Phase 3
N=217
SPD503 (Guanfacine Hydrochloride) in ADHD Plus Oppositional Symptoms
ADHD
Bottom Line
View on ClinicalTrials.gov: NCT00367835 ↗Enrolled (actual)
217
Serious AEs
0.0%
Results posted
Nov 2009
Primary outcome: Primary: Change From Baseline in the Oppositional Subscale of the Conners' Parent Rating Scale-Revised Long Form (CPRS-R:L) Score at Up to 8 Weeks — -10.8; -7.0 Units on a scale — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- SPD503 (Guanfacine hydrochloride) (Drug); Placebo (Drug)
- Age
- Pediatric · 6+ yrs
- Sex
- All
- Sponsor
- Shire
- Primary completion
- Jan 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in the Oppositional Subscale of the Conners' Parent Rating Scale-Revised Long Form (CPRS-R:L) Score at Up to 8 Weeks |
-10.8; -7.0 | <0.001 sig |
| SECONDARY Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS-IV) Total Score at Up to 8 Weeks |
-23.8; -11.4 | <0.001 sig |
| SECONDARY Assessment of Clinical Global Impression-Severity of Illness (CGI-S) |
25; 3; 33; 6; 29; 15 | <0.001 sig |
| SECONDARY Number of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) |
93; 24 | <0.001 sig |
| SECONDARY Change From Baseline in the 40-Item Conduct Problem Scale of the New York Parent's Rating Scale-School-aged (NYPRS-S) Score at Up to 8 Weeks |
-15.6; -10.3 | <0.001 sig |
| SECONDARY Change From Baseline in the Parent Stress Index-Short Form (PSI/SF) Score at Up to 8 Weeks |
17.3; 7.2 | 0.002 sig |
| SECONDARY Number of Participants With Overall Satisfaction on the Medication Satisfaction Survey (MSS) |
84; 21 | <0.001 sig |
| SECONDARY Change From Baseline in Electrocardiogram Results (QTcF Interval) at Up to 8 Weeks |
5.2; 2.1 | — |
| SECONDARY Change From Baseline in Pulse Rate at Up to 8 Weeks |
-4.3; 0.7 | — |
| SECONDARY Change From Baseline in Systolic Blood Pressure at Up to 8 Weeks |
-2.6; 0.7 | — |
| SECONDARY Change From Baseline in Diastolic Blood Pressure at Up to 8 Weeks |
-1.3; 0.9 | — |
Summary
To assess efficacy and safety of SPD503(guanfacine hydrochloride) in subjects with ADHD and oppositional symptoms.
Eligibility Criteria
Inclusion Criteria
- Healthy subjects with ADHD and oppositional symptoms
- ADHD-RS>=24
- CGI >=4
- T-score of Opp subscale CPRS-R:L >=65
- Normal ECG and BP
- >= 55 lbs
Data sourced from ClinicalTrials.gov (NCT00367835). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.