Clinical trial NCT00367835: SPD503 (Guanfacine Hydrochloride) in ADHD Plus Oppositional Symptoms
Official title: A Double-Blind, Randomized, Multi-Center, Flexible Dose Study Evaluating the Efficacy and Safety of SPD503 (Guanfacine Hydrochloride) in Children Aged 6-12 With Symptoms of Oppositionality and a Diagnosis of Attention Deficit/Hyperactivity Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: ADHD
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2006-08-23
Enrollment: 217
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Primary outcomes:
measure: 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
timeFrame: Baseline and up to 8 weeks
Secondary outcomes:
measure: Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS-IV) Total Score at Up to 8 Weeks
timeFrame: Baseline and up to 8 weeks
measure: Assessment of Clinical Global Impression-Severity of Illness (CGI-S)
timeFrame: up to 8 weeks
measure: Number of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I)
timeFrame: up to 8 weeks
measure: 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
timeFrame: Baseline and up to 8 weeks
measure: Change From Baseline in the Parent Stress Index-Short Form (PSI/SF) Score at Up to 8 Weeks
timeFrame: Baseline and up to 8 weeks
measure: Number of Participants With Overall Satisfaction on the Medication Satisfaction Survey (MSS)
timeFrame: up to 8 weeks
measure: Change From Baseline in Electrocardiogram Results (QTcF Interval) at Up to 8 Weeks
timeFrame: Baseline and up to 8 weeks
measure: Change From Baseline in Pulse Rate at Up to 8 Weeks
timeFrame: Baseline and up to 8 weeks
measure: Change From Baseline in Systolic Blood Pressure at Up to 8 Weeks
timeFrame: Baseline and up to 8 weeks
measure: Change From Baseline in Diastolic Blood Pressure at Up to 8 Weeks
timeFrame: Baseline and up to 8 weeks
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: HOPE Research Institute
state: Arizona
city: El Centro
country: United States
facility: Valley Clinical Research
state: California
city: Rolling Hills Estates
country: United States
facility: Peninsula Research Associates Inc
state: California
city: Gainesville
country: United States
facility: Sarkis Clinical Trials
state: Florida
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Hialeah
country: United States
facility: Amedica Research Institute, Inc
state: Florida
city: Maitland
country: United States
facility: CORE Research, Inc
state: Florida
city: Miami
country: United States
facility: Miami Research Associates
state: Florida
city: Orlando
country: United States
facility: Clinical Neuroscience Solutions, Inc
state: Florida
city: Winter Park
country: United States
facility: Childrens Developmental Center
state: Florida
city: Libertyville
country: United States
facility: Capstone Clinical Research
state: Illinois
city: Overland Park
country: United States
facility: Vince and Associates Clinical Research
state: Kansas
city: Owensboro
country: United States
facility: Pedia Research
state: Kentucky
city: Paducah
country: United States
facility: Four Rivers Clinical Research
state: Kentucky
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: Clementon
country: United States
facility: CRI Worldwide, LLC
state: New Jersey
city: New York
country: United States
facility: Mount Sinai School of Medicine
state: New York
city: Rochester
country: United States
facility: University of Rochester, School of Medicine and Dentistry
state: New York
city: Syracuse
country: United States
facility: SUNY Upsate Medical University
state: New York
city: Charlotte
country: United States
facility: Piedmont Neuropsychiatry
state: North Carolina
city: Durham
country: United States
facility: Duke Child & Family Study Center
state: North Carolina
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Cleveland
country: United States
facility: Discovery and Wellness Center for Children
state: Ohio
city: Moore
country: United States
facility: BHI Inc
state: Oklahoma
city: Oklahoma City
country: United States
facility: IPS Research Company
state: Oklahoma
city: Portland
country: United States
facility: Oregon Center for Clinical Investigations, Inc
state: Oregon
city: Salem
country: United States
facility: Oregon Center for Clinical Investigations, Inc
state: Oregon
city: Philadelphia
country: United States
facility: CRI Worldwide, LLC
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Houston
country: United States
facility: Claghorn-Lesem Research Clinic Inc
state: Texas
city: Houston
country: United States
facility: Red Oak Psychiatry Associates, PA
state: Texas
city: Herndon
country: United States
facility: NeuroScience, Inc
state: Virginia
city: Midlothian
country: United States
facility: Dominion Clinical Research
state: Virginia
city: Kirkland
country: United States
facility: Eastside Therapeutic Resource
state: Washington
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References:
citation: Connor DF, Findling RL, Kollins SH, Sallee F, Lopez FA, Lyne A, Tremblay G. Effects of guanfacine extended release on oppositional symptoms in children aged 6-12 years with attention-deficit hyperactivity disorder and oppositional symptoms: a randomized, double-blind, placebo-controlled trial. CNS Drugs. 2010 Sep;24(9):755-68. doi: 10.2165/11537790-000000000-00000.