4 mg, and participants aged 13 to 17 years received doses ranging from 1 to 7 mg. All participants initiated treatment at 1 mg, with dose titration in weekly increments of 1 mg until an optimal dose was achieved. |
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| OG002 | Double-Blinded Period (Part A): Atomoxetine | Participants received atomoxetine administered orally, QD for up to 49 weeks along with TAK-503 matched placebo. Participants weighing <70 kg at baseline initiated treatment at 0.5 mg/kg, with titration to a target dose of 1.2 mg/kg. Participants weighing >= 70 kg at baseline initiated treatment at 40 mg, QD, with weekly dose increases to 80 mg and then to 100 mg if tolerated. The maximum daily dose for participants weighing >=70 kg did not exceed 100 mg. |
| OG003 | Open-Label Period (Part B): Part A (Placebo) - Part B (TAK-503) | Participants who completed Part A in the placebo arm rolled over directly into Part B and received TAK-503 for up to 52 weeks. TAK-503 was administered orally, QD. Participants aged 6 to 12 years received doses ranging from 1 to 4 mg, and participants aged 13 to 17 years received doses ranging from 1 to 7 mg. All participants initiated treatment at 1 mg, with dose titration in weekly increments of 1 mg until an optimal dose was achieved. |
| OG004 | Open-Label Period (Part B): Part A (TAK-503) - Part B (TAK-503) | Participants who completed Part A in the TAK-503 arm rolled over directly into Part B after washout period of >= 30 days and then received TAK-503 for up to 52 weeks. TAK-503 was administered orally, QD. Participants aged 6 to 12 years received doses ranging from 1 to 4 mg, and participants aged 13 to 17 years received doses ranging from 1 to 7 mg. All participants initiated treatment at 1 mg, with dose titration in weekly increments of 1 mg until an optimal dose was achieved. |
| OG005 | Open-Label Period (Part B): Part A (Atomoxetine) - Part B (TAK-503) | Participants who completed Part A in the atomoxetine arm rolled over directly into Part B after washout period of >= 30 days and then received TAK-503 for up to 52 weeks. TAK-503 was administered orally, QD. Participants aged 6 to 12 years received doses ranging from 1 to 4 mg, and participants aged 13 to 17 years received doses ranging from 1 to 7 mg. All participants initiated treatment at 1 mg, with dose titration in weekly increments of 1 mg until an optimal dose was achieved. |
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| OG002 | Double-Blinded Period (Part A): Atomoxetine | Participants received atomoxetine administered orally, QD for up to 49 weeks along with TAK-503 matched placebo. Participants weighing <70 kg at baseline initiated treatment at 0.5 mg/kg, with titration to a target dose of 1.2 mg/kg. Participants weighing >= 70 kg at baseline initiated treatment at 40 mg, QD, with weekly dose increases to 80 mg and then to 100 mg if tolerated. The maximum daily dose for participants weighing >=70 kg did not exceed 100 mg. |
| OG003 | Open-Label Period (Part B): Part A (Placebo) - Part B (TAK-503) | Participants who completed Part A in the placebo arm rolled over directly into Part B and received TAK-503 for up to 52 weeks. TAK-503 was administered orally, QD. Participants aged 6 to 12 years received doses ranging from 1 to 4 mg, and participants aged 13 to 17 years received doses ranging from 1 to 7 mg. All participants initiated treatment at 1 mg, with dose titration in weekly increments of 1 mg until an optimal dose was achieved. |
| OG004 | Open-Label Period (Part B): Part A (TAK-503) - Part B (TAK-503) | Participants who completed Part A in the TAK-503 arm rolled over directly into Part B after washout period of >= 30 days and then received TAK-503 for up to 52 weeks. TAK-503 was administered orally, QD. Participants aged 6 to 12 years received doses ranging from 1 to 4 mg, and participants aged 13 to 17 years received doses ranging from 1 to 7 mg. All participants initiated treatment at 1 mg, with dose titration in weekly increments of 1 mg until an optimal dose was achieved. |
