| Primary | Change From Baseline in Mean Systolic Blood Pressure at Final Assessment | Systolic Blood pressure was measured at supine and standing position and mean supine systolic blood pressure was reported here. Final Assessment is the last valid assessment obtained after Baseline (Visit 2/Day 0) whilst on investigational product and before first dose taper medication [Visit 19/Early Termination (ET)/Day 714]. | Safety Analysis Set includes all enrolled participants who took at least 1 dose of SPD503. Here, n = number of participants analysed for the specific categories for each arm respectively. | Posted | | Mean | Standard Deviation | millimeter of mercury (mmHg) | | Baseline (Day 0) and Final Assessment (last non missing data/up to Day 714) | | | | ID | Title | Description |
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| OG000 | SPD503 (6-12 Years) | Participants aged 6-12 years received extended-release guanfacine hydrochloride (SPD503) one tablet (1 x 1 mg or 2 mg or 3 mg or 4mg) or two tablets (1 x 2+3 mg or 1 x 2+4 mg, 1 x 3+4 mg) once daily for up to 2 years. | | OG001 | SPD503 (13-18 Years) | Participants aged 13-18 years received extended-release guanfacine hydrochloride (SPD503) one tablet (1 x 1 mg or 2 mg or 3 mg or 4mg) or two tablets (1 x 2+3 mg or 1 x 2+4 mg, 1 x 3+4 mg) once daily for up to 2 years. |
| | | Title | Denominators | Categories |
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| Baseline (n = 131, 83) | | | Title | Measurements |
|---|
| - OG000107.5± 8.73
- OG001113.5± 9.23
|
| | Change at Final Assessment (n = 130, 82) | | |
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| Primary | Change From Baseline in Mean Diastolic Blood Pressure at Final Assessment | Diastolic Blood pressure was measured at supine and standing position and mean supine diastolic blood pressure was reported here. Final Assessment is the last valid assessment obtained after Baseline (Visit 2/Day 0) whilst on investigational product and before first dose taper medication (Visit 19/ET/Day 714). | Safety Analysis Set included all enrolled participants who took at least 1 dose of SPD503. Here, n = number of participants analysed for the specific categories for each arm respectively. | Posted | | Mean | Standard Deviation | millimeter of mercury (mmHg) | | Baseline (Day 0) and Final Assessment (last non missing data/up to Day 714) | | | | ID | Title | Description |
|---|
| OG000 | SPD503 (6-12 Years) | Participants aged 6-12 years received extended-release guanfacine hydrochloride (SPD503) one tablet (1 x 1 mg or 2 mg or 3 mg or 4mg) or two tablets (1 x 2+3 mg or 1 x 2+4 mg, 1 x 3+4 mg) once daily for up to 2 years. | | OG001 | SPD503 (13-18 Years) | Participants aged 13-18 years received extended-release guanfacine hydrochloride (SPD503) one tablet (1 x 1 mg or 2 mg or 3 mg or 4mg) or two tablets (1 x 2+3 mg or 1 x 2+4 mg, 1 x 3+4 mg) once daily for up to 2 years. |
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| Primary | Change From Baseline in Mean Supine Pulse at Final Assessment | Pulse was measured at supine and standing position and mean supine pulse was reported here. Final Assessment is the last valid assessment obtained after Baseline (Visit 2/Day 0) whilst on investigational product and before first dose taper medication (Visit 19/ET/Day 714). | Safety Analysis Set included all enrolled participants who took at least 1 dose of SPD503. Here, n = number of participants analysed for the specific categories for each arm respectively. | Posted | | Mean | Standard Deviation | beats per minute (bpm) | | Baseline (Day 0) and Final Assessment (last non missing data/up to Day 714) | | | | ID | Title | Description |
|---|
| OG000 | SPD503 (6-12 Years) | Participants aged 6-12 years received extended-release guanfacine hydrochloride (SPD503) one tablet (1 x 1 mg or 2 mg or 3 mg or 4mg) or two tablets (1 x 2+3 mg or 1 x 2+4 mg, 1 x 3+4 mg) once daily for up to 2 years. | | OG001 | SPD503 (13-18 Years) | Participants aged 13-18 years received extended-release guanfacine hydrochloride (SPD503) one tablet (1 x 1 mg or 2 mg or 3 mg or 4mg) or two tablets (1 x 2+3 mg or 1 x 2+4 mg, 1 x 3+4 mg) once daily for up to 2 years. |
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| Primary | Change From Baseline in Mean Height at Final Assessment | Final Assessment is the last valid assessment obtained after Baseline (Visit 2/Day 0) whilst on investigational product and before first dose taper medication (Visit 19/ET/Day 714). | Safety Analysis Set included all enrolled participants who took at least 1 dose of SPD503. Here, n = number of participants analysed for the specific categories for each arm respectively. | Posted | | Mean | Standard Deviation | centimeter (cm) | | Baseline (Day 0) and Final Assessment (last non missing data/up to Day 714) | | | | ID | Title | Description |
