At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 400 enrolled
Drug / intervention
Paliperidone ERdrug
Likely dose
Paliperidone ER 12 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 6-Month, Open-Label, Single-Arm Safety Study of Flexibly Dosed Paliperidone Extended Release (1.5 - 12 mg/Day) in the Treatment of Adolescents (12 to 17 Years of Age) With Schizophrenia
In Brief
A Phase 3 clinical trial evaluating Paliperidone ER for Schizophrenia and 3 related conditions. Completed, enrolled 400 participants across 53 sites in 11 countries.
Detailed Summary
The purpose of this open-label study is to evaluate the long-term (6-month) safety and tolerability of extended-release paliperidone, an atypical antipsychotic, given in flexible dosages to adolescents with schizophrenia.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBelgium, Bulgaria, Estonia, Finland, India, Poland, Romania, Russia, South Korea, Ukraine, United States
Collaborators--
Timeline
Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJun 2007
First PostedJun 2007
Primary CompletionJul 2012
TodayJul 2026
First PostedJun 20, 2007
Enrollment StartJun 1, 2007
Primary CompletionJul 1, 2012
TodayJul 2, 2026
Enrollment to primary: 5.1 yearsPosted 19.0 years ago
Interventions
Paliperidone ERdrug
1.5 to 12 mg tablet once daily for 6 months