Lipid Efficacy and Safety in Participants With Mixed Hyperlipidemia (MK-0524B-024)

Summary

This is a 12-week clinical trial in participants with mixed hyperlipidemia to study the effects of MK-0524B on lipids.The primary hypothesis is that MK-0524B (dosed as MK-0524A coadministered with simvastatin) will be superior to atorvastatin on decreasing the low denisity lipoprotein cholesterol (LDL-C)/high-density lipoprotein cholesterol (HDL-C) ratio for the following dose comparisons: 2g/20 mg MK-0524B versus 10 mg atorvastatin, 2g/40 mg MK-0524B versus 20 mg atorvastatin, 2g/40 mg MK-0524B versus 40 mg atorvastatin, and 2g/40 mg MK-0524B versus 80 mg atorvastatin.

Timeline

Start

2006-01-24

Primary completion

2010-08-06

Completion

2010-08-06

Outcome

Met primary endpoint

paper At Week 12, ERN/LRPT+SIMVA was superior to ATORVA in decreasing LDL-C/HDL-C (primary endpoint) at each pre-specified dose comparison: PMID 22305632 ↗

registry analysis (superiority or other test); MK-0524B 2g/40mg vs Atorvastatin 40 mg; p <0.001; Difference in Least Squares Mean -5.1 (95% CI -8.1 to -2.1); ANCOVA NCT00289900 ↗

Publications

• Results Chen F, Maccubbin D, Yan L, Sirah W, Chen E, Sisk CM, Davidson M, Blomqvist P, McKenney JM. Lipid-altering efficacy and safety profile of co-administered extended release niacin/laropiprant and simvastatin versus atorvastatin in patients with mixed hyperlipidemia. Int J Cardiol. 2013 Jul 15;167(1):225-31. doi: 10.1016/j.ijcard.2011.12.103. Epub 2012 Feb 4.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Atorvastatin	Small molecule	10 mg	Oral
Comparator	Atorvastatin	Small molecule	20 mg	Oral
Comparator	Atorvastatin	Small molecule	40 mg	Oral
Comparator	Atorvastatin	Small molecule	80 mg	Oral
Subject	MK0524A	Unknown	2 g	—
Subject	Simvastatin	Small molecule	20 mg	—
Subject	Simvastatin	Small molecule	40 mg	—

Indications