| Primary | Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Total Score at Week 8 - Last Observation Carried Forward (LOCF) | The ADHD-RS-IV consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54. | Full Analysis Set (FAS) which includes all subjects who received at least 1 dose of any study drug during this study. | Posted | | Mean | Standard Deviation | Units on a scale | | Baseline and weekly up to 8 weeks | | | | ID | Title | Description |
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| OG000 | SPD503-AM + Psychostimulant | Guanfacine Hydrochloride Extended Release administered in the AM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) administered each morning. This group received a matching placebo in the PM. An optimal dose of Guanfacine Hydrochloride Extended Release (1-4 mg/day once-daily) is determined for each subject over 5 weeks. The subject is then maintained on this optimal dose for an additional 3 weeks. | | OG001 | SPD503-PM + Psychostimulant | Guanfacine Hydrochloride Extended Release administered in the PM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) administered each morning. This group received a matching placebo in the AM. An optimal dose of Guanfacine Hydrochloride Extended Release (1-4 mg/day once-daily) is determined for each subject over 5 weeks. The subject is then maintained on this optimal dose for an additional 3 weeks. | | OG002 | Placebo + Psychostimulant | Placebo was administered in both the AM and PM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) each morning. |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG000-20.4± 12.77
- OG001-21.0± 12.39
- OG002-16.0± 11.77
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| The null hypothesis stated that there was no difference between SPD503 AM or placebo and that there was no difference between SPD503 PM or placebo. 90% power was needed to detect an effect size of at least 0.4 between either SPD503 group and placebo. | ANCOVA | | 0.002 | Both SPD503 groups were compared with placebo using Dunnett's adjustment. Each treatment comparison was evaluated at the 0.05 significance level (Dunnett's adjusted). | Placebo-adjusted difference in LS mean | -4.5 | | | | 95 | -7.5 | -1.4 | | | | | Superiority or Other (legacy) | |
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| Secondary | Percentage of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) at Week 8 - LOCF | Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale. | | Posted | | Number | | Percent of participants | | Baseline and weekly up to 8 weeks | | | | ID | Title | Description |
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| OG000 | SPD503-AM + Psychostimulant | Guanfacine Hydrochloride Extended Release administered in the AM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) administered each morning. This group received a matching placebo in the PM. An optimal dose of Guanfacine Hydrochloride Extended Release (1-4 mg/day once-daily) is determined for each subject over 5 weeks. The subject is then maintained on this optimal dose for an additional 3 weeks. | | OG001 | SPD503-PM + Psychostimulant | Guanfacine Hydrochloride Extended Release administered in the PM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) administered each morning. This group received a matching placebo in the AM. An optimal dose of Guanfacine Hydrochloride Extended Release (1-4 mg/day once-daily) is determined for each subject over 5 weeks. The subject is then maintained on this optimal dose for an additional 3 weeks. |
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| Secondary | Assessment of Clinical Global Impression-Severity of Illness (CGI-S) at Week 8 - LOCF | CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill) | | Posted | | Number | | Percent of participants | | Baseline and weekly up to 8 weeks | | | | ID | Title | Description |
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| OG000 | SPD503-AM + Psychostimulant | Guanfacine Hydrochloride Extended Release administered in the AM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) administered each morning. This group received a matching placebo in the PM. An optimal dose of Guanfacine Hydrochloride Extended Release (1-4 mg/day once-daily) is determined for each subject over 5 weeks. The subject is then maintained on this optimal dose for an additional 3 weeks. | | OG001 | SPD503-PM + Psychostimulant | Guanfacine Hydrochloride Extended Release administered in the PM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) administered each morning. This group received a matching placebo in the AM. An optimal dose of Guanfacine Hydrochloride Extended Release (1-4 mg/day once-daily) is determined for each subject over 5 weeks. The subject is then maintained on this optimal dose for an additional 3 weeks. | | OG002 | Placebo + Psychostimulant |
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| Secondary | Change From Baseline in Conners' Global Index - Parent (CGI-P) Total Score at Week 8 - LOCF: Morning Assessment (Before School) | The index contains 10 items. Each item on the scale is scored from a range of 0 (reflecting never, seldom) to 3 (reflecting very often, very frequent) with total scores ranging from 0 to 30. | | Posted | | Mean | Standard Deviation | Units on a scale | | Baseline and weekly up to 8 weeks | | | | ID | Title | Description |
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| OG000 | SPD503-AM + Psychostimulant | Guanfacine Hydrochloride Extended Release administered in the AM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) administered each morning. This group received a matching placebo in the PM. An optimal dose of Guanfacine Hydrochloride Extended Release (1-4 mg/day once-daily) is determined for each subject over 5 weeks. The subject is then maintained on this optimal dose for an additional 3 weeks. | | OG001 | SPD503-PM + Psychostimulant | Guanfacine Hydrochloride Extended Release administered in the PM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) administered each morning. This group received a matching placebo in the AM. An optimal dose of Guanfacine Hydrochloride Extended Release (1-4 mg/day once-daily) is determined for each subject over 5 weeks. The subject is then maintained on this optimal dose for an additional 3 weeks. | |
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| Secondary | Change From Baseline in Conners' Global Index - Parent (CGI-P) Total Score at Week 8 - LOCF: Evening Assessment (Before Bedtime) | The index contains 10 items. Each item on the scale is scored from a range of 0 (reflecting never, seldom) to 3 (reflecting very often, very frequent) with total scores ranging from 0 30. | | Posted | | Mean | Standard Deviation | Units on a scale | | Baseline and weekly up to 8 weeks | | | | ID | Title | Description |
