CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 201 enrolled
Drug / intervention
Paliperidone +1 moredrug
Likely dose
Paliperidone 3 milligramfrom 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/NCT01662310
NCT01662310Phase 3Completed
CompareCT.gov

Paliperidone Extended Release Tablets for the Prevention of Relapse in Subjects With Schizophrenia: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study

Janssen Research & Development, LLC·interventional·Posted Aug 10, 2012·Updated Sep 29, 2014

In Brief

A Phase 3 clinical trial evaluating Paliperidone and Placebo for Schizophrenia. Completed, enrolled 201 participants across 14 sites.

Detailed Summary

The purpose of this study is to evaluate the efficacy, tolerability and safety of paliperidone extended release (ER) tablets (between 3 to 12 milligram (mg), once a day) in the prevention of relapse in schizophrenia participants.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSchizophrenia
CountriesChina
Collaborators--

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedAug 10, 2012
Enrollment StartJun 1, 2011
Primary CompletionApr 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 13.9 years ago

Interventions

Paliperidonedrug

Paliperidone extended-release (ER) oral tablet will be administered at a starting dose of 3 milligram (mg) up to 12 mg once daily for 8 weeks in Run-in or Stabilization phase, and 3-12 mg fixed dose oral tablet will be administered in DB phase. Participants who will enter open-label extension phase will receive paliperidone as 3-12 mg per day.

Placebodrug

Participants who transitioned from run-in or stabilization phase will receive matching placebo to paliperidone ER once daily during DB phase of the study.