|---|
| OG000 | SPD503 (6-12 Years) | Participants aged 6-12 years received extended-release guanfacine hydrochloride (SPD503) one tablet (1 x 1 mg or 2 mg or 3 mg or 4mg) or two tablets (1 x 2+3 mg or 1 x 2+4 mg, 1 x 3+4 mg) once daily for up to 2 years. | | OG001 | SPD503 (13-18 Years) | Participants aged 13-18 years received extended-release guanfacine hydrochloride (SPD503) one tablet (1 x 1 mg or 2 mg or 3 mg or 4mg) or two tablets (1 x 2+3 mg or 1 x 2+4 mg, 1 x 3+4 mg) once daily for up to 2 years. |
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| Primary | Change From Baseline in Mean Weight at Final Assessment | Final Assessment is the last valid assessment obtained after Baseline (Visit 2/Day 0) whilst on investigational product and before first dose taper medication (Visit 19/ET/Day 714). | Safety Analysis Set included all enrolled participants who took at least 1 dose of SPD503. Here, n = number of participants analysed for the specific categories for each arm respectively. | Posted | | Mean | Standard Deviation | kilogram (kg) | | Baseline (Day 0) and Final Assessment (last non missing data/up to Day 714) | | | | ID | Title | Description |
|---|
| OG000 | SPD503 (6-12 Years) | Participants aged 6-12 years received extended-release guanfacine hydrochloride (SPD503) one tablet (1 x 1 mg or 2 mg or 3 mg or 4mg) or two tablets (1 x 2+3 mg or 1 x 2+4 mg, 1 x 3+4 mg) once daily for up to 2 years. | | OG001 | SPD503 (13-18 Years) | Participants aged 13-18 years received extended-release guanfacine hydrochloride (SPD503) one tablet (1 x 1 mg or 2 mg or 3 mg or 4mg) or two tablets (1 x 2+3 mg or 1 x 2+4 mg, 1 x 3+4 mg) once daily for up to 2 years. |
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| Primary | Change From Baseline in Electrocardiogram Result (QRS Interval) at Final Assessment | Final Assessment is the last valid assessment obtained after Baseline (Visit 2/Day 0) whilst on investigational product and before first dose taper medication (Visit 19/ET/Day 714). | Safety Analysis Set included all enrolled participants who took at least 1 dose of SPD503. Here, n = number of participants analysed for the specific categories for each arm respectively. | Posted | | Mean | Standard Deviation | millisecond (ms) | | Baseline (Day 0) and Final Assessment (last non missing data/up to Day 714) | | | | ID | Title | Description |
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| OG000 | SPD503 (6-12 Years) | Participants aged 6-12 years received extended-release guanfacine hydrochloride (SPD503) one tablet (1 x 1 mg or 2 mg or 3 mg or 4mg) or two tablets (1 x 2+3 mg or 1 x 2+4 mg, 1 x 3+4 mg) once daily for up to 2 years. | | OG001 | SPD503 (13-18 Years) | Participants aged 13-18 years received extended-release guanfacine hydrochloride (SPD503) one tablet (1 x 1 mg or 2 mg or 3 mg or 4mg) or two tablets (1 x 2+3 mg or 1 x 2+4 mg, 1 x 3+4 mg) once daily for up to 2 years. |
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| Primary | Change From Baseline in Electrocardiogram Result (QT Interval) at Final Assessment | Final Assessment is the last valid assessment obtained after Baseline (Visit 2/Day 0) whilst on investigational product and before first dose taper medication (Visit 19/ET/Day 714). | Safety Analysis Set included all enrolled participants who took at least 1 dose of SPD503. Here, n = number of participants analysed for the specific categories for each arm respectively. | Posted | | Mean | Standard Deviation | millisecond (ms) | | Baseline (Day 0) and Final Assessment (last non missing data/up to Day 714) | | | | ID | Title | Description |
|---|
| OG000 | SPD503 (6-12 Years) | Participants aged 6-12 years received extended-release guanfacine hydrochloride (SPD503) one tablet (1 x 1 mg or 2 mg or 3 mg or 4mg) or two tablets (1 x 2+3 mg or 1 x 2+4 mg, 1 x 3+4 mg) once daily for up to 2 years. | | OG001 | SPD503 (13-18 Years) | Participants aged 13-18 years received extended-release guanfacine hydrochloride (SPD503) one tablet (1 x 1 mg or 2 mg or 3 mg or 4mg) or two tablets (1 x 2+3 mg or 1 x 2+4 mg, 1 x 3+4 mg) once daily for up to 2 years. |
