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NCT04030143 · ClinicalTrials.gov registry record · Phase 1
A Trial of Multiple-doses of Aripiprazole in Adults With Schizophrenia or Bipolar 1 Disorder
A Phase 1 study, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- Completed
- Registry status
- Phase 1
- Development phase
- 266
- Enrollment target
NCT04030143: Completed Phase 1 study, sponsored by Otsuka Pharmaceutical Development & Commercialization.
NCT04030143 is a Phase 1 study that has completed, run by Otsuka Pharmaceutical Development & Commercialization. The registered enrollment target is 266 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (343% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04030143, a Phase 1 study, has completed, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 266 participants
- Enrollment target
Study Summary
The purpose of this trial is to determine the safety and tolerability of multiple-dose administrations of aripiprazole, to establish the similarity of aripiprazole concentrations on the last day of the dosing interval following the final administration of aripiprazole into the gluteal muscle site, and to establish the similarity of aripiprazole exposure over the dosing interval following the administration of aripiprazole into the gluteal muscle site in adult participants with schizophrenia or bipolar I disorder.
Primary Outcome
An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical trial participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. A TEAE is defined as an AE that started after investigational medicinal product (IMP) treatment; or if the event was continuous from baseline and was serious, IMP-related, or resulted in death, discontinuation, interruption, or reduction of the IMP.
Interventions
- DRUG Aripiprazole
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 266 participants |
| Start Date | 2019-08-01 |
| Est. Completion | 2020-07-08 |
| Phase | Phase 1 |
What the finished NCT04030143 record still lists
NCT04030143 is an interventional study that assigns participants to a tested intervention. The registered 266 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (343% higher).
The record links to 0 conditions, and to 1 intervention - of which Aripiprazole is the first listed.
NCT04030143 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04030143 about?
NCT04030143 is a clinical study titled "A Trial of Multiple-doses of Aripiprazole in Adults With Schizophrenia or Bipolar 1 Disorder". The purpose of this trial is to determine the safety and tolerability of multiple-dose administrations of aripiprazole, to establish the similarity of aripiprazole concentrations on the last day of the dosing interval following the final administration of aripiprazole into the gluteal muscle site, a...
What is the current status of trial NCT04030143?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 266 participants. The study started on 2019-08-01. Estimated completion is 2020-07-08.
What interventions are being tested in trial NCT04030143?
The interventions under investigation include: Aripiprazole (DRUG).
Who is sponsoring clinical trial NCT04030143?
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 NCT04030143's enrollment target sits among peer trials
266 154th of 2000 higher than 1,847 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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