Overview

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

Status:
Completed

Trial end date:
2006-02-01

Target enrollment:
0

Participant gender:
All

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

Phase:

Phase 3

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Treatments:

Paliperidone Palmitate

Criteria

Inclusion Criteria:

- Subjects who had completed the double-blind phase or discontinued due to lack of
efficacy after at least 21 days of treatment, who signed the informed consent for the
open-label phase, and who the investigator agreed that open-label treatment was in the
best interest of the subject, were eligible to participate in the open-label phase.

Exclusion Criteria:

- Not eligible to enter the open-label phase if believed to be at significant risk for
suicidal or violent behavior during the open-label extension trial, were pregnant, or
had received an injection of a depot antipsychotic since entry into the preceding
double-blind phase