Evaluation of Ezetimibe and Atorvastatin Coadministration Versus Atorvastatin or Rosuvastatin Monotherapy in Japanese Patients With Hypercholesterolemia (Study P06027)(COMPLETED)

Summary

The purpose of this study is to evaluate the efficacy and safety of atorvastatin 10 mg and ezetimibe 10 mg coadministration in Japanese participants with hypercholesterolemia whose low-density lipoprotein (LDL)-cholesterol levels have not reached the lipid management target value with atorvastatin 10 mg alone, versus increasing the dose of atorvastatin to 20 mg or changing to rosuvastatin 2.5 mg.

Timeline

Start

2009-02-01

Primary completion

2010-05-01

Completion

2010-05-01

Outcome

Met primary endpoint

registry Ezetimibe + Atorvastatin vs Atorvastatin; p <0.0001; Mean Difference (Net) -10.6 (95% CI -15.4 to -5.8) NCT00871351 ↗

paper The percent change in LDL cholesterol level from baseline until study completion was statistically greater for the combination of 10 mg ezetimibe + 10 mg atorvastatin compared with increasing atorvastatin to 20 mg (-25.8% vs -15.1%; P < 0.0001). PMID 24653510 ↗

Publications

• Results Teramoto T, Sawada T, Iwamoto K, Daida H. Clinical Efficacy and Tolerability of Ezetimibe in Combination With Atorvastatin in Japanese Patients With Hypercholesterolemia-Ezetimibe Phase IV Randomized Controlled Trial in Patients With Hypercholesterolemia. Curr Ther Res Clin Exp. 2012 Feb;73(1-2):16-40. doi: 10.1016/j.curtheres.2012.02.002.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Atorvastatin	Small molecule	10 mg	—
Comparator	Atorvastatin	Small molecule	20 mg	—
Subject	Ezetimibe	Unknown	10 mg	—
Comparator	Rosuvastatin	Small molecule	2.5 mg	—

Indications