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NCT03325881 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of SHP465 at 6.25 mg in the Treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in Children Aged 6-12 Years
A Phase 3 study, sponsored by Shire.
- Completed
- Registry status
- Phase 3
- Development phase
- 89
- Enrollment target
NCT03325881: Completed Phase 3 study, sponsored by Shire.
NCT03325881 is a Phase 3 study that has completed, run by Shire. The registered enrollment target is 89 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03325881, a Phase 3 study, has completed, sponsored by Shire.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 89 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the efficacy and safety of SHP465 at 6.25 mg in the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in children aged 6-12 years.
Primary Outcome
Clinician administered ADHD-RS-5, child, home version total score were analyzed. ADHD-RS-5 consisted of 18 items designed to reflect current symptomatology of ADHD based on diagnostic and statistical manual of mental disorders, fifth edition (DSM-5) criteria. Each item was scored on a 4-point scale ranging from 0 (reflecting no symptoms) to 3 (reflecting severe symptoms) with total scores ranging from 0-54. The 18 items were grouped into 2 subscales: hyperactivity or impulsivity (9 items) and in
Interventions
- DRUG Placebo
- DRUG SHP465
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 89 participants |
| Start Date | 2017-12-09 |
| Est. Completion | 2018-06-07 |
| Phase | Phase 3 |
What the finished NCT03325881 record still lists
NCT03325881 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 89 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (88% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03325881 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03325881 about?
NCT03325881 is a clinical study titled "Efficacy and Safety of SHP465 at 6.25 mg in the Treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in Children Aged 6-12 Years". The purpose of this study is to evaluate the efficacy and safety of SHP465 at 6.25 mg in the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in children aged 6-12 years.
What is the current status of trial NCT03325881?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 89 participants. The study started on 2017-12-09. Estimated completion is 2018-06-07.
What interventions are being tested in trial NCT03325881?
The interventions under investigation include: Placebo (DRUG), SHP465 (DRUG).
Who is sponsoring clinical trial NCT03325881?
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 NCT03325881's enrollment target sits among peer trials
89 1738th of 2000 higher than 262 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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