CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 387 enrolled
Drug / intervention
Paliperidonedrug
Likely dose
Paliperidone 6 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/NCT00761605
NCT00761605Phase 4Completed
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An Open-label Prospective, Non-comparative Study to Evaluate the Subjective Experiences Upon Transition to Paliperidone Extended Release(ER) in Subjects With Schizophrenia

Janssen Korea, Ltd., Korea·interventional·Posted Sep 29, 2008·Updated Sep 10, 2014

In Brief

A Phase 4 clinical trial evaluating Paliperidone for Schizophrenia. Completed, enrolled 387 participants across 8 sites.

Detailed Summary

The purpose of this study is to investigate the efficacy of flexibly dosed paliperidone extended-release (mechanism to dissolve a drug over time in order to be released slower and steadier into the blood stream) in improving or maintaining the subjective symptoms of the participants in three participants' groups (that is, by the reason to switch: lack of efficacy group, lack of tolerability group, and lack of compliance group) who switched from other previous antipsychotic drugs to paliperidone extended-release tablets at flexible doses.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSchizophrenia
CountriesSouth Korea
Collaborators--

Timeline

Phase 4CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 29, 2008
Enrollment StartApr 1, 2008
Primary CompletionSep 1, 2010
Study CompletionOct 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 17.8 years ago

Interventions

Paliperidonedrug

Paliperidone oral tablet will be administered once daily at a dose of 6 milligram (mg) for 24 weeks, wherein dose range was 3 to 12 mg per day.