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NCT01432444 · ClinicalTrials.gov registry record · Phase 3
Open-label Study to Compare Hospitalization Rates of Schizophrenic Patients Treated With Oral Antipsychotics Versus IM Depot Aripiprazole
A Phase 3 study, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- Completed
- Registry status
- Phase 3
- Development phase
- 493
- Enrollment target
NCT01432444: Completed Phase 3 study, sponsored by Otsuka Pharmaceutical Development & Commercialization.
NCT01432444 is a Phase 3 study that has completed, run by Otsuka Pharmaceutical Development & Commercialization. The registered enrollment target is 493 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (36% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01432444, a Phase 3 study, has completed, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 493 participants
- Enrollment target
Study Summary
The purpose of this study is to compare retrospective hospitalization rates of schizophrenic patients treated with oral antipsychotics to prospective hospitalization rates of these patients treated with IM depot aripiprazole.
Primary Outcome
The comparison of inpatient psychiatric hospitalization rates (proportion of patients with ≥ inpatient psychiatric hospitalizations) between the retrospective period months 4-6 (Weeks-12 to -24) while on oral standard of care antipsychotic treatment and the prospective period Phase B months 4-6 (Weeks 12 to 24) after the switch to aripiprazole IM depot. Open-label Aripiprazole IM Depot Treatment Phase 3-month Completer sample comprised of all participants who entered open-label aripiprazole IM d
Interventions
- DRUG Aripiprazole (Abilify®) IM Depot Injection
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 493 participants |
| Start Date | 2011-09 |
| Est. Completion | 2013-12 |
| Phase | Phase 3 |
What the finished NCT01432444 record still lists
NCT01432444 is an interventional study that assigns participants to a tested intervention. The registered 493 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 (36% lower).
The record links to 0 conditions, and to 1 intervention - of which Aripiprazole (Abilify®) IM Depot Injection is the first listed.
NCT01432444 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01432444 about?
NCT01432444 is a clinical study titled "Open-label Study to Compare Hospitalization Rates of Schizophrenic Patients Treated With Oral Antipsychotics Versus IM Depot Aripiprazole". The purpose of this study is to compare retrospective hospitalization rates of schizophrenic patients treated with oral antipsychotics to prospective hospitalization rates of these patients treated with IM depot aripiprazole.
What is the current status of trial NCT01432444?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 493 participants. The study started on 2011-09. Estimated completion is 2013-12.
What interventions are being tested in trial NCT01432444?
The interventions under investigation include: Aripiprazole (Abilify®) IM Depot Injection (DRUG).
Who is sponsoring clinical trial NCT01432444?
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 NCT01432444's enrollment target sits among peer trials
493 779th of 2000 higher than 1,221 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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