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NCT03345342 · ClinicalTrials.gov registry record · Phase 3
A Study of Paliperidone Palmitate 6-Month Formulation
A Phase 3 study of Schizophrenia, sponsored by Janssen Research & Development.
- Completed
- Registry status
- Phase 3
- Development phase
- 841
- Enrollment target
- 20
- Study locations
NCT03345342 is a Phase 3 study of Schizophrenia that has completed, run by Janssen Research & Development. The registered enrollment target is 841 participants, above the 216-participant average among 315 other Schizophrenia trials with a reported enrollment target (289% higher). The trial reports 20 study locations across 11 states.
The verdict
NCT03345342, a Phase 3 study of Schizophrenia, has completed, sponsored by Janssen Research & Development.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 841 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to demonstrate that injection cycles consisting of a single administration of paliperidone palmitate 6-month (PP6M) are not less effective than 2 sequentially administered injections of paliperidone palmitate 3-month PP3M) (350 or 525 mg eq.) for the prevention of relapse in participants with schizophrenia previously stabilized on corresponding doses of paliperidone palmitate 1-month (PP1M) (100 or 150 mg eq.) or PP3M (350 or 525 mg eq.).
Conditions Studied
Interventions
- OTHER Placebo
- DRUG PP6M
- DRUG PP3M 350 mg eq.
- DRUG PP3M 525 mg eq.
- DRUG PP1M
Study Locations (20)
California
- California Pharmaceutical Research Institute, Inc. - Anaheim
- ATP Clinical Research - Costa Mesa
- Collaborative NeuroScience Network - Garden Grove
- Synergy East - Lemon Grove
- Pacific Research Partners - Oakland
- SF-Care, Inc - San Rafael
Florida
- New Life Medical Research Center, Inc. - Hialeah
- Clintex Research Group - Miami
- Florida Research Center Inc. - Miami
- Olympian Clinical Research - Tampa
Illinois
- Uptown Research Institute - Chicago
- Alexian Behavioral Health Hospital - Hoffman Estates
Arkansas
- Woodland Research Northwest - Rogers
Georgia
- Atlanta Center for Medical Research - Atlanta
Kansas
- Ascension via Christi Research - Wichita
Massachusetts
- Massachusetts General Hospital - Boston
Michigan
- Cherry Street Services, Inc. - Grand Rapids
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 841 participants |
| Start Date | 2017-11-20 |
| Est. Completion | 2020-05-08 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03345342
The ClinicalTrials.gov registry entry for NCT03345342 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 841 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 216-participant average among 315 other Schizophrenia trials with a reported enrollment target (289% higher). The listed sponsor is Janssen Research & Development, which has 593 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Schizophrenia appearing as the primary indexed condition, and to 5 interventions - of which Placebo is the first listed.
NCT03345342 reports 20 study locations spanning 11 distinct geographic areas - top geographies include California, Florida, Illinois.
Frequently Asked Questions
What is clinical trial NCT03345342 about?
NCT03345342 is a clinical study titled "A Study of Paliperidone Palmitate 6-Month Formulation". The purpose of this study is to demonstrate that injection cycles consisting of a single administration of paliperidone palmitate 6-month (PP6M) are not less effective than 2 sequentially administered injections of paliperidone palmitate 3-month PP3M) (350 or 525 mg eq.) for the prevention of relaps...
What is the current status of trial NCT03345342?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 841 participants. The study started on 2017-11-20. Estimated completion is 2020-05-08.
What conditions does trial NCT03345342 study?
This clinical trial studies the following conditions: Schizophrenia.
What interventions are being tested in trial NCT03345342?
The interventions under investigation include: Placebo (OTHER), PP6M (DRUG), PP3M 350 mg eq. (DRUG), PP3M 525 mg eq. (DRUG), PP1M (DRUG).
Who is sponsoring clinical trial NCT03345342?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03345342 being conducted?
This trial has 20 study locations across Arkansas, California, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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