drugset / Trial / NCT00645099

A 6 Month Study to Compare the Metabolic Effects of Paliperidone ER and Olanzapine in Patients With Schizophrenia

NCT00645099

Phase 3 Completed 462 enrolled Janssen-Cilag International NV
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this 6 month study is to compare the metabolic effects of paliperidone ER and olanzapine in patients with schizophrenia, using the ratio of the concentration of lipids (triglycerides (TG)) in the blood to the concentration of good cholesterol (high density lipoproteins (HDL)) in the blood as the primary parameter. Approximately 456 adult patients will participate in this study.

Timeline

Start
2007-10
Primary completion
2009-04
Completion
2009-04

Drugs

EvaluationDrugModalityDoseRoute
Comparator Olanzapine Small molecule 10 mg Oral
Comparator Olanzapine Small molecule 15 mg Oral
Subject Paliperidone Unknown 6 mg Oral
Subject Paliperidone Unknown 9 mg Oral

Indications