| Primary | Safety Assessment in Terms of Adverse Events (Treatment-emergent [TEAEs] and Serious [SAEs]) | Safety assessments were performed at each study visit according to the time and events schedule. All safety analyses were based on safety population | The analysis of the safety data was performed for the safety population which included subjects who took one or more doses of study medication. All subjects in the trial are included in the safety population | Posted | | Number | | Participants | | 1 year | | | | ID | Title | Description |
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| OG000 | KAPVAY (CLONICEL) | One tablet (0.1 mg) for 1 week; At Week 2, one additional 0.1 mg tablet; At Week 3, one additional 0.1 mg tablet; At Week 4, one last 0.1 mg tablet bringing the total dose to a maximum of 0.4 mg/day (0.2 mg twice daily) |
| | | Title | Denominators | Categories |
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| Total Safety Population | | | | Subjects with ≥1 TEAEs | | | | Subjects with ≥1 related TEAEs | | |
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| Secondary | Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHDRS-IV Scale) (18 Items Scored, 0 [Never/Rarely] to 3 [Very Often]; Total Possible Score Range, 0-54) at Months 1, 2, 3, 4, 6, 9, and 12 | The ADHDRS-IV consists of 18 items designed to reflect symptoms of ADHD. Each item is scored on a scale of 0 (Never or rarely) to 3 (Very Often). The subscales of the ADHDRS-IV included the Inattention and the hyperactivity/Impulsivity subscales (total possible score range, 0-54). The Inattention subscale consists of the sum of 9 items: 1, 3, 5, 7, 9, 11, 13, 15, and 17. The Hyperactivity/Impulsivity subscale consists of the sum of 9 items: 2, 4, 6, 8, 10, 12, 14, 16, and 18 | Efficacy summaries and analyses are based on the efficacy evaluable population which included subjects who took one or more doses of study medication and had at least one post-baseline efficacy measurement | Posted | | Mean | Standard Deviation | Units on a scale | | At baseline, months 1, 2, 3, 4, 6, 9, and 12 | | | | ID | Title | Description |
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| OG000 | KAPVAY (CLONICEL) | One tablet (0.1 mg) for 1 week; At Week 2, one additional 0.1 mg tablet; At Week 3, one additional 0.1 mg tablet; At Week 4, one last 0.1 mg tablet bringing the total dose to a maximum of 0.4 mg/day (0.2 mg twice daily) |
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| Primary | Safety Assessment in Terms of Adverse Events (Treatment-emergent [TEAEs] and Serious [SAEs]) | Safety assessments were performed at each study visit according to the time and events schedule. All safety analysis were based on safety population | The analysis of the safety data was performed for the safety population which included subjects who took one or more doses of study medication. All subjects in the trial are included in the safety population | Posted | | Number | | Events | | 1 year | | | | ID | Title | Description |
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| OG000 | KAPVAY (CLONICEL) | One tablet (0.1 mg) for 1 week; At Week 2, one additional 0.1 mg tablet; At Week 3, one additional 0.1 mg tablet; At Week 4, one last 0.1 mg tablet bringing the total dose to a maximum of 0.4 mg/day (0.2 mg twice daily) |
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| Primary | Change From Baseline in 12-lead Electrocardiogram in Terms of QT, QTc Fridericia (QTcF), and QTc Bazett's (QTcB) at Week 4 | | Data was analyzed based on safety population which included subjects who took one or more doses of study medication. All subjects in the trial are included in the safety population | Posted | | Mean | Standard Deviation | milliseconds | | At baseline and at Week 4 | | | | ID | Title | Description |
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| OG000 | KAPVAY (CLONICEL) | One tablet (0.1 mg) for 1 week; At Week 2, one additional 0.1 mg tablet; At Week 3, one additional 0.1 mg tablet; At Week 4, one last 0.1 mg tablet bringing the total dose to a maximum of 0.4 mg/day (0.2 mg twice daily) |
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| Primary | Change From Baseline in Body Weight at Weeks 1, 2, 3, 4, and Months 2, 3, 4, 5, 6, 9, and 12 | | Data was analyzed based on safety population which included subjects who took one or more doses of study medication. All subjects in the trial are included in the safety population | Posted | | Mean | Standard Deviation | Kilograms | | At baseline and at weeks 1, 2, 3, 4, and months 2, 3, 4, 5, 6, 9, and 12 | | | | ID | Title | Description |
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| OG000 | KAPVAY (CLONICEL) | One tablet (0.1 mg) for 1 week; At Week 2, one additional 0.1 mg tablet; At Week 3, one additional 0.1 mg tablet; At Week 4, one last 0.1 mg tablet bringing the total dose to a maximum of 0.4 mg/day (0.2 mg twice daily) |
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| Primary | Change From Baseline in Diastolic Blood Pressure at Week 4 | Blood pressure was measured with the subject in a sitting position and resting for at least 2 minutes prior to taking the measurement. The dominant arm was used for the measurement | Data was anlyzed based on safety population which included subjects who took one or more doses of study medication. All subjects in the trial are included in the safety population | Posted | | Mean | Standard Deviation | mmHg | | At baseline and at Week 4 | | | | ID | Title | Description |