| OG005 | Open-Label Period (Part B): Part A (Atomoxetine) - Part B (TAK-503) | Participants who completed Part A in the atomoxetine arm rolled over directly into Part B after washout period of >= 30 days and then received TAK-503 for up to 52 weeks. TAK-503 was administered orally, QD. Participants aged 6 to 12 years received doses ranging from 1 to 4 mg, and participants aged 13 to 17 years received doses ranging from 1 to 7 mg. All participants initiated treatment at 1 mg, with dose titration in weekly increments of 1 mg until an optimal dose was achieved. |
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| OG002 | Double-Blinded Period (Part A): Atomoxetine | Participants received atomoxetine administered orally, QD for up to 49 weeks along with TAK-503 matched placebo. Participants weighing <70 kg at baseline initiated treatment at 0.5 mg/kg, with titration to a target dose of 1.2 mg/kg. Participants weighing >= 70 kg at baseline initiated treatment at 40 mg, QD, with weekly dose increases to 80 mg and then to 100 mg if tolerated. The maximum daily dose for participants weighing >=70 kg did not exceed 100 mg. |
| OG003 | Open-Label Period (Part B): Part A (Placebo) - Part B (TAK-503) | Participants who completed Part A in the placebo arm rolled over directly into Part B and received TAK-503 for up to 52 weeks. TAK-503 was administered orally, QD. Participants aged 6 to 12 years received doses ranging from 1 to 4 mg, and participants aged 13 to 17 years received doses ranging from 1 to 7 mg. All participants initiated treatment at 1 mg, with dose titration in weekly increments of 1 mg until an optimal dose was achieved. |
| OG004 | Open-Label Period (Part B): Part A (TAK-503) - Part B (TAK-503) | Participants who completed Part A in the TAK-503 arm rolled over directly into Part B after washout period of >= 30 days and then received TAK-503 for up to 52 weeks. TAK-503 was administered orally, QD. Participants aged 6 to 12 years received doses ranging from 1 to 4 mg, and participants aged 13 to 17 years received doses ranging from 1 to 7 mg. All participants initiated treatment at 1 mg, with dose titration in weekly increments of 1 mg until an optimal dose was achieved. |
| OG005 | Open-Label Period (Part B): Part A (Atomoxetine) - Part B (TAK-503) | Participants who completed Part A in the atomoxetine arm rolled over directly into Part B after washout period of >= 30 days and then received TAK-503 for up to 52 weeks. TAK-503 was administered orally, QD. Participants aged 6 to 12 years received doses ranging from 1 to 4 mg, and participants aged 13 to 17 years received doses ranging from 1 to 7 mg. All participants initiated treatment at 1 mg, with dose titration in weekly increments of 1 mg until an optimal dose was achieved. |
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| OG002 | Double-Blinded Period (Part A): Atomoxetine | Participants received atomoxetine administered orally, QD for up to 49 weeks along with TAK-503 matched placebo. Participants weighing <70 kg at baseline initiated treatment at 0.5 mg/kg, with titration to a target dose of 1.2 mg/kg. Participants weighing >= 70 kg at baseline initiated treatment at 40 mg, QD, with weekly dose increases to 80 mg and then to 100 mg if tolerated. The maximum daily dose for participants weighing >=70 kg did not exceed 100 mg. |
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| Open-Label Period (Part B): Part A (TAK-503) - Part B (TAK-503) |