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| OG000 | SPD503-AM + Psychostimulant | Guanfacine Hydrochloride Extended Release administered in the AM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) administered each morning. This group received a matching placebo in the PM. An optimal dose of Guanfacine Hydrochloride Extended Release (1-4 mg/day once-daily) is determined for each subject over 5 weeks. The subject is then maintained on this optimal dose for an additional 3 weeks. | | OG001 | SPD503-PM + Psychostimulant | Guanfacine Hydrochloride Extended Release administered in the PM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) administered each morning. This group received a matching placebo in the AM. An optimal dose of Guanfacine Hydrochloride Extended Release (1-4 mg/day once-daily) is determined for each subject over 5 weeks. The subject is then maintained on this optimal dose for an additional 3 weeks. | |
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| Secondary | Percentage of Participants With Improvement on Parent Global Assessment (PGA) at Week 8 - LOCF | Parent Global Assessment (PGA) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale. | | Posted | | Number | | Percent of participants | | Baseline and week 8 | | | | ID | Title | Description |
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| OG000 | SPD503-AM + Psychostimulant | Guanfacine Hydrochloride Extended Release administered in the AM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) administered each morning. This group received a matching placebo in the PM. An optimal dose of Guanfacine Hydrochloride Extended Release (1-4 mg/day once-daily) is determined for each subject over 5 weeks. The subject is then maintained on this optimal dose for an additional 3 weeks. | | OG001 | SPD503-PM + Psychostimulant | Guanfacine Hydrochloride Extended Release administered in the PM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) administered each morning. This group received a matching placebo in the AM. An optimal dose of Guanfacine Hydrochloride Extended Release (1-4 mg/day once-daily) is determined for each subject over 5 weeks. The subject is then maintained on this optimal dose for an additional 3 weeks. | | OG002 |
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| Secondary | Change From Baseline in the Oppositional Subscale of the Conners' Parent Rating Scale-Revised Long Form (CPRS-R:L) Score at Week 8 - LOCF | The oppositional subscale of the CPRS-R:L contains 10 items designed to reflect criteria for oppositional defiance disorder (ODD). Each item is scored on a range from 0 (not true at all) to 3 (very much true) with total scores ranging from 0 to 30. Higher scores are reflective of more severe symptoms. | | Posted | | Mean | Standard Deviation | Units on a scale | | Baseline and weekly up to 8 weeks | | | | ID | Title | Description |
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| OG000 | SPD503-AM + Psychostimulant | Guanfacine Hydrochloride Extended Release administered in the AM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) administered each morning. This group received a matching placebo in the PM. An optimal dose of Guanfacine Hydrochloride Extended Release (1-4 mg/day once-daily) is determined for each subject over 5 weeks. The subject is then maintained on this optimal dose for an additional 3 weeks. | | OG001 | SPD503-PM + Psychostimulant | Guanfacine Hydrochloride Extended Release administered in the PM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) administered each morning. This group received a matching placebo in the AM. An optimal dose of Guanfacine Hydrochloride Extended Release (1-4 mg/day once-daily) is determined for each subject over 5 weeks. The subject is then maintained on this optimal dose for an additional 3 weeks. |
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| Secondary | Change From Baseline in Before School Functioning Questionnaire (BSFQ) at Week 8 - LOCF | This scale was designed to assess symptoms of ADHD that typically occur in the morning. The BSFQ consists of two components. The first, a 20-item scale with ratings from 0 (none) to 3 (severe) with a range of 0-60 followed by two questions answered with duration of time (in minutes). The second, a 14-item scale with ratings from 0 (no) to 2 (a lot) with a range of 0-28. The results reported here are from the 20-item scale. Lower scores are better. | | Posted | | Mean | Standard Deviation | Units on a scale | | Baseline and weekly up to 8 weeks | | | | ID | Title | Description |
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| OG000 | SPD503-AM + Psychostimulant | Guanfacine Hydrochloride Extended Release administered in the AM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) administered each morning. This group received a matching placebo in the PM. An optimal dose of Guanfacine Hydrochloride Extended Release (1-4 mg/day once-daily) is determined for each subject over 5 weeks. The subject is then maintained on this optimal dose for an additional 3 weeks. | | OG001 | SPD503-PM + Psychostimulant | Guanfacine Hydrochloride Extended Release administered in the PM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) administered each morning. This group received a matching placebo in the AM. An optimal dose of Guanfacine Hydrochloride Extended Release (1-4 mg/day once-daily) is determined for each subject over 5 weeks. The subject is then maintained on this optimal dose for an additional 3 weeks. |
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| Secondary | Post Sleep Questionnaire (PSQ) Quality of Sleep at Week 8 - LOCF | Post Sleep Questionnaire (PSQ) overall rating of quality of sleep. There are 5 rating responses ranging from very poor to very good. No numbers are associated with the rating responses. | | Posted | | Number | | Percent of participants | | Baseline and weekly up to 8 weeks | | | | ID | Title | Description |
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| OG000 | SPD503-AM + Psychostimulant | Guanfacine Hydrochloride Extended Release administered in the AM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) administered each morning. This group received a matching placebo in the PM. An optimal dose of Guanfacine Hydrochloride Extended Release (1-4 mg/day once-daily) is determined for each subject over 5 weeks. The subject is then maintained on this optimal dose for an additional 3 weeks. | | OG001 | SPD503-PM + Psychostimulant | Guanfacine Hydrochloride Extended Release administered in the PM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) administered each morning. This group received a matching placebo in the AM. An optimal dose of Guanfacine Hydrochloride Extended Release (1-4 mg/day once-daily) is determined for each subject over 5 weeks. The subject is then maintained on this optimal dose for an additional 3 weeks. | | OG002 |
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