drugset / Trial / NCT01258920

A Study of Paliperidone Palmitate in Japanese Patients With Schizophrenia

NCT01258920

Phase 3 Completed 201 enrolled Janssen Pharmaceutical K.K.
NaSingle-groupOpen-labelTreatment

Summary

The primary objective of this study is to evaluate the long-term safety and tolerability of paliperidone palmitate in Japanese patients with schizophrenia. Secondary objectives of this study are to: explore the efficacy on symptoms of schizophrenia and the maintenance of treatment effect; explore the pharmacokinetics of paliperidone palmitate through sparse pharmacokinetic sampling.

Timeline

Start
2010-10
Primary completion
2012-11
Completion
2012-11

Drugs

EvaluationDrugModalityDoseRoute
Subject paliperidone palmitate Unknown 25 mg Intramuscular
Subject paliperidone palmitate Unknown 75 mg Intramuscular
Subject paliperidone palmitate Unknown 150 mg Intramuscular

Indications