Participants who completed Part A in the TAK-503 arm rolled over directly into Part B after washout period of >= 30 days and then received TAK-503 for up to 52 weeks. TAK-503 was administered orally, QD. Participants aged 6 to 12 years received doses ranging from 1 to 4 mg, and participants aged 13 to 17 years received doses ranging from 1 to 7 mg. All participants initiated treatment at 1 mg, with dose titration in weekly increments of 1 mg until an optimal dose was achieved. |
| OG002 | Open-Label Period (Part B): Part A (Atomoxetine) - Part B (TAK-503) | Participants who completed Part A in the atomoxetine arm rolled over directly into Part B after washout period of >= 30 days and then received TAK-503 for up to 52 weeks. TAK-503 was administered orally, QD. Participants aged 6 to 12 years received doses ranging from 1 to 4 mg, and participants aged 13 to 17 years received doses ranging from 1 to 7 mg. All participants initiated treatment at 1 mg, with dose titration in weekly increments of 1 mg until an optimal dose was achieved. |
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Participants aged 6 to 12 years received TAK-503 at doses ranging from 1 to 4 mg, and participants aged 13 to 17 years received doses ranging from 1 to 7 mg. TAK-503 was administered orally, QD for up to 49 weeks along with atomoxetine matched placebo capsule. All participants initiated treatment at 1 mg, with dose titration in weekly increments of 1 mg until an optimal dose was achieved. |
| OG002 | Double-Blinded Period (Part A): Atomoxetine | Participants received atomoxetine administered orally, QD for up to 49 weeks along with TAK-503 matched placebo. Participants weighing <70 kg at baseline initiated treatment at 0.5 mg/kg, with titration to a target dose of 1.2 mg/kg. Participants weighing >= 70 kg at baseline initiated treatment at 40 mg, QD, with weekly dose increases to 80 mg and then to 100 mg if tolerated. The maximum daily dose for participants weighing >=70 kg did not exceed 100 mg. |
| OG003 | Open-Label Period (Part B): Part A (Placebo) - Part B (TAK-503) | Participants who completed Part A in the placebo arm rolled over directly into Part B and received TAK-503 for up to 52 weeks. TAK-503 was administered orally, QD. Participants aged 6 to 12 years received doses ranging from 1 to 4 mg, and participants aged 13 to 17 years received doses ranging from 1 to 7 mg. All participants initiated treatment at 1 mg, with dose titration in weekly increments of 1 mg until an optimal dose was achieved. |
| OG004 | Open-Label Period (Part B): Part A (TAK-503) - Part B (TAK-503) | Participants who completed Part A in the TAK-503 arm rolled over directly into Part B after washout period of >= 30 days and then received TAK-503 for up to 52 weeks. TAK-503 was administered orally, QD. Participants aged 6 to 12 years received doses ranging from 1 to 4 mg, and participants aged 13 to 17 years received doses ranging from 1 to 7 mg. All participants initiated treatment at 1 mg, with dose titration in weekly increments of 1 mg until an optimal dose was achieved. |
| OG005 | Open-Label Period (Part B): Part A (Atomoxetine) - Part B (TAK-503) | Participants who completed Part A in the atomoxetine arm rolled over directly into Part B after washout period of >= 30 days and then received TAK-503 for up to 52 weeks. TAK-503 was administered orally, QD. Participants aged 6 to 12 years received doses ranging from 1 to 4 mg, and participants aged 13 to 17 years received doses ranging from 1 to 7 mg. All participants initiated treatment at 1 mg, with dose titration in weekly increments of 1 mg until an optimal dose was achieved. |
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Participants aged 6 to 12 years received TAK-503 at doses ranging from 1 to 4 mg, and participants aged 13 to 17 years received doses ranging from 1 to 7 mg. TAK-503 was administered orally, QD for up to 49 weeks along with atomoxetine matched placebo capsule. All participants initiated treatment at 1 mg, with dose titration in weekly increments of 1 mg until an optimal dose was achieved.
