CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 509 enrolled
Drug / intervention
PP3M 175 mg eq. +4 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/NCT01529515
NCT01529515Phase 3Completed

A Randomized, Multicenter, Double-Blind, Relapse Prevention Study of Paliperidone Palmitate 3 Month Formulation for the Treatment of Subjects With Schizophrenia

Janssen Research & Development, LLC·interventional·Posted Feb 9, 2012·Updated May 11, 2016

In Brief

A Phase 3 clinical trial evaluating PP3M 175 mg eq., PP3M 263 mg eq., and 3 other interventions for Schizophrenia. Completed, enrolled 509 participants across 53 sites in 8 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSchizophrenia
CountriesColombia, Malaysia, Mexico, Romania, South Korea, Turkey (Türkiye), Ukraine, United States
Collaborators--

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedFeb 9, 2012
Enrollment StartMay 1, 2012
Primary CompletionApr 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.9 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 three months up to the patient has a relapse event or meet discontinuation criteria.

PP3M 263 mg eq.drug

Type= exact number, unit= mg eq., number= 263, form= injection, route= intramuscular use. One injection every three months up to the patient has a relapse event or meet discontinuation criteria.

PP3M 350 mg eq.drug

Type= exact number, unit= mg eq., number= 350, form= injection, route= intramuscular use. One injection every three months up to the patient has a relapse event or meet discontinuation criteria.

PP3M 525 mg eq.drug

Type= exact number, unit= mg eq., number= 525, form= injection, route= intramuscular use. One injection every three months up to the patient has a relapse event or meet discontinuation criteria.

Placebo (20% Intralipid emulsion)drug

Form= injection, route= intramuscular use. One injection every three months up to the patient has a relapse event or meet discontinuation criteria.