CompletedNCT04085172
A Study of TAK-503 in Children and Teenagers With Attention Deficit Hyperactivity Disorder (ADHD)
Researchers compared Guanfacine hydrochloride (TAK-503), Atomoxetine hydrochloride and placebo, tracking side effects to assess safety in children and adolescents with ADHD.
Medication studyAges 6–17Multiple countries
Understand this study
What did researchers investigate?
Researchers compared Guanfacine hydrochloride (TAK-503), Atomoxetine hydrochloride and placebo, tracking side effects to assess safety in children and adolescents with ADHD.
Who was this study for?
Listed age limits: 6 years to 17 years.
- Listed locations
- Dothan, United States · Anaheim, United States and 46 more locationsSee all locations and recruitment
- Activities
- Medication described in the protocol · Placebo comparator
- Compensation
- Payment and expense reimbursement have not been verified.
Study information
Study start dateStarted: September 18, 2019
- Recruitment status
- Completed
- Enrollment listed in the registry
- 396
- Sponsor
- Shire
- Sponsor type
- Unknown or unclear
- Study type
- Drug
- Intervention type
- Medication / drug, OTHER
- Study phase
- Phase 4Usually happens after approval, to monitor real-world use, safety, and longer-term outcomes.
- Locations
- United States, United Kingdom, Belgium, ...
- Age range
- From 6 Years to 17 Years
- Official registry ID
- NCT04085172
- Official title
Show the full official title
A Phase 4, Multicenter, 2-part Study Composed of a Randomized, Double-blind, Parallel-group, Placebo-controlled, Active-comparator, Dose-optimization Evaluation Followed by a 1-Year Open-label Evaluation to Assess the Safety and Efficacy of Guanfacine Hydrochloride Prolonged-release (SPD503) in Children and Adolescents Aged 6 to 17 Years With Attention-deficit/Hyperactivity Disorder
Recruitment & locations
CompletedDothan, United States · Anaheim, United States · Imperial, United States
45 more locations
- Long Beach, United States
- San Diego, United States
- Homestead, United States
- Jacksonville, United States
- Miami, United States
- Orlando, United States
- Naperville, United States
- Prairie Village, United States
- Bowling Green, United States
- Owensboro, United States
- Lincoln, United States
- Las Vegas, United States
- Cincinnati, United States
- Oklahoma City, United States
- Memphis, United States
- The Woodlands, United States
- Petersburg, United States
- Graz, Austria
- Vienna, Austria
- Brussels, Belgium
- Leuven, Belgium
- Namur, Belgium
- Mannheim, Germany
- Cologne, Germany
- Mainz, Germany
- Freiburg im Breisgau, Germany
- Almere Stad, Netherlands
- Utrecht, Netherlands
- Alcabideche, Portugal
- Braga, Portugal
- Covilha, Portugal
- Guimarães, Portugal
- Lisbon, Portugal
- Porto, Portugal
- Pamplona, Spain
- Barcelona, Spain
- Madrid, Spain
- Palencia, Spain
- Sabadell, Spain
- Valencia, Spain
- Gothenburg, Sweden
- Mölnlycke, Sweden
- Norsborg, Sweden
- Dundee, United Kingdom
- Stevenage, United Kingdom
Questions about this study
What did researchers investigate?
Researchers compared Guanfacine hydrochloride (TAK-503), Atomoxetine hydrochloride and placebo, tracking side effects to assess safety in children and adolescents with ADHD.
Who is behind this study?
The study sponsor is Shire.
Did this study involve medication?
Yes. The study involved medication, including Guanfacine hydrochloride (TAK-503) and Atomoxetine hydrochloride.
Who was this study for?
Listed age limits: 6 years to 17 years.
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