| OG002 | Double-Blinded Period (Part A): Atomoxetine | Participants received atomoxetine administered orally, QD for up to 49 weeks along with TAK-503 matched placebo. Participants weighing <70 kg at baseline initiated treatment at 0.5 mg/kg, with titration to a target dose of 1.2 mg/kg. Participants weighing >= 70 kg at baseline initiated treatment at 40 mg, QD, with weekly dose increases to 80 mg and then to 100 mg if tolerated. The maximum daily dose for participants weighing >=70 kg did not exceed 100 mg. |
| OG003 | Open-Label Period (Part B): Part A (Placebo) - Part B (TAK-503) | Participants who completed Part A in the placebo arm rolled over directly into Part B and received TAK-503 for up to 52 weeks. TAK-503 was administered orally, QD. Participants aged 6 to 12 years received doses ranging from 1 to 4 mg, and participants aged 13 to 17 years received doses ranging from 1 to 7 mg. All participants initiated treatment at 1 mg, with dose titration in weekly increments of 1 mg until an optimal dose was achieved. |
| OG004 | Open-Label Period (Part B): Part A (TAK-503) - Part B (TAK-503) | Participants who completed Part A in the TAK-503 arm rolled over directly into Part B after washout period of >= 30 days and then received TAK-503 for up to 52 weeks. TAK-503 was administered orally, QD. Participants aged 6 to 12 years received doses ranging from 1 to 4 mg, and participants aged 13 to 17 years received doses ranging from 1 to 7 mg. All participants initiated treatment at 1 mg, with dose titration in weekly increments of 1 mg until an optimal dose was achieved. |
| OG005 | Open-Label Period (Part B): Part A (Atomoxetine) - Part B (TAK-503) | Participants who completed Part A in the atomoxetine arm rolled over directly into Part B after washout period of >= 30 days and then received TAK-503 for up to 52 weeks. TAK-503 was administered orally, QD. Participants aged 6 to 12 years received doses ranging from 1 to 4 mg, and participants aged 13 to 17 years received doses ranging from 1 to 7 mg. All participants initiated treatment at 1 mg, with dose titration in weekly increments of 1 mg until an optimal dose was achieved. |
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Participants aged 6 to 12 years received TAK-503 at doses ranging from 1 to 4 mg, and participants aged 13 to 17 years received doses ranging from 1 to 7 mg. TAK-503 was administered orally, QD for up to 49 weeks along with atomoxetine matched placebo capsule. All participants initiated treatment at 1 mg, with dose titration in weekly increments of 1 mg until an optimal dose was achieved.
| OG002 | Double-Blinded Period (Part A): Atomoxetine | Participants received atomoxetine administered orally, QD for up to 49 weeks along with TAK-503 matched placebo. Participants weighing <70 kg at baseline initiated treatment at 0.5 mg/kg, with titration to a target dose of 1.2 mg/kg. Participants weighing >= 70 kg at baseline initiated treatment at 40 mg, QD, with weekly dose increases to 80 mg and then to 100 mg if tolerated. The maximum daily dose for participants weighing >=70 kg did not exceed 100 mg. |
| OG003 | Open-Label Period (Part B): Part A (Placebo) - Part B (TAK-503) | Participants who completed Part A in the placebo arm rolled over directly into Part B and received TAK-503 for up to 52 weeks. TAK-503 was administered orally, QD. Participants aged 6 to 12 years received doses ranging from 1 to 4 mg, and participants aged 13 to 17 years received doses ranging from 1 to 7 mg. All participants initiated treatment at 1 mg, with dose titration in weekly increments of 1 mg until an optimal dose was achieved. |
| OG004 | Open-Label Period (Part B): Part A (TAK-503) - Part B (TAK-503) | Participants who completed Part A in the TAK-503 arm rolled over directly into Part B after washout period of >= 30 days and then received TAK-503 for up to 52 weeks. TAK-503 was administered orally, QD. Participants aged 6 to 12 years received doses ranging from 1 to 4 mg, and participants aged 13 to 17 years received doses ranging from 1 to 7 mg. All participants initiated treatment at 1 mg, with dose titration in weekly increments of 1 mg until an optimal dose was achieved. |
| OG005 | Open-Label Period (Part B): Part A (Atomoxetine) - Part B (TAK-503) | Participants who completed Part A in the atomoxetine arm rolled over directly into Part B after washout period of >= 30 days and then received TAK-503 for up to 52 weeks. TAK-503 was administered orally, QD. Participants aged 6 to 12 years received doses ranging from 1 to 4 mg, and participants aged 13 to 17 years received doses ranging from 1 to 7 mg. All participants initiated treatment at 1 mg, with dose titration in weekly increments of 1 mg until an optimal dose was achieved. |
