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NCT04085172 · ClinicalTrials.gov registry record · Phase 4
A Study of TAK-503 in Children and Teenagers With Attention Deficit Hyperactivity Disorder (ADHD)
A Phase 4 study, sponsored by Shire.
- Completed
- Registry status
- Phase 4
- Development phase
- 396
- Enrollment target
NCT04085172: Completed Phase 4 study, sponsored by Shire.
NCT04085172 is a Phase 4 study that has completed, run by Shire. The registered enrollment target is 396 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (24% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04085172, a Phase 4 study, has completed, sponsored by Shire.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 396 participants
- Enrollment target
Study Summary
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.
Primary Outcome
The neurocognitive function effects of TAK-503 on adolescents and children were evaluated using CANTAB assessments. The RTI task of CANTAB measured motor, mental response speeds and assessed movement time, reaction time, response accuracy and impulsivity. In CANTAB RTI task, a yellow dot appeared in one of circles (five circles for five-choice variant) and participant must react as soon as possible, releasing the button at bottom of screen and selecting the circle in which the dot appeared. Time
Interventions
- OTHER Placebo
- DRUG Atomoxetine hydrochloride
- DRUG Guanfacine hydrochloride (TAK-503)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 396 participants |
| Start Date | 2019-09-18 |
| Est. Completion | 2025-09-02 |
| Phase | Phase 4 |
What the finished NCT04085172 record still lists
NCT04085172 is an interventional study that assigns participants to a tested intervention. The registered 396 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (24% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT04085172 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04085172 about?
NCT04085172 is a clinical study titled "A Study of TAK-503 in Children and Teenagers With Attention Deficit Hyperactivity Disorder (ADHD)". 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 tab...
What is the current status of trial NCT04085172?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 396 participants. The study started on 2019-09-18. Estimated completion is 2025-09-02.
What interventions are being tested in trial NCT04085172?
The interventions under investigation include: Placebo (OTHER), Atomoxetine hydrochloride (DRUG), Guanfacine hydrochloride (TAK-503) (DRUG).
Who is sponsoring clinical trial NCT04085172?
This trial is sponsored by Shire, which has 245 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04085172's enrollment target sits among peer trials
396 218th of 2000 higher than 1,783 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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