Randomized Parallel Group Trial Of The Efficacy And Safety Of Ezetimibe With A Statin Versus Statin Dose Doubling In Patients With Persistent Primary Hypercholesterolemia (0653-152)(COMPLETED)

Phase 4 Completed 1140 enrolled Organon and Co

RandomizedParallel-groupOpen-labelTreatment

Summary

To compare the percent (%) change in plasma LDL-C concentration, after a six week course of treatment with ezetimibe 10 mg/day co-administered with an existing statin versus doubling of the existing statin dose

Timeline

Start: 2005-05
Primary completion: 2007-05
Completion: 2007-05

Outcome

Met primary endpoint

paper LDL-C) was - 30.9% (18.2) for the EZE+statin group and -18.4% (19.0) for the STAT2 group (p=0.001). PMID 22291820 ↗

Publications

Results Shekhar Pandey A, Bissonnette S, Boukas S, Rampakakis E, Sampalis JS. Effectiveness and tolerability of ezetimibe co-administered with statins versus statin dose-doubling in high-risk patients with persistent hyperlipidemia: The EZE(STAT)2 trial. Arch Med Sci. 2011 Oct;7(5):767-75. doi: 10.5114/aoms.2011.25550. Epub 2011 Nov 8.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ezetimibe	Unknown	10 mg	—