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NCT01469039 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate the Efficacy and Safety of ALKS 9072 (Also Known as Aripiprazole Lauroxil, ALKS 9070, or ARISTADA) in Subjects With Schizophrenia
A Phase 3 study, sponsored by Alkermes.
- Completed
- Registry status
- Phase 3
- Development phase
- 623
- Enrollment target
NCT01469039: Completed Phase 3 study, sponsored by Alkermes.
NCT01469039 is a Phase 3 study that has completed, run by Alkermes. The registered enrollment target is 623 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (19% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01469039, a Phase 3 study, has completed, sponsored by Alkermes.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 623 participants
- Enrollment target
Study Summary
The study will determine the efficacy of ALKS 9072 (also known as aripiprazole lauroxil or ALKS 9070) for the treatment of schizophrenia in subjects experiencing an acute exacerbation.
Primary Outcome
The PANSS scale contains 30 questions, each containing an answer range of 1-7. A total PANSS score can range from between 30 to 210; a higher score indicates a worse disease condition.
Interventions
- DRUG Placebo
- DRUG ALKS 9072
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 623 participants |
| Start Date | 2011-12 |
| Est. Completion | 2014-03 |
| Phase | Phase 3 |
What the finished NCT01469039 record still lists
NCT01469039 is an interventional study that assigns participants to a tested intervention. The registered 623 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 (19% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01469039 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01469039 about?
NCT01469039 is a clinical study titled "A Study to Evaluate the Efficacy and Safety of ALKS 9072 (Also Known as Aripiprazole Lauroxil, ALKS 9070, or ARISTADA) in Subjects With Schizophrenia". The study will determine the efficacy of ALKS 9072 (also known as aripiprazole lauroxil or ALKS 9070) for the treatment of schizophrenia in subjects experiencing an acute exacerbation.
What is the current status of trial NCT01469039?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 623 participants. The study started on 2011-12. Estimated completion is 2014-03.
What interventions are being tested in trial NCT01469039?
The interventions under investigation include: Placebo (DRUG), ALKS 9072 (DRUG).
Who is sponsoring clinical trial NCT01469039?
This trial is sponsored by Alkermes, which has 66 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01469039's enrollment target sits among peer trials
623 588th of 2000 higher than 1,413 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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