At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 1,117 enrolled
Drug / intervention
Paliperidone ERdrug
Likely dose
Paliperidone ER 12 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 Trial to Explore the Tolerability, Safety and Efficacy of Flexibly Dosed Paliperidone ER in Subjects With Schizophrenia
In Brief
A Phase 3 clinical trial evaluating Paliperidone ER for Schizophrenia. Completed, enrolled 1,117 participants.
Detailed Summary
The purpose of this study is to explore the 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) who were previously unsuccessfully treated with other oral antipsychotics.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSchizophrenia
Countries--
Collaborators--
Timeline
Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJun 2007
Primary CompletionApr 2008
Study CompletionApr 2009
First PostedAug 2012
TodayJul 2026
First PostedAug 10, 2012
Enrollment StartJun 1, 2007
Primary CompletionApr 1, 2008
Study CompletionApr 1, 2009
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 13.9 years ago
Interventions
Paliperidone ERdrug
Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day will be given orally for 6 months as per Investigator's discretion.