CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 95 enrolled
Drug / intervention
Paliperidone ERdrug
Likely dose
Paliperidone ER 6 mgfrom 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/NCT01724359
NCT01724359Phase 4Completed
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An Open-label Prospective Trial to Explore the Tolerability, Safety and Efficacy of Flexibly Dosed Paliperidone ER in Subjects With Schizophrenia

Janssen-Cilag, S.A.·interventional·Posted Nov 9, 2012·Updated Mar 15, 2013

In Brief

A Phase 4 clinical trial evaluating Paliperidone ER for Schizophrenia. Completed, enrolled 95 participants across 5 sites in 2 countries.

Detailed Summary

The purpose of this study is to evaluate efficacy, safety and tolerability of flexible, once-daily doses of paliperidone extended-release (ER) in patients with schizophrenia from Argentina and Colombia that previously failed treatment with other antipsychotic agents.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSchizophrenia
CountriesArgentina, Colombia
Collaborators--

Timeline

Phase 4CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 9, 2012
Enrollment StartFeb 1, 2008
Primary CompletionNov 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 13.6 years ago

Interventions

Paliperidone ERdrug

The recommended Paliperidone extended-release (ER) dose will be 6 mg/day. Some patients may benefit from higher or lower doses, in the range of 3 to 12 mg/day. Paliperidone ER will be administered orally once daily. Adjustment of the dosage will be done at the investigator's discretion.