A Study of Ezetimibe Added On to Rosuvastatin Versus Up Titration of Rosuvastatin in Patients With Hypercholesterolemia (MK0653-139)

Summary

A study to evaluate the low-density lipoprotein cholesterol (LDL-C) lowering efficacy of the addition of ezetimibe to rosuvastatin compared with doubling dose of rosuvastatin in participants treated with rosuvastatin alone and not at their National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III) LDL-C goal

Timeline

Start

2008-11

Primary completion

2010-05

Completion

2010-05

Outcome

Met primary endpoint

registry MEAN Rosuvastatin (5 or 10 mg) + Ezetimibe 10 mg: -21.57 (Standard Deviation 25.09) percent change NCT00783263 ↗

registry analysis (unspecified test); Rosuvastatin (5 or 10 mg) + Ezetimibe 10 mg vs Rosuvastatin (10 or 20 mg); p <0.001 NCT00783263 ↗

Publications

• Results Bays HE, Davidson MH, Massaad R, Flaim D, Lowe RS, Tershakovec AM, Jones-Burton C. Safety and efficacy of ezetimibe added on to rosuvastatin 5 or 10 mg versus up-titration of rosuvastatin in patients with hypercholesterolemia (the ACTE Study). Am J Cardiol. 2011 Aug 15;108(4):523-30. doi: 10.1016/j.amjcard.2011.03.079. Epub 2011 May 17.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ezetimibe	Unknown	10 mg	—
Subject	Rosuvastatin	Small molecule	5 mg	—
Subject	Rosuvastatin	Small molecule	10 mg	—
Subject	Rosuvastatin	Small molecule	20 mg	—

Indications