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NCT03325894 · ClinicalTrials.gov registry record · Phase 3
Safety and Tolerability Study of SHP465 in Children Aged 4 to 12 Years Diagnosed With Attention-deficit/Hyperactivity Disorder (ADHD)
A Phase 3 study, sponsored by Shire.
- Terminated
- Registry status
- Phase 3
- Development phase
- 141
- Enrollment target
NCT03325894: Clinical Trial Phase 3 study, sponsored by Shire.
NCT03325894 is a Phase 3 study that was terminated before completion, run by Shire. The registered enrollment target is 141 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (82% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03325894, a Phase 3 study, was terminated before completion, sponsored by Shire.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 141 participants
- Enrollment target
Study Summary
The purpose of the study is to evaluate the long-term safety and tolerability of SHP465 at 6.25 milligram (mg) in children aged 4 to 12 years diagnosed with Attention-Deficit/Hyperactivity Disorder (ADHD).
Primary Outcome
An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. TEAEs was defined as AEs that start or deteriorate on or after the date of the first dose of investigational product and no later than 3 days following the last dose of investigational product.
Interventions
- DRUG SHP465
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 141 participants |
| Start Date | 2018-01-02 |
| Est. Completion | 2019-01-19 |
| Phase | Phase 3 |
Why NCT03325894 stopped before completion
NCT03325894 is an interventional study that assigns participants to a tested intervention. The registered 141 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (82% lower).
The record links to 0 conditions, and to 1 intervention - of which SHP465 is the first listed.
NCT03325894 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03325894 about?
NCT03325894 is a clinical study titled "Safety and Tolerability Study of SHP465 in Children Aged 4 to 12 Years Diagnosed With Attention-deficit/Hyperactivity Disorder (ADHD)". The purpose of the study is to evaluate the long-term safety and tolerability of SHP465 at 6.25 milligram (mg) in children aged 4 to 12 years diagnosed with Attention-Deficit/Hyperactivity Disorder (ADHD).
What is the current status of trial NCT03325894?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 141 participants. The study started on 2018-01-02. Estimated completion is 2019-01-19.
What interventions are being tested in trial NCT03325894?
The interventions under investigation include: SHP465 (DRUG).
Who is sponsoring clinical trial NCT03325894?
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 NCT03325894's enrollment target sits among peer trials
141 1563rd of 2000 higher than 436 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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