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NCT01529515 · ClinicalTrials.gov registry record · Phase 3
A Study of Paliperidone Palmitate 3 Month Formulation for the Treatment of Patients With Schizophrenia
A Phase 3 study, sponsored by Janssen Research & Development.
- Completed
- Registry status
- Phase 3
- Development phase
- 509
- Enrollment target
NCT01529515: Completed Phase 3 study, sponsored by Janssen Research & Development.
NCT01529515 is a Phase 3 study that has completed, run by Janssen Research & Development. The registered enrollment target is 509 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (34% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01529515, a Phase 3 study, has completed, sponsored by Janssen Research & Development.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 509 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the efficacy of paliperidone palmitate 3 month formulation (PP3M) compared with placebo in delay of the time to first occurrence of relapse of the symptoms of schizophrenia.
Primary Outcome
Time to relapse defined as the time between participant randomization into the double blind Phase and the first documentation of a relapse event. Median time to relapse was estimated by the Kaplan-Meier method.
Interventions
- DRUG PP3M 350 mg eq.
- DRUG PP3M 525 mg eq.
- DRUG PP3M 175 mg eq.
- DRUG PP3M 263 mg eq.
- DRUG Placebo (20% Intralipid emulsion)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 509 participants |
| Start Date | 2012-05 |
| Est. Completion | 2014-04 |
| Phase | Phase 3 |
What the finished NCT01529515 record still lists
NCT01529515 is an interventional study that assigns participants to a tested intervention. The registered 509 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 (34% lower).
The record links to 0 conditions, and to 5 interventions - of which PP3M 350 mg eq. is the first listed.
NCT01529515 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01529515 about?
NCT01529515 is a clinical study titled "A Study of Paliperidone Palmitate 3 Month Formulation for the Treatment of Patients With Schizophrenia". The purpose of this study is to evaluate the efficacy of paliperidone palmitate 3 month formulation (PP3M) compared with placebo in delay of the time to first occurrence of relapse of the symptoms of schizophrenia.
What is the current status of trial NCT01529515?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 509 participants. The study started on 2012-05. Estimated completion is 2014-04.
What interventions are being tested in trial NCT01529515?
The interventions under investigation include: PP3M 350 mg eq. (DRUG), PP3M 525 mg eq. (DRUG), PP3M 175 mg eq. (DRUG), PP3M 263 mg eq. (DRUG), Placebo (20% Intralipid emulsion) (DRUG).
Who is sponsoring clinical trial NCT01529515?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01529515's enrollment target sits among peer trials
509 737th of 2000 higher than 1,264 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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