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| OG002 | Double-Blinded Period (Part A): Atomoxetine | Participants received atomoxetine administered orally, QD for up to 49 weeks along with TAK-503 matched placebo. Participants weighing <70 kg at baseline initiated treatment at 0.5 mg/kg, with titration to a target dose of 1.2 mg/kg. Participants weighing >= 70 kg at baseline initiated treatment at 40 mg, QD, with weekly dose increases to 80 mg and then to 100 mg if tolerated. The maximum daily dose for participants weighing >=70 kg did not exceed 100 mg. |
| OG003 | Open-Label Period (Part B): Part A (Placebo) - Part B (TAK-503) | Participants who completed Part A in the placebo arm rolled over directly into Part B and received TAK-503 for up to 52 weeks. TAK-503 was administered orally, QD. Participants aged 6 to 12 years received doses ranging from 1 to 4 mg, and participants aged 13 to 17 years received doses ranging from 1 to 7 mg. All participants initiated treatment at 1 mg, with dose titration in weekly increments of 1 mg until an optimal dose was achieved. |
| OG004 | Open-Label Period (Part B): Part A (TAK-503) - Part B (TAK-503) | Participants who completed Part A in the TAK-503 arm rolled over directly into Part B after washout period of >= 30 days and then received TAK-503 for up to 52 weeks. TAK-503 was administered orally, QD. Participants aged 6 to 12 years received doses ranging from 1 to 4 mg, and participants aged 13 to 17 years received doses ranging from 1 to 7 mg. All participants initiated treatment at 1 mg, with dose titration in weekly increments of 1 mg until an optimal dose was achieved. |
| OG005 | Open-Label Period (Part B): Part A (Atomoxetine) - Part B (TAK-503) | Participants who completed Part A in the atomoxetine arm rolled over directly into Part B after washout period of >= 30 days and then received TAK-503 for up to 52 weeks. TAK-503 was administered orally, QD. Participants aged 6 to 12 years received doses ranging from 1 to 4 mg, and participants aged 13 to 17 years received doses ranging from 1 to 7 mg. All participants initiated treatment at 1 mg, with dose titration in weekly increments of 1 mg until an optimal dose was achieved. |
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Participants received TAK-503-matched placebo tablets, orally, QD and atomoxetine-matched placebo capsule orally, QD for up to 18 weeks. |
| OG001 | Double-Blinded Period (Part A): TAK-503 | Participants aged 6 to 12 years received TAK-503 at doses ranging from 1 to 4 mg, and participants aged 13 to 17 years received doses ranging from 1 to 7 mg. TAK-503 was administered orally, QD for up to 49 weeks along with atomoxetine matched placebo capsule. All participants initiated treatment at 1 mg, with dose titration in weekly increments of 1 mg until an optimal dose was achieved. |
| OG002 | Double-Blinded Period (Part A): Atomoxetine | Participants received atomoxetine administered orally, QD for up to 49 weeks along with TAK-503 matched placebo. Participants weighing <70 kg at baseline initiated treatment at 0.5 mg/kg, with titration to a target dose of 1.2 mg/kg. Participants weighing >= 70 kg at baseline initiated treatment at 40 mg, QD, with weekly dose increases to 80 mg and then to 100 mg if tolerated. The maximum daily dose for participants weighing >=70 kg did not exceed 100 mg. |
| OG003 | Open-Label Period (Part B): Part A (Placebo) - Part B (TAK-503) | Participants who completed Part A in the placebo arm rolled over directly into Part B and received TAK-503 for up to 52 weeks. TAK-503 was administered orally, QD. Participants aged 6 to 12 years received doses ranging from 1 to 4 mg, and participants aged 13 to 17 years received doses ranging from 1 to 7 mg. All participants initiated treatment at 1 mg, with dose titration in weekly increments of 1 mg until an optimal dose was achieved. |
| OG004 | Open-Label Period (Part B): Part A (TAK-503) - Part B (TAK-503) | Participants who completed Part A in the TAK-503 arm rolled over directly into Part B after washout period of >= 30 days and then received TAK-503 for up to 52 weeks. TAK-503 was administered orally, QD. Participants aged 6 to 12 years received doses ranging from 1 to 4 mg, and participants aged 13 to 17 years received doses ranging from 1 to 7 mg. All participants initiated treatment at 1 mg, with dose titration in weekly increments of 1 mg until an optimal dose was achieved. |
