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NCT03345979 · ClinicalTrials.gov registry record · Phase 3
A Study of Aripiprazole Lauroxil or Paliperidone Palmitate for the Treatment of Schizophrenia
A Phase 3 study, sponsored by Alkermes.
- Completed
- Registry status
- Phase 3
- Development phase
- 200
- Enrollment target
NCT03345979: Completed Phase 3 study, sponsored by Alkermes.
NCT03345979 is a Phase 3 study that has completed, run by Alkermes. The registered enrollment target is 200 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (74% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03345979, a Phase 3 study, has completed, sponsored by Alkermes.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 200 participants
- Enrollment target
Study Summary
This study will evaluate the efficacy of initiating treatment of schizophrenia with ARISTADA INITIO plus 30 mg oral aripiprazole followed by a 2-month dose of AL.
Primary Outcome
Change within treatment groups of Positive and Negative Syndrome Scale (PANSS) total score between baseline and week 4 based on the observed data without imputation for missing data. 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 Paliperidone Palmitate
- COMBINATION_PRODUCT Aripiprazole Lauroxil
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2017-11-15 |
| Est. Completion | 2019-03-12 |
| Phase | Phase 3 |
What the finished NCT03345979 record still lists
NCT03345979 is an interventional study that assigns participants to a tested intervention. The registered 200 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 (74% lower).
The record links to 0 conditions, and to 2 interventions - of which Paliperidone Palmitate is the first listed.
NCT03345979 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03345979 about?
NCT03345979 is a clinical study titled "A Study of Aripiprazole Lauroxil or Paliperidone Palmitate for the Treatment of Schizophrenia". This study will evaluate the efficacy of initiating treatment of schizophrenia with ARISTADA INITIO plus 30 mg oral aripiprazole followed by a 2-month dose of AL.
What is the current status of trial NCT03345979?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 200 participants. The study started on 2017-11-15. Estimated completion is 2019-03-12.
What interventions are being tested in trial NCT03345979?
The interventions under investigation include: Paliperidone Palmitate (DRUG), Aripiprazole Lauroxil (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT03345979?
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 NCT03345979's enrollment target sits among peer trials
200 1353rd of 2000 higher than 613 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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