CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 178 enrolled
Drug / intervention
PP6M injection Dose 1 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04072575
NCT04072575Phase 3Completed
CompareCT.gov

Single-arm, Open-label Extension to a Double-blind, Randomized, Active-controlled, Parallel-group Study of Paliperidone Palmitate 6-Month Formulation

Janssen Research & Development, LLC·interventional·Posted Aug 28, 2019·Updated Apr 29, 2025

In Brief

A Phase 3 clinical trial evaluating PP6M injection Dose 1 and PP6M injection Dose 2 for Schizophrenia. Completed, enrolled 178 participants across 30 sites in 6 countries.

Detailed Summary

The main purpose of this study is to assess the long-term safety and tolerability of paliperidone 6-month PP6M (Dose 1 or Dose 2 \[milligram\] mg eq.) and to provide access to PP6M in participants with schizophrenia completing the R092670PSY3015 study without relapse.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSchizophrenia
CountriesArgentina, Hong Kong, Italy, Poland, Russia, Ukraine
Collaborators--

Timeline

Phase 3CompletedFinished
2020202120222023202420252026
First PostedAug 28, 2019
Enrollment StartSep 19, 2019
Primary CompletionMay 3, 2022
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 6.8 years ago

Interventions

PP6M injection Dose 1drug

Participants will receive Dose 1 PP6M intramuscular (IM) injection at Visit 1 (Day) then once every 6 month up to 24 months.

PP6M injection Dose 2drug

Participants will receive Dose 2 PP6M IM injection at Visit 1 (Day) then once every 6 month up to 24 months.