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NCT04987762 · ClinicalTrials.gov registry record · Phase 4
Safety and Tolerability Study of Adhansia XR® Extended-Release Capsules in Children
A Phase 4 study, sponsored by Purdue Pharma.
- Terminated
- Registry status
- Phase 4
- Development phase
- 103
- Enrollment target
NCT04987762: Clinical Trial Phase 4 study, sponsored by Purdue Pharma.
NCT04987762 is a Phase 4 study that was terminated before completion, run by Purdue Pharma. The registered enrollment target is 103 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04987762, a Phase 4 study, was terminated before completion, sponsored by Purdue Pharma.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 103 participants
- Enrollment target
Study Summary
The purpose of this study is to assess the long-term safety of Adhansia XR in children and to characterize the pharmacokinetics (PK) in 4 to 5 year-olds.
Primary Outcome
Adverse events (AEs) were documented and reported from the time the subject/parent(s)/legal guardian provided informed consent/assent up to 7 days after the last study drug administration. AEs that were ongoing at the subject's last study visit were followed until resolution or for 30 days after study drug administration.
Interventions
- DRUG Adhansia XR
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 103 participants |
| Start Date | 2021-08-03 |
| Est. Completion | 2022-04-27 |
| Phase | Phase 4 |
Why NCT04987762 stopped before completion
NCT04987762 is an interventional study that assigns participants to a tested intervention. The registered 103 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 (80% lower).
The record links to 0 conditions, and to 1 intervention - of which Adhansia XR is the first listed.
NCT04987762 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04987762 about?
NCT04987762 is a clinical study titled "Safety and Tolerability Study of Adhansia XR® Extended-Release Capsules in Children". The purpose of this study is to assess the long-term safety of Adhansia XR in children and to characterize the pharmacokinetics (PK) in 4 to 5 year-olds.
What is the current status of trial NCT04987762?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 103 participants. The study started on 2021-08-03. Estimated completion is 2022-04-27.
What interventions are being tested in trial NCT04987762?
The interventions under investigation include: Adhansia XR (DRUG).
Who is sponsoring clinical trial NCT04987762?
This trial is sponsored by Purdue Pharma, which has 54 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04987762's enrollment target sits among peer trials
103 760th of 2000 higher than 1,237 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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