At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 190 enrolled
Drug / intervention
Paliperidonedrug
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.
An Open-Label Prospective, Non-Comparative Study To Explore The Tolerability, Safety and Effectiveness Upon Transition to Paliperidone Slow-Release Tablet in Schizophrenic Patients
In Brief
A Phase 4 clinical trial evaluating Paliperidone for Schizophrenia. Completed, enrolled 190 participants across 8 sites.
Detailed Summary
The purpose of this study is to investigate the safety and efficacy of flexibly dosed paliperidone extended-release (ER) in participants with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSchizophrenia
CountriesSouth Korea
Collaborators--
Timeline
Phase 4CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartApr 2008
First PostedSep 2008
Primary CompletionOct 2010
Study CompletionDec 2010
TodayJul 2026
First PostedSep 29, 2008
Enrollment StartApr 1, 2008
Primary CompletionOct 1, 2010
Study CompletionDec 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 17.8 years ago
Interventions
Paliperidonedrug
Paliperidone oral tablet was administered once daily at a starting dose of either 3 milligram (mg), 6 mg or 9 mg for 48 weeks, wherein recommended dose was 6 mg and dose range was 3 to 12 mg per day.