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Be Part of Research - Trial Details - A Study of TAK-503 in Children and Teenagers With Attention Deficit Hyperactivity Disorder (ADHD)
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A Study of TAK-503 in Children and Teenagers With Attention Deficit Hyperactivity Disorder (ADHD)

Not Recruiting

Open to: ALL

Age: 6.0 - 17.0

Stevenage Dundee

Medical Conditions

Hyperkinesis
Attention Deficit Disorder with Hyperactivity

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


The main aim of this study is learn more about long-term TAK-503 treatment in children and teenagers with ADHD for whom earlier stimulant treatment did not work.

The study has two parts (A and B). In Part A, participants will take tablets of TAK-503, atomoxetine or placebo and in Part B TAK-503 tablets.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

Sep 2019 Jun 2027

INTERVENTIONAL

Intervention Type : DRUG
Intervention Description : Participants aged 6 to 12 years will receive a dose of 1 to 4 mg and aged 13 to 17 years will receive a dose of 5 to 7 mg TAK-503 oral tablets once daily for 18 weeks in Part A or 52 weeks in Part B.

Intervention Arm Group : Part A: Guanfacine hydrochloride (TAK-503);Part B: Guanfacine hydrochloride (TAK-503);

Intervention Type : DRUG
Intervention Description : Participants will receive Atomoxetine hydrochloride oral capsule once daily for 18 weeks in Part A.

Intervention Arm Group : Part A: Atomoxetine hydrochloride;

Intervention Type : OTHER
Intervention Description : Participants aged 6 to 12 years will receive a dose of 1 to 4 mg and aged 13 to 17 years will receive a dose of 5 to 7 mg placebo matched to TAK 503 oral tablets once daily for 18 weeks and placebo matched to atomoxetine hydrochloride oral capsules at once daily for 18 weeks in Part A.

Intervention Arm Group : Part A: Placebo;



You can take part if:



You may not be able to take part if:


This is in the inclusion criteria above


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Lister Hospital
    Stevenage
    SG1 4AB
  • Tayside Children Hospital
    Dundee
    DD1 9SY


The study is sponsored by Shire and is in collaboration with Takeda Development Center Americas, Inc..



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Read full details for Trial ID: NCT04085172
Last updated 08 July 2024

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