SPD503 (Guanfacine Hydrochloride) in ADHD Plus Oppositional Symptoms
NCT ID: NCT00367835
Last Updated: 2021-06-14
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
217 participants
INTERVENTIONAL
2006-12-04
2008-01-04
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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SPD503 (Guanfacine hydrochloride)
SPD503 (Guanfacine hydrochloride)
Subjects will start at 1mg tablet each morning and will subsequently be titrated (in 1 mg weekly increments) to optimal dose based upon tolerance and response to investigational product (not to exceed 4 mg/day).
Placebo
Placebo
Placebo
Interventions
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SPD503 (Guanfacine hydrochloride)
Subjects will start at 1mg tablet each morning and will subsequently be titrated (in 1 mg weekly increments) to optimal dose based upon tolerance and response to investigational product (not to exceed 4 mg/day).
Placebo
Placebo
Eligibility Criteria
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Inclusion Criteria
* ADHD-RS\>=24
* CGI \>=4
* T-score of Opp subscale CPRS-R:L \>=65
* Normal ECG and BP
* \>= 55 lbs
6 Years
12 Years
ALL
No
Sponsors
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Shire
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
Takeda
Locations
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HOPE Research Institute
Phoenix, Arizona, United States
Valley Clinical Research
El Centro, California, United States
Peninsula Research Associates Inc
Rolling Hills Estates, California, United States
Sarkis Clinical Trials
Gainesville, Florida, United States
University of Florida
Gainesville, Florida, United States
Amedica Research Institute, Inc
Hialeah, Florida, United States
CORE Research, Inc
Maitland, Florida, United States
Miami Research Associates
Miami, Florida, United States
Clinical Neuroscience Solutions, Inc
Orlando, Florida, United States
Childrens Developmental Center
Winter Park, Florida, United States
Capstone Clinical Research
Libertyville, Illinois, United States
Vince and Associates Clinical Research
Overland Park, Kansas, United States
Pedia Research
Owensboro, Kentucky, United States
Four Rivers Clinical Research
Paducah, Kentucky, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
CRI Worldwide, LLC
Clementon, New Jersey, United States
Mount Sinai School of Medicine
New York, New York, United States
University of Rochester, School of Medicine and Dentistry
Rochester, New York, United States
SUNY Upsate Medical University
Syracuse, New York, United States
Piedmont Neuropsychiatry
Charlotte, North Carolina, United States
Duke Child & Family Study Center
Durham, North Carolina, United States
University of Cincinnati
Cincinnati, Ohio, United States
Discovery and Wellness Center for Children
Cleveland, Ohio, United States
BHI Inc
Moore, Oklahoma, United States
IPS Research Company
Oklahoma City, Oklahoma, United States
Oregon Center for Clinical Investigations, Inc
Portland, Oregon, United States
Oregon Center for Clinical Investigations, Inc
Salem, Oregon, United States
CRI Worldwide, LLC
Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Claghorn-Lesem Research Clinic Inc
Houston, Texas, United States
Red Oak Psychiatry Associates, PA
Houston, Texas, United States
NeuroScience, Inc
Herndon, Virginia, United States
Dominion Clinical Research
Midlothian, Virginia, United States
Eastside Therapeutic Resource
Kirkland, Washington, United States
Countries
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References
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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.
Related Links
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FDA recall information
FDA-approved label
Other Identifiers
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SPD503-307
Identifier Type: -
Identifier Source: org_study_id
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