Safety and Efficacy of SPD503 in Treating ADHD in Children and Adolescents Aged 6-17
NCT ID: NCT00150618
Last Updated: 2021-06-10
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
324 participants
INTERVENTIONAL
2004-03-30
2004-10-07
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Efficacy and Safety of SPD503 in Combination With Psychostimulants
NCT00734578
Safety, Tolerability and Efficacy of SPD503 in Treating ADHD in Children Aged 6-17
NCT00150592
Safety and Efficacy of SPD503 in Treating Attention-Deficit/Hyperactivity Disorder (ADHD) in Children Aged 6-17
NCT00152009
Safety and Tolerability of SPD503 and Psychostimulants in Children and Adolescents Aged 6-17 With Attention-Deficit/Hyperactivity Disorder (ADHD)
NCT00151996
Safety and Efficacy Study in Preschool Children Aged 4-5 Years With Attention-deficit/Hyperactivity Disorder (ADHD)
NCT03260205
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
SPD503 (Guanfacine HCl) (1 mg)
SPD503 (1 mg)
SPD503 (2 mg)
SPD503 (2 mg)
SPD503 (3 mg)
SPD503 (3 mg)
SPD503 (4 mg)
SPD503 (4 mg)
Placebo
Placebo
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
SPD503 (1 mg)
SPD503 (2 mg)
SPD503 (3 mg)
SPD503 (4 mg)
Placebo
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Females of childbearing potential must have a negative serum beta human chorionic gonadotropin (HCG) pregnancy test
* Male or non-pregnant female subject who agrees to comply with any applicable contraceptive requirements
Exclusion Criteria
* Subject weighs less than 55 lbs or is morbidly overweight with a BMI =\> 35
* Subject has a history of seizure during the last 2 years or a serious tic disorder, including Tourette's Disorder
* Subject is pregnant or lactating
6 Years
17 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Shire
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Study Director
Role: STUDY_DIRECTOR
Takeda
References
Explore related publications, articles, or registry entries linked to this study.
Sallee FR, McGough J, Wigal T, Donahue J, Lyne A, Biederman J; SPD503 STUDY GROUP. Guanfacine extended release in children and adolescents with attention-deficit/hyperactivity disorder: a placebo-controlled trial. J Am Acad Child Adolesc Psychiatry. 2009 Feb;48(2):155-65. doi: 10.1097/CHI.0b013e318191769e.
Related Links
Access external resources that provide additional context or updates about the study.
FDA recall information
FDA-approved label
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
SPD503-304
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.