CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,429 enrolled
Drug / intervention
PP3M 175 mg eq. +8 moredrug
Likely dose
PP3M 175 mg eq.from 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/NCT01515423
NCT01515423Phase 3Completed
CompareCT.gov

A Randomized, Multicenter, Double-Blind, Non-inferiority Study of Paliperidone Palmitate 3 Month and 1 Month Formulations for the Treatment of Subjects With Schizophrenia

Janssen Research & Development, LLC·interventional·Posted Jan 24, 2012·Updated May 2, 2016

In Brief

A Phase 3 clinical trial evaluating PP3M 175 mg eq., PP3M 263 mg eq., and 7 other interventions for Schizophrenia. Completed, enrolled 1,429 participants across 174 sites in 26 countries.

Detailed Summary

The purpose of this study is to demonstrate that a paliperidone palmitate 3 month formulation (PP3M) is as effective as the paliperidone palmitate 1 month formulation (PP1M) in the treatment of patients with schizophrenia who have been stabilized on PP1M.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSchizophrenia
CountriesArgentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, China, Czechia, France, Germany, Greece, Hungary, Japan, Mexico, Poland, Portugal, Romania, Russia, Slovakia, South Korea, Spain, Sweden, Taiwan, Ukraine, United States
Collaborators--

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJan 24, 2012
Enrollment StartMay 1, 2012
Primary CompletionFeb 1, 2015
Study CompletionMar 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 14.4 years ago

Interventions

PP3M 175 mg eq.drug

Type= exact number, unit= mg eq., number= 175, form= injection, route= intramuscular use. One injection every third month for 48 weeks.

PP3M 263 mg eq.drug

Type= exact number, unit= mg eq., number= 263, form= injection, route= intramuscular use. One injection every third month for 48 weeks.

PP3M 350 mg eq.drug

Type= exact number, unit= mg eq., number= 350, form= injection, route= intramuscular use. One injection every third month for 48 weeks.

PP3M 525 mg eq.drug

Type= exact number, unit= mg eq., number= 525, form= injection, route= intramuscular use. One injection every third month for 48 weeks.

Placebo (20% Intralipid)drug

Form= injection, route= intramuscular use. One injection monthly when not receiving active medication for 48 weeks.

PP1M 50 mg eq.drug

Type= exact number, unit= mg eq., number= 50, form= injection, route= intramuscular use. One injection every month for 48 weeks.

PP1M 75 mg eq.drug

Type= exact number, unit= mg eq., number= 75, form= injection, route= intramuscular use. One injection every month for 48 weeks.

PP1M 100 mg eq.drug

Type= exact number, unit= mg eq., number= 100, form= injection, route= intramuscular use. One injection every month for 48 weeks.

PP1M 150 mg eq.drug

Type= exact number, unit= mg eq., number= 150, form= injection, route= intramuscular use. One injection every month for 48 weeks.