| OG005 | Open-Label Period (Part B): Part A (Atomoxetine) - Part B (TAK-503) | Participants who completed Part A in the atomoxetine arm rolled over directly into Part B after washout period of >= 30 days and then received TAK-503 for up to 52 weeks. TAK-503 was administered orally, QD. Participants aged 6 to 12 years received doses ranging from 1 to 4 mg, and participants aged 13 to 17 years received doses ranging from 1 to 7 mg. All participants initiated treatment at 1 mg, with dose titration in weekly increments of 1 mg until an optimal dose was achieved. |
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| OG001 | Double-Blinded Period (Part A): TAK-503 | Participants aged 6 to 12 years received TAK-503 at doses ranging from 1 to 4 mg, and participants aged 13 to 17 years received doses ranging from 1 to 7 mg. TAK-503 was administered orally, QD for up to 49 weeks along with atomoxetine matched placebo capsule. All participants initiated treatment at 1 mg, with dose titration in weekly increments of 1 mg until an optimal dose was achieved. |
| OG002 | Double-Blinded Period (Part A): Atomoxetine | Participants received atomoxetine administered orally, QD for up to 49 weeks along with TAK-503 matched placebo. Participants weighing <70 kg at baseline initiated treatment at 0.5 mg/kg, with titration to a target dose of 1.2 mg/kg. Participants weighing >= 70 kg at baseline initiated treatment at 40 mg, QD, with weekly dose increases to 80 mg and then to 100 mg if tolerated. The maximum daily dose for participants weighing >=70 kg did not exceed 100 mg. |
| OG003 | Open-Label Period (Part B): Part A (Placebo) - Part B (TAK-503) | Participants who completed Part A in the placebo arm rolled over directly into Part B and received TAK-503 for up to 52 weeks. TAK-503 was administered orally, QD. Participants aged 6 to 12 years received doses ranging from 1 to 4 mg, and participants aged 13 to 17 years received doses ranging from 1 to 7 mg. All participants initiated treatment at 1 mg, with dose titration in weekly increments of 1 mg until an optimal dose was achieved. |
| OG004 | Open-Label Period (Part B): Part A (TAK-503) - Part B (TAK-503) | Participants who completed Part A in the TAK-503 arm rolled over directly into Part B after washout period of >= 30 days and then received TAK-503 for up to 52 weeks. TAK-503 was administered orally, QD. Participants aged 6 to 12 years received doses ranging from 1 to 4 mg, and participants aged 13 to 17 years received doses ranging from 1 to 7 mg. All participants initiated treatment at 1 mg, with dose titration in weekly increments of 1 mg until an optimal dose was achieved. |
| OG005 | Open-Label Period (Part B): Part A (Atomoxetine) - Part B (TAK-503) | Participants who completed Part A in the atomoxetine arm rolled over directly into Part B after washout period of >= 30 days and then received TAK-503 for up to 52 weeks. TAK-503 was administered orally, QD. Participants aged 6 to 12 years received doses ranging from 1 to 4 mg, and participants aged 13 to 17 years received doses ranging from 1 to 7 mg. All participants initiated treatment at 1 mg, with dose titration in weekly increments of 1 mg until an optimal dose was achieved. |
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| Stage II |
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| Stage III |
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| Stage IV |
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| Stage V |
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| Mild |
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| Moderate |
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| Severe |
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| Missing |
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| Mild |
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| Moderate |
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| Severe |
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| Missing |
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| Mild |
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| Moderate |
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| Severe |
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| Mild |
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| Moderate |
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| Severe |
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| Minimally Improved |
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| No Change |
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| Minimally Worse |
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| Much Worse |
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| Very Much Worse |
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| Not Assessed |
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