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| Primary | Number of Participants With Suicidal Behavior and / or Ideation ("Yes" Response) on the Columbia Suicide Severity Rating Scale (C-SSRS) | C-SSRS is a clinician rated assessment of suicidal behavior and / or intent categorized as: Suicidal behavior=a "yes" response to any of 5 suicidal behavior questions (preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide); Suicidal ideation=a "yes" response to any one of 5 suicidal ideation questions which includes wish to be dead, and 4 different categories of active suicidal ideation (thought, thought with method, thought with intent, thought with plan and intent). | Safety Analysis Set included all enrolled participants who took at least 1 dose of SPD503 with number of participants evaluable for this outcome at specific categories. | Posted | | Number | | participants | | Final Assessment (last non missing data/up to Day 714) | | | | ID | Title | Description |
|---|
| OG000 | SPD503 (6-12 Years) | Participants aged 6-12 years received extended-release guanfacine hydrochloride (SPD503) one tablet (1 x 1 mg or 2 mg or 3 mg or 4mg) or two tablets (1 x 2+3 mg or 1 x 2+4 mg, 1 x 3+4 mg) once daily for up to 2 years. | | OG001 | SPD503 (13-18 Years) | Participants aged 13-18 years received extended-release guanfacine hydrochloride (SPD503) one tablet (1 x 1 mg or 2 mg or 3 mg or 4mg) or two tablets (1 x 2+3 mg or 1 x 2+4 mg, 1 x 3+4 mg) once daily for up to 2 years. |
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| Secondary | Change From Baseline in Attention-deficit and Hyperactivity Disorder Rating Scale-IV (ADHD-RS-IV) - Total Score at Final Assessment | ADHD-RS-IV was developed to measure the behaviours of children with ADHD with 18 items. Each item is scored from a range of 0 (reflecting no symptoms) to 3 (reflecting severe symptoms) with total scores ranging from 0-54. The 18 items may be grouped into 2 subscales: hyperactivity/impulsivity (even numbered items 2-18) and inattentiveness (odd numbered items 1-17) with possible score range from 0 (no symptoms) to 27 (most severe symptoms). The ADHD-RS-IV possible total scores range from 0 (no symptoms) to 54 (most severe symptoms). Final Assessment is the last valid assessment obtained after Baseline (Visit 2/Day 0) whilst on investigational product and before first dose taper medication (Visit 19/ET/Day 714). | Full Analysis Set included enrolled participants who took at least 1 dose of SPD503, excluding participants from site 403. Here, n = number of participants analysed for the specific categories for each arm respectively. | Posted | | Mean | Standard Error | units on a scale | | Baseline (Day 0) and Final Assessment (last non missing data/up to Day 714) | | | | ID | Title | Description |
|---|
| OG000 | SPD503 (6-12 Years) | Participants aged 6-12 years received extended-release guanfacine hydrochloride (SPD503) one tablet (1 x 1 mg or 2 mg or 3 mg or 4mg) or two tablets (1 x 2+3 mg or 1 x 2+4 mg, 1 x 3+4 mg) once daily for up to 2 years. | | OG001 | SPD503 (13-18 Years) | |
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| Secondary | Number of Participants Assessed With Clinical Global Impression Severity of Illness (CGI-S) Scale | The CGI-S evaluate each participant's severity and improvement over time. The severity of a participant's condition is rated on a 7-point scale ranging from 1 to 7. The scale measures 0 = Not assessed, 1 = Normal, not at all ill, 2 = Borderline mentally ill (BL-MI), 3 = Mildly ill, 4 = Moderately ill, 5 = Markedly ill, 6 = Severely ill, 7 = Among the most extremely ill participant. Final Assessment is the last valid assessment obtained after Baseline (Visit 2/Day 0) whilst on investigational product and before first dose taper medication (Visit 19/ET/Day 714). | Full Analysis Set included enrolled participants who took at least 1 dose of SPD503, excluding participants from site 403. Here, n = number of participants analysed for the specific categories for each arm respectively. | Posted | | Number | | participants | | Baseline (Day 0) and Final Assessment (last non missing data/up to Day 714) | | | | ID | Title | Description |
|---|
| OG000 | SPD503 (6-12 Years) | Participants aged 6-12 years received extended-release guanfacine hydrochloride (SPD503) one tablet (1 x 1 mg or 2 mg or 3 mg or 4mg) or two tablets (1 x 2+3 mg or 1 x 2+4 mg, 1 x 3+4 mg) once daily for up to 2 years. | | OG001 | SPD503 (13-18 Years) | Participants aged 13-18 years received extended-release guanfacine hydrochloride (SPD503) one tablet (1 x 1 mg or 2 mg or 3 mg or 4mg) or two tablets (1 x 2+3 mg or 1 x 2+4 mg, 1 x 3+4 mg) once daily for up to 2 years. |
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