drugset / Trial / NCT00672464

Cardio Risk of Acute Schizophrenia Olanzapine Duke

NCT00672464

Phase 4 Withdrawn Duke University
RandomizedFactorialOpen-labelPrevention

Summary

Primary Objective: To compare added metformin and/or added simvastatin versus no intervention in reducing or eliminating increased cardiovascular risk (as estimated by elevation in non-HDL cholesterol levels) during the treatment of schizophrenia with olanzapine. Secondary Objective(s): To compare added metformin and/or added simvastatin versus no intervention in reducing or eliminating increased cardiovascular risk (as estimated by elevation in triglyceride levels) during the treatment of schizophrenia with olanzapine. To compare added metformin and/or added simvastatin versus no intervention in reducing or eliminating increased cardiovascular risk (as estimated by C-reactive protein levels) during the treatment of schizophrenia with olanzapine

Timeline

Start
2008-04
Primary completion
2009-12
Completion
2010-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Metformin Small molecule 1000 mg
Subject Simvastatin Small molecule 20 mg
Background Olanzapine Small molecule 15 mg