CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,221 enrolled
Drug / intervention
RISPERDAL CONSTA +1 moredrug
Likely dose
RISPERDAL CONSTA 50 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.

Search/NCT00589914
NCT00589914Phase 3Completed
CompareCT.gov

A Randomized, Double-Blind, Parallel-Group, Comparative Study of Flexible Doses of Paliperidone Palmitate and Flexible Doses of Risperidone Long-Acting Intramuscular Injection in Subjects With Schizophrenia

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·interventional·Posted Jan 10, 2008·Updated Jun 24, 2014

In Brief

A Phase 3 clinical trial evaluating RISPERDAL CONSTA and Paliperidone palmitate for Schizophrenia. Completed, enrolled 1,221 participants across 82 sites in 14 countries.

Detailed Summary

The purpose of this study is to demonstrate the effectiveness of paliperidone palmitate in patients with Schizophrenia.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSchizophrenia
CountriesAustria, Bulgaria, Czechia, Estonia, France, Germany, Hungary, India, Lithuania, Poland, Russia, Spain, Ukraine, United States
Collaborators--

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 10, 2008
Enrollment StartMar 1, 2007
Primary CompletionJun 1, 2009
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 18.5 years ago

Interventions

RISPERDAL CONSTAdrug

RISPERDAL CONSTA: Type=exact number, unit=mg, number=25, 37.5, or 50, form=suspension for injection, route=Intramuscular use. One i.m. injection of RISPERDAL CONSTA 25-50 mg eq every 2 weeks at V4, V6, V7, V8, V9, and V10. PALIPERIDONE PALMITATE PLACEBO: Form=suspension for injection, route=Intramuscular use. One i.m. injection every 2 weeks at Baseline and at V4, V7, and V9. RISPERIDONE: Type=up to, unit=mg, number=1 to 6, form=Tablet, route=Oral Use. One tablet for the first 4 weeks (28 days) of the DB treatment period.

Paliperidone palmitatedrug

PALIPERIDONE PALMITATE: Type=exact number, unit=mg, number=50, 100, or 150, form=suspension for injection, route=Intramuscular use. One i.m. injection of Paliperidone palmitate 50-150 mg eq every 4 wks at Baseline, V4, V7, and V9. RISPERDAL CONSTA PLACEBO: Form=suspension for injection, route=Intramuscular use. One i.m. injection every 4 weeks at Baseline, V4, V7, and V9.