At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 188 enrolled
Drug / intervention
Paliperidone ERdrug
Likely dose
Paliperidone ER 6 mg orally once daily for 5 days, then flexibly dosed 3-12 mg/dayAI-extracted
Key inclusion· 4
- ✓Diagnosis of schizophrenia
- ✓PANSS score 80-120 at screening
- ✓Treatment-naïve or no antipsychotics for ≥1 month before screening
- ✓Healthy on physical exam, labs, and vital signs
Key exclusion· 6
- ✕Serious unstable medical condition or clinically relevant lab abnormalities
- ✕High risk for adverse events, violence, or self-harm
- ✕Unable to swallow tablets whole
- ✕Clinically significant out-of-range laboratory results
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 Among Treatment-Naïve and Newly Diagnosed Patients With Schizophrenia
In Brief
A Phase 3 clinical trial evaluating Paliperidone ER for Schizophrenia. Completed, enrolled 188 participants.
Detailed Summary
The purpose of this study is to explore the tolerability, safety and efficacy of flexibly dosed paliperidone extended release (ER) among patients with schizophrenia.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSchizophrenia
Countries--
Collaborators--
Timeline
Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartDec 2007
Primary CompletionDec 2008
First PostedMay 2012
TodayJul 2026
First PostedMay 25, 2012
Enrollment StartDec 1, 2007
Primary CompletionDec 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 14.1 years ago
Interventions
Paliperidone ERdrug
Type= range, unit= mg/day, number= 3 to 12, form= tablet, route= oral use. Paliperidone ER 6 mg orally administered once daily for the first five days. Thereafter, flexible dosing in a range of 3 to 12 mg/day.