At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 201 enrolled
Drug / intervention
Paliperidone ER +2 moredrug
Likely dose
Paliperidone ER 1.5 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.
A Randomized, Double-Blind, Placebo- and Active-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of a Fixed Dosage of 1.5 mg/Day of Paliperidone Extended Release (ER) in the Treatment of Subjects With Schizophrenia
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·interventional·Posted Sep 3, 2007·Updated Jun 4, 2014
In Brief
A Phase 4 clinical trial evaluating Paliperidone ER and Placebo for Schizophrenia. Completed, enrolled 201 participants across 20 sites in 3 countries.
Detailed Summary
The purpose of this study is to assess the efficacy and safety of 1.5 mg/day dose of paliperidone Extended Release (ER) as compared with placebo when used to treat patients with schizophrenia.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSchizophrenia
CountriesIndia, Taiwan, United States
Collaborators--
Timeline
Phase 4CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartSep 2007
First PostedSep 2007
Primary CompletionNov 2008
TodayJul 2026
First PostedSep 3, 2007
Enrollment StartSep 1, 2007
Primary CompletionNov 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 18.8 years ago
Interventions
Paliperidone ERdrug
1.5 mg tablet once daily for 6 weeks
Placebodrug
Once daily for 6 weeks
Paliperidone ERdrug
6 mg tablet once daily for 6 weeks