CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 462 enrolled
Drug / intervention
olanzapine +1 moredrug
Likely dose
olanzapine 15 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/NCT00645099
NCT00645099Phase 3Completed
CompareCT.gov

A Prospective Randomized Open-label 6-Month Head-To-Head Trial to Compare Metabolic Effects of Paliperidone ER and Olanzapine in Subjects With Schizophrenia

Janssen-Cilag International NV·interventional·Posted Mar 27, 2008·Updated May 8, 2014

In Brief

A Phase 3 clinical trial evaluating olanzapine and paliperidone ER for Schizophrenia. Completed, enrolled 462 participants across 46 sites in 14 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSchizophrenia
CountriesArgentina, Egypt, Estonia, France, Greece, Jordan, Latvia, Lebanon, Lithuania, Romania, Slovakia, South Africa, Spain, Turkey (Türkiye)
Collaborators--

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 27, 2008
Enrollment StartOct 1, 2007
Primary CompletionApr 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 18.3 years ago

Interventions

olanzapinedrug

10-15 mg (using 5-mg or 10-mg tablets) once daily flexible dosing for 6 months

paliperidone ERdrug

6-mg or 9-mg tablet once daily flexible dosing for 6 months