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| OG000 | KAPVAY (CLONICEL) | One tablet (0.1 mg) for 1 week; At Week 2, one additional 0.1 mg tablet; At Week 3, one additional 0.1 mg tablet; At Week 4, one last 0.1 mg tablet bringing the total dose to a maximum of 0.4 mg/day (0.2 mg twice daily) |
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| Primary | Change From Baseline in Systolic Blood Pressure at Week 4 | Blood pressure was measured with the subject in a sitting position and resting for at least 2 minutes prior to taking the measurement. The dominant arm was used for the measurement | Data was analyzed based on safety population which included subjects who took one or more doses of study medication. All subjects in the trial are included in the safety population | Posted | | Mean | Standard Deviation | mmHg | | At baseline and at Week 4 | | | | ID | Title | Description |
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| OG000 | KAPVAY (CLONICEL) | One tablet (0.1 mg) for 1 week; At Week 2, one additional 0.1 mg tablet; At Week 3, one additional 0.1 mg tablet; At Week 4, one last 0.1 mg tablet bringing the total dose to a maximum of 0.4 mg/day (0.2 mg twice daily) |
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| Primary | Change From Baseline in Body Temperature at Week 4 | Temperature was measured with the subject in a sitting position and resting for at least 2 minutes prior to taking the measurement | Data analysis was performed on safety population which included subjects who took one or more doses of study medication. All subjects in the trial are included in the safety population | Posted | | Mean | Standard Deviation | Fahrenheit | | At baseline and at Week 4 | | | | ID | Title | Description |
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| OG000 | KAPVAY (CLONICEL) | One tablet (0.1 mg) for 1 week; At Week 2, one additional 0.1 mg tablet; At Week 3, one additional 0.1 mg tablet; At Week 4, one last 0.1 mg tablet bringing the total dose to a maximum of 0.4 mg/day (0.2 mg twice daily) |
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| Primary | Change From Baseline in Heart Rate at Week 4 | Heart rate was measured with the subject in a sitting position and resting for at least 2 minutes prior to taking the measurement | Data was analyzed based on safety population which included subjects who took one or more doses of study medication. All subjects in the trial are included in the safety population | Posted | | Mean | Standard Deviation | beats per minute | | At baseline and at Week 4 | | | | ID | Title | Description |
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| OG000 | KAPVAY (CLONICEL) | One tablet (0.1 mg) for 1 week; At Week 2, one additional 0.1 mg tablet; At Week 3, one additional 0.1 mg tablet; At Week 4, one last 0.1 mg tablet bringing the total dose to a maximum of 0.4 mg/day (0.2 mg twice daily) |
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| Primary | Change From Baseline in 12-lead Electrocardiogram in Terms of Heart Rate at Week 4 | | Data analysis involved the safety population which included subjects who took one or more doses of study medication. All subjects in the trial are included in the safety population | Posted | | Mean | Standard Deviation | beats per minute | | At baseline and at Week 4 | | | | ID | Title | Description |
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| OG000 | KAPVAY (CLONICEL) | One tablet (0.1 mg) for 1 week; At Week 2, one additional 0.1 mg tablet; At Week 3, one additional 0.1 mg tablet; At Week 4, one last 0.1 mg tablet bringing the total dose to a maximum of 0.4 mg/day (0.2 mg twice daily) |
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| Secondary | Change From Baseline in Clinical Global Impressions-Severity (CGI-S) at Months 1, 2, 3, 4, 6, 9, and 12 | CGI-S scale: 1 = Normal, not ill at all; 2 = Borderline ill; 3 = Mildly ill; 4 = Moderately ill; 5 = Markedly ill; 6 = Severely ill; 7 = Among the most extremely ill patients | Efficacy summaries and analyses are based on the efficacy evaluable population which included subjects who took one or more doses of study medication and had at least one post-baseline efficacy measurement | Posted | | Mean | Standard Deviation | Units on a scale | | At baseline, months 1, 2, 3, 4, 6, 9, and 12 | | | | ID | Title | Description |
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| OG000 | KAPVAY (CLONICEL) | One tablet (0.1 mg) for 1 week; At Week 2, one additional 0.1 mg tablet; At Week 3, one additional 0.1 mg tablet; At Week 4, one last 0.1 mg tablet bringing the total dose to a maximum of 0.4 mg/day (0.2 mg twice daily) |
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| Secondary | Change From Baseline in Clinical Global Impressions-Improvement (CGI-I) at Months 1, 2, 3, 4, 6, 9, and 12 | CGI-I scale: 1 = Very much improved; 2 = Much improved; 3 = Minimally improved; 4 = No change; 5 = Minimally worse; 6 = Much worse; 7 = Very much worse | Efficacy summaries and analyses are based on the efficacy evaluable population which included subjects who took one or more doses of study medication and had at least one post-baseline efficacy measurement | Posted | | Mean | Standard Deviation | Units on a scale | | At baseline, months 1, 2, 3, 4, 6, 9, and 12 | | | | ID | Title | Description |
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| OG000 | KAPVAY (CLONICEL) | One tablet (0.1 mg) for 1 week; At Week 2, one additional 0.1 mg tablet; At Week 3, one additional 0.1 mg tablet; At Week 4, one last 0.1 mg tablet bringing the total dose to a maximum of 0.4 mg/day (0.2 mg twice daily) |
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