drugset / Trial / NCT00289900

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

NCT00289900

Phase 3 Completed 2340 enrolled Merck Sharp & Dohme LLC
RandomizedParallel-groupDouble-blindTreatment

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

Drugs

EvaluationDrugModalityDoseRoute
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