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NCT03605849 · ClinicalTrials.gov registry record · Phase 3
A Trial Evaluating the Long-term Safety and Tolerability of Centanafadine Sustained-release Tablets in Adults With Attention-Deficit/Hyperactivity Disorder
A Phase 3 study, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- Completed
- Registry status
- Phase 3
- Development phase
- 662
- Enrollment target
NCT03605849: Completed Phase 3 study, sponsored by Otsuka Pharmaceutical Development & Commercialization.
NCT03605849 is a Phase 3 study that has completed, run by Otsuka Pharmaceutical Development & Commercialization. The registered enrollment target is 662 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (14% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03605849, a Phase 3 study, has completed, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 662 participants
- Enrollment target
Study Summary
This study evaluated the long-term safety and tolerability of centanafadine sustained-release (SR) tablets, administered twice daily (BID) in the treatment of adults with attention deficit hyperactivity disorder (ADHD).
Primary Outcome
An AE is defined as any untoward medical occurrence in a patient or clinical trial participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. TEAEs are defined as AEs with an onset date on or after the first dose of IMP. They are all adverse events that started after the start of centanafadine; or if the event was continuous from baseline and was worsening, serious, study drug-related, or resulted in death, discontinuation, interru
Interventions
- DRUG Centanafadine SR
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 662 participants |
| Start Date | 2019-02-14 |
| Est. Completion | 2021-09-07 |
| Phase | Phase 3 |
What the finished NCT03605849 record still lists
NCT03605849 is an interventional study that assigns participants to a tested intervention. The registered 662 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 (14% lower).
The record links to 0 conditions, and to 1 intervention - of which Centanafadine SR is the first listed.
NCT03605849 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03605849 about?
NCT03605849 is a clinical study titled "A Trial Evaluating the Long-term Safety and Tolerability of Centanafadine Sustained-release Tablets in Adults With Attention-Deficit/Hyperactivity Disorder". This study evaluated the long-term safety and tolerability of centanafadine sustained-release (SR) tablets, administered twice daily (BID) in the treatment of adults with attention deficit hyperactivity disorder (ADHD).
What is the current status of trial NCT03605849?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 662 participants. The study started on 2019-02-14. Estimated completion is 2021-09-07.
What interventions are being tested in trial NCT03605849?
The interventions under investigation include: Centanafadine SR (DRUG).
Who is sponsoring clinical trial NCT03605849?
This trial is sponsored by Otsuka Pharmaceutical Development & Commercialization, which has 221 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03605849's enrollment target sits among peer trials
662 554th of 2000 higher than 1,445 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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