A 52-week, Open-label Extension Study Following a 6-week, Double-blind, Placebo- and Active- Controlled Study (R076477-SCH-303) to Evaluate the Safety and Tolerability of Paliperidone ER in Subjects With Schizophrenia

Phase 3 Completed 473 enrolled Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Non-randomizedSingle-groupOpen-labelTreatment

Summary

The purpose of the study was an Open Label Extension to a completed study that evaluated the efficacy and safety of 3 fixed dosages of Extended Release OROSÂ® Paliperidone

Timeline

Start: 2004-03
Primary completion: —
Completion: 2006-02

Publications

Kozma C, Dirani R, Canuso C, Mao L. Change in employment status over 52 weeks in patients with schizophrenia: an observational study. Curr Med Res Opin. 2011 Feb;27(2):327-33. doi: 10.1185/03007995.2010.541431. Epub 2010 Dec 15.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Paliperidone	Unknown	3 mg	—
Subject	Paliperidone	Unknown	12 mg	—

A 52-week, Open-label Extension Study Following a 6-week, Double-blind, Placebo- and Active- Controlled Study (R076477-SCH-303) to Evaluate the Safety and Tolerability of Paliperidone ER in Subjects With Schizophrenia

Summary

Timeline

Publications

Drugs

Indications